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.

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. 

“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.

“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.

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. 

vaccine
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.

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.

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.

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 .

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.

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.

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.

A child works in a tobacco field in Indonesia

Over the past several decades, the tobacco industry has tried to influence policy by partnering with various United Nations (UN) agencies. Many of these agencies, however, have since cut ties with the industry, thus safeguarding their initiatives and policies from Big Tobacco’s commercial interests. One notable exception remains and must be addressed: the continued membership of the tobacco industry-funded Eliminating Child Labour in Tobacco-Growing Foundation (ECLT) in the UN Global Compact (UNGC). More than 170 civil society organizations have now called on UNGC to end ELCT’s participation.

Tobacco industry benefits from UN partnerships 

The advantages the tobacco industry gains from these types of collaboration are not imagined or hypothetical. There is evidence that shows how it has benefited.

For decades, the tobacco industry nurtured its alliance with the International Labour Organization (ILO). Transnational tobacco companies financially supported the agency’s work, and Philip Morris International even displayed the ILO logo on its website. The closeness was reciprocated. In 2002, the ILO produced a glowing report about trends and prospects in the tobacco industry, and in 2017, included praise for its work with the tobacco industry in its Governing Body’s reference document.

The industry also sought to influence the Food and Agriculture Organization (FAO), positioning experts on various FAO/World Health Organization (WHO) committees and working to direct funding to research and policy groups sympathetic to the industry. And its work with United Nations International Children’s Emergency Fund (UNICEF) in the late 1990s (both directly and via front groups) on youth smoking prevention initiatives was revealed via industry documents to be a way to avoid meaningful tobacco control measures.

BAT used International Chamber of Commerce co-operation to get closer to WHO

An especially concerning example of attempted industry interference in health policy was British American Tobacco (BAT) allegedly using its ties to the International Chamber of Commerce (ICC) to influence WHO. As the “world’s largest business organization,” the ICC is regularly consulted by the UN on business issues. In 2000, then-BAT CEO, Martin Broughton, joined the ICC UK’s governing body; one of the listed membership benefits being “preferential access to the UN and its constituent organisations.”

In July 2000, the WHO published an exposé, Tobacco Company Strategies to Undermine Tobacco Control Activities, based on internal industry documents, claiming that the industry subverted its efforts to control tobacco use. 

The exposé did not stop the tobacco industry. Even as the WHO Framework Convention on Tobacco Control (FCTC) was being prepared, Broughton wrote to the ICC requesting that the organisation get involved in the negotiating process, from which the tobacco industry had been officially excluded. The WHO went on to coordinate and successfully complete the FCTC negotiations which, among other things, set the guidelines for preventing tobacco industry influence in public policy.

Other UN agencies have cut ties with the tobacco industry

In 2019, after a multitude of efforts from sustainable development and public health groups and several international non-governmental organisations, the ILO finally ended tobacco industry funding. The FAO has since moved to demand transparency and accountability from its expert consultants (an effort about which the full effect is still unknown), and UNICEF has stated that it has developed a policy on tobacco, though the policy has yet to be published on UNICEF’s website. These are all important steps in keeping the tobacco industry out of the UN.

The UNGC must end the ECLT’s membership to cut ties with tobacco industry

The UNGC is a voluntary UN initiative made up of businesses, public sector organisations, cities and non-governmental organisations committed to socially responsible business practices in the areas of human rights, labour, the environment, and anti-corruption. Recognizing that “tobacco products are in direct conflict with UN goals, particularly with the right to public health, and undermines the achievement of SDG 3,” the UNGC’s 2017 move to exclude membership from organisations that “derive revenue from the production and/or manufacturing of tobacco” was a smart one.

However, the ECLT remains a member of the UNGC. While its supposed pursuit of ending child labour (which it has yet to accomplish) looks good from the outside, the ECLT is actually an alliance of tobacco companies and growers—an industry front group—and its UNGC membership provides “the industry with the opportunity to have a seat at the policy table among respected organisations and sometimes Member State Delegations…” As we’ve seen with other UN agencies, this type of cooperation can hinder tobacco control and instead provide benefits to the tobacco industry. After two decades of ECLT’s work, child labor remains entrenched in many tobacco-growing regions.

That is why the UNGC should uphold the Model Policy for Agencies of the United Nations System on Preventing Tobacco Industry Interference, which affirms that “engagement with the tobacco industry is contrary to the United Nations system’s objectives, fundamental principles and values,” and look to FCTC Article 5.3 Guidelines for the necessary steps to prevent industry influence.

Ending child labor should not be in the hands of an industry whose supply chain allegedly benefits from practices that keep leaf prices low. A continued partnership promises to only hinder the elimination of child labor and continues to allow tobacco industry influence to stream into the UN.

The fight to eliminate tobacco industry influence within the UN system isn’t over—but UNGC excluding the ECLT would be an important step.

* Mary Assunta is Head of Global Research and Advocacy at the Global Center for Good Governance in Tobacco Control and a Partner in STOP.

 

Image Credits: Human Rights Watch.

Johnson and Johnson single-dose vaccine

The US Food and Drug Administration (FDA) has authorised the release of two batches of the Janssen/ Johnson & Johnson COVID-19 vaccine – about 10 million doses – manufactured at the Emergent BioSolutions facility in Baltimore, according to a statement on Friday.

However, it also “determined several other batches are not suitable for use” while “additional batches are still under review,” it added.

The rejected doses amount to around 60 million doses, according to the New York Times.

For weeks, the future of the Johnson & Johnson vaccines have been up in the air as the FDA conducted “a thorough review of facility records and the results of quality testing performed by the manufacturer”.

This follows the discovery of serious breaches at Emergent, including the cross-contamination of Johnson & Johnson and AstraZeneca vaccines and mould in the Baltimore plant.

The Emergent problems have hampered severely South Africa’s vaccine rollout, as a local company, Aspen, is contracted to fill and finish for Johnson & Johnson, and was due to supply over two million vaccines to the national vaccination programme.

It is unclear how many of the South African vaccines are affected by the FDA decision.

“The FDA’s decision to include these two batches of vaccine drug substance in the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” said the FDA.

“A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.”

The FDA has also extended the expiration date for refrigerated Janssen COVID-19 vaccines from 3 months to 4.5 months.

“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“Additionally, the action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine.”

 

G7 leaders pose ahead of their meeting in Cornwall

Before the G7 leaders sat down on Friday afternoon in Cornwall to discuss how to “build back better” a world devastated by COVID-19, UK Prime Minister and summit host Boris Johnson challenged the Group to accept a target of providing one billion doses to developing countries.

But the People’s Vaccine Alliance, a network of over 50 organisations, has called on the G7 to “agree on a global goal to vaccinate 60% of the world by the end of 2021, with everyone reached in the next 12 months”. 

This would mean that 4.8 billion single-dose vaccines are needed – or 9.6 billion of the two-dose vaccines such as Pfizer, AstraZeneca and Moderna.

In an article published on Thursday, Johnson urged the Group “to adopt an exacting yet profoundly necessary target: to provide one billion doses to developing countries in order to vaccinate everyone in the world by the end of next year”.

According to Johnson: “Our scientists devised vaccines against COVID-19 faster than any disease had ever been overcome before. Britain and many other countries are inoculating their populations more swiftly than anyone thought possible,” he added.

“Now we must bring the same spirit of urgency and ingenuity to a global endeavour to protect humanity everywhere. It can be done, it must be done – and this G7 summit should resolve that it will be done.”

Some 42% of G7 Residents Are Already Vaccinated

By the end of May 2021, 42% of people in G7 countries had received at least one vaccine dose, compared to less than 1% in low-income countries, according to the alliance. COVID-19 cases are surging in large parts of Latin America and Africa.

The US this week committed to donating half a billion Pfizer vaccines to the world’s poorest countries in the next year, according to a White House announcement on Thursday. Deliveries will start in August, and the US has undertaken to deliver 200 million doses this year and the remaining 300 million by mid-2022. Two doses of this vaccine are needed, so the donation will cover 250 million people.

Saturday’s agenda for G7 – which comprises the UK, US, Canada, France, Italy, Germany, Japan and the European Union – will focus on global resilience, foreign policy (including aid) and health.

Leaders are expected to get into the details of vaccine distribution in the health session that will be addressed by the Gates Foundation’s Melinda French Gates and the UK’s Chief Scientific Adviser, Sir Patrick Vallance.

India and South Africa – co-sponsors of the TRIPS waiver proposal at the World Trade Organization (WTO) – have also been invited to the summit, along with South Korea, which has significant vaccine manufacturing capacity, and Australia. 

The World Health Organization, WTO, International Monetary Fund, Organisation for Economic Co-operation and Development and World Bank Group will also be in attendance.

But the People’s Vaccine Alliance has warned that any G7 promise to vaccinate the world by 2022 will not happen if governments continue to block proposals to waive patents and transfer technology and know-how.

It also wants the Group to “support the immediate suspension of intellectual property rules and enforce the transfer of vaccine technology to all qualified vaccine manufacturers in the world” and “pay their fair share of the money needed to manufacture billions of doses as fast as possible”.

‘Fantastic” French Support for TRIPS Waiver 

French President Emmanuel Macron and UK Prime Minister Boris Johnson greet each other at the G7 Summit.

“Of the G7 nations, only the US has explicitly supported waiving patents for vaccines – though not for treatments or diagnostics – and Japan has said it will not oppose the moves if they are agreed,” according to the People’s Vaccine Alliance.

“Germany and the UK continue to vehemently oppose the plan, despite its potential to massively increase vaccine production and save millions of lives, while Canada, Italy and France remain on the fence,” it adds.

However, following a quick visit to South Africa late last month, French President Emmanuel Macron appears to have climbed off the fence and stated on Thursday that he would support the TRIPS waiver.

Oxfam’s Health Policy Manager, Anna Marriott, described this news as “fantastic”, and called on the rest of the G& countries to follow suit.

“It doesn’t make sense for the entire world to be dependent on just a handful of pharmaceutical corporations that cannot make enough vaccines for everyone,” said Marriot. 

“Developing countries do not want to be dependent on donations of leftover vaccines from rich nations, most of which won’t even be given until next year. They simply want the rights and the recipes to make these vaccines themselves as fast as possible and this is what must be agreed at the G7 summit this week.”

Ahead of the summit, the US and the UK agreed to a new effort to combat future pandemics, through a partnership between the UK Health Security Agency (UKHSA) and the US National Centre for Epidemic Forecasting and Outbreak Analysis, run by the US Centers for Disease Control and Prevention (CDC).

The partnership will bolster “disease surveillance, as well as genomic and variant sequencing capacity worldwide” and establish an early warning system to detect diseases, particularly in low and middle-income countries that do not yet have the same capabilities.

This international approach to future pandemics builds on the Prime Minister’s recent launch of a new ‘Global Pandemic Radar’ to identify emerging COVID-19 variants and track new diseases around the world.

 

Image Credits: G7/UK.