New Study Shows Correlation Between Vitamin D Deficiency and Severe COVID 07/02/2022 Maayan Hoffman Researchers make the argument for increasing vitamin D supplementation in low- and middle-income countries, where vaccines and other methods of COVID prevention may be less available. Vitamin D supplements Maintaining adequate vitamin D levels could play a critical role in protecting against serious illness or death from COVID-19, according to new Israeli research. The study, published last week in the journal PLOS ONE by researchers from the Azrieli Faculty of Medicine of Bar-Ilan University in Safed and the Galilee Medical Center in Nahariya, offers the most convincing evidence to date of the correlations between vitamin D deficiency and poor COVID-19 outcomes – making a case for supplementation, especially in low- and middle-income countries where vaccines and other prevention methods may be less available. Vitamin D is a fat-soluble vitamin that has long been understood to affect immune response. However, as much as 70% of the adult population in Israel – and even larger percentages in some countries worldwide – has insufficient or even deficient levels, according to Dr Amiel Dror, who led the study. “We know that in countries from Africa to Georgia, and in much of the Middle East, people suffer from deficiency,” he said. “In some places, individuals avoid the sun because it is too hot; they stay inside their tents or huts or cover their bodies. Among some religious communities, like the ultra-Orthodox or traditional Islamic community in Israel, women are at higher risk for deficiency because of how they dress.” Studies also show that low-income levels affect vitamin D levels due to poor diet or reduced exposure to sun, Dror explained. As such, even before COVID-19, most health authorities recommended supplementation. This new research shows that taking those supplements before contracting the virus could help patients avoid the worst effects of the disease. People with sufficient vitamin D are 20% less likely to die from COVID-19 The Israeli study examined the records of 1,176 COVID-19-positive patients admitted to Galilee Medical Centre between April 2020 and February 2021 whose vitamin D levels had been evaluated between two weeks and two years prior to infection. Patients with vitamin D deficiency (less than 20 nanograms per milliliter or ng/mL) were 14 times more likely to have severe or critical cases of COVID-19 than those with more than 40 ng/mL, the study found. Even more strikingly, mortality among patients with sufficient vitamin D levels was 2.3% compared to 25.6% in the vitamin D deficient group. The study adjusted for age, gender, season (summer/winter) and chronic diseases, and found similar results across the board. The study was conducted during Israel’s first two COVID waves, before vaccines were widely available, and before the recent Omicron outbreak. Dror said that coronavirus mutations should not negate vitamin D’s effectiveness. Study checks vitamin D levels before infection The study builds on a pre-print study that the team published in June on the health sharing server MedRxiv. Those preliminary results found that people who were deficient in vitamin D were at least 20% more likely to die from COVID-19 than people who were not and that 26% of people who had a pre-infection level of vitamin D of 20 ng/mL died, compared with 3% of those who had higher levels of vitamin D. Dr. Amiel Dror However, that study received some pushback as it was unclear whether the vitamin D deficiency found in hospitalized COVID-19 patients was the result of the virus, making low vitamin D levels a symptom rather than a contributing factor to severe disease and death. The newer study corrected that by analyzing vitamin D levels prior to infection. “The infection itself alters the inflammatory status of our body and vitamin D is consumed, among other nutrients,” Dror said. As such, “we cannot conclude anything about vitamin D levels” in acute patients. In October, soon after Dror’s first report, Israel’s Coronavirus National Information and Knowledge Center aggregated research studies that likewise showed a circumstantial relationship between one’s level of vitamin D and coronavirus, recommending supplementation. As a result, the country’s Health Ministry recommended increased vitamin D levels during the pandemic. Different countries recommend different levels of vitamin D for their citizens, but on average the recommended amounts are as follows: Children under 1 should take 10 micrograms a day, kids and teens between the ages of 1 and 18 should take 15, and adults should consume 20 to 100 depending on their BMI. Israel’s recommended vitamin D levels by age group. There have been interventional studies in which doctors tried to supply high doses of vitamin D to acute patients during hospitalization, but most of those studies did not show positive outcomes. “The vitamin D we consume in drops, pills or in our food has to be activated in both our kidney and liver in order to be functional,” Dror explained. During COVID-19, liver function is generally impaired, which means that the patient will not necessarily be able to transform the consumed dose. However, there was one study published last June that showed different results. In that study, scientists provided 447 patients at a Spanish hospital between March and May 2020 with calcifediol – a form of vitamin D that has already undergone liver activation – at admission. Of the patients, 20 required the intensive care unit compared to 82 out of 391 nontreated patients. Likewise, 21 out of the 447 patients treated with calcifediol at admission died compared to 62 patients out of 391 nontreated. Not a replacement for vaccination The positive results of the Israeli study have led some individuals “with a conspiracy theory mindset” to accuse the pharma industry of withholding information about the supplement in exchange for expensive vaccines or anti-viral treatments, Dror said. But he stressed that vitamin D is not a replacement for inoculation and that while the Israeli study shows a strong correlation between vitamin D and severe disease and mortality, this is not the same thing as causation. “In order to see if vitamin D truly abolishes COVID or makes the outcome so much better, we have to run a randomized, controlled study and give one group of patients vitamin D ahead of time and then measure the outcomes,” he explained. “It is still unclear why certain individuals suffer severe consequences of COVID-19 infection while others don’t. Our finding adds a new dimension to solving this puzzle,” added study co-author Prof Michael Edelstein. Dror recommended that countries consider giving out the supplement to get people used to taking it before the next wave, which he said is sure to come. The vitamin is cheap, easy to produce and simple to take, and unlikely to be met with hesitancy. “We are not saying that vitamin D is the key to all bad coronavirus or that it is the ultimate solution,” Dror cautioned. “But we should take vitamin D to help our bones and our immune system anyway. If we can also benefit against COVID-19, it is a double win.” Image Credits: Pixabay, Tomasz Solinski, Health Ministry. Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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.
Switzerland Plans Major Relaxation of COVID-19 Restrictions – Despite Omicron Rates Among Europe’s Highest 02/02/2022 Elaine Ruth Fletcher Geneva’s central train station where masks, a universal apparel for public transport users and shoppers, may soon be discarded along with most COVID restrictions. Switzerland could be the next European country to lift virtually all COVID restrictions, federal officials said Wednesday – despite warnings from the World Health Organization, headquartered in Geneva, that a total relaxation of the pandemic rules could be premature. In a press briefing on Wednesday, Swiss federal government officials lifted all work-from-home and some quarantine requirements as of Thusday, and said they were considering a complete lifting of mask mandates, vacccine certificate requirements and other measures by 17 February. The other option would be to take a two-phase approach to the relaxation, government officials said. This would lift requirements for vaccine certificates to enter restaurants and other leisure and cultural venues, but maintain a “2-G” (two vaccine dose) requirement for entry to indoor pools, discotheques, and other similar venues. The government said that it would undertake a series of consultations with Cantonal authorities in the coming two weeks to decide whether to remove the domestic restrictions all in one go – or in two stages. Additionally, the government said it would propose the lifting of all restrictions on entry into Switzerland, including requirements for vaccine passports, testing, and the collection of contact data. Swiss Federal Council President Ignaio Cassis at a press conference in Berne, on Wednesday “Today is a beautiful day – and not only because of the weather. Today is a great day. It marks the beginning of a new phase in this long and difficult crisis,” declared Ignazio Cassis, president of the Swiss Federal Council, in a press conference, speaking in Italian, French and German. “The pandemic is not entirely behind us, but the Federal Council is very pleased to see light on the horizon.” He spoke even as Swiss reports of confirmed new COVID cases remain among the highest in Europe, although there are signs of a plateau in just the past couple of days. Premature to declare victory or surrender’ Two hours away in Geneva, at a WHO press briefing on Tuesday, WHO Director General Tedros Adhanom Ghebreysus appealed to countries to move gradually in relaxing restrictions. He noted that the Omicron variant of SARS-CoV2 had caused 90 million infections in just the past 10 weeks – more than all of the cases recorded in 2021. “It is premature for any country either to surrender or to declare victory,” Tedros said. “This virus is dangerous and it continues to evolve,” he warned, noting the evolution of yet new Omicron sub-variants in Europe as well as India. With deaths in four of the WHO’s six regions increasing over the past week “now is not the time to lift everything all at once,” cautioned Dr Maria van Kerkhove, WHO’s lead on COVID-19, cautioned Tuesday. In Europe at least, more and more countries seem to be disregarding those WHO warnings. Last week, Denmark lifted most COVID-19 restrictions despite registering over 40,000 new cases daily, with France, Norway, Finland and Sweden among the other European countries following suit or poised to do so. Swiss moves could be among the most far-reaching However, Switzerland’s moves, if made all at once in just two weeks, could be among the most far-reaching yet on the European continent. In his briefing, Cassis credited the relaxation to a successful vaccination campaign – although in fact, Swiss vaccine rates also remain somewhat below the average of other comparably high-income European countries. “We can enter this new phase thanks to the vaccination,” Cassis said. “This has contributed to a much more favorable epidemiological evolution [of the virus].” While the Omicron variant has infected a very large numbers of people “its repercussions had been much lighter” with a significant reduction in hospitalization rates, as in other countries, Cassis added. Thanks to that, as well, “we can envisage the future with optimism. A new phase is beginning and we will soon be able to recover all of our liberties – while also living with one more virus.” Asked for a comment on the planned Swiss measures, WHO not had not responded at the time of publication. See related Health Policy Watch story: https://healthpolicy-watch.news/as-denmark-scraps-covid-restrictions-who-urges-caution/ Image Credits: HP-Watch/Svet Lustig Vijay. In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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.
In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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. 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HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. 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
As Denmark Scraps COVID Restrictions, WHO Urges Caution 01/02/2022 Kerry Cullinan Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions. The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021. Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven. Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants. But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday. ‘Premature to declare victory or surrender’ “It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that the WHO is currently tracking for sub-variants of Omicron. Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”. “We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”. “Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove. Dr Maria Van Kerkhove Celebrate a new phase of disease control Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems. Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan. He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”. He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”. In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges” Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”. “We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added. Omicron sub-variants Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1). Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”. “There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.” New SARS-CoV2 origins group report weeks away Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November. Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2. They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. “This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove. Image Credits: Febiyan/ Unsplash. Posts navigation Older postsNewer posts