Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Five Virus Variants Fuel Second Wave of COVID-19 in Uganda 18/06/2021 Esther Nakkazi Uganda is dealing with five different coronavirus variants that have fuelled aggressive transmission as the country enters the second wave of the pandemic. Uganda is suffering an acute shortage of oxygen and intensive care beds as the country grapples with a deadly second wave of the pandemic that is being fuelled by five different virus variants. Regional referral hospitals and the country’s biggest hospital, Mulago National Referral Hospital, have run out of oxygen or have reported acute shortages, forcing medical staff to decide who gets the life-saving treatment. At least 22 countries on the African continent are in the midst of new infection waves, with Uganda, Namibia, South Africa, Tunisia and Zambia being the worst-hit. On 16 June, Uganda recorded 1,564 new infections and 42 new deaths. On Wednesday, the country received 75,200 doses of the AstraZeneca vaccine, donated by the French government through the COVAX facility. Ugandan Health Minister Dr Jane Ruth Aceng, told a WHO Africa Region press briefing on Thursday, that her country was dealing with five major variants and that COVID-19 transmission was “very aggressive”. Aceng said the variants registered in Uganda include Delta (B.1.617.2 first identified in India), Eta (B.1.525), Beta (B.1.351 from South Africa), Alpha (B.1.117 identified in the UK) and the local strain, which she identified as B.1.617. These strains are on the rise and are fuelling the transmission, according to Aceng. “We have started a robust intervention in the communities. We are handing the pandemic back to the community to take it up themselves and ensure that everybody adheres to [standard operating procedures] and account for all the infected,” said Aceng, adding that more research is being conducted into how the variants are spreading. Last week, the WHO warned of a third wave of the pandemic across Africa, with 90% of countries likely to miss the global vaccination target of at least 10% of their populations by September. No New Vaccinations Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou (right) on 17 June received the 75,200 doses of the AstraZeneca COVID-19 vaccine donated by the French government through the COVAX facility. The new vaccine doses delivered on Wednesday brings the total number of COVID-19 doses received in the country to 1,139,200. Uganda’s first two batches, totalling 964,000 doses, arrived in the country in March and are expected to expire by 10 July. By 15 June, over 812,000 people including health workers, teachers, security personnel, airport staff, the elderly and people with diabetes, hypertension and other underlying conditions had been vaccinated. However, Aceng said that health workers, teachers and all those who got a first shot will be prioritized to get their second shots, as the demand for vaccines rises among the public. Out of the targeted 160,000 registered health workers in the country only 69,000 have been fully vaccinated according to the Ministry of Health. President Yoweri Museveni recently decreed that all teachers should be vaccinated before being allowed back in the class. “Vaccine hesitancy was real at the beginning and we opened up beyond the categories we wanted to target, but now we have more demand than we can meet. Many people are now rushing to get vaccinated,” presidential adviser on epidemics Dr Monica Musenero told reporters at a press briefing on Wednesday. Last week, 14,460 COVID-19 vaccine doses went to waste as they were opened, but not used. Scientists say vaccines lose their potency and effectiveness if they are exposed to temperatures outside of the required range or when exposed to light. Once a vial’s seal is punctured, workers have only six hours within which to administer the vaccine. Each vial can vaccinate 10 to 12 people. Catherine Makumbi Ntabadde, UNICEF’s country communication specialist, said Uganda is expected to receive another batch of 688,000 vaccine doses in August, which will also be administered as a second jab. The country aims to vaccinate 21 million people in a phased manner. Acute Oxygen Shortages Uganda’s medical oxygen demands outweigh the current supplies due to an increasing number of critically ill patients. Although the oxygen production capacity is available in the private sector and from neighbouring Kenya, Aceng said the country did not have enough cylinders. An additional 8,000 cylinders would help reduce the COVID-19 death rate. However, according to intensive care staff, more piped oxygen is needed instead of cylinders as patients are not responding to nasal oxygen that is distributed via the cylinders. The oxygen shortage is further fuelled by the private sector, the biggest provider of health services in the country, charging exorbitant treatment prices, “The private sector is fleecing desperate Ugandans. Why charge for oxygen? It should be given out free of charge,” said a frustrated Aceng. Some private providers have been caught out charging for vaccines meant to be distributed for free. Government had allowed the private sector to import and distribute COVID-19 vaccines as they were already key players in immunisation of children on behalf of the government. “It is not that they accessed the vaccine through the wrong route. The government gave them the vaccine to distribute on its behalf, but now there is just no truth and transparency in the distribution,” said Aceng. It is likely that Uganda will follow Kenya in banning private sector participation in the procurement and distribution of vaccines if the vice does not stop. Stricter Control Measures to Help Curb the Pandemic Last week, President Museveni instituted a ban on inter-district travel and restricted the number of people to attend weddings and burials to 20 in a bid to contain the virus. Aceng however said the surge in new cases in Uganda was due to citizens becoming complacent after the first wave and when some schools reopened. “When we opened up after the first strict lockdown last year, people wanted to have their normal lives and regain economic stability so they became complacent and the number of cases started rising,” said Aceng, referring to the two-month lockdown that started last March. WHO Regional Director for Africa Dr Matshidiso Moeti, speaking at the same briefing, warned that the continent’s third wave is gaining pace and is nearing the first wave’s peak of more than 120,000 weekly cases recorded in July 2020. “Africa is in the midst of a full blown third wave. The sobering trajectory of surging cases should rouse everyone into urgent action. We’ve seen in India and elsewhere just how quickly COVID-19 can rebound and overwhelm health systems. So, public health measures must be scaled up fast to find, test, isolate and care for patients and to quickly trace their contacts,” Moeti said. Image Credits: © WHO/Otto B., Health Journalist Network. Guinea Poised to Declare End of Ebola Outbreak 17/06/2021 Paul Adepoju Last Ebola patients leave a treatment centre in the Democratic Republic of Congo at the end of March, marking the countdown to declaring the end of the pandemic. The government of Guinea is a few days away from declaring the end of the country’s Ebola outbreak after 45 days of reporting no new case, World Health Organization Officials said on Thursday. On 14 February, a new Ebola outbreak was declared in Guinea, but four months later, the outbreak will be declared over according to Guinea’s Health Minister Dr Remy Lama. Speaking at a WHO AFRO press briefing on Thursday, Lama attributed the country’s ability to quickly control the outbreak to swift mobilisation to organise the response to the disease and break the transmission. “We made a huge adjustment to involve communities in this response, so that they would accept the proposed measures. We chose as a priority to involve communities,” Lama said. Initial challenges regarding vaccine hesitancy were quickly resolved by actively engaging communities who became aware of the reasons behind the recommended lines of action, said Lama. The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives. The DRC faced a major outbreak in 2018, which concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support. In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead. However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else. Lessons learned from the Ebola response have also better positioned the country to respond to COVID-19 considering engagement with its citizens has also been crucial in encouraging vaccine adoption. WHO Regional Director for Africa Dr Matshidiso MoetiMoeti noted the overlap between responses to Ebola and COVID-19 and said both required political leadership, quick decision making and collaboration with various partners. “All of this is valuable in both responding to pandemics, and in putting in place the kind of resilient health systems that we need so that next time there is a threat, we’re better positioned to respond and contain the outbreak,” Moeti said. Image Credits: WHO African Region. Antibody Cocktail Reduces Risk of Death by 20% in Patients lacking Adequate SARS-CoV2 Immune Response 17/06/2021 Madeleine Hoecklin The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases. A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths. The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford. Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system. Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response. And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. “Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation For every 100 patients treated, there would be six fewer deaths, calculated the study authors. Our investigational antibody cocktail improved overall survival in hospitalized #COVID19 patients who had not mounted their own immune response, in the @UniofOxford RECOVERY trial. We’ll be discussing the data with regulatory authorities. — Regeneron (@Regeneron) June 16, 2021 “It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. ‘Groundbreaking’ New COVID Therapy “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. “These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. “Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. “If you already have antibodies, giving you more may not make much difference,” said Horby. This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000. The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in high-resource health systems, and only a few monoclonals are available in low- and middle-income countries. The result is hugely important. But monoclonal antibodies are expensive. “There really must be initiatives to make these drugs accessible … you have to scale up manufacturing, and they have to be affordable” 💬 @PeterHorbyhttps://t.co/pIospHChPn pic.twitter.com/SGHPrBGHid — Wellcome (@wellcometrust) June 16, 2021 “There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. Regeneron to Request Expanded Authorization The therapy was first granted a United States Food and Drug Administration (FDA) emergency use authorization (EUA) in December. That EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. “Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron. “We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. “It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. Commitment to Invest in COVID Treatments Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year. Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come. “There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.” The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times. Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms. “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'” Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School. Image Credits: Flickr – US Navy, Regeneron. Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Five Virus Variants Fuel Second Wave of COVID-19 in Uganda 18/06/2021 Esther Nakkazi Uganda is dealing with five different coronavirus variants that have fuelled aggressive transmission as the country enters the second wave of the pandemic. Uganda is suffering an acute shortage of oxygen and intensive care beds as the country grapples with a deadly second wave of the pandemic that is being fuelled by five different virus variants. Regional referral hospitals and the country’s biggest hospital, Mulago National Referral Hospital, have run out of oxygen or have reported acute shortages, forcing medical staff to decide who gets the life-saving treatment. At least 22 countries on the African continent are in the midst of new infection waves, with Uganda, Namibia, South Africa, Tunisia and Zambia being the worst-hit. On 16 June, Uganda recorded 1,564 new infections and 42 new deaths. On Wednesday, the country received 75,200 doses of the AstraZeneca vaccine, donated by the French government through the COVAX facility. Ugandan Health Minister Dr Jane Ruth Aceng, told a WHO Africa Region press briefing on Thursday, that her country was dealing with five major variants and that COVID-19 transmission was “very aggressive”. Aceng said the variants registered in Uganda include Delta (B.1.617.2 first identified in India), Eta (B.1.525), Beta (B.1.351 from South Africa), Alpha (B.1.117 identified in the UK) and the local strain, which she identified as B.1.617. These strains are on the rise and are fuelling the transmission, according to Aceng. “We have started a robust intervention in the communities. We are handing the pandemic back to the community to take it up themselves and ensure that everybody adheres to [standard operating procedures] and account for all the infected,” said Aceng, adding that more research is being conducted into how the variants are spreading. Last week, the WHO warned of a third wave of the pandemic across Africa, with 90% of countries likely to miss the global vaccination target of at least 10% of their populations by September. No New Vaccinations Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou (right) on 17 June received the 75,200 doses of the AstraZeneca COVID-19 vaccine donated by the French government through the COVAX facility. The new vaccine doses delivered on Wednesday brings the total number of COVID-19 doses received in the country to 1,139,200. Uganda’s first two batches, totalling 964,000 doses, arrived in the country in March and are expected to expire by 10 July. By 15 June, over 812,000 people including health workers, teachers, security personnel, airport staff, the elderly and people with diabetes, hypertension and other underlying conditions had been vaccinated. However, Aceng said that health workers, teachers and all those who got a first shot will be prioritized to get their second shots, as the demand for vaccines rises among the public. Out of the targeted 160,000 registered health workers in the country only 69,000 have been fully vaccinated according to the Ministry of Health. President Yoweri Museveni recently decreed that all teachers should be vaccinated before being allowed back in the class. “Vaccine hesitancy was real at the beginning and we opened up beyond the categories we wanted to target, but now we have more demand than we can meet. Many people are now rushing to get vaccinated,” presidential adviser on epidemics Dr Monica Musenero told reporters at a press briefing on Wednesday. Last week, 14,460 COVID-19 vaccine doses went to waste as they were opened, but not used. Scientists say vaccines lose their potency and effectiveness if they are exposed to temperatures outside of the required range or when exposed to light. Once a vial’s seal is punctured, workers have only six hours within which to administer the vaccine. Each vial can vaccinate 10 to 12 people. Catherine Makumbi Ntabadde, UNICEF’s country communication specialist, said Uganda is expected to receive another batch of 688,000 vaccine doses in August, which will also be administered as a second jab. The country aims to vaccinate 21 million people in a phased manner. Acute Oxygen Shortages Uganda’s medical oxygen demands outweigh the current supplies due to an increasing number of critically ill patients. Although the oxygen production capacity is available in the private sector and from neighbouring Kenya, Aceng said the country did not have enough cylinders. An additional 8,000 cylinders would help reduce the COVID-19 death rate. However, according to intensive care staff, more piped oxygen is needed instead of cylinders as patients are not responding to nasal oxygen that is distributed via the cylinders. The oxygen shortage is further fuelled by the private sector, the biggest provider of health services in the country, charging exorbitant treatment prices, “The private sector is fleecing desperate Ugandans. Why charge for oxygen? It should be given out free of charge,” said a frustrated Aceng. Some private providers have been caught out charging for vaccines meant to be distributed for free. Government had allowed the private sector to import and distribute COVID-19 vaccines as they were already key players in immunisation of children on behalf of the government. “It is not that they accessed the vaccine through the wrong route. The government gave them the vaccine to distribute on its behalf, but now there is just no truth and transparency in the distribution,” said Aceng. It is likely that Uganda will follow Kenya in banning private sector participation in the procurement and distribution of vaccines if the vice does not stop. Stricter Control Measures to Help Curb the Pandemic Last week, President Museveni instituted a ban on inter-district travel and restricted the number of people to attend weddings and burials to 20 in a bid to contain the virus. Aceng however said the surge in new cases in Uganda was due to citizens becoming complacent after the first wave and when some schools reopened. “When we opened up after the first strict lockdown last year, people wanted to have their normal lives and regain economic stability so they became complacent and the number of cases started rising,” said Aceng, referring to the two-month lockdown that started last March. WHO Regional Director for Africa Dr Matshidiso Moeti, speaking at the same briefing, warned that the continent’s third wave is gaining pace and is nearing the first wave’s peak of more than 120,000 weekly cases recorded in July 2020. “Africa is in the midst of a full blown third wave. The sobering trajectory of surging cases should rouse everyone into urgent action. We’ve seen in India and elsewhere just how quickly COVID-19 can rebound and overwhelm health systems. So, public health measures must be scaled up fast to find, test, isolate and care for patients and to quickly trace their contacts,” Moeti said. Image Credits: © WHO/Otto B., Health Journalist Network. Guinea Poised to Declare End of Ebola Outbreak 17/06/2021 Paul Adepoju Last Ebola patients leave a treatment centre in the Democratic Republic of Congo at the end of March, marking the countdown to declaring the end of the pandemic. The government of Guinea is a few days away from declaring the end of the country’s Ebola outbreak after 45 days of reporting no new case, World Health Organization Officials said on Thursday. On 14 February, a new Ebola outbreak was declared in Guinea, but four months later, the outbreak will be declared over according to Guinea’s Health Minister Dr Remy Lama. Speaking at a WHO AFRO press briefing on Thursday, Lama attributed the country’s ability to quickly control the outbreak to swift mobilisation to organise the response to the disease and break the transmission. “We made a huge adjustment to involve communities in this response, so that they would accept the proposed measures. We chose as a priority to involve communities,” Lama said. Initial challenges regarding vaccine hesitancy were quickly resolved by actively engaging communities who became aware of the reasons behind the recommended lines of action, said Lama. The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives. The DRC faced a major outbreak in 2018, which concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support. In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead. However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else. Lessons learned from the Ebola response have also better positioned the country to respond to COVID-19 considering engagement with its citizens has also been crucial in encouraging vaccine adoption. WHO Regional Director for Africa Dr Matshidiso MoetiMoeti noted the overlap between responses to Ebola and COVID-19 and said both required political leadership, quick decision making and collaboration with various partners. “All of this is valuable in both responding to pandemics, and in putting in place the kind of resilient health systems that we need so that next time there is a threat, we’re better positioned to respond and contain the outbreak,” Moeti said. Image Credits: WHO African Region. Antibody Cocktail Reduces Risk of Death by 20% in Patients lacking Adequate SARS-CoV2 Immune Response 17/06/2021 Madeleine Hoecklin The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases. A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths. The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford. Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system. Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response. And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. “Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation For every 100 patients treated, there would be six fewer deaths, calculated the study authors. Our investigational antibody cocktail improved overall survival in hospitalized #COVID19 patients who had not mounted their own immune response, in the @UniofOxford RECOVERY trial. We’ll be discussing the data with regulatory authorities. — Regeneron (@Regeneron) June 16, 2021 “It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. ‘Groundbreaking’ New COVID Therapy “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. “These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. “Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. “If you already have antibodies, giving you more may not make much difference,” said Horby. This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000. The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in high-resource health systems, and only a few monoclonals are available in low- and middle-income countries. The result is hugely important. But monoclonal antibodies are expensive. “There really must be initiatives to make these drugs accessible … you have to scale up manufacturing, and they have to be affordable” 💬 @PeterHorbyhttps://t.co/pIospHChPn pic.twitter.com/SGHPrBGHid — Wellcome (@wellcometrust) June 16, 2021 “There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. Regeneron to Request Expanded Authorization The therapy was first granted a United States Food and Drug Administration (FDA) emergency use authorization (EUA) in December. That EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. “Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron. “We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. “It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. Commitment to Invest in COVID Treatments Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year. Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come. “There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.” The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times. Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms. “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'” Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School. Image Credits: Flickr – US Navy, Regeneron. Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Five Virus Variants Fuel Second Wave of COVID-19 in Uganda 18/06/2021 Esther Nakkazi Uganda is dealing with five different coronavirus variants that have fuelled aggressive transmission as the country enters the second wave of the pandemic. Uganda is suffering an acute shortage of oxygen and intensive care beds as the country grapples with a deadly second wave of the pandemic that is being fuelled by five different virus variants. Regional referral hospitals and the country’s biggest hospital, Mulago National Referral Hospital, have run out of oxygen or have reported acute shortages, forcing medical staff to decide who gets the life-saving treatment. At least 22 countries on the African continent are in the midst of new infection waves, with Uganda, Namibia, South Africa, Tunisia and Zambia being the worst-hit. On 16 June, Uganda recorded 1,564 new infections and 42 new deaths. On Wednesday, the country received 75,200 doses of the AstraZeneca vaccine, donated by the French government through the COVAX facility. Ugandan Health Minister Dr Jane Ruth Aceng, told a WHO Africa Region press briefing on Thursday, that her country was dealing with five major variants and that COVID-19 transmission was “very aggressive”. Aceng said the variants registered in Uganda include Delta (B.1.617.2 first identified in India), Eta (B.1.525), Beta (B.1.351 from South Africa), Alpha (B.1.117 identified in the UK) and the local strain, which she identified as B.1.617. These strains are on the rise and are fuelling the transmission, according to Aceng. “We have started a robust intervention in the communities. We are handing the pandemic back to the community to take it up themselves and ensure that everybody adheres to [standard operating procedures] and account for all the infected,” said Aceng, adding that more research is being conducted into how the variants are spreading. Last week, the WHO warned of a third wave of the pandemic across Africa, with 90% of countries likely to miss the global vaccination target of at least 10% of their populations by September. No New Vaccinations Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou (right) on 17 June received the 75,200 doses of the AstraZeneca COVID-19 vaccine donated by the French government through the COVAX facility. The new vaccine doses delivered on Wednesday brings the total number of COVID-19 doses received in the country to 1,139,200. Uganda’s first two batches, totalling 964,000 doses, arrived in the country in March and are expected to expire by 10 July. By 15 June, over 812,000 people including health workers, teachers, security personnel, airport staff, the elderly and people with diabetes, hypertension and other underlying conditions had been vaccinated. However, Aceng said that health workers, teachers and all those who got a first shot will be prioritized to get their second shots, as the demand for vaccines rises among the public. Out of the targeted 160,000 registered health workers in the country only 69,000 have been fully vaccinated according to the Ministry of Health. President Yoweri Museveni recently decreed that all teachers should be vaccinated before being allowed back in the class. “Vaccine hesitancy was real at the beginning and we opened up beyond the categories we wanted to target, but now we have more demand than we can meet. Many people are now rushing to get vaccinated,” presidential adviser on epidemics Dr Monica Musenero told reporters at a press briefing on Wednesday. Last week, 14,460 COVID-19 vaccine doses went to waste as they were opened, but not used. Scientists say vaccines lose their potency and effectiveness if they are exposed to temperatures outside of the required range or when exposed to light. Once a vial’s seal is punctured, workers have only six hours within which to administer the vaccine. Each vial can vaccinate 10 to 12 people. Catherine Makumbi Ntabadde, UNICEF’s country communication specialist, said Uganda is expected to receive another batch of 688,000 vaccine doses in August, which will also be administered as a second jab. The country aims to vaccinate 21 million people in a phased manner. Acute Oxygen Shortages Uganda’s medical oxygen demands outweigh the current supplies due to an increasing number of critically ill patients. Although the oxygen production capacity is available in the private sector and from neighbouring Kenya, Aceng said the country did not have enough cylinders. An additional 8,000 cylinders would help reduce the COVID-19 death rate. However, according to intensive care staff, more piped oxygen is needed instead of cylinders as patients are not responding to nasal oxygen that is distributed via the cylinders. The oxygen shortage is further fuelled by the private sector, the biggest provider of health services in the country, charging exorbitant treatment prices, “The private sector is fleecing desperate Ugandans. Why charge for oxygen? It should be given out free of charge,” said a frustrated Aceng. Some private providers have been caught out charging for vaccines meant to be distributed for free. Government had allowed the private sector to import and distribute COVID-19 vaccines as they were already key players in immunisation of children on behalf of the government. “It is not that they accessed the vaccine through the wrong route. The government gave them the vaccine to distribute on its behalf, but now there is just no truth and transparency in the distribution,” said Aceng. It is likely that Uganda will follow Kenya in banning private sector participation in the procurement and distribution of vaccines if the vice does not stop. Stricter Control Measures to Help Curb the Pandemic Last week, President Museveni instituted a ban on inter-district travel and restricted the number of people to attend weddings and burials to 20 in a bid to contain the virus. Aceng however said the surge in new cases in Uganda was due to citizens becoming complacent after the first wave and when some schools reopened. “When we opened up after the first strict lockdown last year, people wanted to have their normal lives and regain economic stability so they became complacent and the number of cases started rising,” said Aceng, referring to the two-month lockdown that started last March. WHO Regional Director for Africa Dr Matshidiso Moeti, speaking at the same briefing, warned that the continent’s third wave is gaining pace and is nearing the first wave’s peak of more than 120,000 weekly cases recorded in July 2020. “Africa is in the midst of a full blown third wave. The sobering trajectory of surging cases should rouse everyone into urgent action. We’ve seen in India and elsewhere just how quickly COVID-19 can rebound and overwhelm health systems. So, public health measures must be scaled up fast to find, test, isolate and care for patients and to quickly trace their contacts,” Moeti said. Image Credits: © WHO/Otto B., Health Journalist Network. Guinea Poised to Declare End of Ebola Outbreak 17/06/2021 Paul Adepoju Last Ebola patients leave a treatment centre in the Democratic Republic of Congo at the end of March, marking the countdown to declaring the end of the pandemic. The government of Guinea is a few days away from declaring the end of the country’s Ebola outbreak after 45 days of reporting no new case, World Health Organization Officials said on Thursday. On 14 February, a new Ebola outbreak was declared in Guinea, but four months later, the outbreak will be declared over according to Guinea’s Health Minister Dr Remy Lama. Speaking at a WHO AFRO press briefing on Thursday, Lama attributed the country’s ability to quickly control the outbreak to swift mobilisation to organise the response to the disease and break the transmission. “We made a huge adjustment to involve communities in this response, so that they would accept the proposed measures. We chose as a priority to involve communities,” Lama said. Initial challenges regarding vaccine hesitancy were quickly resolved by actively engaging communities who became aware of the reasons behind the recommended lines of action, said Lama. The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives. The DRC faced a major outbreak in 2018, which concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support. In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead. However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else. Lessons learned from the Ebola response have also better positioned the country to respond to COVID-19 considering engagement with its citizens has also been crucial in encouraging vaccine adoption. WHO Regional Director for Africa Dr Matshidiso MoetiMoeti noted the overlap between responses to Ebola and COVID-19 and said both required political leadership, quick decision making and collaboration with various partners. “All of this is valuable in both responding to pandemics, and in putting in place the kind of resilient health systems that we need so that next time there is a threat, we’re better positioned to respond and contain the outbreak,” Moeti said. Image Credits: WHO African Region. Antibody Cocktail Reduces Risk of Death by 20% in Patients lacking Adequate SARS-CoV2 Immune Response 17/06/2021 Madeleine Hoecklin The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases. A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths. The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford. Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system. Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response. And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. “Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation For every 100 patients treated, there would be six fewer deaths, calculated the study authors. Our investigational antibody cocktail improved overall survival in hospitalized #COVID19 patients who had not mounted their own immune response, in the @UniofOxford RECOVERY trial. We’ll be discussing the data with regulatory authorities. — Regeneron (@Regeneron) June 16, 2021 “It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. ‘Groundbreaking’ New COVID Therapy “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. “These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. “Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. “If you already have antibodies, giving you more may not make much difference,” said Horby. This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000. The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in high-resource health systems, and only a few monoclonals are available in low- and middle-income countries. The result is hugely important. But monoclonal antibodies are expensive. “There really must be initiatives to make these drugs accessible … you have to scale up manufacturing, and they have to be affordable” 💬 @PeterHorbyhttps://t.co/pIospHChPn pic.twitter.com/SGHPrBGHid — Wellcome (@wellcometrust) June 16, 2021 “There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. Regeneron to Request Expanded Authorization The therapy was first granted a United States Food and Drug Administration (FDA) emergency use authorization (EUA) in December. That EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. “Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron. “We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. “It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. Commitment to Invest in COVID Treatments Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year. Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come. “There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.” The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times. Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms. “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'” Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School. Image Credits: Flickr – US Navy, Regeneron. Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Guinea Poised to Declare End of Ebola Outbreak 17/06/2021 Paul Adepoju Last Ebola patients leave a treatment centre in the Democratic Republic of Congo at the end of March, marking the countdown to declaring the end of the pandemic. The government of Guinea is a few days away from declaring the end of the country’s Ebola outbreak after 45 days of reporting no new case, World Health Organization Officials said on Thursday. On 14 February, a new Ebola outbreak was declared in Guinea, but four months later, the outbreak will be declared over according to Guinea’s Health Minister Dr Remy Lama. Speaking at a WHO AFRO press briefing on Thursday, Lama attributed the country’s ability to quickly control the outbreak to swift mobilisation to organise the response to the disease and break the transmission. “We made a huge adjustment to involve communities in this response, so that they would accept the proposed measures. We chose as a priority to involve communities,” Lama said. Initial challenges regarding vaccine hesitancy were quickly resolved by actively engaging communities who became aware of the reasons behind the recommended lines of action, said Lama. The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives. The DRC faced a major outbreak in 2018, which concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support. In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead. However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else. Lessons learned from the Ebola response have also better positioned the country to respond to COVID-19 considering engagement with its citizens has also been crucial in encouraging vaccine adoption. WHO Regional Director for Africa Dr Matshidiso MoetiMoeti noted the overlap between responses to Ebola and COVID-19 and said both required political leadership, quick decision making and collaboration with various partners. “All of this is valuable in both responding to pandemics, and in putting in place the kind of resilient health systems that we need so that next time there is a threat, we’re better positioned to respond and contain the outbreak,” Moeti said. Image Credits: WHO African Region. Antibody Cocktail Reduces Risk of Death by 20% in Patients lacking Adequate SARS-CoV2 Immune Response 17/06/2021 Madeleine Hoecklin The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases. A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths. The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford. Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system. Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response. And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. “Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation For every 100 patients treated, there would be six fewer deaths, calculated the study authors. Our investigational antibody cocktail improved overall survival in hospitalized #COVID19 patients who had not mounted their own immune response, in the @UniofOxford RECOVERY trial. We’ll be discussing the data with regulatory authorities. — Regeneron (@Regeneron) June 16, 2021 “It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. ‘Groundbreaking’ New COVID Therapy “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. “These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. “Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. “If you already have antibodies, giving you more may not make much difference,” said Horby. This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000. The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in high-resource health systems, and only a few monoclonals are available in low- and middle-income countries. The result is hugely important. But monoclonal antibodies are expensive. “There really must be initiatives to make these drugs accessible … you have to scale up manufacturing, and they have to be affordable” 💬 @PeterHorbyhttps://t.co/pIospHChPn pic.twitter.com/SGHPrBGHid — Wellcome (@wellcometrust) June 16, 2021 “There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. Regeneron to Request Expanded Authorization The therapy was first granted a United States Food and Drug Administration (FDA) emergency use authorization (EUA) in December. That EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. “Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron. “We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. “It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. Commitment to Invest in COVID Treatments Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year. Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come. “There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.” The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times. Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms. “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'” Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School. Image Credits: Flickr – US Navy, Regeneron. Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Antibody Cocktail Reduces Risk of Death by 20% in Patients lacking Adequate SARS-CoV2 Immune Response 17/06/2021 Madeleine Hoecklin The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases. A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths. The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford. Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system. Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response. And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. “Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation For every 100 patients treated, there would be six fewer deaths, calculated the study authors. Our investigational antibody cocktail improved overall survival in hospitalized #COVID19 patients who had not mounted their own immune response, in the @UniofOxford RECOVERY trial. We’ll be discussing the data with regulatory authorities. — Regeneron (@Regeneron) June 16, 2021 “It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. ‘Groundbreaking’ New COVID Therapy “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. “These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. “Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. “If you already have antibodies, giving you more may not make much difference,” said Horby. This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000. The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in high-resource health systems, and only a few monoclonals are available in low- and middle-income countries. The result is hugely important. But monoclonal antibodies are expensive. “There really must be initiatives to make these drugs accessible … you have to scale up manufacturing, and they have to be affordable” 💬 @PeterHorbyhttps://t.co/pIospHChPn pic.twitter.com/SGHPrBGHid — Wellcome (@wellcometrust) June 16, 2021 “There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. Regeneron to Request Expanded Authorization The therapy was first granted a United States Food and Drug Administration (FDA) emergency use authorization (EUA) in December. That EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. “Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron. “We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. “It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. Commitment to Invest in COVID Treatments Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year. Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come. “There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.” The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times. Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms. “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'” Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School. Image Credits: Flickr – US Navy, Regeneron. Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Latin America Plagued by Slow Vaccine Rollouts, While Region Remains Major COVID Epicenter 17/06/2021 Madeleine Hoecklin & Raisa Santos Dr Carissa Etienne, Director of the Pan American Health Organization. Despite the global decline in COVID-19 cases by 12% over the last week, countries in Central and South America continue to be epicenters of pandemic, with high mortality rates and insufficient access to vaccines. Over 1.1 million new COVID-19 cases and 31,000 deaths were reported in the Americas over the last week, officials from the Pan American Health Organization (PAHO) announced at a press briefing on Wednesday. “Cases are peaking, hospitals are full, and we are home to four of the five highest death rates in the world,” said Dr Carissa Etienne, PAHO Director. In terms of cases and deaths per-capita, Uruguay, Argentina, Colombia and Brazil, just to cite a few examples, are still experiencing rates 4-5 times higher than new case rates in the United States and even India – despite relatively high rates of vaccination in those same Latin American countries. In Bolivia, Chile, Uruguay, and Brazil, recent surges are filling hospitals. In São Paulo, 80% of the ICU beds are occupied by COVID patients and Colombia is at its worst point yet in the pandemic, reporting a record of 577 new deaths on Tuesday. Against this backdrop, PAHO officials urged countries with high transmission to tighten public health measures until vaccination campaigns have accelerated further. “When [public health measures] are strictly implemented and monitored, they are very effective in bending the epidemiological curve and protecting the health care facilities for severe and critical patients,” said Dr Sylvain Aldighieri, PAHO’s COVID-19 Incident Manager. Vaccination Campaigns Stall in Central and South America Less than 10% of people in Latin America and the Caribbean, a region of 600 million people, have been fully vaccinated against COVID. Vaccine rollouts continue to progress slower than what is needed, said PAHO officials. Doses are urgently needed to protect the most vulnerable populations, obtain vaccine coverage, and to control transmission. “We welcome the announcement by the Group of Seven [G7], who pledged one billion COVID vaccine doses to countries around the world,” said Etienne. This commitment offers “fresh hope” to countries struggling to secure enough vaccines to protect their populations. PAHO officials urged G7 nations to prioritise doses for countries at greatest risk and to not delay the delivery of their donations. The Americas has been in crisis for months and without the support from the international community, “recovery remains in the distant future,” said Etienne. In countries where vaccination coverage has been high, including the US, United Kingdom, and Israel, a dramatic reduction in COVID-related hospitalizations and deaths has been seen. G7 Donation is Insufficient to Fully Vaccinate the Region “Even with this generous donation, we are still a long way from protecting the more than 600 million people living in Latin America and the Caribbean,” said Etienne. Reaching everyone in the region will require greater vaccine sharing, financial support to secure supplies, and investment to expand the region’s vaccine manufacturing capacity. “No country and no region is safe until high vaccination coverage is reached,” said Dr Jarbas Barbosa, Assistant Director of PAHO. Dr. Jarbas Barbosa, Assistant Director of PAHO. “We are counting on the support of countries, of donors, and the international community to get us there as quickly as possible,” said Etienne. “No country has reached herd immunity, so more remains to be seen about how we can achieve population-wide protections, particularly as variants circulate,” said Etienne. This will likely involve strengthening the capacity of surveillance systems to detect transmission, expanding the capacity of national and local governments to rapidly implement and maintain strict public health measures, and strengthening the capacity of health systems to manage the surge in severely ill patients. Vaccine Hesitancy Needs to be Addressed by Governments Through Communication Campaigns While PAHO officials stressed that vaccine access is the primary issue across Latin America and the Caribbean and not vaccine acceptance, they also highlighted the need for efforts to increase confidence in vaccination campaigns. As vaccine campaigns will likely begin ramping up soon in light of the recent vaccine sharing commitments, governments must provide clear and transparent information about COVID vaccines to improve trust. “It is where there are breakdowns in information and communication, or when details are slow to arrive that misinformation takes root,” said Etienne. Etienne called for health workers to have the information they need to answer the questions and concerns of their communities and their own families regarding vaccination. “Health workers should receive special attention, as they’re not just at greater risk of contracting the virus, but they’re also some of the most trusted voices for vaccines,” said Etienne. “People naturally turn to health workers, including doctors, nurses, and community health workers for medical advice,” she added. Haiti Hasn’t Received COVAX vaccines Haiti, in particular, has seen a lack of trust in the health system and distrust of vaccines. It is the only country in the Americas participating in COVAX that hasn’t received any vaccines. The delay in deliveries was due to governmental instability and a lack of implementation of the administrative measures required to receive the vaccines. A shipment of 132,000 AstraZeneca vaccine doses from COVAX is scheduled to arrive in Haiti in July and the US plans to deliver doses in the near future. Haiti has been prioritised to receive vaccines because of the deadly wave that is hitting the country, with sharply escalating cases, hospitalizations and deaths in recent weeks. “We will probably face a very…challenging situation in Haiti,” said Barbosa. “It’s crucial that they adopt the public health measures, and at the same time, they get the vaccine to protect the most vulnerable groups in the country.” A good communication strategy is “probably the most crucial part of vaccinations,” said Barbosa. “Unfortunately, the vaccine was the target of many anti-vax groups and people sharing rumours and conspiracy theories.” “It’s very important that the national authorities in each country establish a direct chain of communication with healthcare workers, with the communities, with the population, showing the data…that vaccines can save your life and contribute to controlling this pandemic,” he added. Metropolitan Areas Fuel Surges The uptick of cases in some parts of Latin America can be attributed to socio-economic factors, said Aldighieri. Dr. Sylvain Aldighieri, Incident Manager at PAHO. In particular, countries with significant large metropolitan areas means that even during lockdowns, there remains a pattern of intensive, continuing close contact between citizens, which can fuel continued infections. From the cities, COVID-19 can be quickly amplified and spread again to more remote and rural areas where control of the virus was more successful. Mexico’s spike in transmission about a month ago has prompted national authorities to monitor the situation in several states, specifically in Baja California and the Yucatan peninsula. Recent weeks have also seen increases in Costa Rica, Guatemala, and Panama. “In order to have an impact on the SARS-CoV-2 transmission, countries need to find the right balance between strict implementation of public health measures for lowering transmission, and economic activities,” said Aldighieri. Image Credits: WHO PAHO, PAHO. Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Groundbreaking Study: Mosquitoes Armed with Wolbachia Bacteria Reduced Symptomatic Dengue Infections by 77% In Indonesian Trial 16/06/2021 Madeleine Hoecklin Infecting mosquitoes with Wolbachia could be an effective and self-sufficient manner of controlling dengue. In a “groundbreaking” trial conducted in Indonesia, lab-grown mosquitoes infected with Wolbachia bacteria reduced the rate of symptomatic dengue infections by 77%, and hospitalizations by 86%, in communities where the bacteria-armed mosquitoes were released. The three-year study, which was led by the World Mosquito Program, provides compelling evidence for a new method of controlling dengue. The study was published in the New England Journal of Medicine last week. Dengue is a mosquito-borne viral infection with approximately 100 million to 400 million infections recorded per year. Some 70% of the global burden of dengue is in Asia, where severe dengue has become the leading cause of hospitalisation and death among children and adults. The incidence of dengue has grown dramatically around the world in recent decades. Indonesia is a global hotspot for dengue, which is present in all provinces of the country and endemic in many large cities. Disease modelling studies have predicted that the Wolbachia-mediated blocking of dengue virus infection in Aedes aegypti mosquitoes could be sufficient to eliminate dengue in low or moderate transmission settings. However, the Indonesia trial is one of the first to demonstrate efficacy in a large population setting. In the wake of the results of this and other trials, the World Health Organization is reportedly developing recommendations for Wolbachia mosquitoes as a method of dengue control. Bacteria-infected Mosquitoes Curbed Dengue Infections and Hospitalizations Researchers infected lab-grown Aedes aegypti mosquitoes in the city of Yogyakarta with the Wolbachia bacteria, which is found naturally in many insects and blocks the dengue virus from replicating and spreading to humans. Aedes aegypti mosquitoes are the main transmitters of dengue virus. The city was separated into 24 clusters. Eggs of the disease-fighting mosquitoes were released in 12 of the clusters every 2 weeks for 18 to 28 weeks – while in the other half of the city the mosquito populations were not treated. Ten months after the releases began, the prevalence of Wolbachia among the local mosquito population in the treated clusters reached over 80%. The researchers then studied disease outcomes among some 6,306 people who came to primary care clinics with a fever in the treated and the untreated areas. Of the patients who lived in treated clusters, only 2.3% tested positive for dengue virus, compared to 9.4% of those in control areas. The incidence of symptomatic dengue cases was reduced by 77% and hospitalizations dropped by 86%. “This result is groundbreaking,” said Dr Katie Anders, Director of Impact Assessment at the World Mosquito Program. “We think it can have an ever greater impact when it is deployed at scale in large cities around the world, where dengue is a huge public health problem.” In 11 of the 12 treated clusters, the proportion of participants with dengue was lower than in the control groups. There were 67 cases recorded among the participants residing in the intervention clusters and 318 recorded among those who lived in the control clusters. Some 13 hospitalizations for dengue were reported among participants in intervention clusters as compared to 102 hospitalizations in the control clusters. The efficacy of the lab-grown mosquitoes was similar in reducing incidence of four dengue virus serotypes. “[This study] provides the gold standard of evidence that Wolbachia is a highly effective intervention against dengue,” said Oliver Brady, a dengue expert at the London School of Hygiene and Tropical Medicine, who was not involved in the study. “It has the potential to revolutionize mosquito control,” Brady added. Wolbachia as Possible New Dengue Control Measure Following the positive trial results, the World Mosquito Program and Yogyakarta’s District Health Office deployed Wolbachia-infected mosquitoes throughout untreated areas of Yogyakarta city in January 2021. Releases are also now underway in the neighbouring districts of Sleman and Bantul. Trials are meanwhile also ongoing in Colombia, Sri Lanka, India, and countries in the Western Pacific. “I am confident that Wolbachia can complement other methods in controlling dengue,” said Rhamawati Ningrum, a study nurse at Puskesmas Health Center. “I expect that this Wolbachia program continues, not only in the city of Yogyakarta, but in other cities across Indonesia.” According to the researchers, once mosquitoes are infected with the Wolbachia bacteria, the infection is maintained in the mosquito population and doesn’t need reapplication, which makes it a cost-effective strategy for controlling dengue. The Wolbachia method is also considered to be harmless to ecosystems, as 60% of insect species already carry the bacteria anyway. The results are consistent with findings from non-randomized Wolbachia deployments in northern Australia and Brazil, suggesting that the results could be replicated in different epidemiological settings. So far seven million people are under the protection of Wolbachia and the World Mosquito Program aims to cover at least 75 million by 2025 and half a billion by 2030. Wolbachia has the potential to also be effective against other diseases that Aedes aegypti mosquitoes carry, including Zika and yellow fever. Image Credits: Commons Wikimedia. Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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.
Africa’s COVID-19 Vaccination Rollouts Falter as Third Wave Grips Parts of the Continent 15/06/2021 Kerry Cullinan One of the lucky few: A woman shows her vaccination card after getting the AstraZeneca vaccine. Twenty-two African countries are experiencing a surge in COVID-19 infections, yet the vaccination rollouts on the continent have ground to a halt because of lack of supply. African vaccination figures, as recorded by the Africa Centers for Disease Control and Prevention, are dismal. Apart from the tiny island state of Seychelles, only Morocco’s vaccination rate is in the double digits with 16.7% of its population fully vaccinated. The next highest are Equatorial Guinea (6,26%), Tunisia (2,93%) and Zimbabwe (2,6%). In terms of numbers, Egypt has delivered the most vaccinations, which by Monday had topped 3,3 million. But in a country with a population of over 100 million, and each person needing two vaccinations, this means that only 0,39% of Egyptians are fully vaccinated. Meanwhile, Uganda has virtually run out of vaccines and oxygen, as COVID-19 cases increased by 2,800% in the past month. Its test positivity rate is 21.5%. Last week, the country entered a new 42-day lockdown in a bid to contain cases. Results of COVID-19 tests done on 13 June 2021 confirm 1,422 new cases. The cumulative confirmed cases are 64,251. pic.twitter.com/3aQmfdPgjR — Ministry of Health- Uganda (@MinofHealthUG) June 15, 2021 South Africa officially entered its third wave last week and is reporting over 5000 new cases per day with a test positivity rate of over 15%. On Tuesday night, President Cyril Ramaphosa announced that the country would move immediately to lockdown Level Three with a longer curfew, more limits on public gatherings and curbs on the sale of alcohol. The Democratic Republic of Congo, Namibia, Zambia and Kenya are also battling increased cases. “The steep increase in Africa is especially concerning because it is the region with the least access to vaccines, diagnostics and oxygen,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s biweekly COVID-19 briefing on Monday. “A recent study in the Lancet showed Africa has the highest global mortality rate among critically ill COVID-19 patients, despite having fewer reported cases than most other regions,” he added. Most African countries have relied on the COVAX-facility for vaccines, but these supplies dried up in late March when the global vaccine platform’s key supplier, the Serum Institute of India, redirected all its AstraZeneca vaccines to address India’s pandemic. To date, COVAX has supplied 37 of the 55 African states with vaccines. Almost 60% of African countries are reliant solely on AstraZeneca, according to the Africa Centres for Disease Control, and many countries have only administered a single dose to citizens with no idea of when they will receive supplies to administer the second dose. Countries that have been able to reach more than 1% of their populations have done so largely because they have had other vaccine sources besides COVAX – primarily China’s Sinopharm, which is available in Morocco, Egypt, Tunisia, Seychelles, Zimbabwe and Equatorial Guinea among other countries. Some of the north African countries also have access to Russia’s Sputnik V vaccine. Two Million J&J Vaccines Destined for South Africa Have to be Destroyed South Africa decided not to use the AstraZeneca vaccine following research which showed diminished efficacy against the Beta variant (B1.351) dominant in the country and has bought Pfizer vaccines – reportedly at great cost – as well as Johnson & Johnson vaccines. However, South Africa’s worst fears were realised over the past weekend when all two million Johnson & Johnson COVID-19 vaccines ready for distribution in the country were found to be made from batches that the US Food and Drug Administration (FDA) ruled unsuitable last Friday. Last week, the country officially entered a third wave of the pandemic but it has only administered 1,350,000 vaccines – which translates into 0,5% of its population being fully vaccinated as two-thirds of these are the two-dose Pfizer vaccine. With a drip supply of the costly Pfizer COVID-19 vaccines arriving every week, doses have been strictly rationed to health workers and those over the age of 60. Johnson & Johnson has undertaken to replace the two million doses by the end of June – but they were expected to have been dispensed in early May, which means that the rollout is running two months behind schedule. However, Ramaphosa said on Tuesday night that “the pace of vaccinations has steadily picked up, and we are now vaccinating around 80,000 people a day at over 570 sites in the public and private sector. This number will grow rapidly in the weeks to come, as we aim to protect as many vulnerable people as possible.” Officially, South Africa has been the worst affected on the African continent with over 1,7million COVID-19 cases. The official COVID-19 death toll is over 57,000 but “excess deaths” of 166,794 were recorded between 3 May 2020 and 5 June 2021, according to the SA Medical Research Council (SAMRC). The peaks and troughs of these excess deaths correlate almost exactly with the COVID-19 waves. Huge ‘Excess Deaths’ in Egypt Meanwhile Egypt appears to have completely under-reported the impact of COVID-19. Between March 2020 and May 2021, it claimed a death toll of little more than 13,000 – yet its excess mortality for this period was over 175,000, according to the University of Washington’s Institute for Health Metrics and Evaluation (IHME). This means that it has more deaths than South Africa, even when that country’s excess deaths are taken into account. Egypt has the highest obesity rate on the continent, so its death rate is in keeping with global trends. It is likely that the impact of the pandemic is much greater in a number of other African countries, but only a handful have functioning civil death registration systems – namely Egypt, South Africa, Tunisia, Algeria, Cape Verde, São Tomé and Príncipe, Seychelles and Mauritius. In a preprint article based on the world mortality dataset, academics Ariel Karlinsky and Dmitry Kobak report that they found the highest undercounts of excess mortality in Uzbekistan (30), Kazakhstan (12), Belarus (15), Egypt (13), and Russia (6.7). “Such large undercount ratios strongly suggest purposeful misdiagnosing or underreporting of COVID-19 deaths,” according to the authors. Countries Need Logistical Support to Prepare for Vaccine Rollouts Ghaanian President Nana Akufo-Addo gets vaccinated against COVID-19 with the first COVAX vaccine to be distributed in the world. Last Sunday, the G7 countries announced that they would be donating 870 million doses to countries in need – primarily through COVAX. However, many of these will be Pfizer vaccines that need to be stored at ultra-cold temperatures. Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly,” Ryan told Monday’s WHO press briefing on COVID-19. “There is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines,” urged Ryan. Meanwhile, a statement from the COVAX partners this week in response to the G7 donation also urged support for countries for rollouts. “Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest,” said the partners in a media statement. “In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months,” it added. The Democratic Republic of the Congo has already sent some of 1.7 million of its COVAX-donated vaccines to other countries because it was unable to distribute them before their expiry date. Meanwhile, South Sudan intends to destroy 59,000 vaccines that have expired and Malawi earlier destroyed 20,000 expired vaccines despite being told by Africa CDC and other bodies that they could be used. Image Credits: WHO, WHO African region . WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO to Study Social Measures That Keep COVID-19 at Bay – in Case of No Vaccines in Future Pandemics 14/06/2021 Kerry Cullinan Wearing masks, social distancing, travel restrictions: the WHO plans to study social and behavioral interventions that have kept COVID-19 away. The World Health Organization (WHO) is planning to study the public health and social measures that countries have used to keep COVID-19 at bay successfully – in case there is no quick vaccine for the next pandemic. A special working group has been set up with the support of Norway to study these measures, WHO Director-General Dr Tedros Adhanom Ghebreyesus told Monday’s WHO COVID-19 media briefing. “The emergence of more transmissible variants means public health and social measures may need to be more stringent and applied for longer, in areas where vaccination rates remain low,” said Dr Tedros. “To improve the evidence base on the effectiveness of public health and social measures, WHO is collecting data from around the world on which measures are used and the level at which they are applied.” However, he warned that it was hard to study these measures because countries typically use a range of them at the same time, and “untangling the precise impact of each individual measure can be challenging”. Norway’s Minister of Health and Care services, Bent Høie, told the briefing: “We have been lucky this time. The next pandemic may behave differently from COVID-19 and we may have to depend on public health and social measures for a much longer time in the next pandemic before vaccines are available.” Although thousands of scientific papers have been produced about the science of COVID-19, very few have examined the impact of measures such as wearing masks, social distancing, testing-and-tracing and travel restrictions, said Høie. “Even though most countries have been using these restrictive measures extensively for more than a year, our knowledge on the precise effects of each of these measures is unclear, and the effects are difficult to research,” he added. The WHO working group will examine the impact, social and economic costs of the different measures used, and develop better tools that can be deployed during the next pandemic, he added. Countries Need Help with Vaccination Preparedness People waiting to register for COVID-19 vaccines in the Pakistan Institute of Medical Science. “Globally, the number of new cases of COVID-19 reported to WHO has now declined for seven weeks in a row, which is the longest sequence of weekly declines during the pandemic so far,” said Tedros. However, he added that the decline masked a “worrying increase” in many countries. “The steep increase in Africa is especially concerning, because it is the region with the least access to vaccines, diagnostics and oxygen,” said Tedros, pointing out that around 420 people would have died of COVID-19 during the hour-long briefing. While Tedros welcomed the G7 Summit’s announcement on Sunday that it would donate 870 million vaccine doses, he stressed that “we need more, and we need them faster”. A wide range of civil society organisations have condemned the G7 for failing to agree to the UK’s call to donate one billion vaccine doses. Former UK Prime Minister Gordon Brown told Sky News that the G7 leaders were guilty of an “unforgivable moral failure” for failing to donate the vaccines. The majority of the vaccine donations will be Pfizer vaccines, which need to be transported and stored in ultra-cold conditions – although once they have been taken out of cold storage, they can be kept in normal refrigeration for up to three months, according to Mariangela Simao, WHO’s Assistant Director General for Access to Medicines. But Dr Mike Ryan, WHO’s Director of Health Emergencies, warned that the logistics around cold chain management and vaccination rollouts was complex. “Countries need assistance in preparing for that. A second tragedy will be to have vaccines and not be able to use them properly. And there is underfunding right now of basic preparedness in many, many countries. We would urge donors and others to not only just fund vaccines, but to fund the operations needed to deliver those vaccines, and to fund the agencies like UNICEF, like ourselves and other NGOs who are working very closely with governments to improve their capacity to deliver vaccines.” Addressing the $16 billion shortage faced by COVAX, the global vaccine platform, Ryan pointed out that this was around 1% of a year’s spending on global military defence. “Surely we can afford 1% of that to save lives, and bring this pandemic to an end?” asked Ryan. Image Credits: Cross River State Primary Health Care, Nigeria , Flickr: Joseph Gage, Rahul Basharat Rajput. Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. 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
Novavax could make 100 million monthly doses of COVID-19 vaccine by October 14/06/2021 Paul Adepoju A PREVENT-19 phase 3 trial volunteer receives the Novavax vaccine at a trial site in Plano, Texas. Biotech manufacturer Novavax announced on Monday it would be able to manufacture 100 million doses of its two-dose COVID-19 vaccine every month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year – once it has secured regulatory approval for its vaccine. This follows a successful Phase 3 trial, which showed that the vaccine, NVX-CoV2373, had an overall efficacy of 90.4% and showed 100% protection against moderate and severe COVID-19 disease, according to the company. Almost 30,000 participants across 119 sites in the US and Mexico participated in the trial. Trial participants were representative of communities and demographic groups most impacted by the disease, according to the company. The recombinant nanoparticle protein-based vaccine acts by inducing antibodies that block the binding of spike protein to cellular receptors. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.” Efficacy of Over 90% NVX-CoV2373 demonstrated overall efficacy of 90.4%. In all, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease. “NVX-CoV2373 also showed success among ‘high-risk’ populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0%, with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group,” Novavax stated. Regarding strains of SARS-CoV-2, the vaccine demonstrated 100% efficacy against variants not considered Variants of Interest (VoI) and Variants of Concern (VoC). Novavax also stated that of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2%, achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group. Preliminary safety data also showed the vaccine to be generally well-tolerated considering serious and severe adverse events were low in number and balanced between vaccine and placebo groups. Adverse reactions were restricted to less than 1%. Fatigue, headache and muscle pain were the most common symptoms, lasting less than two days. Ready to File by Third Quarter Before the vaccine can be included in the panel of vaccines that will become available for use in the fight against the pandemic, it needs to complete the final phases of process qualification in addition to assay validation which is required for it to meet chemistry, manufacturing and controls (CMC) requirements. According to Novavax’s estimates, it will be ready to file for regulatory authorizations in the third quarter of 2021. Of particular interest will be authorizations by the European Medicines Agency (EMA) and the World Health Organization’s Emergency Use Listing. Even though several steps are still ahead before NVX-CoV2373 joins the list of approved vaccines for use, Gregory M. Glenn, President of Research and Development at Novavax expressed confidence that the results from the PREVENT-19 clinical trial are strong indications on the candidate vaccine making it to the end users. “PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government,” Glenn said. Our partner @Novavax has today released extremely encouraging Phase III trial results for its #COVID19 vaccine. This will be a critically important addition to the armamentarium. We invested up to $388m in early R&D, testing the potential of the vaccine, and manufacturing (1/3) https://t.co/ERZZzpRw3q — CEPI (@CEPIvaccines) June 14, 2021 There is also a green light for the vaccine getting added to the list of vaccines that are available to countries through the COVAX Facility. In a statement, the Coalition for Epidemic Preparedness Innovations (CEPI) said Novavax’s COVID-19 vaccine will be “a critically important addition to the armamentarium”. CEPI said it invested up to $384 million, in early research and development, in testing the potential of Novavax’s vaccine technology. CEPI also announced agreements with its partner GAVI to supply vaccines to COVAX. As part of the agreement, Novavax will supply 350 million doses of its COVID-19 vaccine, from as soon as it has secured regulatory approval. “A total of 1.1 billion doses of the Novavax vaccine are expected to be made available to COVAX, with the remaining volumes set to be supplied through the Serum Institute of India,” CEPI stated. Image Credits: Matt Feldman, Novavax. Posts navigation Older postsNewer posts