COVID-19 Infection Provides Temporary Immunity, Though Not From Transmission, Says Study 15/01/2021 Raisa Santos COVID-19 immunity from previous infection does not guarantee people still won’t carry and transmit the virus Past COVID-19 infection may provide immunity for several months, but still leaves risk of transmission to others, a Public Health England (PHE) study has found. “This means even if you believe you already had the disease and are protected, you can be reassured it is highly unlikely you will develop severe infections but there is still a risk that you could acquire an infection and transmit to others,” said Professor Susan Hopkins, Senior Medical Advisor at PHE and study lead at SARS-CoV-2 Immunity and Infection EvaluatioN (SIREN). Since June, the PHE’s SIREN study has performed regular antibody and PCR testing on 20,787 healthcare workers, including frontline clinical staff and those in non-clinical roles. 6,614 of these participants tested positive for COVID-19 antibodies upon recruitment. Between 18 June to 24 November, there were 44 potential reinfections identified by the study, with 2 designated ‘probable’ and 42 ‘possible’ based on available evidence. If all 44 cases were confirmed, this would represent an 83% rate of protection from reinfection, though if only the 2 ‘probable’ reinfections were confirmed, the rate would be 99%. Further research is ongoing to clarify this range. The study found that antibody protection after infection lasts for at least 5 months, on average. Scientists are studying whether this protection may last for longer, but this means that many people who contracted the disease in the first wave of the pandemic may now be vulnerable to reinfection. Although those with antibodies have some temporary protection against COVID-19, some of these individuals carry high levels of the virus and could continue to transmit the virus to others. More Research Needed to Understand Effectiveness of Vaccines in Reducing Transmission In December, the UK identified a vriation of SARS-CoV-2 now known as VOC 202012/01 (Variant of Concern), but formerly referred to as VUI 202012/01 (Variant Under Investigation). Further work is underway to understand whether and to what extent antibodies also provide protection from this variant. The study will continue to follow participants for 12 months to explore how long any immunity may last and to what extent people with immunity are able to carry and transmit the virus. Peer reviewed Phase 3 clinical trial results for Moderna vaccine, published 30 December 2020 in the New England Journal of Medicine, have suggested that vaccination also reduced asymptomatic transmission by about two-thirds, in the case of Moderna’s mRNA-1273 vaccine, though the numbers examined were small. The duration of immunity and the amount of the virus reduced in those vaccinated still needs to be researched. SIREN data from the first report does not provide evidence towards antibody or immune responses from COVID-19 vaccines. Vaccine effectiveness will also be studied later this year by the PHE SIREN study. With cases at their highest level to date in the United Kingdom, the PHE advocates that everyone does their part to avoid the risk of transmitting to other people. Said Hopkins: “This study has given us the clearest picture to date of the nature of antibody protection against COVID-19 but it is critical people do not misunderstand these early findings.” “Now more than ever it is vital we all stay at home to protect our health service and save lives.” Image Credits: Yuri Samilov/Flickr. As WHO Team Finally Arrives In Wuhan To Investigate SARS-CoV2 Virus Origins – Two Members Left Behind In Singapore 14/01/2021 Madeleine Hoecklin A doctor preparing to administer a Sinopharm COVID-19 vaccine in China. After months of delay, a pared-down WHO research team charged with investigating the origins of the SARS-CoV2 virus finally arrived in China on Thursday – but two members of the team were left behind in Singapore after they tested positive for COVID-19 antibodies, WHO said. In the 24 hours since, one of these two members – a British scientist – has now been permitted to enter after reportedly testing negative on subsequent tests. The remaining team member – a scientist from Qatar – still tested positive, China’s Foreign Ministry confirmed. The remaining WHO team members flew directly to Wuhan, where the first clusters of SARS-CoV2 virus cases in humans first emerged just over a year ago, and were set to begin work with their Chinese colleagues remotely while they waited out a 14-day quarantine. A brief update on their activities was provided at the WHO press briefing on Friday, however, officials emphasized the independence the team will need to conduct their investigation. “What we need to do is let them do the work and carry that out and put the information that all of them are learning together into context,” said Maria Van Kerkhove, WHO COVID-19 Technical Lead. “Let’s let them follow the science and we’ll report when we can.” The team of scientists are “a wonderful group of people, and we trust that with the cooperation and the hospitality of the Chinese government and Chinese people and the authorities in Hubei and Wuhan, we will have a successful mission,” said Mike Ryan, WHO’s Executive Director of WHO’s Health Emergencies Programme, on Friday. The arrival of the team coincided with a domestic surge in COVID-19 cases in China, where some 22 million people were placed under lockdown after the nation recorded its highest one-day incidence of new COVID-19 cases since July. Outbreaks were concentrated in three cities of Hebei Province – a northern Chinse province near Beijing that was the site of the imperial summer residences of Qing-dynasty leaders. The WHO team investigating the origins of the COVID-19 pandemic arriving at the Wuhan Tianhe International Airport on Thursday. According to the WHO, the two members of team remaining in Singapore had tested positive on IgM antibody tests, which indicates that they may have a recent infection – even though other tests had been negative. The team members will undergo further testing, and WHO said it would provide an update on their status. During the Wuhan quarantine period, the team will work remotely with counterparts at the China CDC, health ministry, and research centers, whom they will also meet in person after two weeks. The experts will then visit sites and conduct research for the investigation. “The idea is to advance a number of studies that were already designed and decided upon months ago to get a better understanding of what happened last year in December,” said Peter Ben Embarak, expert on food safety and zoonosis at WHO and WHO coordinator of the expert team, in a WHO interview released on Wednesday. “[We] will be looking in more detail at the initial cases [and]…the famous market…trying to find out everything that went in and out of that market in the weeks ahead of the event.” Many, but not all, of the first cases were concentrated around the Wuhan Seafood Market, where wild animals were typically kept alive in pens, before being slaughtered for shoppers, in conditions that allowed viruses to fester and potentially infect humans. Even so, not all of the first SARS-CoV2 cases have been traced to the market. “It could be a very long journey before we get a full understanding of what happened,” he added. “I don’t think we will have clear answers after this initial mission, but we will be on the way and hopefully in the coming months, that will be completed by additional missions and additional studies.” In contrast to its actions two weeks ago, When China barred the mission’s entry at the last minute over alleged VISA issues, China’s National Health Commission said that the country was willing to cooperate with the investigation. But it highlighted what it said was a need for the hunt for the virus origins to be on a worldwide scale. “Origin-tracing of the novel coronavirus is a scientific matter, and should be conducted in cooperation [with] scientists across the world,” said Zhao Lijian, a Foreign Ministry spokesperson, in a press release. “With constantly intensified knowledge about the virus, and the discovery of more early cases, it is highly likely that origin-tracing will involve many places across the world, and the WHO will conduct similar inspections in other countries if needed.” Over the past few months, China’s state-controlled news channels have begun to construct an alternative narrative, claiming that the human infections with SARS-CoV2 may not have first originated in China at all – even though China is the place where the most genetically comparable strains of coronaviruses have been reported to be circulating in the wild, in bat populations in Hunnan province. Foreign journalists and researchers have been recently barred, however, from accessing those remote rural sites. There have meanwhile been months of delay, first in forming the 10-member team of international experts that was mandated by the World Health Assembly in May to conduct the investigation, followed by more delays in getting China’s agreement to permit the visit. The international team of 13 scientists examining the origins of the virus that causes #COVID19 arrived in Wuhan, #China, today. The experts will begin their work immediately during the 2 weeks quarantine protocol for international travelers. — World Health Organization (WHO) (@WHO) January 14, 2021 Surge of Cases in China Most of the new cases were reported in the cities of Shijiazhuang, Xingtai and Langfang – located in the province neighbouring Beijing. The outbreak is suspected to have arisen from a series of weddings and funerals. The National Health Commission of the People’s Republic of China reported its first COVID-19 death in eight months on Wednesday in Hebei province. According to state health agencies, no deaths have been reported on mainland China since May, however, the WHO has recorded 12 deaths so far in 2021 in the nation – a discrepancy that has not been explained by Chinese health officials. Authorities have implemented stringent restrictions and have stepped up screening and prevention measures. Bans on gatherings, outbound travel, school meetings, and the provincial Communist Party conference have been established and millions are under stay-at-home orders. Efforts to tackle the outbreaks have been swift, particularly as fears of the development of more clusters mount ahead of the week-long Lunar New Year holiday next month. Over 3,000 medical workers were mobilised to assist with a mass testing programme, which has tested more than 10 million people since early last week. A citywide testing programme in Langfang was begun on Tuesday, which plans to test 5 million people in three days, while residents in Shijiazhuang and Xingtai will go through a second round of mass testing, the National Health Commission announced on Wednesday. Concern about the outbreak is especially high, given its proximity to Beijing and the upcoming annual meetings of the national legislature and advisory conference. The Chinese Center for Disease Control and Prevention (CDC) published a press release last week, emphasising the need to “resolutely safeguard the safety of the capital,” trace the origins of the outbreak, and strictly control movement in the city. “Due to the special security needs of the capital and the flow of people and freight between Beijing and Hebei, [we must] heighten our sense of responsibility to reduce the risks of importing cases,” said the government of Tongzhou, a district in Beijing bordering two Hebei cities. China plans to continue with its goal of inoculating 50 million people prior to the Lunar New Year, when hundreds of millions are expected to travel. Over 9 million doses of the Sinopharm COVID-19 vaccine have been administered nationwide as of Monday, with the prioritisation of health care workers, workers handling imported cold-chain food, and high risk individuals. Officials have reassured the public that the outbreaks are under control, while also advising individuals to avoid public gatherings and travel ahead of and during the holiday. “I’m deeply confident that the epidemic spread in Shijiazhuang will be controlled within a month,” Zhang Wenhong, leader of the Shanghai team of experts responsible for the clinical management of COVID-19 cases, said in a press release. “Individuals should stay alert to the pandemic but there’s no need to be excessively nervous.” Image Credits: CGTN, 中国新闻网. Hundreds of Victims of Bhopal Gas Leak Tragedy Recruited To India’s Covaxin Clinical Trials – Civil Society Groups Say 14/01/2021 Menaka Rao DELHI, INDIA – In the last week of December 2020, Chanda Devi heard a truck roll into her neighborhood in North Bhopal, Central India. Residents were called outside by a voice, booming through loudspeakers. They were eligible to collect Rs 750 (about US$10) to receive a “corona vaccine”. The people said that they were recruiters, representing the People’s Hospital, Bhopal. “They told us that we can get the Corona vaccine now,” Devi, 60, said. “Later we may have to pay for it. They told us that if we take the vaccine we won’t get corona disease.” Devi, 60, sells costume jewellery house-to-house for a living, making about US$2-6 a day. She also lives in one of the areas worst affected by the 1984 Bhopal gas tragedy – widely regarded as the worst industrial disaster of modern times – whose impacts echoed around a globalizing world. The disaster took place on 3 December 1984, when about 45 tonnes of methyl isocyanate, an input in the manufacture of pesticides, leaked from the American-owned Union Carbide Corporation plant, exposing 500,000 of the city’s residents to the highly toxic gas. The leak killed nearly 4,000 people immediately and upwards of 20,000 people in subsequent years. Many of those who survived, like Devi who was 24 at the time, have continued to live in slums just behind the now-abandoned plant. Some have suffered from long-term disabilities, such as blindness and respiratory complications. Compounding those problems, the community was also exposed for decades to groundwater contamination from years of toxic waste dumping on the site. It was against this difficult background that Devi presented herself at the People’s Hospital, Bhopal, on December 19 2020, to take part in the randomised double-blinded Phase 3 trials for India’s leading domestically-created vaccine candidate, Covaxin, developed by the pharma company Bharat Biotech together with India’s National Institute of Virology. Devi, who is also illiterate, did not understand, however, that she was being recruited as a clinical trial participant. She was under the impression she was going to receive an already approved COVID-19 vaccine. Participant Death Adds To Questions About Clinical Trial Recruitment Process An estimated 700-800 vulnerable victims of the Bhopal gas tragedy have been recruited for the Covaxin trial since early December, allege community activists, like Rachna Dhingra, who work with gas leak victims. Questions were amplified when, in the last week of December, one trial participant – Deepak Marawi, a 45-year old daily wage labourer – died after receiving the first dose of Covaxin. The deceased Mawari was a participant at a trial site of People’s Hospital, Bhopal. He got his first dose on 12 December and died on 21 December. A postmortem has since suggested the death was unrelated to the clinical trial, but it has sparked alarm regardless. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 In a statement, Bharat Biotech said that “the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning”. It added: “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.” His family alleged that he was not followed up regularly after he received the dose. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 Ethical Questions Emerge Over Recruitment of Bhopal Community Members ‘Whose Health is Compromised’ Even so, the circumstances around Mawari’s death have raised broader ethical questions about Covaxin’s clinical trial process. Concerns are even greater since the Indian Health Ministry recently approved the Covaxin vaccine for restricted emergency use despite the fact that Phase 3 trials are not even concluded – in a process that was obscure and under terms that are still unclear. Following that approval, Covaxin is due to be administered to members of the broader public beginning 16 January, at the launch of India’s vaccination programme. Alongside Covaxin, the AstraZeneca vaccine, already approved by British regulators, is also due to begin rollout at the same time. On Sunday 10 January 2021, Devi and three other trial participants spoke about their clinical trial recruitment experiences during a virtual conference, organised with the support of a network of nonprofits that work with victims of the 1984 gas leak – and in which Health Policy Watch participated. The four participants said they were led to believe they were receiving the vaccine as a part of the government’s vaccination drive, and were not clearly told that they were taking part in a clinical trial. They were not provided with any informed consent forms to review and sign, alone or with a literate family member. Nor was their consent video-recorded, in the case of people like Devi who are illiterate. In other words, they said that they did not provide their informed consent. Despite being illiterate, Devi and other participants in the video conference said that they received sheaves of papers to record any symptoms they experience after they receive their dose – even though they would not know how to fill them out. On the same day that Marawi died, a group of NGOs wrote to both the Indian Prime Minister and Indian Health Minister, Narendra Modi and Dr Harsh Vardhan, to stop the trial and conduct a detailed inquiry into the incidents. “Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the letter stated. “This is leading to exploitation and harm to a community of people that are not just economically and socially deprived but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences.” In response, Bharat Biotech in a statement that the trials were conducted “in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organization to conduct our phase III clinical trials”. Trial Participants Include At Least 700-800 People From the Bhopal Communities Affected By the Gas Leak At least 700-800 people were recruited from the communities in the areas affected by the gas leak, and related groundwater contamination, said Rachna Dhingra, an activist who works with victims of the Bhopal gas tragedy, at the briefing. 3rd Phase #Covaxine trial taking place in Bhopal hasviolated every rule in d bookPoor & vulnerable residents of gasaffected communities r herded by d People's 🏥 with a promise of Rs750. No copy of informed consent is being given 2 d participants @CDSCO_INDIA_INF pic.twitter.com/dsb9u8L77T — Rachna Dhingra (@RachnaDhingra) January 3, 2021 “Almost all these communities drank contaminated ground water,” she notes. “There are persistent organic pollutants in the water. People here suffer from a range of health problems. Instead of paying attention to their problems, they have been used,” she said. “Most of the people living in this area have one phone between five people,” Dhingra said, speaking at the video conference. “The phone is only with the head of the family who is often out of the house during day time. If someone (from the hospital) has to follow up [with a participant] in these areas, they have to go to their homes.” Some Trial Participants Say They Fell Ill – But Had No Recourse Some of the trial participants who fell sick after being administered either the vaccine or a placebo, said that they had to seek treatment on their own, with their limited income. The day wage earners became stuck at home, unable to work. Twenty-six year-old Chotu Das Bairagi said that he was diagnosed with COVID-19 only a few days after receiving the first vaccine dose. “When I went to get treatment, they just prescribed some medicines. I was asked to buy them myself,” said Bairagi. Only after he posted a video about his illness, the hospital called him back and provided some treatment. “They did not know that it is their right to receive free treatment when they participate in a trial. Some of them are scared of going back to the hospital,” said Dhingra. While other participants said that they were told they were participating in a “trial”, they said that they did not really understand the meaning of the English word. And additionally, the Hindi poster published to recruit participants said that participating would be “beneficial”. “Why do you need to conduct a clinical trial if they know that the product is beneficial. Why were consent forms not given to them?” said Anant Bhan, a researcher in bioethics and global health in the video conference. “These are vulnerable populations. There are special provisions under the New Drugs and Clinical Trial Rules, 2019 and national ethical guidelines for clinical trials which say that the informed consent needs to be audio-visually recorded.” Dr Anil Dixit, the dean of the hospital conducting the trial said that the trial site had followed all the norms and said in a video statement: “The signed consent forms can be given to the participants if they wish. They are kept in the hospital usually.” Critics Attacked For ‘Sullying Name’ of India’s R&D Dhingra said that the stories about the participation of Bhopal gas victims in the Covaxin trial shed concerns on broader issues associated with the clinical trial process. “These people are saying that the adverse events they suffered were not recorded properly. They were not followed up regularly. Their data is not being recorded. How do we know about the efficacy of the vaccine?” she asked. In a tweeted response, People’s Hospital’s called the attempts to sully the trial “pathetic” and said that instead of applauding the Indian’ government’s endeavour in developing vaccines, some people are making “spurious comments to be in public attention.” W.r.t. . @RachnaDhingra's tweet- It’s pathetic, instead of applauding the GoI's endeavour for prevention of pandemic in development of suitable & potent vaccines & encouraging the medical colleges & healthcare workers people are making spurious comments to be in public attention! — People's University Bhopal (@Uni_Peoples) January 4, 2021 So far Ministry of Health regulators have not addressed the allegations around the Covaxin clinical trial processes in Bhopal. Nor has Bharat Biotech made any statement – beyond the one referring to the death of Marawi. That silence has added to the concerns around the transparency and safety of clinical trial processes – and with that, of the vaccine that is due to be rolled out at a much larger scale in just two days time. “By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month”, said Nousheen Khan of the Children Against Dow Carbide. African Union Secures 270 Million COVID-19 Vaccines – WHO Says Its Not Opposed To Deals Outside COVAX 14/01/2021 Paul Adepoju The Africa Union has secured an additional 270 million COVID-19 vaccine doses outside of WHO’s COVAX platform. At least 60% of the continent’s 1.2 billion population must be vaccinated to achieve population immunity. IBADAN, NIGERIA – So far the continent has been obliged to look on as developed countries vaccinate millions of their citizens against SARS-CoV-2, but now African countries may also soon gain access to COVID-19 vaccines. In a striking show of political unity, the African Union (AU) has secured provisional commitments to procure some 270 million COVID-19 vaccine doses for its 55 member states, and 50 million of those doses will be available before April 2021. Notably, the move was taken independently and outside of channels of international donor assistance. The doses which were secured by the African Vaccine Acquisition Task Team (AVATT), will be supplied by Pfizer, AstraZeneca (through an independent licensee, the Serum Institute of India) and Johnson & Johnson, whose vaccine is set to go before the United States Food and Drug Administration for approval later this month. AU Chair and the President of South Africa, Cyril Ramaphosa, disclosed in a statement that the secured doses are in addition to those the continent has been guaranteed through the WHO co-sponsored COVAX Facility. Dr Matshidiso Moeti, WHO Regional Director for Africa. COVAX — an initiative aiming to deliver vaccines to low- and middle-income countries, and co-led by Gavi, the Vaccine Alliance — has secured an estimated 600 million doses for the continent. The need to access vaccines outside of the COVAX framework has become apparent insofar as the limited supplies available would leave many Africans unprotected if the continent were to rely on the Facility alone, said Dr John Nkengasong, Director of the Africa Centers for Disease Control (Africa CDC). COVAX aims to procure and supply vaccines for about 20% of the population in countries that have joined the facility in 2021. “COVAX has said [it] will supply the continent with about 20% of our needs,” Nkengasong said during a press conference. “And our vaccine strategic plan states that we need to vaccinate at least 60% of the population of the continent of 1.2 billion to achieve population immunity.” “From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort,” Ramaphosa said. “We have held steadfastly to the principle that no country should be left behind. “With this in mind, we have not only campaigned vigorously for changes through all the available international forums, but we have taken the additional step to independently secure vaccines using our own limited resources as member states.” John Nkengasong, Director of the Africa CDC. WHO Not Opposed To Procurement Outside COVAX Framework Dr Matshidiso Moeti, WHO Regional Director for Africa told Health Policy Watch on Thursday that the Organization is not opposed to individual African countries securing their own doses outside of the COVAX arrangement. Moeti’s remarks directly contradicted those of WHO Director General Dr Tedros Adhanom Ghebreyesus at a WHO press conference last Friday, when the DG admonished countries not to make more deals outside of the COVAX framework. Her more positive reaction to the AU moves, likely reflect both an increasing realism about the limits of what COVAX can supply – as well as the fact that the AU is acting on behalf of a large bloc of states that have often been the last in line for new health innovations. According to Moeti, WHO encourages countries to try every opportunity to mobilize the additional resources outside of COVAX, and to secure additional supplies. “The important thing is to reach a coverage of the population that will then stop the circulation of the virus,” Moeti said. Warns Against Procuring Vaccines Lacking Regulatory Approval Data as of 8 January, prior to the African Union announcement, which would more than double the available doses But she also warned Africa’s WHO member states to refrain from ordering vaccines that have not been adequately tested in clinical trials. “These should be vaccines that have been looked at and data reviewed in terms of their efficacy and in terms of their safety.,” she told Health Policy Watch. “WHO is and will continue to license some vaccines for emergency use, as manufacturers share data” with the health body, she added. In fact, two of the three vaccines on the AU shopping list, Pfizer’s and AstraZeneca’s have already been approved already by United States, British and/or European regulatory authorities. And the J&J vaccine’s Phase 3 results are due to be published in about two weeks time, with the USFDA submission following shortly thereafter, according to a statement by the company on Wednesday. While Moeti did not mention specific vaccines to avoid, or countries, by name, The Seychelles is reportedly rolling out the Sinopharm vaccine produced by China, that has not undergone an independent and transparent review. In a related development, Brazil just reported that China’s CoronaVac vaccine had shown an efficacy rate of just over 50 percent in trials conducted there – meaning it barely passes the mark for efficacy. That was after Brazil had already pre-ordered some 380 million doses. Some other African countries also are reportedly considering purchases of Russia’s Sputnik vaccine, produced by the Gamalaya research institute. Phase 3 Clinical trial results on the Sputnik vaccine also have not yet been reported either in the peer-reviewed press, to WHO or to any national regulatory agency that undertakes a transparent review process. One recent report, published just before the AU announcement, noted that so far 21 African countries had ordered vaccines in bilateral deals, for a total 260 million doses. Some 35% of those orders involve AstraZeneca doses for 7 countries, 33% of the doses represent China’s Sinopharm vaccine orders by 4 African countries, and just 1% of total doses are being ordered from Russia, the report by Development Reimagined stated. “Overall, only 4 of the 21 have ordered enough to cover more than 20% of their population so far,” the report went on to say, noting this was not even considering “the other 34 African countries that have not made any orders as yet”. Putting the orders from Africa into global perspective Development Reimagined said orders from Africa account for only 3.4% of the global doses that have been ordered to date. Data as of 8 January, prior to the African Union announcement. AU Setes Up Vaccine Financing Plans With regards to accessing the bulk AU vaccine purchase, African countries across the continent can either use their own funds or obtain a five-year loan with the African Export-Import Bank (Afreximbank), to ensure African countries are not locked out of mass vaccination. “Afreximbank will, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to US$2 billion to the manufacturers on behalf of member states,” an AU statement read. According to the terms of the loan, repayment will be required by installments and over a period of five years. Additional funding arrangements have also been arranged by the AU and the World Bank so that AU member states will be able to access about US$5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank. Vaccine Plans Come As Second Wave Hits Africa Over the last four weeks, Africa CDC said the number of confirmed cases across the continent has increased by 8% but the outlook varies across the regions. In East Africa, despite the threats posed to the pandemic by the holiday season, cases dropped by 13%: a development that Nkenkasong described as “a good sign of hope”. But there was a 5% increase in Central Africa, 21% increase in West Africa and 31% increase in South Africa. In Northern Africa, at least, Africa CDC said the pandemic recorded no changes suggesting some stability in the region. Moeti noted the state of the pandemic suggests that there is a need to reinvigorate response at different levels, particularly at the individual and community levels. “We need to be looking for cases and contacts. We need to be testing and getting the results as fast as possible,” she said. “And we need to be more consistent about isolating and breaking the chain of infection from people who are infected so I do think we’ll go through a difficult month or so as we see the surge from the festive season.” Image Credits: NIAID, Africa CDC, Development reimagined , Development Reimagined . Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy 14/01/2021 Madeleine Hoecklin The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
As WHO Team Finally Arrives In Wuhan To Investigate SARS-CoV2 Virus Origins – Two Members Left Behind In Singapore 14/01/2021 Madeleine Hoecklin A doctor preparing to administer a Sinopharm COVID-19 vaccine in China. After months of delay, a pared-down WHO research team charged with investigating the origins of the SARS-CoV2 virus finally arrived in China on Thursday – but two members of the team were left behind in Singapore after they tested positive for COVID-19 antibodies, WHO said. In the 24 hours since, one of these two members – a British scientist – has now been permitted to enter after reportedly testing negative on subsequent tests. The remaining team member – a scientist from Qatar – still tested positive, China’s Foreign Ministry confirmed. The remaining WHO team members flew directly to Wuhan, where the first clusters of SARS-CoV2 virus cases in humans first emerged just over a year ago, and were set to begin work with their Chinese colleagues remotely while they waited out a 14-day quarantine. A brief update on their activities was provided at the WHO press briefing on Friday, however, officials emphasized the independence the team will need to conduct their investigation. “What we need to do is let them do the work and carry that out and put the information that all of them are learning together into context,” said Maria Van Kerkhove, WHO COVID-19 Technical Lead. “Let’s let them follow the science and we’ll report when we can.” The team of scientists are “a wonderful group of people, and we trust that with the cooperation and the hospitality of the Chinese government and Chinese people and the authorities in Hubei and Wuhan, we will have a successful mission,” said Mike Ryan, WHO’s Executive Director of WHO’s Health Emergencies Programme, on Friday. The arrival of the team coincided with a domestic surge in COVID-19 cases in China, where some 22 million people were placed under lockdown after the nation recorded its highest one-day incidence of new COVID-19 cases since July. Outbreaks were concentrated in three cities of Hebei Province – a northern Chinse province near Beijing that was the site of the imperial summer residences of Qing-dynasty leaders. The WHO team investigating the origins of the COVID-19 pandemic arriving at the Wuhan Tianhe International Airport on Thursday. According to the WHO, the two members of team remaining in Singapore had tested positive on IgM antibody tests, which indicates that they may have a recent infection – even though other tests had been negative. The team members will undergo further testing, and WHO said it would provide an update on their status. During the Wuhan quarantine period, the team will work remotely with counterparts at the China CDC, health ministry, and research centers, whom they will also meet in person after two weeks. The experts will then visit sites and conduct research for the investigation. “The idea is to advance a number of studies that were already designed and decided upon months ago to get a better understanding of what happened last year in December,” said Peter Ben Embarak, expert on food safety and zoonosis at WHO and WHO coordinator of the expert team, in a WHO interview released on Wednesday. “[We] will be looking in more detail at the initial cases [and]…the famous market…trying to find out everything that went in and out of that market in the weeks ahead of the event.” Many, but not all, of the first cases were concentrated around the Wuhan Seafood Market, where wild animals were typically kept alive in pens, before being slaughtered for shoppers, in conditions that allowed viruses to fester and potentially infect humans. Even so, not all of the first SARS-CoV2 cases have been traced to the market. “It could be a very long journey before we get a full understanding of what happened,” he added. “I don’t think we will have clear answers after this initial mission, but we will be on the way and hopefully in the coming months, that will be completed by additional missions and additional studies.” In contrast to its actions two weeks ago, When China barred the mission’s entry at the last minute over alleged VISA issues, China’s National Health Commission said that the country was willing to cooperate with the investigation. But it highlighted what it said was a need for the hunt for the virus origins to be on a worldwide scale. “Origin-tracing of the novel coronavirus is a scientific matter, and should be conducted in cooperation [with] scientists across the world,” said Zhao Lijian, a Foreign Ministry spokesperson, in a press release. “With constantly intensified knowledge about the virus, and the discovery of more early cases, it is highly likely that origin-tracing will involve many places across the world, and the WHO will conduct similar inspections in other countries if needed.” Over the past few months, China’s state-controlled news channels have begun to construct an alternative narrative, claiming that the human infections with SARS-CoV2 may not have first originated in China at all – even though China is the place where the most genetically comparable strains of coronaviruses have been reported to be circulating in the wild, in bat populations in Hunnan province. Foreign journalists and researchers have been recently barred, however, from accessing those remote rural sites. There have meanwhile been months of delay, first in forming the 10-member team of international experts that was mandated by the World Health Assembly in May to conduct the investigation, followed by more delays in getting China’s agreement to permit the visit. The international team of 13 scientists examining the origins of the virus that causes #COVID19 arrived in Wuhan, #China, today. The experts will begin their work immediately during the 2 weeks quarantine protocol for international travelers. — World Health Organization (WHO) (@WHO) January 14, 2021 Surge of Cases in China Most of the new cases were reported in the cities of Shijiazhuang, Xingtai and Langfang – located in the province neighbouring Beijing. The outbreak is suspected to have arisen from a series of weddings and funerals. The National Health Commission of the People’s Republic of China reported its first COVID-19 death in eight months on Wednesday in Hebei province. According to state health agencies, no deaths have been reported on mainland China since May, however, the WHO has recorded 12 deaths so far in 2021 in the nation – a discrepancy that has not been explained by Chinese health officials. Authorities have implemented stringent restrictions and have stepped up screening and prevention measures. Bans on gatherings, outbound travel, school meetings, and the provincial Communist Party conference have been established and millions are under stay-at-home orders. Efforts to tackle the outbreaks have been swift, particularly as fears of the development of more clusters mount ahead of the week-long Lunar New Year holiday next month. Over 3,000 medical workers were mobilised to assist with a mass testing programme, which has tested more than 10 million people since early last week. A citywide testing programme in Langfang was begun on Tuesday, which plans to test 5 million people in three days, while residents in Shijiazhuang and Xingtai will go through a second round of mass testing, the National Health Commission announced on Wednesday. Concern about the outbreak is especially high, given its proximity to Beijing and the upcoming annual meetings of the national legislature and advisory conference. The Chinese Center for Disease Control and Prevention (CDC) published a press release last week, emphasising the need to “resolutely safeguard the safety of the capital,” trace the origins of the outbreak, and strictly control movement in the city. “Due to the special security needs of the capital and the flow of people and freight between Beijing and Hebei, [we must] heighten our sense of responsibility to reduce the risks of importing cases,” said the government of Tongzhou, a district in Beijing bordering two Hebei cities. China plans to continue with its goal of inoculating 50 million people prior to the Lunar New Year, when hundreds of millions are expected to travel. Over 9 million doses of the Sinopharm COVID-19 vaccine have been administered nationwide as of Monday, with the prioritisation of health care workers, workers handling imported cold-chain food, and high risk individuals. Officials have reassured the public that the outbreaks are under control, while also advising individuals to avoid public gatherings and travel ahead of and during the holiday. “I’m deeply confident that the epidemic spread in Shijiazhuang will be controlled within a month,” Zhang Wenhong, leader of the Shanghai team of experts responsible for the clinical management of COVID-19 cases, said in a press release. “Individuals should stay alert to the pandemic but there’s no need to be excessively nervous.” Image Credits: CGTN, 中国新闻网. Hundreds of Victims of Bhopal Gas Leak Tragedy Recruited To India’s Covaxin Clinical Trials – Civil Society Groups Say 14/01/2021 Menaka Rao DELHI, INDIA – In the last week of December 2020, Chanda Devi heard a truck roll into her neighborhood in North Bhopal, Central India. Residents were called outside by a voice, booming through loudspeakers. They were eligible to collect Rs 750 (about US$10) to receive a “corona vaccine”. The people said that they were recruiters, representing the People’s Hospital, Bhopal. “They told us that we can get the Corona vaccine now,” Devi, 60, said. “Later we may have to pay for it. They told us that if we take the vaccine we won’t get corona disease.” Devi, 60, sells costume jewellery house-to-house for a living, making about US$2-6 a day. She also lives in one of the areas worst affected by the 1984 Bhopal gas tragedy – widely regarded as the worst industrial disaster of modern times – whose impacts echoed around a globalizing world. The disaster took place on 3 December 1984, when about 45 tonnes of methyl isocyanate, an input in the manufacture of pesticides, leaked from the American-owned Union Carbide Corporation plant, exposing 500,000 of the city’s residents to the highly toxic gas. The leak killed nearly 4,000 people immediately and upwards of 20,000 people in subsequent years. Many of those who survived, like Devi who was 24 at the time, have continued to live in slums just behind the now-abandoned plant. Some have suffered from long-term disabilities, such as blindness and respiratory complications. Compounding those problems, the community was also exposed for decades to groundwater contamination from years of toxic waste dumping on the site. It was against this difficult background that Devi presented herself at the People’s Hospital, Bhopal, on December 19 2020, to take part in the randomised double-blinded Phase 3 trials for India’s leading domestically-created vaccine candidate, Covaxin, developed by the pharma company Bharat Biotech together with India’s National Institute of Virology. Devi, who is also illiterate, did not understand, however, that she was being recruited as a clinical trial participant. She was under the impression she was going to receive an already approved COVID-19 vaccine. Participant Death Adds To Questions About Clinical Trial Recruitment Process An estimated 700-800 vulnerable victims of the Bhopal gas tragedy have been recruited for the Covaxin trial since early December, allege community activists, like Rachna Dhingra, who work with gas leak victims. Questions were amplified when, in the last week of December, one trial participant – Deepak Marawi, a 45-year old daily wage labourer – died after receiving the first dose of Covaxin. The deceased Mawari was a participant at a trial site of People’s Hospital, Bhopal. He got his first dose on 12 December and died on 21 December. A postmortem has since suggested the death was unrelated to the clinical trial, but it has sparked alarm regardless. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 In a statement, Bharat Biotech said that “the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning”. It added: “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.” His family alleged that he was not followed up regularly after he received the dose. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 Ethical Questions Emerge Over Recruitment of Bhopal Community Members ‘Whose Health is Compromised’ Even so, the circumstances around Mawari’s death have raised broader ethical questions about Covaxin’s clinical trial process. Concerns are even greater since the Indian Health Ministry recently approved the Covaxin vaccine for restricted emergency use despite the fact that Phase 3 trials are not even concluded – in a process that was obscure and under terms that are still unclear. Following that approval, Covaxin is due to be administered to members of the broader public beginning 16 January, at the launch of India’s vaccination programme. Alongside Covaxin, the AstraZeneca vaccine, already approved by British regulators, is also due to begin rollout at the same time. On Sunday 10 January 2021, Devi and three other trial participants spoke about their clinical trial recruitment experiences during a virtual conference, organised with the support of a network of nonprofits that work with victims of the 1984 gas leak – and in which Health Policy Watch participated. The four participants said they were led to believe they were receiving the vaccine as a part of the government’s vaccination drive, and were not clearly told that they were taking part in a clinical trial. They were not provided with any informed consent forms to review and sign, alone or with a literate family member. Nor was their consent video-recorded, in the case of people like Devi who are illiterate. In other words, they said that they did not provide their informed consent. Despite being illiterate, Devi and other participants in the video conference said that they received sheaves of papers to record any symptoms they experience after they receive their dose – even though they would not know how to fill them out. On the same day that Marawi died, a group of NGOs wrote to both the Indian Prime Minister and Indian Health Minister, Narendra Modi and Dr Harsh Vardhan, to stop the trial and conduct a detailed inquiry into the incidents. “Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the letter stated. “This is leading to exploitation and harm to a community of people that are not just economically and socially deprived but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences.” In response, Bharat Biotech in a statement that the trials were conducted “in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organization to conduct our phase III clinical trials”. Trial Participants Include At Least 700-800 People From the Bhopal Communities Affected By the Gas Leak At least 700-800 people were recruited from the communities in the areas affected by the gas leak, and related groundwater contamination, said Rachna Dhingra, an activist who works with victims of the Bhopal gas tragedy, at the briefing. 3rd Phase #Covaxine trial taking place in Bhopal hasviolated every rule in d bookPoor & vulnerable residents of gasaffected communities r herded by d People's 🏥 with a promise of Rs750. No copy of informed consent is being given 2 d participants @CDSCO_INDIA_INF pic.twitter.com/dsb9u8L77T — Rachna Dhingra (@RachnaDhingra) January 3, 2021 “Almost all these communities drank contaminated ground water,” she notes. “There are persistent organic pollutants in the water. People here suffer from a range of health problems. Instead of paying attention to their problems, they have been used,” she said. “Most of the people living in this area have one phone between five people,” Dhingra said, speaking at the video conference. “The phone is only with the head of the family who is often out of the house during day time. If someone (from the hospital) has to follow up [with a participant] in these areas, they have to go to their homes.” Some Trial Participants Say They Fell Ill – But Had No Recourse Some of the trial participants who fell sick after being administered either the vaccine or a placebo, said that they had to seek treatment on their own, with their limited income. The day wage earners became stuck at home, unable to work. Twenty-six year-old Chotu Das Bairagi said that he was diagnosed with COVID-19 only a few days after receiving the first vaccine dose. “When I went to get treatment, they just prescribed some medicines. I was asked to buy them myself,” said Bairagi. Only after he posted a video about his illness, the hospital called him back and provided some treatment. “They did not know that it is their right to receive free treatment when they participate in a trial. Some of them are scared of going back to the hospital,” said Dhingra. While other participants said that they were told they were participating in a “trial”, they said that they did not really understand the meaning of the English word. And additionally, the Hindi poster published to recruit participants said that participating would be “beneficial”. “Why do you need to conduct a clinical trial if they know that the product is beneficial. Why were consent forms not given to them?” said Anant Bhan, a researcher in bioethics and global health in the video conference. “These are vulnerable populations. There are special provisions under the New Drugs and Clinical Trial Rules, 2019 and national ethical guidelines for clinical trials which say that the informed consent needs to be audio-visually recorded.” Dr Anil Dixit, the dean of the hospital conducting the trial said that the trial site had followed all the norms and said in a video statement: “The signed consent forms can be given to the participants if they wish. They are kept in the hospital usually.” Critics Attacked For ‘Sullying Name’ of India’s R&D Dhingra said that the stories about the participation of Bhopal gas victims in the Covaxin trial shed concerns on broader issues associated with the clinical trial process. “These people are saying that the adverse events they suffered were not recorded properly. They were not followed up regularly. Their data is not being recorded. How do we know about the efficacy of the vaccine?” she asked. In a tweeted response, People’s Hospital’s called the attempts to sully the trial “pathetic” and said that instead of applauding the Indian’ government’s endeavour in developing vaccines, some people are making “spurious comments to be in public attention.” W.r.t. . @RachnaDhingra's tweet- It’s pathetic, instead of applauding the GoI's endeavour for prevention of pandemic in development of suitable & potent vaccines & encouraging the medical colleges & healthcare workers people are making spurious comments to be in public attention! — People's University Bhopal (@Uni_Peoples) January 4, 2021 So far Ministry of Health regulators have not addressed the allegations around the Covaxin clinical trial processes in Bhopal. Nor has Bharat Biotech made any statement – beyond the one referring to the death of Marawi. That silence has added to the concerns around the transparency and safety of clinical trial processes – and with that, of the vaccine that is due to be rolled out at a much larger scale in just two days time. “By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month”, said Nousheen Khan of the Children Against Dow Carbide. African Union Secures 270 Million COVID-19 Vaccines – WHO Says Its Not Opposed To Deals Outside COVAX 14/01/2021 Paul Adepoju The Africa Union has secured an additional 270 million COVID-19 vaccine doses outside of WHO’s COVAX platform. At least 60% of the continent’s 1.2 billion population must be vaccinated to achieve population immunity. IBADAN, NIGERIA – So far the continent has been obliged to look on as developed countries vaccinate millions of their citizens against SARS-CoV-2, but now African countries may also soon gain access to COVID-19 vaccines. In a striking show of political unity, the African Union (AU) has secured provisional commitments to procure some 270 million COVID-19 vaccine doses for its 55 member states, and 50 million of those doses will be available before April 2021. Notably, the move was taken independently and outside of channels of international donor assistance. The doses which were secured by the African Vaccine Acquisition Task Team (AVATT), will be supplied by Pfizer, AstraZeneca (through an independent licensee, the Serum Institute of India) and Johnson & Johnson, whose vaccine is set to go before the United States Food and Drug Administration for approval later this month. AU Chair and the President of South Africa, Cyril Ramaphosa, disclosed in a statement that the secured doses are in addition to those the continent has been guaranteed through the WHO co-sponsored COVAX Facility. Dr Matshidiso Moeti, WHO Regional Director for Africa. COVAX — an initiative aiming to deliver vaccines to low- and middle-income countries, and co-led by Gavi, the Vaccine Alliance — has secured an estimated 600 million doses for the continent. The need to access vaccines outside of the COVAX framework has become apparent insofar as the limited supplies available would leave many Africans unprotected if the continent were to rely on the Facility alone, said Dr John Nkengasong, Director of the Africa Centers for Disease Control (Africa CDC). COVAX aims to procure and supply vaccines for about 20% of the population in countries that have joined the facility in 2021. “COVAX has said [it] will supply the continent with about 20% of our needs,” Nkengasong said during a press conference. “And our vaccine strategic plan states that we need to vaccinate at least 60% of the population of the continent of 1.2 billion to achieve population immunity.” “From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort,” Ramaphosa said. “We have held steadfastly to the principle that no country should be left behind. “With this in mind, we have not only campaigned vigorously for changes through all the available international forums, but we have taken the additional step to independently secure vaccines using our own limited resources as member states.” John Nkengasong, Director of the Africa CDC. WHO Not Opposed To Procurement Outside COVAX Framework Dr Matshidiso Moeti, WHO Regional Director for Africa told Health Policy Watch on Thursday that the Organization is not opposed to individual African countries securing their own doses outside of the COVAX arrangement. Moeti’s remarks directly contradicted those of WHO Director General Dr Tedros Adhanom Ghebreyesus at a WHO press conference last Friday, when the DG admonished countries not to make more deals outside of the COVAX framework. Her more positive reaction to the AU moves, likely reflect both an increasing realism about the limits of what COVAX can supply – as well as the fact that the AU is acting on behalf of a large bloc of states that have often been the last in line for new health innovations. According to Moeti, WHO encourages countries to try every opportunity to mobilize the additional resources outside of COVAX, and to secure additional supplies. “The important thing is to reach a coverage of the population that will then stop the circulation of the virus,” Moeti said. Warns Against Procuring Vaccines Lacking Regulatory Approval Data as of 8 January, prior to the African Union announcement, which would more than double the available doses But she also warned Africa’s WHO member states to refrain from ordering vaccines that have not been adequately tested in clinical trials. “These should be vaccines that have been looked at and data reviewed in terms of their efficacy and in terms of their safety.,” she told Health Policy Watch. “WHO is and will continue to license some vaccines for emergency use, as manufacturers share data” with the health body, she added. In fact, two of the three vaccines on the AU shopping list, Pfizer’s and AstraZeneca’s have already been approved already by United States, British and/or European regulatory authorities. And the J&J vaccine’s Phase 3 results are due to be published in about two weeks time, with the USFDA submission following shortly thereafter, according to a statement by the company on Wednesday. While Moeti did not mention specific vaccines to avoid, or countries, by name, The Seychelles is reportedly rolling out the Sinopharm vaccine produced by China, that has not undergone an independent and transparent review. In a related development, Brazil just reported that China’s CoronaVac vaccine had shown an efficacy rate of just over 50 percent in trials conducted there – meaning it barely passes the mark for efficacy. That was after Brazil had already pre-ordered some 380 million doses. Some other African countries also are reportedly considering purchases of Russia’s Sputnik vaccine, produced by the Gamalaya research institute. Phase 3 Clinical trial results on the Sputnik vaccine also have not yet been reported either in the peer-reviewed press, to WHO or to any national regulatory agency that undertakes a transparent review process. One recent report, published just before the AU announcement, noted that so far 21 African countries had ordered vaccines in bilateral deals, for a total 260 million doses. Some 35% of those orders involve AstraZeneca doses for 7 countries, 33% of the doses represent China’s Sinopharm vaccine orders by 4 African countries, and just 1% of total doses are being ordered from Russia, the report by Development Reimagined stated. “Overall, only 4 of the 21 have ordered enough to cover more than 20% of their population so far,” the report went on to say, noting this was not even considering “the other 34 African countries that have not made any orders as yet”. Putting the orders from Africa into global perspective Development Reimagined said orders from Africa account for only 3.4% of the global doses that have been ordered to date. Data as of 8 January, prior to the African Union announcement. AU Setes Up Vaccine Financing Plans With regards to accessing the bulk AU vaccine purchase, African countries across the continent can either use their own funds or obtain a five-year loan with the African Export-Import Bank (Afreximbank), to ensure African countries are not locked out of mass vaccination. “Afreximbank will, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to US$2 billion to the manufacturers on behalf of member states,” an AU statement read. According to the terms of the loan, repayment will be required by installments and over a period of five years. Additional funding arrangements have also been arranged by the AU and the World Bank so that AU member states will be able to access about US$5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank. Vaccine Plans Come As Second Wave Hits Africa Over the last four weeks, Africa CDC said the number of confirmed cases across the continent has increased by 8% but the outlook varies across the regions. In East Africa, despite the threats posed to the pandemic by the holiday season, cases dropped by 13%: a development that Nkenkasong described as “a good sign of hope”. But there was a 5% increase in Central Africa, 21% increase in West Africa and 31% increase in South Africa. In Northern Africa, at least, Africa CDC said the pandemic recorded no changes suggesting some stability in the region. Moeti noted the state of the pandemic suggests that there is a need to reinvigorate response at different levels, particularly at the individual and community levels. “We need to be looking for cases and contacts. We need to be testing and getting the results as fast as possible,” she said. “And we need to be more consistent about isolating and breaking the chain of infection from people who are infected so I do think we’ll go through a difficult month or so as we see the surge from the festive season.” Image Credits: NIAID, Africa CDC, Development reimagined , Development Reimagined . Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy 14/01/2021 Madeleine Hoecklin The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Hundreds of Victims of Bhopal Gas Leak Tragedy Recruited To India’s Covaxin Clinical Trials – Civil Society Groups Say 14/01/2021 Menaka Rao DELHI, INDIA – In the last week of December 2020, Chanda Devi heard a truck roll into her neighborhood in North Bhopal, Central India. Residents were called outside by a voice, booming through loudspeakers. They were eligible to collect Rs 750 (about US$10) to receive a “corona vaccine”. The people said that they were recruiters, representing the People’s Hospital, Bhopal. “They told us that we can get the Corona vaccine now,” Devi, 60, said. “Later we may have to pay for it. They told us that if we take the vaccine we won’t get corona disease.” Devi, 60, sells costume jewellery house-to-house for a living, making about US$2-6 a day. She also lives in one of the areas worst affected by the 1984 Bhopal gas tragedy – widely regarded as the worst industrial disaster of modern times – whose impacts echoed around a globalizing world. The disaster took place on 3 December 1984, when about 45 tonnes of methyl isocyanate, an input in the manufacture of pesticides, leaked from the American-owned Union Carbide Corporation plant, exposing 500,000 of the city’s residents to the highly toxic gas. The leak killed nearly 4,000 people immediately and upwards of 20,000 people in subsequent years. Many of those who survived, like Devi who was 24 at the time, have continued to live in slums just behind the now-abandoned plant. Some have suffered from long-term disabilities, such as blindness and respiratory complications. Compounding those problems, the community was also exposed for decades to groundwater contamination from years of toxic waste dumping on the site. It was against this difficult background that Devi presented herself at the People’s Hospital, Bhopal, on December 19 2020, to take part in the randomised double-blinded Phase 3 trials for India’s leading domestically-created vaccine candidate, Covaxin, developed by the pharma company Bharat Biotech together with India’s National Institute of Virology. Devi, who is also illiterate, did not understand, however, that she was being recruited as a clinical trial participant. She was under the impression she was going to receive an already approved COVID-19 vaccine. Participant Death Adds To Questions About Clinical Trial Recruitment Process An estimated 700-800 vulnerable victims of the Bhopal gas tragedy have been recruited for the Covaxin trial since early December, allege community activists, like Rachna Dhingra, who work with gas leak victims. Questions were amplified when, in the last week of December, one trial participant – Deepak Marawi, a 45-year old daily wage labourer – died after receiving the first dose of Covaxin. The deceased Mawari was a participant at a trial site of People’s Hospital, Bhopal. He got his first dose on 12 December and died on 21 December. A postmortem has since suggested the death was unrelated to the clinical trial, but it has sparked alarm regardless. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 In a statement, Bharat Biotech said that “the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning”. It added: “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.” His family alleged that he was not followed up regularly after he received the dose. Deepak Meravi died on 21 Dec after enrolling Ind Covaxin trial at People's 🏥. The ethics Committee of this 🏥 has not even once reached out to d family to explain his cause of death. Isn't it d responsibility of ethics committee to safeguard d Intrest of trial participants. https://t.co/geRSBQNpjG pic.twitter.com/pWNT1LOwu9 — Rachna Dhingra (@RachnaDhingra) January 9, 2021 Ethical Questions Emerge Over Recruitment of Bhopal Community Members ‘Whose Health is Compromised’ Even so, the circumstances around Mawari’s death have raised broader ethical questions about Covaxin’s clinical trial process. Concerns are even greater since the Indian Health Ministry recently approved the Covaxin vaccine for restricted emergency use despite the fact that Phase 3 trials are not even concluded – in a process that was obscure and under terms that are still unclear. Following that approval, Covaxin is due to be administered to members of the broader public beginning 16 January, at the launch of India’s vaccination programme. Alongside Covaxin, the AstraZeneca vaccine, already approved by British regulators, is also due to begin rollout at the same time. On Sunday 10 January 2021, Devi and three other trial participants spoke about their clinical trial recruitment experiences during a virtual conference, organised with the support of a network of nonprofits that work with victims of the 1984 gas leak – and in which Health Policy Watch participated. The four participants said they were led to believe they were receiving the vaccine as a part of the government’s vaccination drive, and were not clearly told that they were taking part in a clinical trial. They were not provided with any informed consent forms to review and sign, alone or with a literate family member. Nor was their consent video-recorded, in the case of people like Devi who are illiterate. In other words, they said that they did not provide their informed consent. Despite being illiterate, Devi and other participants in the video conference said that they received sheaves of papers to record any symptoms they experience after they receive their dose – even though they would not know how to fill them out. On the same day that Marawi died, a group of NGOs wrote to both the Indian Prime Minister and Indian Health Minister, Narendra Modi and Dr Harsh Vardhan, to stop the trial and conduct a detailed inquiry into the incidents. “Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the letter stated. “This is leading to exploitation and harm to a community of people that are not just economically and socially deprived but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences.” In response, Bharat Biotech in a statement that the trials were conducted “in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organization to conduct our phase III clinical trials”. Trial Participants Include At Least 700-800 People From the Bhopal Communities Affected By the Gas Leak At least 700-800 people were recruited from the communities in the areas affected by the gas leak, and related groundwater contamination, said Rachna Dhingra, an activist who works with victims of the Bhopal gas tragedy, at the briefing. 3rd Phase #Covaxine trial taking place in Bhopal hasviolated every rule in d bookPoor & vulnerable residents of gasaffected communities r herded by d People's 🏥 with a promise of Rs750. No copy of informed consent is being given 2 d participants @CDSCO_INDIA_INF pic.twitter.com/dsb9u8L77T — Rachna Dhingra (@RachnaDhingra) January 3, 2021 “Almost all these communities drank contaminated ground water,” she notes. “There are persistent organic pollutants in the water. People here suffer from a range of health problems. Instead of paying attention to their problems, they have been used,” she said. “Most of the people living in this area have one phone between five people,” Dhingra said, speaking at the video conference. “The phone is only with the head of the family who is often out of the house during day time. If someone (from the hospital) has to follow up [with a participant] in these areas, they have to go to their homes.” Some Trial Participants Say They Fell Ill – But Had No Recourse Some of the trial participants who fell sick after being administered either the vaccine or a placebo, said that they had to seek treatment on their own, with their limited income. The day wage earners became stuck at home, unable to work. Twenty-six year-old Chotu Das Bairagi said that he was diagnosed with COVID-19 only a few days after receiving the first vaccine dose. “When I went to get treatment, they just prescribed some medicines. I was asked to buy them myself,” said Bairagi. Only after he posted a video about his illness, the hospital called him back and provided some treatment. “They did not know that it is their right to receive free treatment when they participate in a trial. Some of them are scared of going back to the hospital,” said Dhingra. While other participants said that they were told they were participating in a “trial”, they said that they did not really understand the meaning of the English word. And additionally, the Hindi poster published to recruit participants said that participating would be “beneficial”. “Why do you need to conduct a clinical trial if they know that the product is beneficial. Why were consent forms not given to them?” said Anant Bhan, a researcher in bioethics and global health in the video conference. “These are vulnerable populations. There are special provisions under the New Drugs and Clinical Trial Rules, 2019 and national ethical guidelines for clinical trials which say that the informed consent needs to be audio-visually recorded.” Dr Anil Dixit, the dean of the hospital conducting the trial said that the trial site had followed all the norms and said in a video statement: “The signed consent forms can be given to the participants if they wish. They are kept in the hospital usually.” Critics Attacked For ‘Sullying Name’ of India’s R&D Dhingra said that the stories about the participation of Bhopal gas victims in the Covaxin trial shed concerns on broader issues associated with the clinical trial process. “These people are saying that the adverse events they suffered were not recorded properly. They were not followed up regularly. Their data is not being recorded. How do we know about the efficacy of the vaccine?” she asked. In a tweeted response, People’s Hospital’s called the attempts to sully the trial “pathetic” and said that instead of applauding the Indian’ government’s endeavour in developing vaccines, some people are making “spurious comments to be in public attention.” W.r.t. . @RachnaDhingra's tweet- It’s pathetic, instead of applauding the GoI's endeavour for prevention of pandemic in development of suitable & potent vaccines & encouraging the medical colleges & healthcare workers people are making spurious comments to be in public attention! — People's University Bhopal (@Uni_Peoples) January 4, 2021 So far Ministry of Health regulators have not addressed the allegations around the Covaxin clinical trial processes in Bhopal. Nor has Bharat Biotech made any statement – beyond the one referring to the death of Marawi. That silence has added to the concerns around the transparency and safety of clinical trial processes – and with that, of the vaccine that is due to be rolled out at a much larger scale in just two days time. “By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month”, said Nousheen Khan of the Children Against Dow Carbide. African Union Secures 270 Million COVID-19 Vaccines – WHO Says Its Not Opposed To Deals Outside COVAX 14/01/2021 Paul Adepoju The Africa Union has secured an additional 270 million COVID-19 vaccine doses outside of WHO’s COVAX platform. At least 60% of the continent’s 1.2 billion population must be vaccinated to achieve population immunity. IBADAN, NIGERIA – So far the continent has been obliged to look on as developed countries vaccinate millions of their citizens against SARS-CoV-2, but now African countries may also soon gain access to COVID-19 vaccines. In a striking show of political unity, the African Union (AU) has secured provisional commitments to procure some 270 million COVID-19 vaccine doses for its 55 member states, and 50 million of those doses will be available before April 2021. Notably, the move was taken independently and outside of channels of international donor assistance. The doses which were secured by the African Vaccine Acquisition Task Team (AVATT), will be supplied by Pfizer, AstraZeneca (through an independent licensee, the Serum Institute of India) and Johnson & Johnson, whose vaccine is set to go before the United States Food and Drug Administration for approval later this month. AU Chair and the President of South Africa, Cyril Ramaphosa, disclosed in a statement that the secured doses are in addition to those the continent has been guaranteed through the WHO co-sponsored COVAX Facility. Dr Matshidiso Moeti, WHO Regional Director for Africa. COVAX — an initiative aiming to deliver vaccines to low- and middle-income countries, and co-led by Gavi, the Vaccine Alliance — has secured an estimated 600 million doses for the continent. The need to access vaccines outside of the COVAX framework has become apparent insofar as the limited supplies available would leave many Africans unprotected if the continent were to rely on the Facility alone, said Dr John Nkengasong, Director of the Africa Centers for Disease Control (Africa CDC). COVAX aims to procure and supply vaccines for about 20% of the population in countries that have joined the facility in 2021. “COVAX has said [it] will supply the continent with about 20% of our needs,” Nkengasong said during a press conference. “And our vaccine strategic plan states that we need to vaccinate at least 60% of the population of the continent of 1.2 billion to achieve population immunity.” “From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort,” Ramaphosa said. “We have held steadfastly to the principle that no country should be left behind. “With this in mind, we have not only campaigned vigorously for changes through all the available international forums, but we have taken the additional step to independently secure vaccines using our own limited resources as member states.” John Nkengasong, Director of the Africa CDC. WHO Not Opposed To Procurement Outside COVAX Framework Dr Matshidiso Moeti, WHO Regional Director for Africa told Health Policy Watch on Thursday that the Organization is not opposed to individual African countries securing their own doses outside of the COVAX arrangement. Moeti’s remarks directly contradicted those of WHO Director General Dr Tedros Adhanom Ghebreyesus at a WHO press conference last Friday, when the DG admonished countries not to make more deals outside of the COVAX framework. Her more positive reaction to the AU moves, likely reflect both an increasing realism about the limits of what COVAX can supply – as well as the fact that the AU is acting on behalf of a large bloc of states that have often been the last in line for new health innovations. According to Moeti, WHO encourages countries to try every opportunity to mobilize the additional resources outside of COVAX, and to secure additional supplies. “The important thing is to reach a coverage of the population that will then stop the circulation of the virus,” Moeti said. Warns Against Procuring Vaccines Lacking Regulatory Approval Data as of 8 January, prior to the African Union announcement, which would more than double the available doses But she also warned Africa’s WHO member states to refrain from ordering vaccines that have not been adequately tested in clinical trials. “These should be vaccines that have been looked at and data reviewed in terms of their efficacy and in terms of their safety.,” she told Health Policy Watch. “WHO is and will continue to license some vaccines for emergency use, as manufacturers share data” with the health body, she added. In fact, two of the three vaccines on the AU shopping list, Pfizer’s and AstraZeneca’s have already been approved already by United States, British and/or European regulatory authorities. And the J&J vaccine’s Phase 3 results are due to be published in about two weeks time, with the USFDA submission following shortly thereafter, according to a statement by the company on Wednesday. While Moeti did not mention specific vaccines to avoid, or countries, by name, The Seychelles is reportedly rolling out the Sinopharm vaccine produced by China, that has not undergone an independent and transparent review. In a related development, Brazil just reported that China’s CoronaVac vaccine had shown an efficacy rate of just over 50 percent in trials conducted there – meaning it barely passes the mark for efficacy. That was after Brazil had already pre-ordered some 380 million doses. Some other African countries also are reportedly considering purchases of Russia’s Sputnik vaccine, produced by the Gamalaya research institute. Phase 3 Clinical trial results on the Sputnik vaccine also have not yet been reported either in the peer-reviewed press, to WHO or to any national regulatory agency that undertakes a transparent review process. One recent report, published just before the AU announcement, noted that so far 21 African countries had ordered vaccines in bilateral deals, for a total 260 million doses. Some 35% of those orders involve AstraZeneca doses for 7 countries, 33% of the doses represent China’s Sinopharm vaccine orders by 4 African countries, and just 1% of total doses are being ordered from Russia, the report by Development Reimagined stated. “Overall, only 4 of the 21 have ordered enough to cover more than 20% of their population so far,” the report went on to say, noting this was not even considering “the other 34 African countries that have not made any orders as yet”. Putting the orders from Africa into global perspective Development Reimagined said orders from Africa account for only 3.4% of the global doses that have been ordered to date. Data as of 8 January, prior to the African Union announcement. AU Setes Up Vaccine Financing Plans With regards to accessing the bulk AU vaccine purchase, African countries across the continent can either use their own funds or obtain a five-year loan with the African Export-Import Bank (Afreximbank), to ensure African countries are not locked out of mass vaccination. “Afreximbank will, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to US$2 billion to the manufacturers on behalf of member states,” an AU statement read. According to the terms of the loan, repayment will be required by installments and over a period of five years. Additional funding arrangements have also been arranged by the AU and the World Bank so that AU member states will be able to access about US$5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank. Vaccine Plans Come As Second Wave Hits Africa Over the last four weeks, Africa CDC said the number of confirmed cases across the continent has increased by 8% but the outlook varies across the regions. In East Africa, despite the threats posed to the pandemic by the holiday season, cases dropped by 13%: a development that Nkenkasong described as “a good sign of hope”. But there was a 5% increase in Central Africa, 21% increase in West Africa and 31% increase in South Africa. In Northern Africa, at least, Africa CDC said the pandemic recorded no changes suggesting some stability in the region. Moeti noted the state of the pandemic suggests that there is a need to reinvigorate response at different levels, particularly at the individual and community levels. “We need to be looking for cases and contacts. We need to be testing and getting the results as fast as possible,” she said. “And we need to be more consistent about isolating and breaking the chain of infection from people who are infected so I do think we’ll go through a difficult month or so as we see the surge from the festive season.” Image Credits: NIAID, Africa CDC, Development reimagined , Development Reimagined . Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy 14/01/2021 Madeleine Hoecklin The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
African Union Secures 270 Million COVID-19 Vaccines – WHO Says Its Not Opposed To Deals Outside COVAX 14/01/2021 Paul Adepoju The Africa Union has secured an additional 270 million COVID-19 vaccine doses outside of WHO’s COVAX platform. At least 60% of the continent’s 1.2 billion population must be vaccinated to achieve population immunity. IBADAN, NIGERIA – So far the continent has been obliged to look on as developed countries vaccinate millions of their citizens against SARS-CoV-2, but now African countries may also soon gain access to COVID-19 vaccines. In a striking show of political unity, the African Union (AU) has secured provisional commitments to procure some 270 million COVID-19 vaccine doses for its 55 member states, and 50 million of those doses will be available before April 2021. Notably, the move was taken independently and outside of channels of international donor assistance. The doses which were secured by the African Vaccine Acquisition Task Team (AVATT), will be supplied by Pfizer, AstraZeneca (through an independent licensee, the Serum Institute of India) and Johnson & Johnson, whose vaccine is set to go before the United States Food and Drug Administration for approval later this month. AU Chair and the President of South Africa, Cyril Ramaphosa, disclosed in a statement that the secured doses are in addition to those the continent has been guaranteed through the WHO co-sponsored COVAX Facility. Dr Matshidiso Moeti, WHO Regional Director for Africa. COVAX — an initiative aiming to deliver vaccines to low- and middle-income countries, and co-led by Gavi, the Vaccine Alliance — has secured an estimated 600 million doses for the continent. The need to access vaccines outside of the COVAX framework has become apparent insofar as the limited supplies available would leave many Africans unprotected if the continent were to rely on the Facility alone, said Dr John Nkengasong, Director of the Africa Centers for Disease Control (Africa CDC). COVAX aims to procure and supply vaccines for about 20% of the population in countries that have joined the facility in 2021. “COVAX has said [it] will supply the continent with about 20% of our needs,” Nkengasong said during a press conference. “And our vaccine strategic plan states that we need to vaccinate at least 60% of the population of the continent of 1.2 billion to achieve population immunity.” “From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort,” Ramaphosa said. “We have held steadfastly to the principle that no country should be left behind. “With this in mind, we have not only campaigned vigorously for changes through all the available international forums, but we have taken the additional step to independently secure vaccines using our own limited resources as member states.” John Nkengasong, Director of the Africa CDC. WHO Not Opposed To Procurement Outside COVAX Framework Dr Matshidiso Moeti, WHO Regional Director for Africa told Health Policy Watch on Thursday that the Organization is not opposed to individual African countries securing their own doses outside of the COVAX arrangement. Moeti’s remarks directly contradicted those of WHO Director General Dr Tedros Adhanom Ghebreyesus at a WHO press conference last Friday, when the DG admonished countries not to make more deals outside of the COVAX framework. Her more positive reaction to the AU moves, likely reflect both an increasing realism about the limits of what COVAX can supply – as well as the fact that the AU is acting on behalf of a large bloc of states that have often been the last in line for new health innovations. According to Moeti, WHO encourages countries to try every opportunity to mobilize the additional resources outside of COVAX, and to secure additional supplies. “The important thing is to reach a coverage of the population that will then stop the circulation of the virus,” Moeti said. Warns Against Procuring Vaccines Lacking Regulatory Approval Data as of 8 January, prior to the African Union announcement, which would more than double the available doses But she also warned Africa’s WHO member states to refrain from ordering vaccines that have not been adequately tested in clinical trials. “These should be vaccines that have been looked at and data reviewed in terms of their efficacy and in terms of their safety.,” she told Health Policy Watch. “WHO is and will continue to license some vaccines for emergency use, as manufacturers share data” with the health body, she added. In fact, two of the three vaccines on the AU shopping list, Pfizer’s and AstraZeneca’s have already been approved already by United States, British and/or European regulatory authorities. And the J&J vaccine’s Phase 3 results are due to be published in about two weeks time, with the USFDA submission following shortly thereafter, according to a statement by the company on Wednesday. While Moeti did not mention specific vaccines to avoid, or countries, by name, The Seychelles is reportedly rolling out the Sinopharm vaccine produced by China, that has not undergone an independent and transparent review. In a related development, Brazil just reported that China’s CoronaVac vaccine had shown an efficacy rate of just over 50 percent in trials conducted there – meaning it barely passes the mark for efficacy. That was after Brazil had already pre-ordered some 380 million doses. Some other African countries also are reportedly considering purchases of Russia’s Sputnik vaccine, produced by the Gamalaya research institute. Phase 3 Clinical trial results on the Sputnik vaccine also have not yet been reported either in the peer-reviewed press, to WHO or to any national regulatory agency that undertakes a transparent review process. One recent report, published just before the AU announcement, noted that so far 21 African countries had ordered vaccines in bilateral deals, for a total 260 million doses. Some 35% of those orders involve AstraZeneca doses for 7 countries, 33% of the doses represent China’s Sinopharm vaccine orders by 4 African countries, and just 1% of total doses are being ordered from Russia, the report by Development Reimagined stated. “Overall, only 4 of the 21 have ordered enough to cover more than 20% of their population so far,” the report went on to say, noting this was not even considering “the other 34 African countries that have not made any orders as yet”. Putting the orders from Africa into global perspective Development Reimagined said orders from Africa account for only 3.4% of the global doses that have been ordered to date. Data as of 8 January, prior to the African Union announcement. AU Setes Up Vaccine Financing Plans With regards to accessing the bulk AU vaccine purchase, African countries across the continent can either use their own funds or obtain a five-year loan with the African Export-Import Bank (Afreximbank), to ensure African countries are not locked out of mass vaccination. “Afreximbank will, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to US$2 billion to the manufacturers on behalf of member states,” an AU statement read. According to the terms of the loan, repayment will be required by installments and over a period of five years. Additional funding arrangements have also been arranged by the AU and the World Bank so that AU member states will be able to access about US$5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank. Vaccine Plans Come As Second Wave Hits Africa Over the last four weeks, Africa CDC said the number of confirmed cases across the continent has increased by 8% but the outlook varies across the regions. In East Africa, despite the threats posed to the pandemic by the holiday season, cases dropped by 13%: a development that Nkenkasong described as “a good sign of hope”. But there was a 5% increase in Central Africa, 21% increase in West Africa and 31% increase in South Africa. In Northern Africa, at least, Africa CDC said the pandemic recorded no changes suggesting some stability in the region. Moeti noted the state of the pandemic suggests that there is a need to reinvigorate response at different levels, particularly at the individual and community levels. “We need to be looking for cases and contacts. We need to be testing and getting the results as fast as possible,” she said. “And we need to be more consistent about isolating and breaking the chain of infection from people who are infected so I do think we’ll go through a difficult month or so as we see the surge from the festive season.” Image Credits: NIAID, Africa CDC, Development reimagined , Development Reimagined . Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy 14/01/2021 Madeleine Hoecklin The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy 14/01/2021 Madeleine Hoecklin The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Israel As Global Guinea Pig – Data On Initial COVID-19 Vaccines Encouraging – But Infections Still Surging 13/01/2021 Elaine Ruth Fletcher Waiting after the jab at Tel Aviv’s mobile vaccine station operating in a large city partk to ensure no adverse reactions. Strict criteria but no coddling. JERUSALEM – Racing ahead in a relentless vaccine campaign that has made it a global leader, Israel has now administered an initial COVID-19 jab to nearly 2 million people – about 20% of its population, including 70% of people over the age of 60. And it is set to have some 5.2 million people completely vaccinated by mid- or late-March – after obtaining a commitment from Pfizer to rush millions more doses of its vaccine to the country this month – in exchange for fresh data on vaccine safety and efficacy from a country that is becoming the world’s largest live vaccine laboratory. Israel sets out a timeline to immunize 5.2 million people – more than 60% of its population, by late March – with intensive media coverage. While smaller in size than Los Angeles County, Israel’s population is ethnically highly diverse and has long been a popular place for medical research. Its largest communities of Middle Eastern Jews and Palestinian Arabs hail from the immediate region. But there are also huge populations of recent or distant immigrants from Europe and the Americas, as well as Asia and Africa. So researchers and policymakers elsewhere are also watching to see if the vaccines can really work their magic – in a place that also has been haunted by one of the highest rates of new SARS-CoV2 infections in the world. Initial results coming out have good news and bad – suggesting that vaccine efficacy is high just two weeks after the first dose. But the data also suggests that a very high rate of overall immunization may be required to halt and reverse infection trends. Until that can happen, the reopening of schools and cultural activities will be cautious and staged, authorities warn. Continued adherence to social distancing guidance along with other restrictions on social gatherings, travel and economies may still remain sad facts of life for some time to come. And along with that, equity issues are in stark display here. Most of Israel’s 5 million Palestinian neighbors have had almost no access to the COVID vaccines. The exceptions have been the Palestinian residents of Israeli-controlled East Jerusalem who hold official Israeli residency and thus also belong to Israeli health funds. As a first-world country mixing daily with lower-income Palestinians, who live in a patchwork of West Bank areas controlled to varying degrees by the Israel military and the Palestinian Authority, as well as in Hamas-controlled Gaza, Israel may also have to learn the hard way that as per the maxim of WHO Director General Dr Tedros Adhanom Ghebreyesus: “no one is safe until everyone is safe.” 60% Reduction in Infections 13 Days After First Pfizer Dose – As Real World Results Begin To Emerge Looking forward, Israel appears set to maintain very high pace of vaccinations – administering between 100,000 and 200,000 doses daily – after clinching a deal with Pfizer for the expedited delivery of millions more doses from now through March. While that deal was ostensibly secured in exchange for an agreement on data-sharing, in fact, Israeli researchers are already beginning to crunch the numbers on the vaccine campaign independently. And initial findings reflect both hope and challenges that lay ahead. On the hopeful side – a review of disease incidence among the first 460,000 Israelis over the age of 60 to receive the first dose of the Pfizer vaccine showed that infection rates among those getting the jab had dropped by 60% 13 days after receipt of the first dose. That research, conducted by the Maccabee Health Fund’s KSM Research Center, suggests that there is a strong protective quality even to the first vaccine – among older, and higher-risk groups. Another broader Israeli Ministry of Health analysis of data from all four national health funds that are managing the large-scale vaccine campaign yielded similar results – a decline of some 50% in SARS-CoV2 infections, two weeks after the first dose was received. One initial study of over 460,000 Israelis by researchers at Maccabee Health Fund showed a 60% decline in reported COVID infections, 13 days after receiving a first vaccine dose. At the same time, Israel is still seeing record rates of new infections daily – with over 9,600 newly reported cases on Wednesday. And among the most serious 1,000 COVID cases in intensive care, some 180 are people who had already received one vaccine dose, according to Israel’s Health Ministry. This reflects the fact that one dose on it’s own cannot guarantee protection from serious COVID disease – particularly if you were exposed to the SARS-CoV2 virus before you were immunized or shortly thereafter. “In the competition between the vaccines and the disease, the disease is still winning,” observed former Israeli Director General Moshe Bar Siman-Tov, speaking on Israeli television Tuesday evening. He said he had been ‘optimistic’ about the vigour of the vaccine drive, but was more cautious now. “On the one hand, the Health Funds, which have been around for about 100 years, are performing extremely well – you reserve an appointment, you come and get the vaccine. On the other hand, we have the rising rate of infections among young people and children, who were not supposed to be vaccinated at all.” Israel’s ‘Secret’ Formula – Universal Health Coverage Simply Media hype has accompanied the vaccines of politicians and celebrities – in this case a well-known TV reporter, Moshe Nussbaum who had a blood analysis on camera to examine levels of SARS-CoV2 antibodies between the first and second dose – in his case still low. If anything, Israel’s success in the vaccine rollout is based on key principles of Universal Health Coverage (UHC), anchored in community-based, primary health care systems, which the World Health Organization has been preaching about for years and aspires to extend to most countries by 2030. A sophisticated management of medical records and data has also been key – along with a ready available pharma capacity to support cold chain management. More specifically: Public health funds are leading the drive. Every Israeli resident must belong to one of four public health funds. While these funds are heavily subsidized – people also get to choose which fund to join – and a small monthly membership fee is deducted from the paychecks of people who are employed. While highly centralized – the four health funds are also deeply rooted in communities with primary health care branches. Every community has at least one clinic. Large towns and cities having multiple branches of all of the funds. The community-based system has enabled the creation of multiple vaccine distribution points – which are local enough to be accessible. Central management has enabled huge efficiencies of scale. In larger cities, health funds and some hospitals have also set up vaccine stations in gyms, arenas, hospitals and public parks – ensuring ample space to receive and vaccinate large numbers of people everyday. Digitalization of all Israeli medical records means that people can sign up to be vaccinated online, and their ID will immediately show if they are eligible (in terms of age), allowing them to book a slot. There is no need for a consultation – although people can of course turn to their health care providers first before they are vaccinated – most make a decision on their own to roll up their sleeves. Quick-turn around is prioritized over personalized services – at vaccine delivery points, people simply read and sign an information form about potential allergic conditions before the jab – and then wait in a large room for 30 minutes after the vaccine to ensure there are no adverse reaction afterwards. Supply chain and distribution logistics support from a large and experienced pharma firm – in this case Teva Pharmaceuticals – Israel’s generics pharma manufacturer. The support has helped ensure the superfreeze conditions required by the Pfizer vaccine to point of delivery. The involvement underlines a broader point on the importance of fostering domestic pharma industries to maintain healthy product supply chains. This is an issue that is gaining more recognition as a global health issue, and which WHO member states plan to discuss in more detail at next week’s bi-annual meeting of the WHO Executive Board, the organization’s key governing body. Vaccine Eligbility – Strict Criteria with Some Flexibility Just-vaccinated – Client walks out of a Maccabee Health Fund’s night station in Jerusalem after getting her first dose. Stations are operating 12 hours a day. In terms of the thorny question of vaccine eligibility – strict criteria have been established – beginning with vaccinations for people aged 60+ and health care workers. But flexibility is proving to be an advantage – both in terms of efficiencies and vaccine acceptance. For instance, Israelis who don’t meet the age limit have still been able to get vaccinated simply by hanging out at the vaccine stations at the end of the 12-hour day. The spontaneous vaccination of drop-ins when there are lulls or cancellations have helped boost vaccine acceptance in Israeli ultra-orthodox and Israeli Arab communities, where vaccine turnout was initially low – but a stream of younger vaccine wannabes have helped inspire turnout among older people in the same community. Along with older people, health workers and chronically ill people, Israeli teachers are now being prioritized in an effort to get children back to school as quickly as possible. As the immunization drive for teachers began, however, the vaccine age limit for others eligible was also dropped to 50. “This makes good use of the vaccines available,” said the head of one Israeli health fund, Meuchedet (United). “Teachers are a limited group and they will come in spurts, so we don’t want to be wasting time or doses meanwhile.” Other countries are now looking at the Israeli model. In the United States, decisions by some states to begin expanding the eligibility criteria for vaccination were taken after informal consultations with Israel’s Minister of Health Yuli Edelstein about what that might mean. Edelstein has been sharing insights and advice with his European counterparts, where vaccine campaigns got off to a much slower start. Israelis are also watching Europe and pondering why the pace there has been slower – in health systems that are widely admired as a kind of global gold standard. Explained Gabi Barbash, a former Ministry of Health director general as well as hospital director, and now a popular TV commentator on the virus and vaccine rollout: “More of Europe’s systems are based around private doctors’ offices – these aren’t as well equipped to receive and handle the vaccines,” explaining that such fragmentation also makes rollout more challenging. In addition, each Israeli health fund maintains a centralized medical data registry on every patient that is enrolled. That makes it comparatively easier to register people for vaccines, harder for people that don’t qualify to cut the line – and it also facilitates rapid assessment of vaccine results and trends in real-time. Some factors are clearly beyond the control of any government, however – including geography and weather. Israel is tiny and its population is small – particularly in comparison to the vast spaces and populations of Europe and the Americas where campaigns are advancing much more slowly. Most of the northern hemisphere (where most of the vaccine rollouts are taking place in the world’s richest countries) is also wrapped in winter. That has included snowstorms seen in places like Spain. In comparison, weather in the eastern Mediterranean region has been particularly dry and mild; some of Israel’s vaccine stations have even been set up outdoors in under huge tents. Success is Not Guaranteed – Virus Variants & Geopolitics New Covid cases per million people; the United States still leads the way, but United Kingdom, much of Europe and Israel are not far behind. But even this massive vaccine drive, and gratifying public response, is still no guarantor of success. And this, experts say, illustrates how vaccines alone are not going to be a panacea for the COVID-19 pandemic. Nearly a week after declaring a strict lockdown, Israel was still seeing rising levels of new COVID-19 cases – reaching record highs. With new virus variants that were first identified in Great Britain and South Africa now surfacing here, as they have in Europe, Africa, Asia and the Americas, the country is also set to become a test case of whether the vaccine can hold against a wide range of new SARS-CoV2 mutations. Of particular concern are the mutations from the virus that may change the protein structures of the characteristic coronavirus ‘spike’ that could allow the virus to elude the vaccine. Those variants are now being closely monitored to see how widespread they become in the general population – and the extent to which they do or do not infect people who have been vaccinated. But one thing is becoming clear, and that is vaccinating older people may no longer be enough – thanks to the emergence of new and more infectious variants – that also infect younger people more widely. With the new mutations in play, vaccine rates would need to approach 80% or 90% to reach herd immunity, rather than the 70% of previous estimates, some researchers in Israel as well as in the United States are saying. “I was more optimistic, now I am a little more concerned,” said Bar Siman-Tov in his TV interview, who says that he is seeing “more symptomatic infections among younger people and children.” To halt the spread of those mutations, Israel may need to vaccinate almost everyone right down to the age of 16, the minimum allowed for the vaccine, said Eran Nir-Paz, a professor of infectious diseases at Jerusalem’s Hadassah Medical Center, in an interview on Tuesday with Israel public radio. “We will want to immunize 80% of the population to stop mutations and illness in younger groups – and if we don’t immunize the younger groups, the virus will eventually rebound on older people again,” he warned. Palestinians – No Vaccine Access Yet Palestinian Authority Health Minister Mai al-Kaila (WAFA) In addition, even if 80% of Israelis are immunized, their next door neighbors, Palestinians in the occupied West Bank and Hamas-controlled Gaza, have not yet even begun to vaccinate – with questions still circling around how and when the Palestinian Authority (PA) will access vaccine supplies. On Monday, PA Health Minister Mai al-Kaila announced that the PA had authorized use of the Russian Sputnik vaccine produced by the Gamalaya Institute, along with that of the UK-approved Oxford University/AstraZeneca vaccine. All in all, she said that deals with three pharma firms to cover some 70% of Palestinians with vaccines had been signed. But she also threw cold water on reports that vaccines being procured by the PA from AstraZeneca – which is among the three COVID vaccines recently approved by the British regulatory authority – could arrive as early as 15 February. “There is not yet a definite deadline for the arrival of the coronavirus vaccine, although it is probable that they will arrive in the first quarter of this year,” al-Kaila said in a press relesase, Israeli and Palestinian human rights groups have meanwhile asserted that Israel has a legal obligation to ensure Palestinian vaccine access – under the Geneva Conventions that call for an occupying power to ensure the health and well-being of people living in occupied territories. However, Israel has claimed that the 1995 Oslo II Accord delegates the Palestinian Authority with responsibility for health care – even if Israel’s military controls large swathes of the West Bank. The PA, keen to project its image as a national authority, has also not formally requested Israeli support. In fact, up until the pandemic, the PA had always imported its own vaccines for routine childhood immunizations – often via large procurement deals with UNICEF and other global health bodies. However, the Oslo treaty also obligates the two sides to “cooperate” in fighting epidemics – and that’s what many people say is now needed in the vaccine drive. Israel says it has indeed cooperated in providing PPE and training to the PA. But mass vaccinations would require a whole new level of coordination – which also opens up thorny issues of Palestinian access to health services more generally. Palestinian Access to Health Services a Longstanding Issue Current Israeli limitations on Palestinian movement around the West Bank – as well as into East Jerusalem, where more specialized Palestinian health services are located – have long been a barrier. Even more problematic is access in and out of the Hamas-controlled Gaza, under a longstanding Israeli military blockade, which Israel in turn says is needed to reduce the frequency of Hamas missile and military attacks. “Israel might also be afraid that offering Palestinians vaccines might imply that it is taking a responsibility that would extend to other health services later on,” speculated one leading human rights advocate. According to one report, about 100 vaccines have indeed been shipped to the PA for their highest-risk health workers – although that has been denied by both sides. In addition to the wider issue, there is also an appeal to Israel’s Supreme Court to get the government to vaccinate some 4,000 Palestinian prisoners who are being held in Israeli jails. Those vaccinations have been mandated by Israel’s attorney general – but the hardline Minister of Internal Security, Amir Ohana, has refused to implement the order. Another Supreme Court appeal, by the family of a missing Israeli soldier whose body is reportedly being held by Hamas authorities in Gaza, aims to bar Israel from facilitating Gazans’ access to vaccines at all until the soldier’s body is returned. Particularly with regards to Gaza, the appeal illustrates how deeply entangled vaccine access may become in geopolitical issues. “A big problem is the optics,” one source told Health Policy Watch, underlining how quickly the issue can become politicized by both sides. “Israel has been so successful with its vaccine programme and the Palestinians are left behind.” No One is Safe Until Everyone Is Safe – WHO Attempting to Mediate Vaccines per 100,000 people – leading countries At the same time, some leading Israeli physicians and even some senior Ministry of Health officials have said that medical ethics and equity factors mean that Israel should help ensure and facilitate broad Palestinian vaccine access. Boaz Lev, a Ministry of Health official in charge of setting criteria for Israelis to access vaccines, told Health Policy Watch that, “while I don’t represent the government’s position in that respect, if you ask me as a physician, then I think that people should be vaccinated. It’s very important for Israel and for the Palestinians to be vaccinated. Period.” “Equitable access to vaccines is an issue everywhere – but here it is something very immediate,” said Gerald Rockenschaub, who heads up the WHO Office in Jerusalem for Occupied Palestinian territory – West Bank and Gaza, in an interview with Health Policy Watch. “What we are trying to do is to advocate for Israel to consider to closely collaborate with the Palestinians to facilitate vaccine availability on the Palestinian side, both for pubilc health and equity reasons. We obviously are in close consultations with both regional offices and with headquarters.” He said that WHO had spoken recently with Israeli official sources about shifting some of the vaccines that Israel is receiving to Palestinian hospitals where front-line health workers are also facing high levels of COVID-19 infections and risks. “The initial feedback was that they are looking into it, but it requires some further discussion, also on their side,” Rockenshaub said. However, he added that “the discussions were before these new [Pfizer vaccine] supplies became available – we will also need to engage other levels of the Organization to facilitate the dialogue with the Israelis.” Image Credits: Israel Television N12 . Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Global Ebola Vaccine Stockpile Created By WHO, UNICEF & Partners 12/01/2021 Editorial team Establishing a global Ebola vaccine stockpile will prevent future outbreaks NEW YORK/ GENEVA. The World Health Organization, UNICEF and two leading international health and humanitarian civil society organizations announced on Tuesday the establishment of a global Ebola vaccine stockpile to ensure rapid response to future outbreaks. Establishment of the stockpile was led by the International Coordinating Group (ICG) on Vaccine Provision, which also includes the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF). It has received financial support from Gavi, the Vaccine Alliance. The stockpile will allow countries, with the support of humanitarian organizations, to contain future Ebola epidemics by ensuring timely access to vaccines for populations at risk during outbreaks. The injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration as well as in eight African countries. Before receiving regulatory approval, the vaccine was administered to more than 350,000 people, beginning in Guinea at the end of the 2013-2016 Ebola outbreak in West Africa and then later in the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo under a protocol for “compassionate use”. The vaccine, which is recommended by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of outbreak response tools, protects against the Zaire ebolavirus species which is the strain of the virus that has been most commonly implicated in large outbreaks. Example of Solidarity Infectious diseases such as malaria have been made preventable with vaccines “The COVID-19 pandemic is reminding us of the incredible power of vaccines to save lives from deadly viruses,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement that accompanied the announcement of the vaccine stockpile. “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.” UNICEF is managing the stockpile on behalf of the ICG which, as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release. The stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a request from a country; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision. The targeted overall delivery time from the stockpile to countries is seven days. “We are proud to be part of this unprecedented effort to help bring potential Ebola outbreaks quickly under control,” said Henrietta Fore, UNICEF Executive Director. “We know that when it comes to disease outbreaks, preparedness is key. This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible.” As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine. Vaccines are only secured through the establishment of the stockpile and are available in limited quantities. The Ebola vaccine is reserved for outbreak response to protect people at the highest risk of contracting Ebola – including healthcare and frontline workers. “This is an important milestone. Over the past decade alone we have seen Ebola devastate communities in West and Central Africa, always hitting the poorest and most vulnerable the hardest,” said IFRC Secretary General, Jagan Chapagain. “Through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.” “The creation of an Ebola vaccine stockpile under the ICG is a positive step”, said Dr Natalie Roberts, Programme Manager, MSF Foundation. “Vaccination is one of the most effective measures to respond to outbreaks of vaccine preventable diseases, and Ebola is no exception. An Ebola vaccine stockpile can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed, something MSF has called for during recent outbreaks in the Democratic Republic of Congo.” An initial 6,890 doses are now available for outbreak response with further quantities to be delivered into the stockpile this month and throughout 2021 and beyond. Depending on the rate of vaccine deployment, it could take 2 to 3 years to reach the SAGE-recommended level of 500,000 doses for the emergency stockpile of Ebola vaccines. WHO, UNICEF, Gavi and vaccine manufacturers are continuously assessing options to increase vaccine supply should global demand increase. Image Credits: Trocaire/Flickr, Asian Development Bank/Flickr. WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO Has ‘Outsourced’ Its Role On Vaccine Access – Civil Society Groups Claim 12/01/2021 Kerry Cullinan WHO has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI and CEPI. The World Health Organization (WHO) has “outsourced” its role in vaccine access and sidelined member states by leaving the running of the COVAX vaccine procurement facility to GAVI, The Vaccine Alliance and CEPI (Coalition for Epidemic Preparedness Initiative), Third World Network’s Sangeeta Shashikant told a civil society forum on Tuesday. “Disparity in access is the ugly reality of COVID-19 right now. This is getting a lot of attention because you can see some countries are getting vaccines but most of the countries are not,” Shashikant told a meeting of the G2H2 Geneva Global Health Hub, a network of civil society organizations that is convening virtually this week to discuss how to influence discussions at the upcoming WHO’s Executive Board meeting, WHO’s 33-member governing body, next week. Shashikant proposed that WHO be lobbied to adopt four interventions to ensure that vaccines are developed as a public good, namely: Securing legal commitments from manufacturers that they will reserve a proportion of their supplies for developing countries, Promote vaccine manufacturing in developing countries. Showing strong support for a World Trade Organization “TRIPS waiver” proposal, aimed at suspending aspects of intellectual property rights related to COVID health products during the pandemic, Promoting more transparency, particularly in reporting about the details of COVAX deals with vaccine manufacturers as well as voluntary license agreements between vaccine manufacturers and production companies, “AstraZeneca has reportedly signed licensing agreements with several manufacturers around the world, including the Serum Institute of India for one billion doses to supply low and middle-income countries. But one billion doses is never sufficient to address the need of developing countries,” Shashikant said. Researcher and activist Els Torreele “So why have they only licensed Serum Institute? This is what we refer to as limited and restrictive licensing. In the case of Pfizer and Moderna, there is no licensing. “For the big pharmaceutical industry, it’s really business as usual, as they limit competition artificially, limiting supply because they are not offering global licences.” Shashikant added that WHO “has also played a peripheral role in this whole setup of the COVAX facility”, where “decisions have primarily been taken by GAVI and its board and WHO member states are not involved in any kind of decision making”. “The reality is that the developed countries are all relying on bilateral deals for supply. They say they’re part of COVAX, but they have all pre-booked vaccine supply for themselves outside of COVAX. There have been a lot of different issues of transparency, accountability and even scepticism about whether this facility will deliver. Researcher and activist Els Torreele asked why, “when the US National Institutes of Health and Oxford University were the actual innovators using public money, we have agreements that transfer all of that work to Moderna and AstraZeneca?” “How can we create a more participative, inclusive governance scheme where the ownership and the control of the vaccine is distributed among the different actors?” WHO should Consider Human Rights Factors On Monday, civil society organisations called for WHO to ensure that human rights considerations are part of any pandemic preparedness and response in the wake of widespread state abuse of citizens during the pandemic. Cristina Palabay of the Karapatan Alliance in the Philippines reported that over 100,000 people had been imprisoned for “quarantine violations”. “Many experienced physical violence including torture such as being placed in dog cages, being tied and left in the heat of the sun, hit with police batons, or placed in coffins to supposedly teach them a lesson,” said Palabay. People in compulsory quarantine in Nepal, Bangladesh, India and Malaysia were kept in poor conditions, with reports of rapes and suicide and food shortages, particularly in Nepal, according to Richa Chinton of Jan Swasthya Abhiyan (People’s Health Movement India). Workers who violated curfews by a few minutes in India were dealt with harshly, and wages were cut or not paid as trading hours were curtailed, she added. School closures meant many children didn’t get food and exposed children to abuse, while there has been an increase in gender-based violence. In Kenya, Christine Ajulu of the Health Rights Advocacy Forum said that mandatory quarantine “appeared to be a punishment”. “If you’re found roaming out during the curfew hours, you are forced on quarantine. If you are found without a mask, you’re forced to quarantine. .The facilities were not up to standard and we have cases where lack of water was reported inadequate food was reported.” During lockdowns, Israel has closed its borders with the Palestinian Authority, further restricting travel between the two regions, and around 80% of the workforce was affected, according to Ubai Al-Aboudi from the Bitan Centre for Research and Development in Palestine. Israel has also refused Palestinians access to the COVID-19 vaccine, including around 4000 Palestinian prisoners being held in Israeli jails. A group of Israeli and Palestinian human rights organizations have appealed to Israel’s Supreme Court demanding that the Palestinian prisoners, who are living in crowded conditions that put them at high risk of infection, be provided with access to the vaccines now being distributed en masse in Israel – in line with a decision by Israel’s Attorney General. That is a decision that Israel’s hardline Minister of Public Security, Amir Ohana, has so far refused to carry out. “With the review of the International Health Regulations (IHR) in the context of COVID-19, WHO has the opportunity to strengthen human rights considerations in pandemic preparedness and response, but we have not seen this matter addressed,” according to the G2H2 hub. “The Covid-19 response requires more immediate action from WHO. The precedent of ignoring human rights abuses in the name of public health is a dangerous one, that should not be allowed to go unchallenged.” Image Credits: Flickr – Mecklenburg County, United Nations Photo. Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Rapid Increase In COVID Cases ‘Not Due To The Variant’, WHO Says 12/01/2021 J Hacker Shoppers gathered in malls in Geneva, Switzerland after restaurants and stores reopened on 6 June. WHO officials said that changing mixing patterns over the summer, into the fall and over the holidays has directly impacted the current spikes around the world. The “almost vertical” spike in SARS-CoV-2 infections seen in many countries over the last few weeks is largely due to increased social contact and not virus mutations, WHO has said. Speaking at a media briefing on Monday, Dr Maria Van Kerkhove, WHO’s COVID-19 Technical Lead, stated that sharp increases in transmission had occurred in a number of countries “before these variants were circulating”, adding that this “was due to increased mixing of people”. Countries currently being overwhelmed with COVID cases include the United Kingdom, the United States, Israel and Ireland. Yesterday, the latter recorded 1,288 cases per million people, while the UK and US recorded 854 and 751 respectively. “We changed our mixing patterns over the summer, into the fall and especially around the Christmas and holiday period,” Dr Van Kerkhove added. “The number of contacts that individuals and their families had increased significantly over the Christmas and New Year holiday. That’s had a direct impact on the exponential growth in many countries.” She highlighted that, when plotted on a line graph (as below), the rising case rates appear vertical for some countries. “[It’s] not at a slant, it’s almost vertical,” she repeated. Daily new confirmed COVID-19 cases per million people, as of 12 January 2020. Dr Maria Van Kerkhove highlighted the “almost vertical” increase. Variants Are Not The Drivers Of Transmission Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, pointed to Ireland to illustrate exactly how case rates have been impacted by poor adherence to social distancing measures. On 10 December, Ireland had recorded just 282 new daily cases; that was in comparison to more than 6,500 new cases on 10 January. “[Ireland] has suffered one of the most acute disease incidents of any country in the world over the last couple of months, and not due to the variant let me add,” he said,” but mainly due to increased social mixing and reduction of physical distancing.” Over the past few weeks, authorities in the UK, as well as elsewhere in Europe and the world have suggested that the emergence of new mutations, such as those identified in the UK and South Africa in December and in Japan last week, have been the cause of the current spikes being seen in infections. British Prime Minister Boris Johnson insisted that its regional-lockdown tier system “[was] working with the old variant but alas this mutation, spreading with frightening speed and ease, has led to more cases than we’ve seen ever before”. Johnson made this claim on 6 January, as he announced England would be returning to a full lockdown – its third national tightening – until at least March. Ryan’s warning appears, then, to serve as a reminder that these restrictions are now vital in countries which “lost control” of the virus in the second half of 2020. “The national reference laboratory [in Ireland is] doing superb surveillance for the new variant strains which they are tracking,” Dr Ryan added. “They have not been the driver of new transmission, but new variants will emerge.” “Those countries that have managed to bring transmission down: keep it down. Do everything you can to keep it down,” Van kerkhove added. “If any clusters are identified, really quick, rapid, aggressive investigation of those cases [are needed], so that those small numbers of cases do not become community transmission. We have been shown over and over again that countries can do this.” Image Credits: S. Lustig Vijay/HP-Watch, Our World in Data. Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Unitaid Funded Long-Acting Medicines Centre At University Of Liverpool To Shape The Future of Treatment 12/01/2021 Raisa Santos Center of Excellence for Long-acting Therapeutics launched at the University of Liverpool A US$40 million research consortium has been created to repurpose existing medicines for hepatitis, tuberculosis and malaria into long-acting treatments that can benefit low- and middle-income countries (LMICs) where people often have trouble accessing medicine over and over again, Unitaid experts told Health Policy Watch. The consortium on Tuesday launched the new Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool, as a first of its kind research center in the world. Unitaid, a global WHO-hosted partnership of private and public sector actors, is engaged in finding innovative solutions to prevent, diagnose, and treat infectious diseases more quickly, cheaply, and efficiently in LMICs, was the major funder of the cutting-edge Centre and research consortium. Initially research will focus on developing three long-acting products as part of the Unitaid-funded LONGEVITY project – a single-injection cure for hepatitis C over a treatment period of 12-weeks, and tuberculosis and malaria preventative treatment through one-dose injectables. “If you can replace [multiple doses] with one single shot injectable that can last for the whole malaria season, you are logistically gaining a lot. [Medicine] will be less costly to distribute, and it is more certain that people will receive treatment because they no longer need to come back [for additional treatment],” said Carmen Perez Casas, Senior Technical Manager at Unitaid, adding that the aim is to cover an individual for an entire malaria season with one injection – making medication cheaper to deliver and easier to use. Unitaid-funded CELT is currently working on a malaria injectable that could last a whole malaria season. “We are working to shape the market to ensure that any of the emerging long-acting technologies – whether for HIV, malaria, tuberculosis, are affordable and manufactured in sufficient volumes.” Long-acting technology allows the release of medication to be manipulated, with sufficient concentration of the drug to last long periods of time – for months to a year, or even longer. There are various types of long-acting technologies, including implants, oral medicines that dissolve over a period of time, and injectables. Diverse health fields, from reproductive and mental health have already benefited and continue to benefit from long-acting technology. Patients with schizophrenia and other psychoses who have difficulty accessing therapy and treatment can use long-acting injectables to replace the daily pill. “One-fifth of [schizophrenia] patients will have relapses and be admitted into hospitals for emergencies. They can now be stable because of continuous intake,” said Perez Casas. Long-Acting Technology: Ease of Access Leads to Increased Uptake of Medicines in LMICs Long-acting technology eases the complication of difficult and strict dose regimens for oral medication Perez Casas addressed the complications that exist with traditional oral medications. These medications do not properly tackle chronic diseases or treatments that adhere to a strict dosage regimens. There is also the stigma associated with taking a pill every day, she said. Such complications make prevention campaigns difficult to organize in LMICs, given the multiple doses required of certain medicines and the necessary accessibility to healthcare facilities. Long-acting technology eases the stigma and increases the uptake and efficacy of the drug, giving it the potential to be applied to other diseases, especially those common in LMICs, by reaching more people with long-acting medications as opposed to oral daily treatments. For instance, HIV prevention through pre-exposure prophylaxis (PrEP) typically can only be done through an oral pill, but the efficiency of long-acting PrEP can aid in preventing HIV through increased uptake over a longer period of time. Though the research will be conducted primarily at laboratories at the University of Liverpool, there is continual multi-partner collaboration between scientists and global stakeholders, all working with affected communities in mind. Long-Acting Treatments Are Particularly Suitable To Pandemic Context The COVID-19 pandemic has heavily impacted malaria, HIV, and tuberculosis in terms of continuity of treatment through the dependence of health systems and supplies. With CELT, Unitaid is working to urgently address affected treatment and chain of supply issues for those in LMICs impacted by COVID-19. Cherise Scott, Technical Manager of Strategy at Unitaid, said: “CELT aims to bring together various parties on the science and global health side. Learnings across various entities are shared, and that’s one way we can get our products to people who need them quickly.” Given the current vaccine hesitancy in regards to COVID-19, Unitaid is working with representatives of communities and governments for each stage of project development, as well as community advisory boards to ensure that long acting medicines will be accepted by community members, and will not impose a cost-burden compared to standard treatments. Co-director of CELT, Professor Andrew Owen, said: “Long-acting drug delivery promises to transform patient management, with huge potential impact for treatment and prevention of infectious diseases. Benefits for efficacy flow from overcoming issues associated with patients sometimes not taking their medication, which may also help reduce emergence of antimicrobial resistance. CELT harnesses the power of local, national and international collaboration to accelerate understanding of the medicines of the future.” Image Credits: Vita Student/Flickr, World Bank/Flickr, AL.Eyad/Flickr. Posts navigation Older postsNewer posts