COVID-19 has spread to rural India where many are dying of COVID-like symptoms. Experts are certain India’s already high official numbers do not reflect the true extent of the spread of the virus.

PUNE: India’s second wave is devastating the country’s rural areas where health infrastructure is rickety and a lack of trained healthcare workers, government support and access to healthcare is likely to worsen the spread of the COVID-19 pandemic.

Health experts believe the number of new COVID-19 cases and deaths are vastly underreported and that strict lockdown regulations and amping up vaccinations will be the key to help curb a possible third wave.

Rabeena Manral, a young mother of two boys who lives in the Champawat region of the picturesque Himalayan state of Uttarakhand, is certain that she was infected with the virus this year, but due to a lack of testing in her village, could not confirm her status. 

While the COVID-19 surge last year left her hilly village of roughly 200 people untouched, this time around there are dozens of known cases and three confirmed COVID deaths so far. 

To get tested Manral will have to hire a private vehicle and travel 15 to 20 km away – a distance too expensive to cover. Public buses are no longer plying as the state is currently under a lockdown to stop the spread of the virus. 

For weeks Indians have been turning to social media with pleas for help and finding help from fellow citizens, instead of the government, as Health Policy Watch reported earlier. Those living in rural areas like Manral are not on Twitter. Even if they were, there is no nearby hospital a sick patient can be taken to in an emergency. 

India has been consistently recording over 3,50,000 new daily cases and over 4,000 deaths for around two weeks now. Experts like Ashish K Jha, dean of the Brown University School of Public Health, believes that both the number of new cases, and the deaths are vastly underreported in India’s vast rural areas. 

Doctors working in rural areas confirm this assumption. Yogesh Jain, a physician and founding member of the Jan Swasthya Sahyog, a health non-profit that runs low-cost health programs in the central Indian state of Chhattisgarh, said that during the first wave of COVID-19 in 2020 he saw only a handful of cases and no deaths in the villages of the state. “It is now 50-50 (urban-rural case spread). There have been several, several deaths. The disease is well spread everywhere.”

Jain worries that the situation will worsen in the coming weeks and that the problem might neither be documented, nor acknowledged.

Indian government has consistently downplayed the toll the pandemic has taken on the country. The government has also pushed the task of procuring the vaccines on to the states, who are now trying desperately to arrange vaccines for their residents and failing.

In rural India people are simply dropping dead without access to tests or treatment. “There was a time most people in my village were sick and had symptoms like fever and cough, including me. None of us got tested,” Manral said speaking over the phone. Some tests were done sometime in April following a death in the village after a wedding party and so Manral knows that dozens are currently positive.

In Rabeena Manral’s rural Himalayan village there are dozens of COVID-19 cases. She suspects she herself might have had the virus but without access to tests there is no sure way to know.

But weddings have continued. Manral says there were a dozen or so in the past month, but now instead of hundreds of attendees only a handful family members are present. 

Jha has consistently communicated that large gatherings like weddings and election rallies are out of the question but Uttarakhand was one of the states that allowed thousands of devotees to gather for Kumbh, a religious event where devotees pray at the banks of the river Ganges that is considered sacred by the Hindus. The event ended up being a super spreader.

In recent days dozens of dead bodies of suspected COVID patients have washed ashore in villages downstream. Petitioners have approached India’s Supreme Court seeking its intervention in the deteriorating health and administrative situation. 

India’s High Positivity Rate

India is reporting a high positivity rate, leading experts to believe that a large number of cases are unreported.

Currently of every five samples tested for COVID in India, one comes back positive. 

The World Health Organization (WHO) recommends that this rate be below 5% for at least two weeks before countries consider easing their restrictions. At 20% test positivity rate, India is likely missing many COVID-19 cases.

Women have been hit particularly hard. Husbands who work as migrant workers outside are back home and without incomes. Anecdotal evidence suggests a rise in cases of domestic violence and stress for the women.  

“The burden on women has increased tremendously,” said Arvind Malik, CEO of Udyogini, an NGO that works with women enterprises across five states in central and northern India. “All these areas we work with are remote. The economy is run by migrant workers. All that has been disrupted. Many households are on the verge of not having food.”

Vaccinations Will be the Key in India

Along with restrictions that many states in India are now resorting to, ramping up vaccinations will be the key, according to experts. In Manral’s village all those above the age of 45 have received vaccinations.

Overall, around 2.5% of Indians are currently fully vaccinated against COVID and a tenth of the population has received at least one dose. If India has to avoid a third wave this number will have to be scaled up quickly. 

As authorities come under fire for not doing enough to pre-empt and handle the second wave, they are pointing out that India’s large size makes vaccinating its roughly 1,391,716,282 population a challenge. India’s health ministry has said that more indigenous vaccines could be available in the market in the coming months, a claim experts in India have called misleading and exaggerated. 

With the situation in urban India dire, those in rural areas are not receiving any media or aid attention this time around, according to Malik. The large digital divide has affected every aspect of life in rural India as children lose learning hours in the absence of mobile and internet connectivity.

Jain points to some urgent measures that need to be taken. “We should stop counting infected people now,” he said, adding that the focus now ought to be on mitigation. “Have a clinical diagnostic criteria. Those who can be managed at home should get high-quality home care and the health workers need to be given adequate protective gear. Those who require hospitalization, the government has to ensure transportation and have a helpline to tell people where to go. Everyone should be able to reach a hospital within one hour.”

Disha Shetty is an independent journalist based in Pune, India

Image Credits: Udyogini, Rabeena Manral.

Researchers have quickly developed an outstanding arsenal of vaccines, treatments and diagnostics to counter COVID-19. But closer global coordination of diverse clinical trials testing the same or similar treatments, extending even to a global platform to pool anonymized patient data, could strengthen and accelerate research findings – especially as emerging variants threaten to unwind gains.

These were among the key points made during a two-day COVID-19 Global Research and Innovation Forum hosted by the World Health Organization (WHO), which brought together two dozen leading figures across academia, civil society, and ministries of health.

There was also growing recognition that equity needs to be built into global health funding –  mainly by redirecting resources to the global south and embedding access provisions into funding agreements.

“The lesson is clear. A collaborative approach to research and innovation is essential to responding to COVID-19 and to the epidemics and pandemics of the future,” said WHO Director-General Dr Tedros Adhanom Ghebreyusus on Thursday. 

“There is a need for us to look at how we organise not just individual pieces of research, but how each individual research initiative or innovation is linked to each other, and how we can drive a coherent strategy for the world,” stressed WHO’s Executive Director of Emergencies Mike Ryan.  

“The issue has not been that science has not delivered,” added WHO’s Chief Scientist Soumya Swaminathan. “We haven’t been able to [work together] as a global community to really achieve the equity that we would have liked to have seen in the availability and access to these absolutely life-saving interventions.”

COVID-19 Research Has Boomed – But More Collaboration Needed

Despite astonishing progress in R&D since the novel coronavirus first emerged – from the development of mRNA vaccines to the use of lifesaving steroids for severe COVID-19 – the findings of many studies remain limited, warned panelists on Thursday. The most common flaws were methodological weaknesses and a lack of comparability, they added.

“There is so much diversity in studies with a lack of standardization across the board that it’s really difficult to reach conclusive evidence for many of the questions that are still outstanding,” said Marion Koopmans from Rotterdam’s Erasmus University Medical Centre Rotterdam, who is a member of the WHO-convened group to investigate the origins of SARS-CoV-2.  

Sylvie Briand, WHO’s Director of Infectious Diseases, explained that coronavirus variants have been particularly difficult to study because a wide range of data from diverse world regions is needed, including genetic sequencing data, epidemiological data, and clinical data. 

All of these data streams are crucial to investigate whether variants are becoming more contagious, virulent, and resistant to existing vaccines, she said. Yet in many regions comprehensive data is scarce and mechanisms to pool all of those streams together are still lacking.

“We need some more new research but particularly we may need different coordination mechanisms because the key challenges that are outstanding really require a multidisciplinary endeavor,” added Briand.

And if existing vaccines turn out to require an update as a result of new variants, that will also require active involvement from the pharmaceutical industry, added Philip Krause from the US FDA’s Office of Vaccines Research and Review. 

“Because vaccination is an international enterprise, you can’t modify vaccines in just a few countries as developers and manufacturers are making vaccines for the world,” he added.

“Some of the companies that hold the critical supplies, reagents and groups, like Illumina, need to contribute and participate,” added Trevor Mundel, President of Global Health at the Bill and Melinda Gates Foundation. 

“We need to be sure that our ability to sequence the virus as it spreads is much better distributed according to where we may anticipate problems [but] so far we haven’t seen at a certain level,” said Mundel.

The Future? A Portfolio of Coordinated Clinical Trials

Going forward, a portfolio of coordinated clinical trials could represent a fruitful strategy that would yield more robust data faster, while also avoiding duplication of research efforts, the panelists suggested.

While such a portfolio has not yet been developed, there are signs that large-scale clinical trials are being increasingly harmonized. Examples including the WHO’s Solidarity Trials to test possible therapeutics, the UK’s Recovery Trials, as well as three large-scale clinical trials investigating antithrombotic treatments  – ATTACC, ACTIV, and REMAP-CAP.

“Something quite remarkable that happened was that three of the large-scale platform trials [anti-thrombotics] were able to collaborate and to agree on common protocols in order to address some of the key questions in the fastest way possible,” emphasized Professor Michael Jacobs, the Clinical Director of Infection at London’s Royal Free Hospital.

“This is an incredibly important achievement for three trials that evolved independently to be able to come together to use common approaches to address key questions as quickly as possible for the benefit of patients.”

Antithrombotics have the potential to broaden the COVID-19 treatment menu, which remains limited to treating severe cases with dexamethasone or through expensive monoclonal antibodies, thus leaving few effective options to treat mild cases, said Jacobs.

Randomisation of Vaccine Distribution

There is also an increasing appetite for a global platform to pool anonymized patient data from large-scale trials. This could shed light on a range of questions about vaccine effectiveness, safety, and dosage regimens in populations after they are approved.

Ideally, those large-scale trials of vaccines following their approval would be randomized to yield more robust results, emphasized Krause, adding that randomization would be ethical in contexts where vaccine supplies are scarce – which seems to be the case across many low- and middle-income countries worldwide.

“You can address important questions by embedding randomised studies within normal vaccine deployment,” said Krause.

“Instead of usual procedures for allocating vaccines, researchers use randomisation to define who and how to vaccinate. And randomization is considered a fair means of allocation, especially when vaccine supplies are limited.”

Importantly, a randomised vaccine distribution strategy would not affect participants nor healthcare personnel as the logistics would be managed by researchers, who would inform vaccinators which participants are eligible for their doses.

“The person who gets vaccinated sees nothing different from what they would otherwise see in registering for a vaccine, and the vaccination personnel doesn’t do anything different from what they would otherwise do if they were administering a vaccine.

“And that’s [randomization of vaccine distribution] a simple thing to do where vaccine supplies are limited. It doesn’t mean that you will get vaccinated while other people don’t get vaccinated.”

Those studies would be particularly useful to understand the impacts of delayed second doses, the efficacy of single doses, and mixing doses, he emphasized. 

“We can use that randomisation to answer very important questions about these vaccines,” explained Krause. Studies could understand the impact of a delayed second dose, the efficacy of a single dose, especially when vaccine supplies are limited.”

But in the long run, a stronger incentive system will need to be developed to encourage such collaborative research efforts, as coordination is easy to recommend, but difficult to implement, warned Jacobs.

Building Access Into Funding Agreements 

Meanwhile, a proposal to integrate explicit access-to-medicines provisions into funding agreements drew widespread support, including from CEPI CEO Richard Hatchett,  Executive Director of Drugs for Neglected Diseases Initiative (DNDi) Bernard Pecoul, the Gates Foundation’s Mundel and the  WHO’s Swaminathan. 

“The great missed opportunity of 2020 is that the funders of vaccine development did not include access provisions in their funding agreements,” said Hatchett. “The major funders could develop and adopt common approaches to achieving equitable access including in their grant and contract provisions.”

“Innovation and access should be combined and should be linked from the start. We do not have to wait until we have innovation to start thinking about access,” added Pecoul.

“Why not have in place clear and transparent terms and conditions in contractual agreements so from the start you include those criteria or incentives to be sure that all knowledge will be shared.”

For that to happen, however, global health funders will have to work together, as most global health initiatives are funded by multiple bodies rather than having one funder from end-to-end.

Tipping Global Health Funding To Global South 

There is also growing recognition that, for equity to be achieved, global health funding will have to be redirected to the global south to leverage untapped research capacity and reduce dependency on rich countries for vaccines, treatments, and diagnostics. 

“There is research capacity available around the globe that has not yet been sufficiently utilized in the pandemic response, particularly in the Global South,” said Dr Tedros.

“Today, the opportunity to carry out research at the highest level is not equally distributed around the world,” said Australian philosopher Peter Singer, who is a professor of bioethics at the University of Princeton. “Talent, without the opportunity to use it, is a shocking waste.”

Of the 9,500 coronavirus-related research projects that are funded to the tune of more than $4 billion, less than 1,000 were funded in the global south, including Asia, Africa, and South America, stressed Charu Kaushic, Chair of the Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R).

“When we track that funding to see where exactly that funding has gone and where most of the dollars are invested, it is unfortunately primarily in the global north. And if you look at the global south, there’s not a lot of investment that has gone in there,” she added.

Image Credits: National Institutes of Health (NIH) , Twitter: @WHO.

Healthcare workers vaccinating at risk patients with the Pfizer-BioNTech COVID-19 vaccine in Lima, Peru.

Delaying the second dose of the Pfizer/BioNTech COVID-19 vaccine by 12 weeks could generate antibody responses in those over the age of 80 more than threefold, found a pre-print study published on Friday.

The study, conducted by the University of Birmingham and Public Health England, is the first to directly compare the immune response derived from the recommended three-week dosing interval with the extended 12-week interval.

Some 175 participants over 80 years of age were included in the study, 99 of whom received the second dose after three weeks and 73 had the second jab at 12 weeks. 

The peak antibody levels were 3.5 times higher in those who waited 12 weeks for their second shot, compared to those who waited three weeks. 

“The enhanced antibody responses seen after an extended interval may help to sustain immunity against COVID-19 over the longer term and further improve the clinical efficacy of this powerful vaccine platform,” said Paul Moss, Professor of Haematology at the University of Birmingham, in a press release. 

The peak T cell immune response, which plays a role in maintaining antibody production, was lower in those with the extended interval, but the responses were comparable between the two groups when measured at the same interval after the first dose. 

In addition, T cell levels rose two weeks following the second dose. Further research is required to understand the different T cell immune responses, said the authors. 

“This research is crucial, particularly in older people, as immune responses to vaccination deteriorate with age. Understanding how to optimise COVID-19 vaccine schedules and maximise immune responses within this age group is vitally important,” said Dr Helen Parry, lead author of the study, in a press release. 

“Individuals need to really complete their second dose when it’s offered to them because it not only provides additional protection but potentially longer lasting protection against COVID-19,” said Dr Gayatri Amirthalingam, Consultant Epidemiologist at Public Health England.

The “extension of interval of the second vaccine dose in older people may potentially reduce the need for subsequent booster vaccines,” said Moss, highlighting the use of the findings to develop global vaccination strategies.

Findings Useful in Optimizing Vaccinations, But Pfizer Vaccine not Available to Many Countries

While the findings are reassuring and could be useful in optimizing vaccination protocols and strategies, the results are specific to the Pfizer vaccine, which is largely not available to many low- and middle-income countries. In addition, in several countries where variants are spreading rapidly, the risk of infection may be higher after only one vaccine dose. 

In the United Kingdom, however, the study findings are supportive of the controversial approach taken by the government in late December to delay the second dose up to 12 weeks.The decision was made amid rising cases in an effort to expand partial immunity to more of the population. 

The study “provides further supportive evidence of the benefits of the UK approach to prioritise the first dose of vaccine,” said Dr Amirthalingam.

Experts Study Link Between COVID-19 Vaccines and Rare Blood Clots

The AstraZeneca vaccine being administered in Catalonia, Spain in mid-February.

In other vaccine news, scientists are investigating the possible connection between the AstraZeneca and Johnson & Johnson COVID-19 vaccines and rare blood clots, which have been reported across numerous countries in recent months. 

Both the AstraZeneca and Johnson & Johnson COVID-19 vaccines have been investigated by regulatory agencies for links to rare blood clots, known as cerebral venous thrombosis (CVT). Several countries, including the United States, the European Union, and South Africa, paused or limited the rollout of both vaccines due to reports of CVT.  

“Understanding the cause is of highest importance for the next-generation vaccines, because [the novel] coronavirus will stay with us and vaccination will likely become seasonal,” Eric van Gorp, Professor of Infectious Diseases at Erasmus University in the Netherlands, told the Wall Street Journal. 

A German research team, led by Andreas Greinacher, a transfusion medicine expert at the University of Greifswald, found that certain proteins and molecules in viral vector vaccines – which the AstraZeneca and J&J vaccines both are – could cause an autoimmune response that leads to blood clots. 

In a peer reviewed study published in the New England Journal of Medicine in April, the researchers proposed naming this type of clotting ‘vaccine-induced immune thrombotic thrombocytopenia’ (VITT).

According to Greinacher, it might be possible to reduce the risk of blood clots by removing proteins and reducing the level of the EDTA preservative in the jabs after the manufacturing process. Data would have to be collected on how this may impact the safety and efficacy of the vaccines. 

Although this is only one possible explanation for the cases of rare blood clotting and experts disagree on the exact mechanism at work, Greinacher is reportedly in communication with AstraZeneca and J&J to conduct more research on the vaccines and VITT.

“We strongly support raising awareness of the signs and symptoms of this very rare event, and we are currently exploring a potential collaboration with Dr. Greinacher,” said a J&J spokesperson. 

Image Credits: Flickr – Province of British Columbia, International Monetary Fund/Ernesto Benavides, Flickr.

WHO Director General Dr Tedros Adhanom Ghebreyusus

Being vaccinated against COVID-19 this week was a “bittersweet” moment, reflecting both a “triumph of science” and a “gross distortion” in vaccine access, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyusus told the body’s media briefing on Friday.

Thanking health workers at the Geneva Emergency Hospital for vaccinating him on Wednesday, Dr Tedros said that his thoughts “were very much with the health workers around the world who have been fighting this pandemic for more than a year” but still could not get protected. 

“At present, only 0.3% of vaccine supply is going to low income countries. Trickle-down vaccination is not an effective strategy for fighting a deadly respiratory virus,” noted Tedros.

He described India’s COVID-19 surge as “hugely concerning”, but added that Nepal, Sri Lanka, Vietnam, Cambodia, Thailand and Egypt, were also dealing with spikes in cases and hospitalisations. 

“Some countries in the Americas still have high numbers of cases and as a region, the Americas accounted for 40% of all COVID-19 cases last week. There are also some spikes in some countries in Africa,” added Tedros.

However, he highlighted three developments that gave him hope. The first was that countries were sharing vaccines with COVAX, following Sweden’s announcement last week to share one million doses with the global vaccine platform. Norway, France and New Zealand have also pledged doses.

The second was “new deals on technology transfer, and sharing of know-how between international manufacturers to scale up vaccine production”, said Tedros.

A new WHO vaccine mRNA manufacturing training facility aims to train and develop more vaccine manufacturing professionals – who could help kickstart new vaccine facilities in LMICs.

Earlier this week, Health Policy Watch reported that WHO has already received some 42 expressions of interest from countries, institutions and biotech partners to create the hub to train professionals in vaccine manufacturing to help to jumpstart manufacturing LMICs.

The 42 expressions of interest from countries, institutions and biotech partners to create the mRNA vaccine technology transfer hub.

In addition, in the past week, COVAX unveiled a three-stage plan to enhance existing vaccine production capacity, developed by its new Supply Chain and Manufacturing Task Force as well as a new “vaccine manufacturing group” to further expand production long-term.   

The third reason for hope, said Tedros,  is the fact that more leaders, including Spanish Prime Minister Pedro Sanchez have called for the lifting of all trade barriers to address the pandemic. This follows last week’s announcement by the US that it supported text-based negotiations on the proposed TRIPS waiver, which has resulted in countries previously opposed to this to reconsider their position, including the European Union and the UK.

India Clamours for Remdesivir Despite WHO Research

WHO Chief Scientist Soumya Swaminathan

 

Amid India’s surge, the country has seen growing demand for the antiviral medicine, remdesivir – resulting in the government banning the export of the medicine or any of its active ingredients.

However, the WHO reiterated that large studies found that remdesivir had no effect on the SARS-CoV2 virus.

WHO Chief Scientist Soumya Swaminathan said that the development of therapeutics had fallen behind vaccine development, but corticosteroids showed the most promise of reducing mortality in severe COVID-19 cases.

On the other hand, the large Solidarity trial that had tested remdesivir had found that it had no impact on mortality when compared with the control group, said Swaminathan.

The Solidarity Trial, which published interim results last October, found that all four treatments evaluated – remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon – had “little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients”.

However, India had already registered remdesivir for emergency use last July and continues to insist on its efficacy despite the WHO’s position. Meanwhile, the drug’s manufacturer, Gilead has been quoted in the Indian media as saying that the WHO research is potentially  “biased”.

Remdesivir is being produced by seven Indian companies and retails at over $37 per 100mg.

Swaminathan said it was important that Indian doctors were aware of the WHO recommendations, but that member states were free to make their own policies.

“Oxygen is probably the most essential and the most life-saving right now of all the drugs and all countries need to be prepared now with the oxygen supplies,” she stressed.

US Mask-Wearing Decision: ‘Very Contextual’

Maria Van Kerkhove, WHO COVID-19 Technical Lead

While wearing masks is part of the WHO’s comprehensive strategy to address the pandemic, this was “very contextual”, said Maria van Kerkhove, the WHO’s COVID-19 Technical Lead, when asked about the decision by the US Centers for Disease Control (CDC) to allow fully vaccinated people to forgo masks outdoors and in many indoor settings.

“Fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance,” the CDC announced on Thursday.

“It’s about how much virus is circulating around in the country. It’s about the amount of vaccines and vaccinations that are rolling out, it’s about the variants of interest and the variants of concern that are circulating,” said Van Kerkhove.

“We have to keep all of this in mind when thinking about how to adjust the policies associated with the use of masks, so it is contextual and all of these considerations need to be taken into account.”

While highlighting that Australia and New Zealand had been able to control the pandemic without vaccines, Van Kerkhove also cautioned that there were “uncertainties ahead because of these virus variants”. 

Mike Ryan, WHO’s executive director of health emergencies, added that any country that wanted to reduce or remove mask mandates had to consider both “the intensity of transmission and the level of vaccination coverage”.

Some countries were in a “strange period” of transition, where transmission hasn’t completely ended and people aren’t completely vaccinated. 

“And as long as we can sustain the public health measures, as long as we can keep the distance and as long as we can reduce exposure while we get vaccination levels to the highest level, then countries will be in a much stronger position when they do get to high vaccine coverage levels to start saying to people, you don’t have to wear a mask anymore,” said Ryan.

 

Image Credits: WHO.

The Wuhan Institute of Virology, guarded by police officers during the visit of the WHO team in early February, 2021. Critics say WIV officials did not cough up the laboratory’s secrets.

A group of 18 prominent scientists, primarily based in the United States, have called for further investigations into the origins of the SARS-CoV2 virus, including that it could have been created in the Wuhan Institute of Virology lab, in a letter published on Thursday in the journal Science. 

The letter, organised by David Relman, Professor of Microbiology and Immunology at Stanford University, and Jesse Bloom, virologist at the University of Washington, is seen as giving weight to calls to include all hypotheses about natural and laboratory spillovers.

They believe that previous “theories of accidental release from a lab and zoonotic spillover both remain viable” and were not “given balanced consideration” by an earlier joint WHO-China report.

In the letter, they demand that the two hypotheses “be taken seriously…until we have sufficient data.”

As of Thursday, the COVID-19 pandemic has claimed 3.3 million lives globally, and the scientists point out that: “Knowing how COVID-19 emerged is critical for informing global strategies to mitigate the risk of future outbreak.”

Among the signatories is Ralph Baric, a virologist at the University of North Carolina and one of the world’s leading experts on coronaviruses, who has collaborated with scientists at the Wuhan Institute of Virology, the institution at the center of the lab spillover hypothesis. 

Lack of Sufficient Evidence to Rule Out Lab Leak Hypothesis

The letter echoed the statements made by the US government, the EU, several other countries, and Dr Tedros Adhanom Ghebreyesus, Director General of WHO, who said: “I do not believe that this assessment was extensive enough. Further data and studies will be needed to reach more robust conclusions.”

The scientists said: “A proper investigation should be transparent, objective, data-driven, inclusive of broad expertise, subject to independent oversight, and responsibly managed to minimise the impact of conflicts of interest.”

“Public health agencies and research laboratories alike need to open their records to the public,” the authors stated, pushing for greater scientific rigour. “Investigators should document the veracity and provenance of data from which analyses are conducted and conclusions drawn, so that analyses are reproducible by independent experts.”

Efforts to Depoliticize Origins Investigation – But Topic will be Central to Political Debates at Next WHA

The letter is the first to be published in a scientific journal. Previous letters from other scientists requesting further investigations into the origin of the virus were published in news outlets.

“Our goal in putting out a letter that was signed solely by practising scientists…and published in a scientific journal was to emphasise that this is a scientific question and it needs to be addressed in the same way we address all scientific questions,” Bloom told Seattle Times in an interview. 

“I wanted this to be addressed to my fellow colleagues, the working scientists, and use a venue they respect and see as a place for scientists to talk about science and the importance of science,” Relman told the Wall Street Journal. 

“Our message here is wherever the data takes us, thou shalt go, and only go to the degree that the data allow,” he added.

A separate group of international scientists released three letters in recent months. The latest charted a political and technical way forward, calling for more explicit language in a draft World Health Assembly (WHA) resolution, a broader mandate for the origins investigation team, and an overhaul of the methods and protocols used in the virus origins research.

The appeals for further investigations are growing, coinciding with the upcoming (WHA), set to convene from 24 May to 1 June. The 74th WHA will likely feature contentious debates among member states over how the virus origins investigation should proceed. 

Image Credits: WHO, CNN.

Ursula von der Leyen, President of the European Commission, giving the opening remarks at the civil society consultation ahead of the Global Health Summit.

A draft “Rome Declaration” to be issued at next Friday’s G-20’s Global Health Summit, co-hosted by Italy and the European Commission (21 May), makes a series of 10 sweeping commitments to ensure equitable access to vaccines; expand medicines manufacturing capacity; assure WHO access to sites posing an outbreak risk; and invest in global health systems. 

But the draft manifesto seen by Health Policy Watch, framed as a “statement of principles,” also lacks any concrete targets for COVID vaccine dose-sharing, or medicines and vaccines finance. 

WHO and other global health officials have repeatedly said that COVAX and the other ACT-Accelerator initiatives urgently need some US$18.5 billion from the world’s most industrialised nations to fund purchases of medicines and tests, as well as vaccines. WHO and other global health officials have also begged for more vaccine donations. 

That means that if any such concrete commitments are to be made, they will have to be negotiated up until, and on, the day of the meeting of G-20 leaders. Meanwhile, a placeholder text for “announcements and actions” suggests a mere mention of: “Global dose sharing through COVAX?”  

A weak outcome document would be a major setback to the very immediate concerns around getting needed COVID vaccines and medicines to areas of need in low- and middle-income countries as fast as possible, say observers, with whom the draft declaration was shared.

Key events leading up to the G20 Global Health Summit.

Sidesteps mention of WTO Waiver 

The draft declaration so far also sidesteps mention of another thorny issue – the proposed World Trade Organization (WTO) waiver on intellectual property rights for COVID products, that the United States recently said it would support, in the case of vaccine IP.  

A placeholder text, however, leaves open “{…possible references to ACT-A, WTO activity, WHO, the MPP, C-TAP, and through bilateral arrangements}.” C-TAP is the WHO-sponsored patent pool for COVID technologies – which so far has failed to garner significant support from industry. ACT-A is the still desperately underfunded initiative.

The declaration affirms the importance of supporting developing and least developed countries to “build expertise” and increasing “global, regional, and local manufacturing … and the potential for voluntary and mutually agreed knowledge and technology transfer and licensing partnerships.”

That language, as well, represents code words for encouraging voluntary measures to share COVID-related medicines and vaccines IP and technologies – which pharma voices would find reassuring and access advocates disappointing.

Draft resolution sidesteps mention of the WTO waiver to expand the manufacturing capacity of low- and middle-income countries and improve vaccine equity.

No Pandemic Treaty – Extra Investigative Powers for WHO  

The draft language takes a relatively tough line on the investigation of the origins of SARS-CoV2 and other emerging pathogen threats, saying that countries need to ensure: “international cooperation for WHO-led teams’ access to sites of potential and actual outbreak origin, in full compliance with the IHR and relevant national regulations.”

It stops short, however, of calling for a new Pandemic Treaty, as had been recommended recently by WHO, some two dozen global leaders, and the recent Independent Panel Report for Pandemic Preparedness and Response  – saying rather that countries should “support and enhance the existing international health framework for early warning, preparedness and response, prevention and detection, and recovery capacities.”

Countries also need to invest in stronger “early warning information, surveillance and trigger systems at all geographic levels, as well as laboratory capacity, for human and animal health, “including genomic sequencing capacity…rapid data and sample sharing.”

The declaration also highlights the underlying environmental drivers of pandemics and climate change, calling for a “One Health approach…to address threats emerging at the human-animal-ecosystems interface, and anti-microbial resistance.”

This “should include action to address ecosystem and biodiversity loss, habitat encroachment, illegal wildlife trade and climate change as contributing factors increasing these threats,” the statement adds. 

Fully Funded-Independent WHO 

Finally, the draft Rome declaration also calls for a stronger global health architecture with a “fully funded, independent and effective WHO at its centre”. 

That includes advancing Universal Health Coverage, stronger systems for combatting long-standing infectious diseases like HIV/TB and malaria, as well as “education and promotion of healthy lifestyles in addressing among others non-communicable diseases as factors enhancing resilience.”

That, the declaration acknowledges, requires countries to “invest in the global health workforce, in health systems strengthening to achieve resilient, high quality health systems and public health capacities in all countries, in multilateral mechanisms to facilitate capacity building and the transfer of knowledge, data and expertise, and for dedicated assistance and response capacity building, especially in fragile settings.”

Rome Declaration – Statement of Principles not Actions?

The Rome Declaration is being pitched primarily as a general statement of principles, according to the summit’s advance statement: 

“The Summit is an opportunity for G20 and invited leaders, heads of international and regional organisations, and representatives of global health bodies, to share lessons learned from the COVID-19 pandemic, and develop and endorse a ‘Rome Declaration’ of principles. 

“Principles can be a powerful guide for further multilateral cooperation and joint action to prevent future global health crises, and for a joint commitment to build a healthier, safer, fairer and more sustainable world.”  

Italy, as co-chair of the G20, is hosting the Global Health Summit on 21 May. 

“It will provide a timely opportunity to share the lessons learned during the COVID-19 pandemic. We will discuss how to improve health security, strengthen our health systems and enhance our ability to deal with future crises in a spirit of solidarity,” Italy’s Prime Minister, Mario Draghi, is quoted as saying. 

Mario Draghi, Italy’s Prime Minister, speaking at the G20 Tourism Ministers’ Meeting in early May.

The summit will include G-20 members along with Spain, Singapore and the Netherlands as guests; leaders of WHO and other related UN agencies, as well as global health actors such as Gavi, The Vaccine Alliance, the Global Fund and the Coalition for Epidemic Preparedness Innovations (CEPI), which has been investing in key aspects of COVID vaccine R&D. 

According to the statement, the preparation of the Rome Declaration’s summit principles is supposed to involve civil society consultation and debate. Indeed, a public consultation with key civil society stakeholders was held on 20 April. 

But just a week before the meeting, the draft declaration has not yet been widely circulated among civil society groups.

G20 Global Health Summit, set to commence on the 21 May.

Image Credits: European Commission, European Union, Flickr, Governo Italiano.

americas
COVID vaccination in Brazil

Though more than 114 million people have been vaccinated against COVID-19 in the Americas, the WHO Pan American Health Organization (PAHO) has warned that the pandemic is far from over. 

Last week, the region reported more than 1.2 million new COVID-19 cases and nearly 34,000 COVID related deaths – nearly 40% of all global deaths reported.

“This is a clear sign that transmission is far from being controlled here in the Americas,” said PAHO Regional Director Carissa Etienne at a briefing on Wednesday. 

She noted that while countries such as the United States and Brazil were reporting a reduction in cases, other countries such as Canada, Cuba, and Trinidad and Tobago, are seeing higher rates of infections.  

The WHO’s approval of Chinese Sinopharm vaccine offers ‘fresh confidence’ to countries in the Americas who currently use the vaccine, and ‘brings hope for expanding access to vaccines’ in the region. But Etienne stressed the dire toll the pandemic has taken on health systems – rising hospitalization rates have impacted both oxygen supplies and the health workforce. 

“Until we have enough vaccines to protect everyone, our health systems and the patients that rely on them remain in danger.” 

Countries that have begun their vaccination programmes may also have a ‘false sense of security and safety that things are improving, when in reality this is not the case at all right now’, added PAHO Director of Health Emergencies Ciro Ugarte, citing the lack of oxygen supply and increased transmission of the virus in the region. 

Vaccine Donations Urgently Needed to Supplement COVAX 

Assistant Director of PAHO Jarbas Barbosa

In light of the growing spread of COVID in the region, prompting Latin America and the  Caribbean to be labeled an epicenter of the current pandemic wave, PAHO continues seek out donations from countries that ‘already have vaccines for their own needs’, said Assistant Director of PAHO Jarbas Barbosa.

Such donations, he added, will be used to supplement vaccines offered through COVAX, in addition to the Sinopharm vaccines, which will take time to arrive in the region.  

Barbosa emphasized that in the meantime, vulnerable groups must continue to be prioritized. 

“We need to continue using vaccines in a rational fashion for the most vulnerable groups.” 

Spain has already announced that they will make donations to Latin America and the Caribbean through the WHO co-sponsored global COVAX facility, and negotiations are ongoing with the United States. 

Healthcare Capacity Needs to Expand 

PAHO Regional Director Carissa Etienne

The pandemic also has underlined the need to expand healthcare capacity, scale up oxygen production, and make needed investments in equipment, maintenance, and human resources. 

“Countries are being forced to act quickly to make up for years of underinvestment,” said Etienne. 

Across the Americas, nearly 80% of intensive care units (ICU) are filled with COVID-19 patients, with the numbers ‘even more dire’ in countries such as Chile – with 95% of ICU beds occupied by COVID patients – and Brazil, which has waiting lists for ICU beds. 

Etienne estimates that based on the increasing spread of COVID-19, 20,000 doctors and more than 30,000 nurses will be needed to manage the ICU needs of ‘just half’ of the countries in Latin America and the Caribbean. 

In response, PAHO has deployed 26 emergency medical teams across 23 countries in the Americas to provide specialized care. More than 400 emergency medical teams and alternative medical care sites have been set up to expand hospital capacity.  

Oxygen Supply Challenge in the Americas

Rising hospitalizations rates leads to lack of oxygen for COVID patients

The rise in hospitalizations has triggered an ‘unprecedented oxygen supply challenge throughout the Americas, forcing countries and governments to find urgent solutions to the supply problem. 

While hospitalized COVID patients typically require up to 300,000 liters of oxygen during a 20-day hospital stay, patients in critical care often require double that.

In response, PAHO has donated more than several thousand pulse oximeters and nearly 2000 oxygen concentrators to aid health workers in identifying when a patient needs oxygen, and to ensure that workers are equipped with the supplies to help recovery. PAHO is also working alongside Ministries of Health to ensure the availability of oxygen now and for future emergencies. 

Protecting Health Workers Through Vaccinations 

Healthcare worker in Peru preparing COVID-19 vaccines. Healthcare workers in the Americas have been hard hit by COVID.

Since the start of the pandemic, at the least 1.8 million health workers have become infected with COVID in the Americas – 12% of the estimated regional health workforce – and over 9000 have died, the majority of them women and nurses.  

Etienne urged countries to protect the 8.4 million nurses in the Americas, honoring their work, sacrifice, and contribution in commemoration of International Nurses Day, celebrated 12 May.

“Let’s invest in the nurses and ensure that they have the tools and resources that they need to do their job.” 

Quarterly reports from 18 countries in Latin America and the Caribbean show that 1.5 million health workers are vaccinated, but countries are urged to make the most of limited doses and prioritize health workers first.

Image Credits: Flickr: IMF/ Raphael Alves, PAHO, Flickr: UNICEF Ethiopia/2015/Mersha, Andres Montesinos Malpartida/Flickr.

Faisal Shuaib, Executive Director and CEO of Nigeria’s National Primary Health Care Development Agency

IBADAN – The Nigerian government has decided to move ahead with a second dose of the AstraZeneca vaccine for the nearly 2 million citizens who already received the vaccine – despite advice from Africa CDC and the World Health Organization (WHO), that vaccine-strapped African countries could also choose to administer just one vaccine dose  – so as to reach as many citizens as possible very quickly. 

The decision to shun the Africa CDC and WHO advice comes at a critical moment. On the one hand, cases in Nigeria seem to be plateauing right now. On the other, national and regional officials are eyeing nervously India’s crisis – and ramping up oxygen supplies in the event of a third wave here and imposing a lockdown for the Muslim Eid al-Fitr holiday taking place this week. 

But insofar as the country is planning to shift to the one-shot Johnson & Johnson vaccine, with deliveries, hopefully to begin by September, officials seem prepared to take a calculated risk and finish off the remaining supply of AstraZeneca doses among those who have already received the jab.  

Speaking at a press briefing on Thursday, Dr Faisal Shuaib, Executive Director and CEO of Nigeria’s National Primary Health Care Development Agency (NPHCDA), said the country would much rather ensure the full vaccination(two doses) of those who had already received the first dose of the vaccine as recommended by its manufacturer, AstraZeneca.

This means that the four million doses Nigeria received via the COVAX Facility will only reach two million people – half of what it could have reached if health authorities used the available doses to vaccinate up to four million Nigerians as recommended by the WHO and the Africa CDC.

“Nigeria’s presidential steering committee made a strategic choice to utilise our current COVID-19 vaccine supply to administer double doses rather than single doses. This will ensure that every Nigerian who receives a vaccine from our present supply receives their second dose within the recommended time frame.”

Shuaib said that administration of the two doses on time – even to a more limited group of people: “ is very important to ensure the population benefits from the vaccine.” 

A Nigerian health worker receiving a COVID-19 vaccine jab.

In April this year, Health Policy Watch reported that the Africa CDC warned that the administration of the second jab was threatened in many African countries – citing then the case of Rwanda, which had already used up all of its vaccine doses.

The shipment delivery plans of vaccines were disrupted by the government of India’s decision  to direct the Serum Institute of India (SII) to halt the export of vaccine doses as a result of the country’s burgeoning COVID-19 pandemic. 

At that point, Africa CDC recommended that countries vaccinate as many citizens as possible with their initial shipments of doses – without holding back reserves for a second dose. While Dr John Nkengasong, Director of the Africa CDC said implications of the delay in receiving the second vaccine dose was unknown, he assured recipients of the first dose that they already would have acquired some form of immune protection against the virus.

“We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said.

The WHO’s position on maximising vaccinations with available doses is similar to that of Africa CDC. Dr Richard Mihigo, Immunisation and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, said: “African countries, I must say, took the right decision with the limited supply, to use most of their doses as the first dose with the expectation that the second dose will come quite soon.”

To date, 1,748,242 Nigerians, out of a population of 200 million, have been vaccinated with one dose of the AstraZeneca vaccine. But even though the total proportions are small, they still represent 86.9% of the high risk groups of frontline health workers and older people, particularly those with underlying conditions who were targeted first, according to Shuaib. The successful roll out of the COVID-19 vaccine could play a major role “in helping the country to better cope with the pandemic”, he said.

“We have rolled out a digitised registration and immunisation data system. This is the first of its kind in Nigeria. This is to help ensure efficiency and accountability in our initial rollout. We are continuing to optimise the system, and we are seeing its benefits,” Shuaib said.

A percentage share of people who have received at least one dose of a COVID-19 vaccine.

Steady Decline and Plateauing of the COVID Pandemic

After peaking in mid-January at around 1,400 reported cases a day, new COVID-19 infections  in Nigeria have been in a slow decline, plateauing at a few dozen new cases daily in May, with just 38 cases reported on May 10. 

Official data released by the Nigeria Centre for Disease Control (NCDC), show that 165,515 cases of COVID-19 have been confirmed in Nigeria, Africa’s most populous country, with 2,065 deaths. However, recent global estimates have documented how many cases in African countries also go under-reported, escaping  the radar of official data. 

Daily new COVID-19 cases per million people.

Risk of Imcomplete Immunisation “Too High”

Despite the reassuring statistics, Nigeria is not taking any risks, Shuaib told Health Policy Watch.

And incomplete immunisation of highly vulnerable groups that already got the first AstraZeneca vaccine dose, is one such risk that was “too high”, and which the country wants to avoid, he said. 

“What we did in Nigeria was to actually divide the four million doses we got into two compartments. We have around two million doses that we plan to give exactly the same people that have gotten their first doses.” he said.

Moreover, Nigeria had already started administering the second dose of the vaccine to those who have received the first dose – before the latest Africa CDC advance, as well as information about vaccine supplies was available, he said. Continuing one course with the plan will reinforce confidence in the overall vaccination programme, he added:  

“Nigerians have shown incredible interest in receiving the vaccine and cooperating with our health teams to have the system succeed. This is incredibly important because, to move beyond COVID-19, this must be a national effort.” 

Preparing for a Third Wave  

With a case fatality ratio of 1.3%, Shuaib said Nigeria is taking other key  measures to improve its health system’s ability to withstand a third wave of the COVID-19 pandemic, should one occur, and this includes expanding the country’s medical oxygen capacity nationwide. 

In Lagos state, which has been the epicentre of the pandemic in Nigeria, accounting for over 35% of all confirmed cases in the country, Shuaib announced up to four oxygen producing plants are being established to enable the country to combat oxygen shortage.

“There’s no doubt about the fact that we need to ramp up our capacity to provide oxygen, because this is something that can happen anytime, oxygen shortage can happen in any country,” he said.

Also speaking at Thursday’s briefing, hosted by the WHO’s African Regional Office, Nkengasong said the Africa CDC is supporting African countries to expand their oxygen supply chain as a key component of the continent’s response strategy to combating COVID-19 and ensuring that African countries do not get complacent with their disease response.

“This is part of the adaptive strategy which calls for enhanced prevention, enhanced monitoring and enhanced treatment—especially making sure that oxygen is available, and that we do not get complacent with where we are with the pandemic. We saw what happened in India,” he added.

While Shuaib was addressing journalists from his office in Nigeria’s capital city of Abuja, a development of public health importance was ongoing across the country – which was observing a public holiday to commemorate Eid al-Fitr at the end of the Ramadan fast—in a country that is home to the world’s fifth-largest Muslim population – and where Muslim’s make up about one-half of Nigeria’s population.

To avert a possible surge in the number of COVID-19 cases as a result of the Ramadan festivities, the Nigerian government reintroduced nationwide curfews and other movement and public gathering restriction measures this week. 

“We shall maintain restrictions on mass gatherings in and outside work settings with a maximum number of 50 people in any enclosed space, approved gatherings must be held, maintaining physical distancing and other non-pharmaceutical measures,” said Nigeria’s National COVID-19 Incident Manager, Mukhtar Mohammed.

 

St Peter’s Basilica in Vatican City, Italy.

Italy is pushing for the Vatican – a steadfast opponent of sexual and reproductive health rights – to have an enhanced role and greater privileges at the WHO member state meetings of the World Health Assembly and its governing Executive Board, according to a copy of a draft resolution, seen by openDemocracy.

A handful of other European countries, including conservative Hungary and Poland, are understood to be co-sponsors of Italy’s draft decision that would go before the 74th session of the World Health Assembly (WHA), the governing body of the World Health Organization (WHO), meeting from 24 May-1 June. 

The measure would give the Vatican added rights to participate directly in WHA and Executive Board debates with member states, as well as the right to “co-sponsor draft WHA resolutions and decisions that make reference to the Holy See”.

The Vatican’s right to intervention would be immediately “after the last Member State inscribed on the list”, according to the draft, and “seating for the Holy See shall be arranged immediately after Member States.”

Effectively, the proposal also formalises a decades-long ad hoc arrangement in which it has been invited to the WHA every year at the discretion of WHO’s Director-General, under the rules governing “observers of non-Member states and territories” giving the Holy See a permanent seat at the table.

The Vatican also would have speaking priority over the other entities that currently attend the WHA as observers, upon DG invitation, including:  Palestine (Palestinian Authority, the Sovereign Military Order of Malta, the International Committee of the Red Cross, the International Federation of Red Cross and Red Crescent Societies, the South Centre, and the Inter-Parliamentary Union.  In the past, Taiwan has also been an observer; its exculsion from an invite over the past several years has prompted heated debates and sharp criticism from the United States and other allies.

Worries About Hidden Agendas On Sexual and Reproductive Health Rights

Since February, Italy has been led by a coalition that includes both the right-wing Lega party and the centre-left Democratic Party. The government’s key, stated goal is to tackle health, economic and social crises related to the COVID-19 pandemic.

But Italy’s move to advance a decision formalizing the status of the Holy See at the WHA to participate shoulder to shoulder with member states in debates and meetings, including those of policy and budget committees, has alarmed advocates of reproductive and sexual health rights. 

Jessica Stern, executive director of the LGBTIQ rights group OutRight Action International, contrasted the WHO’s mission to support the health of all people with the Vatican’s “exclusionary” position towards sexual minorities. 

“The WHO is no place for religiously-based exclusion, especially in the midst of a pandemic which has disproportionately harmed those who are most vulnerable, including LGBTIQ people and women,” she said. 

Jamie Manson, president of Catholics for Choice, said the Vatican has tried to thwart progress on women’s and LGBT rights at the UN for decades. Church doctrine on sexual and reproductive health issues, Manson added, “has life or death consequences, particularly in the poorest parts of the global south. It’s very serious.”

When Italy’s initial draft of the proposal was first shared with government delegations earlier this month, it proposed giving the Holy See the right to co-sponsor decisions on any topic whatsoever – potentially including measures referring to the right to abortion, contraception and LGBT rights.

Holy See to ‘Co-Sponsor’ Resolutions?

Italy later backtracked on that initial draft – with the current, more limited text, referring only to the Vatican’s right to co-sponsor those “[WHA] resolutions and decisions that make reference to the Holy See”. 

Effectively, the proposal also formalises a decades-long ad hoc arrangement in which it has been invited to the WHA each year at the discretion of its director-general, under the rules governing “observers of non-Member states and territories” giving the Holy See a permanent seat at the table.

The Vatican already holds a similar role at the UN General Assembly. However, rights advocates are still concerned – because of how the Vatican has used other UN bodies to “obstruct” resolutions and decisions on sexual and reproductive rights. 

Neil Datta, secretary of the European Parliamentary Forum on Sexual and Reproductive Rights (EPF), argued: “Pope Francis gives the Vatican a softer image, but its international diplomacy and the content behind it hasn’t changed.”

“With such an institutionalised status at the WHA, as opposed to courtesy invitations, the Holy See could start acting here as it does elsewhere in the UN and that could cause trouble for sexual and reproductive rights,” Datta warned. 

Italian journalist and activist Nicoletta Dentico, who heads the Global Health Programme at Society for International Development, said that while “faith-based entities should be allowed to express their points of view at UN agencies, they should “in no way play an enhanced role” as it remains unclear to whom they are accountable. 

“The Holy See should not have the same status as member states on health issues,” she added, both because of its “viewpoint on sexual and reproductive health and women’s health rights,” as well as the fact that the Vatican also serves as a private healthcare provider, with a vast network of hospitals and clinics around the world. 

Anti-rights Track Record

The Vatican has long opposed access to abortion, contraception, surrogacy and in-vitro fertilisation (IVF) – as well as marriage and adoption for same-sex couples. 

Stern at OutRight Action International cited as examples previous Vatican guidance “denying the existence and rights of transgender and intersex people”, and advocacy at the UN “against numerous gender and LGBTIQ equality initiatives”.

Gualberto Garcia Jones, the Holy See’s legal officer at the Organization of American States (OAS), is also on the board of CitizenGO – which launched a 2020 petition to defund the WHO over “promoting Communist China’s false COVID-19 information”.

Several Vatican officials were also listed as speakers in the programme of the 2019 summit of the World Congress of Families. This is a network of anti-abortion and anti-LGBT rights movements, founded by US and Russian ultra-conservatives. 

Negotiations over Italy’s resolution are ongoing behind closed doors and positions appear to be changing rapidly – both within the European Union and internationally. An informal meeting over the text was held on Thursday morning. 

None of the states believed to be co-sponsors of the resolution, including Italy, responded to requests for comment. The Holy See also did not reply. 

Additional reporting by Nandini Archer, Lou Ferreira and Elaine Ruth Fletcher

 

Image Credits: DAVID ILIFF. License: CC BY-SA 3.0, Pixabay.

The sixth meeting of the ACT-Accelerator Facilitation Council on Wesnesday.

In a rush to jumpstart more global vaccine manufacturing capacity, the global COVAX vaccine facility is now stepping into the fray. 

A new COVAX Supply Chain and Manufacturing Task Force has laid out a three-stage plan to enhance existing vaccine production capacity, as well setting up a new “vaccine manufacturing group” – to further expand production long-term.   

The plan aims to address immediate manufacturing bottlenecks, expanding existing capacity and workforce capacity limitations as fast as possible, through: 

  • Identifying and matching “fill and finish” manufacturers with  producers of active ingredient; 
  • Accelerating approvals of export permits/customs clearances;
  • Facilitating partnerships for the supply of vital vaccine inputs. 

“From the COVAX facility, the critical issue that we’re focused on as of today, is how do we get doses today to try to make a difference, and that means stopping these export bans, it means making sure that if there are surplus doses that those get shared, it means trying to accelerate the production of vaccines that are being made and to make sure that every facility that has capability can be used,” said Seth Berkley, CEO of Gavi, the Vaccine Alliance, speaking at the session. 

According to Berkley’s vision, over the next few months, COVAX will be focused on ensuring there aren’t shortages in products or delays at existing manufacturing facilities. Over the medium-term, through end- 2022, a manufacturing workforce will be developed to maximize even more production using existing systems. 

The long-term goals of COVAX, meanwhile, include expanding production capacity in low- and middle-income countries, and particularly in Africa, through efforts such as a new mRNA vaccine technology hub, led by WHO.

The Task Force’s three-part preliminary plan to enhance and expand vaccine production capacity.

As an opening shot, a US-based foundation said it would donate some US$213 million to catalyze the expansion of manufacturing capacity in South Africa, announced Dr Patrick Soon Shiong, CEO of ImmunityBio and NantHealth, and chairman of the US-based Chan Soon-Shiong Family Foundation. 

The Foundation will provide seed funding to South African biotech partners “so that the capacity, and most importantly second generation vaccinology, second generation cell therapy, and signature delivery systems could be enabled,” said Shiong, a South African native, now living in the United States. 

“I’ve been interacting directly with my fellow South Africans for the last year and I am more and more convinced that not only do we have the science, we have the human capital, and the capacity and the desire. So South Africa could catalyze capacity building, and self-sufficiency, and most importantly the innovation for Africa and for vaccines,” said Shiong, of the partnership. 

Dr Patrick Soon Shiong, CEO of ImmunityBio and NantHealth, and chairman of the US-based Chan Soon-Shiong Family Foundation.

He was speaking at a meeting of the ACT-Accelerator’s Facilitation Council, which provides WHO member state oversight to the global COVAX vaccine facility, and its umbrella  ACT-A  initiative, dedicated to expanding equitable access to tests and medicines, as well as vaccines. 

Addressing ‘Shocking Global Disparity’

While the COVAX facility has delivered 60 million doses to 122 countries, “the shocking global disparity in access to vaccines and other COVID-19 tools remains one of the biggest risks to ending the pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the beginning of the meeting.  

Cumulative cases and deaths are double what that at the beginning of 2021, he stressed – and part of that is due to uneven rollout of vaccines. 

High- and upper-middle-income countries represent 53% of the world’s population, but have received 83% of the world’s vaccines. In contrast, over the first five months of 2021, the African continent has vaccinated under 1% of its population, Dr Tedros said. 

The same inequalities extend to diagnostics, therapeutics, personal protective equipment (PPE), and oxygen – with one million people in low- and middle-income countries (LMICs) needing over four million cylinders of oxygen per day.  The ACT- Accelerator, led by Gavi, the Vaccine Alliance, WHO and CEPI (the Coalition for Epidemics Preparedness) – are struggling to address all of these needs simultaneously.

Long-term: mRNA Vaccine Technology Transfer – Training Hub 

As a longer-term thrust, a new WHO vaccine mRNA manufacturing training facility aims to train and develop more vaccine manufacturing professionals – who could help kickstart new vaccine facilities in LMICs. 

WHO has already received some 42 expressions of interest from countries, institutions and biotech partners to create the hub – which would train professionals in vaccine manufacturing- who would then help to jump start manufacturing facilities in partner LMICs.  

The 42 expressions of interest from countries, institutions and biotech partners to create the mRNA vaccine technology transfer hub.

The approach has been used successfully in the past to stimulate the creation of capacity in LMICs to manufacture flu vaccines – beginning with the H5N1 pandemic (so-called bird flu)  scare of 2005.  While some vaccine facilities folded after a few years, once  pandemic fears declined, others manufacturers have become sustainable producers of vaccines for seasonal flu and childhood diseases – both for domestic and export consumption, WHO insiders say. 

“Manufacturing of vaccine needs capacity building, not just in the manufacturing, but also in the regulatory environment, in the clinical research environment, in ethics, in quality assurance, and a number of areas, so that will have to happen side by side,” said Soumya Swaminathan, WHO Chief Scientist.  

The hub and training center are expected to launch by 2022,  according to WHO, Gavi and CEPI officials – urging realism against the calls from LMICs to expand manufacturing capacity even more rapidly.

Timeline and vision for the WHO COVID-19 mRNA vaccine technology transfer hub.

COVAX Sets Up Manufacturing Task Force Coordination Office  

In yet another thrust, a COVAX Task Force Coordination Office will also be created to map the vaccine manufacturing ecosystem, including shortages in key vaccine raw ingredients, identifying supply gaps for the Task Force address.  

For instance, nearly 300 vaccine components and inputs, coming from different parts of the world, are required to manufacture one vaccine dose of a Pfizer mRNA vaccine – and so shortages in just one input can create a bottleneck that halts production. 

“There is this concept of having a Coordination Office where the data is collected, where the supply baseline is being done, and that really is to make sure that we’re all operating from the same point, and share that information as we work with all of those groups including new groups that will come in that have a role to play here,” said Berkley.

“The multiple work streams create a very complex set of interactions and tasks and as we have within COVAX where we coordinate across the work stream, we are also going to create a coordinating office that we’re in the process of setting up,” said Dr Richard Hatchett, CEO of CEPI.

Gavi and CEPI officials announced that they expect to have the coordination office “fully up and running very shortly,” said Hatchett.

WTO Set To Join Manufacturing Task Force 

Dr Ngozi Okonjo-Iweala, Director General of the World Trade Organization (WTO), announced that WTO would join the COVAX Supply Chain and Manufacturing Task Force at the Facilitation Council meeting on Wednesday.

“I’ve decided that WTO should join the effort that is being made on vaccine manufacturing,” said Okonjo-Iweala. “Through the pandemic, trade and supply chains have helped countries meet skyrocketing demand for medical products, like personal protective equipment.”

Dr Ngozi Okonjo-Iweala, Director General of the World Trade Organization.

“We must continue this by facilitating the cross border flow of vaccines and vaccine components,” Okonjo-Iweala added.

Expanding manufacturing capacity and addressing vaccine inequity is related to the TRIPS waiver proposed to the WTO by South Africa and India. The acceptance of this waiver would “allow for increased and diversified access to technology know-how [for the] manufacturing of vaccines, diagnostics and therapeutics,” said Okonjo-Iweala. 

“An agreement that allows access to vaccines and to manufacturing capability with some automaticity married with trying to still incentivize research and development is very important,” said Okonjo-Iweala.

“I’m convinced that if we work hard…we will be able to come to a conclusion that will be practical and beneficial for low income countries,” she added.

COVID-19 Vaccine Manufacturing Working Group – Long Term Horizon

Meanwhile, as part of a longer-term initiative – a “COVID-19 Vaccine Manufacturing Working Group”, was announced Wednesday by the ACT Accelerator Initiative. 

That high-level effort, co-chaired by Germany and South Africa, aims to address more fundamental shortages in raw materials, and opportunities for technology transfer by vaccine manufacturers – to increase the long-term stability of doses to the global vaccine facility, COVAX, and ensure the equitable distribution of vaccines by 

“It has become clear that worldwide demand exceeds existing vaccine supply by far. We therefore very much welcome the establishment of the new COVAX manufacturing and supply chain task force and the respective high level working group,” said Germany’s delegate. 

“Germany stands ready to take on responsibility and is glad to announce strong commitment to this new working group by taking on the role as co-chair alongside South Africa,” she added.

Increased Funding Required for ACT-Accelerator

In order to deliver on the promises of the ACT-Accelerator, US$18.5 billion is needed to fill the financing gap. Some US$6 billion was mobilized in 2020 and an additional US$8.5 billion was mobilized so far in 2021, however, more is needed urgently. 

“More financing is needed. That’s the only way to really deliver on what we have been talking about today, both [to address] the needs, the hardship and the difficult situations in many countries, and to deliver on full implementation in equitable manners of the technologies,” said John-Arne Røttingen, Chair of the ACT-Accelerator Resource Mobilization Working Group.

Numerous member states and WHO officials called for increased financial commitments to the ACT-Accelerator at the meeting on Wednesday. 

“We have to fully finance the ACT accelerator, as [it is] the only global solution to bring about the fastest possible end to the pandemic,” said Okonjo-Iweala. 

 

Image Credits: WHO.