Ethiopia led the appeal to WHO for support to develop “national policies and evidence-based comprehensive strategies and plans of action for local production”. [Pictured, Professor of Vaccinology, Shabir Madhi of Wits University leading the first Covid-19 vaccine trial in Africa, July.]
Ten African countries, supported by China, have appealed to the World Health Organization (WHO) to support increased local production of medicines, vaccines and other health products – to improve their access and drive down prices, according to a draft resolution presented to WHO’s Executive Board Friday.

Ethiopia, supported by nine other African countries – eSwatini, Ghana, Kenya, Namibia, Rwanda, South Africa, Sudan, Togo and Zimbabwe – led the appeal to WHO for support to develop “national policies and evidence-based comprehensive strategies and plans of action for local production”.

The resolution brings to the fore a key issue that emerged in the first months of the pandemic when the globalized and highly concentrated global supply chains for critical medicines were interrupted – leaving both high and low income countries in the lurch. Anchoring more manufacturing in a wider range of countries would help address similar future risks – while also bolstering technology transfer and economic development in low- and middle- income countries, advocates of the proposal say.

The intervention came as the executive board discussed WHO report on expanding access to effective treatments for cancers and rare and orphan diseases, the prices of which are usually unaffordable for low and middle-income countries. WHO points to high prices preventing 72% of African countries from providing hepatitis B vaccinations despite the high prevalence of this disease.

Speaking at the EB session, WHO Director-General Dr Tedros Adhanom Ghebreyesus praised Ethiopia, his home country, for its initiative and leadership in championing the resolution. Ethiopia has worked hard to establish its own pharmaceutical industry, offering various incentives to the pharmaceutical industry over a number of years to establish local manufacturing businesses.

COVID Pandemic Highlighted Need To Expand Manufacturing Capacity

“The COVID-19 pandemic has shown the great need to strengthen and expand global manufacturing capacity to timely meet global health demands for priority COVID-19 products to combat the pandemic,” Dr Tedros told the board meeting.

“Local production can play a critical role in expanding global manufacturing capacity and achieve equitable access to COVID-19 vaccines, therapeutics and medical devices and equipment,” added Tedros, stressing that this was “of particular importance to address equitable access”.

“WHO is committed to working with member states and partners from the public and private sector for strengthening and scaling up local production, promoting technology transfer and reducing barriers to quality assured safe, effective, and affordable medicines and other health products,” said Tedros.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

Also thanking Ethiopia, Dr Mariângela Simão, WHO’s Assistant Director-General for Drug Access, said that the pandemic had highlighted that “we live in a world where there is a concentration of production in some countries”, and there was a need to “diversify and increase manufacturing capacity in different locations in the world”.

She also thanked Costa Rica for championing the COVID-19 Technology Access Pool (C-TAP), an initiative set up to promote sharing intellectual property and scientific knowledge to address the pandemic.

 

However, according to Simão only 40 member states support C-TAP, which highlights how hard it has been to get countries to share information.

Earlier today, renowned medicine access activist and academic Ellen ‘t Hoen of Medicines, Law & Policy, released an article saying that the “elephant in the room” at the WHO executive board meeting was that “most pharmaceutical companies refuse to share the know-how and technology needed to produce vaccines on a large scale”.

“Despite the fine words of European leaders who, just under a year ago, promised that no one could ‘own the vaccine’, C-TAP is empty. Forty one countries officially support C-TAP in words but few with action. This failure cannot be bought off with donations to the COVAX facility. COVAX after all, also needs the success of C-TAP to be able to buy affordable vaccines on a large scale,” said t’ Hoen.

Health Access International and the People’s Vaccine alliance also expressed unhappiness with C-TAP’s functioning in a letter delivered to the board meeting today. In it, they asked for “clarification of the strategy for C-TAP, who is providing political leadership, and who is providing the necessary technical leadership with regards practical issues for the transfer of know-how and technology for manufacturing” and also called for “bi-weekly public briefings to report on the progress of C-TAP”.

WHO Working for Access To Medicines With Other Agencies

Simão says that WHO implementing its roadmap to improve access to medicines on a number of fronts, including through a “tripartite collaboration” on intellectual property (IP) with the World Intellectual Property Organisation (WIPO) and the World Trade Organisation (WTO), and through initiatives with a range of UN agencies on IP, technology transfer and voluntary licenses.

Indonesia, which invested in the rapid expansion in its pharmaceutical industry, said told the board meeting that “expanding equitable access needs to be supported by transparency of market for medicine, vaccines, other health products”. It added that the prices of medicines and medical devices were available online.

Meanwhile, Bangladesh said that high cost meant that treatments for cancer and other rare diseases “is still limited in our country”, and urged WHO to both support local production and make available “clear and equitable pricing” for these diseases.

Mariângela Simão, Assistant Director General of WHO Access to Medicines and Health Products.

Colombia reported that it had saved itself R18-million since last March by controlling the prices of “approximately 2,513 commercial medicines and 279 active ingredients”.

Even high-income Norway reported that “unreasonably high prices on new medicines threaten sustainability of our health budgets and our ability to provide universal health coverage”.

“Industry demands for confidential prices contribute to our struggle to explain access decisions to the public,” added the Norwegian delegate. “Without transparency, it is challenging to justify to the public why we accept the production of some new medicines. while rejecting others.”

Norway expressed support for the WHO’s report on increased transparency on the prices of health technology, which combines earlier proposals by South Africa and Peru.

“However, to achieve more transparency, we need to collaborate, both with our national health authorities international organizations, and other stakeholders. We cannot do this alone,” stressed Norway.

Japan stressed that “incentives to develop new therapeutic tools” had to be maintained, urging “dialogue with relevant stakeholders, including stakeholders in industry, such as the International Federation of Pharmaceutical Manufacturers & Associations (IFMPA).

Image Credits: Wits University, WHO.

The meeting of the 148th session of the WHO Exeuctive Board.

Reform and diversification of the World Health Organization’s (WHO) funding model is vital if the global health body is to avoid repeating the consequences of the US’s withdrawal in April 2020, member states have said during WHO’s Executive Board meetings.

The global COVID-19 pandemic has magnified the “open secret” within the field of global health that WHO has long suffered from disproportionate expectations and resources, Singapore said Wednesday, during the 148th EB session.

“Stable funding will be required for adequacy, predictability and stability they have been lacking in WHO’s budget for some time now,” the EB representative said.

It is no coincidence that such a reference to predictability and stability was made on the same that the new US President Joe Biden’s inauguration: a day that also marked the first step in the country’s return to the global health organization.

In April, former President Donald Trump announced that the US was to immediately suspend its WHO funding, followed in July by his announcement that the country would withdraw from the Organization entirely.

Trump’s decision highlighted the delicate nature of the Organization’s resource base, which relies heavily on voluntary donations from member states as well as from other charities. At the time Trump gave notice, the US was the biggest single donor to WHO, providing US$400 million in 2019, and accounting for around 15% of its annual budget.

And it was as Biden made his way to the Capitol for his inauguration, on 20 January, that the WHO Executive Board members were examining the future of the body’s financing.

Top contributors to WHO’s Budget (2018) – The United States has historically been the largest contributor overall.

“It is timely to initiate a discussion on sustainable financing for the WHO, to take a comprehensive look at its functions, work, and associated costs,” the representative from Canada noted.

Furthering the point that there is a growing gap between what Member States expect from WHO and what resources are currently available to meet those expectations, he added:

“The challenges arising from the current funding model are evident in the persistent pockets of poverty across various technical areas as well as in the chronic underfunding of particular WHO functions including core science and normative work, emergency preparedness and enabling functions such as internal oversight.”

The US’ decision to rejoin the body, and pay up on its contributions, as Biden’s newly appointed Chief Medical Advisor Anthony Fauci promised to do on Thursday (see related HPW story)  is clearly a positive step towards restabilizing WHO’s finances, EB members said. But that doesn’t solve the long-term problems of the Organization, which include an overreliance on a few key member states, as well as on voluntary contributions, which may vary year to year, instead of fixed member state assessments.

Other budget challenges include the need to improve staffing and resources at country level – which are at the core of WHO’s work with governments and Ministries of Health.

The committee also noted that improving geographical representation among WHO staff should be considered through the lens of member states geographical representation— and not that of WHO regions.

Also, although WHO Director General Dr Tedros Adhanom Ghebreyesus has trumpeted the fact that his senior staff has reached gender parity – in lower levels of the Organization and particularly in countries and regional offices, men still well outnumber women professionals, the EB committee members noted, saying that more steps be taken towards the goal of gender parity at all levels, especially among heads of country offices.

Image Credits: WHO, WHO .

Major fire at Serum Institute Vaccine Complex in Pune, India

Five people have died in a major fire at the Serum Institute’s manufacturing facility, charged with producing India’s supply of the Oxford/AstraZeneca vaccine –  just days after the country’s national vaccine campaign got underway.

Serum Institute Chief Executive Adar Poonawalla was quick to say that the fire at its main complex in Pune, would not affect its delivery of some one bilion doses of vaccines in 2021.

“I would like to reassure all governments & the public that there would be no loss of COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies,” Poonawalla said. ‘COVISHIELD’ is the branded name for the AstraZeneca vaccine being produced by the Serum Institute in India. The fire would mean delays in launching new products, he added however.

Even so, the huge billows of smoke pouring out of the buildng plainly visible on social media led observers to wonder if that optimistic forecast would hold up.  Along with supplying India’s domestic market, the Serum Institute has major contracts with other low- and middle-income countries in Africa and South-East Asia, as well as with the WHO co-sponsored COVAX global procurement facility – which has promised to start rolling out vaccines to countries worldwide in the first quarter of 2021.

The fire could have been caused by an electrical fault, according to government officials. India media reported that the fire had broken out in a part of the complex that was under construction.

 

The Serum Institute is producing approximately 50 million doses of COVISHIELD a month across multiple facilities in India: a number it plans to up to 100 million.

Additionally, the manufacturer is set to produce up to 50 million doses of the US’ Novavax candidate from April, if the vaccine, now in Phase 3 trials, is approved.

India began its COVID immunization campaign over the weekend, but the rollout saw lower turnout than expected with only around 50% of people registered to be vaccinated receiving their dose. Additionally, there is a lot of hesitancy among its health workforce.

Serum Institute vaccines figure heavily in the distribution timeline for the WHO co-sponsored COVAX facility’s commitment to distriute some 2 billion vaccine doses in 2021 (Gavi, 7 January 2021).

Image Credits: Twitter via https://en.gaonconnection.com/, WHO.

A small study of 50 blood samples from people previously infected with SARS-CoV-2 found that 90% had reduced immune response to the 501Y.V2 variant and almost half did not recognise it at all.

CAPE TOWN – Scientists are concerned that antibodies that could detect SARS-CoV-2 in South Africa’s first wave will be less effective against a virus variant that first emerged here and is known as 501Y.V2.  What’s worse, they still don’t know if brand new COVID-19 vaccines will work against the variant – which is deemed to be 50% more transmissible than ones prevailing until now.

The uncertainty contrasts sharply with the more optimistic profile of vaccine efficacy against British variants that have spread widely across the world.

A small study of 50 blood samples from people previously infected with SARS-CoV-2 found that 90% had reduced immune response to the 501Y.V2 variant and almost half did not recognise it at all, South African scientists told reporters at a scientific briefing this week.

They stressed that there was no evidence yet that a vaccine would not be effective against the variant, but acknowledged that the lack of antibody sensitivity, known as ‘immune escape’, among people who had already recovered from COVID-19 in the first wave could suggest they might be vulnerable to re-infection with the new variant.

Professor Penny Moore, research chair of Virus-Dynamics at the University of the Witwatersrand and the National Institute of Communicable Diseases, conducted the research on blood samples of 50 people who had been previously infected.

While there was a concern that the new variant could drive reinfections, “the data at this point does not point in that direction” says Professor Salim Abdool Karim.

Given that vaccines are also based on triggering similar antibody responses, they might also be less effective. But while the immune escape was “concerning”, Moore stressed that the dynamics of antibodies triggered by vaccines also could be different than natural antibody response.

“What we are doing now is taking blood from those people who mounted a response to the vaccine during vaccine trials and we are testing those antibodies against the viruses,” said Moore.

“That will give us a sense of whether the new variant is less sensitive to the antibodies that various vaccines elicit. But again, there are lots of caveats, because there are many vaccines, they all behave in a different way, and they all tickle the immune system to produce antibodies in a different way.”

‘Tweaking’ Vaccines a Possibility – But World May be Constantly Dealing with More & More Variants

Moore said that while it might be possible to “tweak” existing vaccines, slightly adjusting them to deal with the new variant, a new strategy might be necessary: “There is potential to do this [tweak the design] for some of the vaccines but in the future I think we will be consistently dealing with more and more of these variants.

“So we might need to be a little bit cleverer in how we design vaccines and look for other parts of the virus that cannot change so effectively and try to design vaccines to target these.”

‘Don’t Call It South African Variant’
Salim Abdool Karim
Prof Salim Abdool Karim, co-chair of the South African Health Minister’s advisory committee

Professor Salim Abdool Karim, co-chair of the South African health minister’s advisory committee on COVID-19, who led the briefing, appealed for the variant to be called by its scientific name, 501Y.V2, and “not the South African variant” just as COVID-19 “is not called the China virus”.

Variants have been identified in many parts of the world including the UK and Brazil, all with mutations to the spike protein that binds to the human cells.

Abdool Karim reported that the 501Y.V2 variant has 23 mutations including a 20% rotation in the spike protein which enables it to bind more strongly to human cells. Mathematical modelling predicts that it is 50% more infectious than its predecessor but not more severe.

In the Western Cape province, it took 107 days for 100,000 cases to develop, whereas in the second wave, it took only 54 days. However, hospitalisations for both waves were similar, indicating that the variant was not more severe.

Reinfection and The Variant

While there was a concern that the new variant could drive reinfections, Abdool Karim said “the data at this point does not point in that direction”.

Dr Koleka Mlisana, Executive Manager of Research at the National Health Laboratory Service (NHLS), said that an analysis of over 1.1 million positive tests found that by 6 January, there had been about 4000 reinfections.

“We have not seen a marked increase in reinfections since the variant, but bear in mind, we’re only talking about a month’s data so far, so this is an area that we need to look very closely,” said Mlisana.

Although national statistics are not yet available, the latest data for KwaZulu-Natal province found that the variant was present in 59 of the 61 genome sequences analysed.

501Y.V2 Variant Raises More Concern than UK-Identified Variant

While the variant identified in the United Kingdom has received a great deal of attention for driving a big surge of infections there, across Europe and elsewhere, scientists have been even more concerned about the 501Y.V2 – which makes more significant changes in the protein structure of the characteristic coronavirus spike, which new vaccines are targeting.

Pfizer/BioNTech has already published a number of studies on the variant identified in the UK late last year, (known as B.1.1.7).  One such pre-print study claimed the antibodies in the blood of vaccinated people still recognize the variant.  However, that study has already been hammered by online reviewers saying that the study sizes are far too small (16), and Pfizer’s interpretation of the data was overly optimistic.

Some Pharma Companies Already Preparing For Next Stage Variant Vaccines

While scientists try to assess the impacts of variants on existing vaccines, some pharma companies are already gearing up for a second generation of vaccine development to address them.

One example is the startup biotech firm, Gritstone Oncology, which will begin human testing for a “backstop” vaccine in the event that mutant strains do evade the current range of vaccines, STAT has reported.

Preclinical work on the vaccine was supported by the Bill and Melinda Gates Foundation. Though no data is publicly available yet, its Phase 1 clinical trial is due to begin shortly.

The firm’s CEO Andrew Allen told the outlet that “we all hope that this will not be necessary” and that he thinks “it’s prudent to have it developed as a backstop”.

It should also be noted, however, that if a virus variant were to escape the immune response generated by existing vaccines, updating the tool would take only a matter of months.

Image Credits: National Institute of Allergy and Infectious Diseases, NIH, Twitter: @WHO.

Researchers have reported pausing many or all of their late-stage trials due to the COVID-19 pandemic. This is likely to have a knock-on effect.

The demands of fighting the COVID-19 pandemic are draining resources from global health research and development (R&D) programs and disrupting clinical trials and other work, presenting a potential post-pandemic scenario of a world more vulnerable to a host of infectious threats.

That’s what our organization, the Global Health Technologies Coalition (GHTC), learned after conducting extensive, candid conversations at the end of 2020 with global health researchers around the world from both the public and private sectors. We reached out to them to understand how the fight against COVID-19, an effort that has often relied on their expertise and innovations, may be imperiling science to reduce the burden of many other infectious pathogens. That includes malaria, tuberculosis, HIV/AIDS and a broad spectrum of neglected tropical diseases.

Their reports revealed an urgent need to bring together the global health research community and our allies—in government, industry and international institutions—to avoid lasting damage to hard-fought progress and prevent further delays in delivering new advances.

Everyone understands that right now, COVID-19 must be the focus. We spoke with many researchers who were proud to see their capabilities contributing to developing better diagnostics, vaccines and new treatments. But they also were keenly aware of the toll it was taking on any work not related to the pandemic.

Scientists, speaking confidentially in order to provide a frank assessment, talked about staffing and funding being shifted to focus on pandemic-related work—and with no clear indication on when non-COVID-19 work would resume, or if diverted funding would be restored.

Meanwhile, clinical trials—the most costly and complex aspect of developing new health interventions—have been hit especially hard by pandemic-related shutdowns. Nearly every interviewee involved in clinical trials, many of which are located in low- and middle-income countries, reported significant issues, including trials being delayed indefinitely. The biggest disruptions have involved phase 3 trials. That’s understandable, as these trials are logistically complex and typically require managing thousands of participants. But reaching Phase 3 means a project is tantalizingly close to delivering a new breakthrough, which makes interruptions at this stage particularly devastating.

Researchers reported pausing many or all of their late-stage trials. One clinical trial administrator reported that where a trial was already underway, numerous trial participants were not showing up for essential follow-up visits at the clinic due to fears of contracting COVID-19. Virtual follow-ups were proving challenging in many cases, in part due to infrastructure barriers in low-resource settings—such as the need for many people to regularly purchase new SIM cards for their phones, which changes their phone number. Virtual visits are also not an option for trials that require in-person follow-up to collect samples.

Outside of clinical trial disruptions, scientists noted a number of discrete challenges. For example, there were reports of work stymied because laboratory reagents or personal protective equipment (PPE) were needed for pandemic response. Operational expenses have increased significantly for many projects, due to issues like higher shipping costs and additional resources needed for safety.

The cumulative effect of so many obstacles is presenting staggering challenges for global health researchers. But there is a way to recover from these setbacks—and avoid a situation where we emerge from the battle against one deadly disease less prepared to fight off many others.

First, we must work with our partners in the public and private sector to ensure scientists are given the resources and flexibility to recover from their pandemic-related problems and restart their work. Second, we must emphasize that decades of investments in global health R&D generated new insights and alliances that have played a big role in speeding the development of COVID-19 interventions. The fast pace of that work, especially around vaccines, demonstrates that, with greater funding, the field is poised to produce rapid progress in fighting many other infectious diseases.

In fact, we did hear a measure of optimism among some of the researchers we interviewed that the harsh experience of the pandemic—and the fact that scientists are leading the effort to end it— could create a new era in which investments in global health R&D become an enduring political priority.

But another scenario is one in which disruptions caused by the pandemic are compounded by long-term funding problems. Global health R&D funding always has been a hard sell and the economic impact of the pandemic is likely to constrain spending in both the public and private sector for years to come. It will require a concerted effort by our community to ensure global health R&D quickly regains lost ground and, equally important, that we can capitalize on opportunities revealed by pandemic-related advances to accelerate work on a number of diseases.

Jamie Bay Nishi is director of the Global Health Technologies Coalition (GHTC), a coalition of 30 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. For more on this topic, read the GHTC’s full synthesis of the interviews: Pain Points and Potential: How COVID-19 is Reshaping Global Health R&D.

Image Credits: Dato Koridze /STUDIO for TB Alliance.

Helen Clark, former Prime Minister of New Zealand and co-chair of the Independent Panel review of the COVID-19 pandemic response

The World Health Organization’s (WHO) response to COVID-19 was too slow, hampered by an antiquated pandemic alert system, lack of resources and a lack of authority with member states, according to an interim report by the Independent Panel on Pandemic Preparedness and Response, presented to the WHO’s Executive Board meeting on Tuesday.

It took the WHO an entire month from the time an alarm was sounded in Wuhan to declare a public health emergency. And it’s alert and response system “seems to come from an earlier analogue era and needs to be brought into the digital age,” panel co-chair Helen Clark, the former Prime Minister of New Zealand told a media briefing. She added: “Modern information systems pick up signals of potential diseases by sifting through hundreds of thousands of data points daily, outpacing formal country reporting and outpacing the procedures and protocols of the International Health Regulations.”

But the human deliberations of WHO also slowed down responses. Although the WHO Emergency Committee was convened on 22 January 2020, WHO only declared a “public health emergency of international concern” on 30 January, and first used the word “pandemic” on 11 March.

“Even when WHO declared a Public Health Emergency of International Concern on 30 January – the loudest alarm possible under the International Health Regulations – many countries took minimal action to prevent the spread internally and internationally,” Clark said in the briefing. 

The brand-new report, mandated by the World Health Assembly in May, when the world was reeling from the initial impacts of the pandemic – was presented at the EB during a second day of the exhaustive EB review of the COVID-19 pandemic. EB members also heard a report from yet another review committee, examining the International Health Regulations framework that governs countries’ obligations to monitor, report and respond to emergencies, which found compliance wanting, due partly to a “lack of teeth” in the IHR’s legal enforcement mechanisms.   

“The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels,” said Professor Lothar Wieler, President of the Robert Koch Institute in Berlin, in a statement.

“The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response,” said Wieler, speaking to WHO member states.

Lessons about the past are more relevant than ever today, Clark stressed. Since 1 January, the world is recording almost 12,500 daily deaths and 682,000 new cases, and countries need to urgently implement “basic measures like testing, contact tracing, isolation, physical distancing, and wearing masks,” which are even more pressing as new and reportedly more infectious variants of SARS-CoV2 are detected.

Not Laying Blame on WHO – But …

Former Liberian President Ellen Johnson Sirleaf, co-chair, of the Independent Panel’s review of the COVID19 pandemic response, at a media briefing.

Co-chair Ellen Johnson Sirleaf, former President of Liberia, stressed that the panel was not trying to blame the WHO: “The world is more reliant on an effective WHO than ever before. But while member states turn to the WHO for leadership, they have kept it underpowered and under-resourced to do the job expected of it.”

She added: “Member states are looking to the WHO for leadership, coordination and guidance, but are not equipping it with the authority or access to the funding needed to provide this. WHO has no powers to enforce anything or investigate anything of its own volition within a country.

“When it comes to a potential new disease threat, all WHO can do is ask and hope to be invited in. The panel is asking whether this is enough.”

At the same time, the report makes a number of damning observations about how member states had failed to act on “numerous evaluations, panels and commissions which have issued many recommendations for strengthening preparedness and response” of WHO.

And the Panel also criticised the sometimes overly technical nature of WHO’s advice to countries, saying that it had issued over 330 reports to states, which may have confused them about what their priorities should be.

Panel Criticism of China – Receive Rocky Reception From Beijing  

China’s representative to the Executive Board at the 148th session on Tuesday.

The panel report also criticises China, stressing that “public health measures could have been applied more forcefully by local and national health authorities in China in January.”

“It is also clear to the Panel that there was evidence of cases in a number of countries by the end of January 2020. Public health containment measures should have been implemented immediately in any country with a likely case. They were not.”

Clark would not comment further on China, saying that the panel would have a more detailed report on the chronology of events at a later stage. The final report is due to be presented to the World Health Assembly in May.

However, in a later EB debate, China protested about the way that its response had been characterised, saying that it was being unfairly “judged” for early days when authorities were still grappling with “understanding the unknown”. 

“On January 23 2020, when only four countries outside China reported seven cases, China pressed the pause button in Wuhan, a city with a population of over 10 million, which was not taken lightly. But we did it. And we made huge sacrifices for global fight against the virus that has gone way beyond the traditional public health measures. 

“We urge the international community to look at China’s anti-epidemic efforts from a rational and scientific perspective. 

“These extraordinary and forceful public health measures are mass contributions that China made to the world. China suggests that the review committee …should further improve the report and make scientific, objective, fair, comprehensive and balanced assessments on both prevention and response.”

Incentives For International Cooperation Are Too Weak 

Well beyond the WHO or China, however, the panel made it clear that responsibility is shared globally, while the incentives fostering international cooperation between states remain too weak. 

“Our panel report does identify a series of critical early failings in global and national responses to COVID-19. There had been a failure to prepare adequately for a pandemic threat despite years of warnings that better preparation was necessary,” said Clark at a subsequent afternoon briefing with the EB members themselves on the report’s findings.

“Preparedness methods which were being used did not appear to predict how well individual countries would be able to control COVID-19. Perhaps because they couldn’t capture what seems to be a critical dimension of pandemic control: the mix of government effectiveness, concern and leadership, capacity to work with communities, and being able to be guided by science,” said Clark.

“The panel notes with deep concern that the failure to enact fundamental change despite the warnings issued has left the world dangerously exposed, as the COVID-19 pandemic proves,” according to the report, which added that there has been “a wholesale failure to take seriously the existential risk posed by the pandemic’s threat to humanity and its place in the future of the planet”.

Adds the report: “the incentives for cooperation are too weak to ensure the effective engagement of states with the international system in a disciplined, transparent, accountable and timely manner” despite the fact that the pandemic offers “a once-in-a-generation opportunity for member states to recognize the common benefit of a suitably reinforced suite of tools to enable robust pandemic alert and outbreak containment functions.”

Major weaknesses in the Global Supply Chain 

Other problems flagged by the panel include “major weaknesses in the global supply chain,” while the critical funding gap hampering the Access to COVID-19 Tools Accelerator (ACT-A) platform might result in a “two-tier world, divided between countries where COVID-19 is relatively controlled, and those where COVID-19 adds to the overall burden of disease as yet another ongoing, endemic disease”.

“The effective flow and access of new diagnostics, therapeutics, and vaccines to the populations most in need, based on equitable public health criteria, must be the central plank of international co-operative efforts,” the report notes.

Vaccine Rollout Also Criticized by Panellists  

Related to that, the unequal pattern of vaccine rollout also came in for sharp criticism by the panel’s leaders at the EB session: “The panel is discouraged and frankly disappointed by the unequal vaccine rollout. Tens of millions of vaccines are already available in some of the wealthiest countries, but based on current plans, vaccines will not be widely available across the African continent until 2022 or even 2023,” said Sirleaf.

“It is unacceptable for wealthy countries to be able to vaccinate 100% of their population, while poorer countries may do with only 20%. It is no exaggeration to say that we are at risk of creating a vaccine distribution system grounded in inequity. We cannot let this happen.

“This is a unique opportunity, born out of the gravity of this crisis, to reset the system. Real change in global and national health systems will benefit every country and every citizen,” Sirleaf added. 

EB Members Frame Reviews As Buildup to WHA Resolution Strengthening Emergency Response  

Garett Grigsby, director of the Office of Global Affairs, US Department of Health and Human Services

Despite resistance from China, member states in Europe, the Americas and elsewhere framed the findings of the three reports as useful inputs to a planned resolution to strengthen WHO’s Emergency Response mechanisms, that will go before the World Health Assembly in May.

“It is our duty to provide the WHO and the broader international system with the tools to do its work effectively, efficiently, independently and transparently,” said Garett Grigsby, director of the Office of Global Affairs at the United States Department of Health and Human Services, speaking at Tuesday’s EB session. 

“We must rise to the occasion, even as we combat the pandemic and resurrect our economies,” said Grigsby. “That is why we need to be sure that the recommendations put forward will be given thoughtful consideration, and any additional funding requests for WHO will be justified and directed at areas where strengthening is necessary, such as pandemic preparedness and response. The United States will work with other member states to strengthen the WHO to make it fit for purpose.”

Grigsby also said that the United States was joining the European Union and a wide range of other member states to advance a resolution for the World Health Assembly strengthening WHO’s Emergency Response. 

The statement represented the first sign of other substantive shifts in policy that can be expected from the White House after President-elect Joe Biden is inaugurated in Washington, DC on Wednesday. 

Biden is expected to work rapidly to restore the previously close relationship between WHO and Washington – which was shattered by the maverick policies of outgoing Donald Trump – who leaves the White House in disgrace after igniting the emotions of rioters who charged the Capitol on 6 January in a failed attempt to violently overturn the election results.  

WHO Reaction – We All Have To Learn Lessons 

“We all have lessons to learn from the pandemic, every member state and the Secretariat….We are committed to accountability and we will continue to learn, to change, and to listen,” said Dr Tedros Adhanom Ghebreyesus, responding to the report at the EB’s afternoon session. 

While the report remains an interim one, countries should act immediately on some of the lessons learned, the Independent Panel Co-chairs underlined:

“We are building the necessary evidence base required for the comprehensive, impartial and independent review of the international health response to COVID-19 with which we were tasked,” Clark told delegates. “While our evidence gathering continues, the progress report before you now does have an unequivocal message that course correction of the handling of the pandemic is needed now.

“The panel does strongly recommend that all countries immediately and consistently adopt and implement those public health measures which will reduce the spread and the impact of COVID-19. Simply put, we must do all we can to stop the pandemic now.” 

Image Credits: WHO.

Health care workers administered the COVID-19 vaccine on 16 January at Chacha Nehru Bal Chikitsalaya (children’s hospital) in Delhi.

The Indian government began the world’s largest COVID-19 vaccination program this weekend aiming to vaccinate more than 300 million people, beginning with 10 million health workers, but in the three days since, it appears there has been low uptake among that key demographic.

Based on Health Policy Watch’s estimate, only slightly more than half of the people registered have received their vaccine in the three days since the launch. 100 people are registered per session, with 7,860 sessions held. Despite this, only 4,54,049 have been vaccinated as of Monday night.

Additionally,  vaccination rates in three states  — Tamil Nadu, Punjab and Puducherry — were 40% lower than expected.

“It is sad that members of our medical fraternity – our doctors and nurses – are declining the vaccine,” said Dr VK Paul, member of Indian government think-tank Niti Ayog, said in a press conference on Tuesday.

“I request them to please take the vaccine. We do not know what shape this pandemic will take.”

The country, which began its rollout on Saturday 16 January, is distributing two vaccines: the Oxford/AstraZeneca candidate, known as Covishield, manufactured by India’s own Serum Institute, and Covaxin, developed by Indian-based Bharat Biotech in collaboration with the Indian Council of Medical Research.

Earlier this month, India’s chief drug regulator granted the Serum Institute vaccine an emergency use license based on Phase 3 data from trials in Brazil and the United Kingdom, where the vaccine has already been approved.

But the decision to authorize Covaxin, a vaccine developed by the local firm Bharat Biotech together with the Indian Council of Medical Research, was made without final Phase 3 data. And the lack of transparency around that approval process may also be fuelling vaccine hesitancy.

Anyone receiving a Covaxin shot will be asked to fill in a consent for which notes that “the clinical efficacy of Covaxin is yet to be established and is still being studied in Phase 3 clinical trial” – although Phase 1 and 2 trials indicated the vaccine produces antibodies.

Two people, aged 43 and 52, have reportedly died following their vaccination. It has been confirmed that these deaths were both due to cardiopulmonary disease, and were unrelated to the vaccine.

Dr Manohar Agnani, additional secretary with Indian Ministry of Health and Family Welfare, said: “So far no case of serious or severe adverse events following immunisation attributable to vaccination till date.”

Confusion over Rollout Of Experimental Covaxin Vaccine Fuels Hesitancy

Many doctors employed in national hospitals have been cautious as to go on record about the mixed sentiments the campaign is thus generating.  As one senior doctor in Safdarjung Hospital told Health Policy Watch: “There is a little bit of confusion over Covaxin. Everybody does not want to become part of a trial (as the vaccine is being administered under clinical trial mode). It would have been better if I was given a choice. I would have taken Covishield.”

He later clarified he would be taking his Covaxin shot when offered, however his colleague also expressed apprehensions due to the lacking Phase 3 data.

Each vaccination site has only been provided with one of the two authorized candidates, meaning that people who are registered in that hospital have no choice but to take the vaccine available at the center.

Of the 37 states and union territories in India, 12 received the Covaxin vaccine.

On Saturday, about 22 million health workers were vaccinated were vaccinated across India.

In the Dr Ram Manohar Lohia Institute of Medical Science in Delhi, resident doctors wrote a letter to their hospital’s authority on Saturday,outlining why they were not comfortable taking Covaxin.

The letter read: “The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers thus defeating the purpose of vaccination.”

Signatories then requested to be vaccinated with the Serum Institute-manufactured vaccines.

But Dr D R Meena, Registrar of Safdarjung Hospital, Delhi, took the Covaxin vaccine on Saturday, saying he “had mild myalgia” – or muscle pain – and that he “did not even need paracetamol”.

There have also been some cases of death following vaccination that were widely reported in the media – although these have so far been attributed to pre-existing conditions.

‘A Proud Moment’: Vaccination As A Lifeline

For some doctors, however, the launch of the vaccine campaign process was still an emotional moment.

Dr Prashant Lohmore, 28, is a resident doctor working in the emergency ward at Max Smart Superspeciality Hospital, a private hospital in Delhi. He received his Astra/Zeneca vaccine on Monday.

“I saw a lot of patients facing respiratory distress after Diwali,” he said. “We did not have enough beds at the time.”

That the country’s vaccination program has now begun “is a proud moment for us”, he added.

Dr Meena – the doctor who said he experienced only mild muscle pain from Covaxin – spent 2020 working as an anaesthetist in the Intensive Care Unit. His wife, also a doctor, works about 80km out of Delhi, and was gone for several months.

Their two children – a nine-year-old daughter and a 17-year-old son – both had little contact with their parents. Dr Meena and his wife both received their vaccine on the same day.

“I used to isolate myself in a room. My daughter would insist on talking to me. She is a small girl,” he said.

“Those were the hardest months of my life. Vaccination provides hope to us.”

Image Credits: Press Information Bureau, India.

The vaccine developed by Oxford University and AstraZeneca is the only one to have both been secured by COVAX and already approved by a national regulatory authority (the United Kingdom) in a transparent review process.  

The World Health Organization’s (WHO) COVID-19 vaccine access platform, COVAX, is geared up to deliver vaccines to “far more” than 20% of member states’ populations beyond 2021, Dr Kate O’Brien, the body’s director of vaccines, told its Executive Board meeting on Tuesday.

She was responding to concerns and criticisms expressed by member states at the EB’s opening session on Monday about the ability of COVAX to deliver vaccines to member states that have not been able to purchase them on their own.

As Austria’s Dr Clemens Martin Auer, told the meeting: “COVAX is slow. It has not closed a crucial number of contracts, and therefore, substantial numbers of vaccines are not being timely delivered to member states.”

Distribution datelines for COVAX delivery of 2 billion vaccine doses in 2021, based on data available on 7 January 2021.

Auer, who is also the co-chair of the EU’s vaccine procurement group’s board, said that the EU group had been meeting up to three times a week since June to put together a broad portfolio of vaccines, but the management of COVAX lacked transparency about its procurement programme.

“We did do our homework within the EU to secure the needs for 450 million EU citizens to have access to urgently needed vaccines. We were sceptical that GAVI had the means and the capabilities to fulfill its tasks to negotiate the necessary contracts and to secure the needs of our citizens. 

“The proposals that GAVI negotiated side-by-side with the EU with the producers was rejected by the management of GAVI COVAX. So I would like to express the clear statement that the EU and its member states are exercising their global solidarity and we are the single largest donor when it comes to supporting GAVI COVAX facility.” 

Auer also asked why the COVAX management had initially decided to exclude the mRNA vaccines being produced by Pfizer and Moderna, which have been the first to receive European and American regulatory approvals; what COVAX’s delivery plans were and how many vaccine doses member states could expect?

Dr Bruce Aylward, Senior Advisor to the Director-General, reported that GAVI has “145 million doses contracted for release during the first quarter of this year.”

Bruce Aylward, WHO Senior Advisor to the Director General, at the Executive Board session on Tuesday.

Timing depended on countries’ regulatory support, continued financing of COVAX and co-operation from countries and entities that have large bilateral vaccine deals “because choices have to be made as to which contracts get served in which order, and the dose sharing that we mentioned yesterday,” added Aylward, who represents the WHO at GAVI. 

“There is no question that we can achieve the Director General’s vision of all countries vaccinating their highest risk populations by World Health Day [7 April], which is only a couple of months away, but to achieve that ambition will require a new level of cooperation and coordination as we go forward,” said Aylward.

“Any suggestion that COVAX is not operational has to be scrutinised, as the facility is operational,” stressed Aylward.

WHO Now Examining Indian, Russian & Chinese Vaccines – While Moderna & Pfizer Hold Back

One key holdup with COVAX, in fact, appears to lie in the mismatch between the vaccines for which COVAX has arranged pre-order deals – and those that have received approval so far by WHO or another strict regulatory authority as safe to use. 

Brand names of doses secured by COVAX that would be available for delivery – however only following WHO approval of AstraZeneca, Serum Institute of India and J&J vaccines.

So far, the AstraZeneca/Oxford University vaccine is the only one to have both been secured by COVAX and already approved by national regulators.  

Another key COVAX product, a vaccine candidate by Johnson & Johnson has not yet received US or European regulatory approval. Yet a third, by Sanofi/GSK lags even further behind. 

Meanwhile, as Auer pointed out, COVAX has either been unable or unwilling to secure deals with the other two leading pharma companies that are rolling out millions of mRNA vaccine doses, Pfizer and Moderna. 

And Moderna has not yet even submitted a full dossier on its product for WHO review – despite the fact that it has been approved in Europe, the United Kingdom, the United States and Switzerland.  

In the interim, WHO is in the process of reviewing vaccine candidate submissions by Indian, Chinese and Russian counterparts – which are eager to get the Organization’s seal of approval – and market them independently to the dozens of countries that have already submitted pre-orders. 

In the case of the Indian vaccine, a generic version of the AstraZeneca/Oxford vaccine technology, WHO manufacturing approval would also clear the way for offering it through COVAX – where it comprises the largest single pre-order by the facility. 

“We have full dossiers from three other drug companies right now, Sinopharm, Sinovac, and the Serum Institute of India and they are under assessment,” said WHO’s Dr Mariangela Simao, Assistant Director-General for Access to Medicines, who said the real time status of WHO review and approval for all vaccines can be tracked on the WHO’s website. 

“We have a mission in China right now, to do the inspections in Sinopharm, in Sinovac,” she added.

Mariângela Simão, WHO Assistant Director General of Access to Medicines and Health Products, at the morning session of the EB meeting on Tuesday.

She added that she expects more information on Russia’s Sputnik vaccine next week following a meeting with the vaccines developers at the Gamaleya Research Institute. 

“For Russia, we are still waiting for additional information from Gamalaya, we have a meeting with the team next week.”

She said that WHO is also awaiting further information from the Republic of Korea, where the firm SK Bio is set to produce the AstraZeneca vaccine under a generic license – using the core vaccine technology approved by the United Kingdom. 

Among all of the vaccines in late stage trials or already being rolled out, only the Pfizer vaccine has actually received the full and final WHO seal of approval – although so far there is no COVAX pre-purchase agreement with Pfizer – and the vaccine requires ultra cold storage conditions.

Mixed Results from Chinese and Russian Phase 3 Trials So Far 

While WHO approvals would also be reassuring for the many countries that have already placed orders for the Chinese and Russian vaccines – there have been diverse reports so far about their efficacy. 

Sinovac’s results have generated the most concern. In the results of a Phase 3 trial in Turkey, released late in December, the company proudly announced an efficacy of 91.3%, but subsequent results in other countries have been much less impressive, showing 78% efficacy in one Brazil trial, 65.3% in Indonesia – and only 50.3% in the most recent Brazilian trial of 12,000 healthcare workers. 

That barely makes the 50% mark for the minimum efficiency standards set by WHO  and the FDA – although Sinovac said that the trial of healthcare workers was biased because they would be more intensively exposed to the virus than the general public. 

The Sinopharm vaccine, co-developed by the Beijing Institute of Biological Products, has reportedly yielded an efficacy result of 79.3% in China and 86% in another Phase 3 trial in the United Arab Emirates – although again these have yet to be reviewed independently. 

Over 60,000 volunteers from 125 countries, including Morocco and Peru, are still taking part in late stage clinical trials, said Sinopharm.

Of the three, the Russian Sputnik vaccine claims the highest overall efficacy rate of more than 90%, just trailing behind Pfizer’s and Moderna’s mRNA vaccines by a few percentage points, according to interim findings from late-stage trials in Russia. 

But once more, while the WHO review is still pending, the data has yet to be published in a peer-reviewed journal or reviewed transparently by a regulatory authority.   

Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 14 January.

 

–Svet Lustig Vijay contributed to this story

Image Credits: John Cairns, WHO, WHO.

WHO Director General Dr Tedros Adhanom Ghebreyesus Tedros makes opening remarks at EB148

The world is “on the brink of a catastrophe and moral failure – and the price of this failure will be paid with the lives and livelihoods in the world’s poorest countries,” declared WHO Director General Dr Tedros Adhanom Ghebreyesus, in his harshest rebuke to date of both countries and the pharma industry for failing to roll out out life-saving COVID-19 vaccines more equitably across the world. 

Speaking on the opening day of what is set to be a marathon session of WHO’s Executive Board, the WHO Director General noted that “more than 79 million doses of the vaccine have now been administered in at least 49 higher income countries, while just 25 doses have been given in one low income country.” 

While some WHO member states, including India’s Minister of Health Harsh Vardhan, EB Board Chair, framed the vaccine roll-outs now underway as the glass “half full” in his opening remarks – which coincided with the launch of India’s own vaccine’s campaign set to become the largest in the world, the WHO DG was not so upbeat. 

Rather Dr Tedros expressed the deep rumbles of dissatisfaction echoing among senior WHO officials over the way in which the WHO co-sponsored COVAX facility is being sidelined in the rush by countries – and even blocs of countries – to arrange their own vaccine deals. In fact that rush, which began with the United States, the European Union and other rich countries, now includes South Africa, Brazil, India, and most recently the African Union – which announced last week that it had secured pre-orders of some 270 million vaccine doses from manufacturers for its member states, outside of the COVAX framework.   Earlier this month, South Africa also announced that it had arranged for its own vaccine purchases, following on from India and Brazil. 

Countries and Companies Continue to Prioritize Bilateral Deals

“Some countries and companies continue to prioritize bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue,” said Dr Tedros, noting that some 44 such deals were signed last year. 

“The situation is compounded by the fact that most manufacturers have prioritized regulatory approval in rich countries where the profits are highest rather than submitting full dossiers to the WHO,” he added.  

The lack of communication from pharma producers, he warned, could also delay WHO approval of vaccines to be rolled out through COVAX: “This could delay COVAX deliveries and create exactly the scenario COVAX was designed to avoid with hoarding a chaotic market, an uncoordinated response and continued social and economic disruption.”

The WHO Director General called on countries and pharma producers to “change the rules of the game in three ways,” including by countries transparently reporting to COVAX the nature of their bilateral deals – “including on volumes, pricing and delivery dates.” 

He also called on countries with large vaccine orders to “share their own doses with COVAX, especially once they have vaccinated their own health workers and at risk populations, so that other countries can do the same.”

And, he called on pharma vaccine producers to “provide WHO full data for regulatory review in real time to accelerate approval… to prioritize supplying COVAX rather than new bilateral deals” as well as to allow countries to share any extra doses with COVAX. 

“My challenge to all member states is to ensure that by the time World Health Day arrives on the seventh of April. COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming, both the pandemic and the inequalities that lie at the root of so many global health challenges,” said Tedros. 

India’s Health Minister More Upbeat  
Indian Minister of Health and Social Welfare Harsh Vardhan presiding at WHO EB 148

While the WHO Director General’s comments certainly reflect the frustrations being experienced by people in many countries who are watching vaccine distribution campaigns get underway among wealthier neighboring states, India’s Vardhan cast a more positive light on the progress seen so far in his opening remarks at the EB:

“Scientific capabilities raced against time and delivered on the promise of a vaccine in the shortest possible time in history,” declared Vardhan, who is the EB chair. “While 2020 was the year of science, 2021 shall be the year of global solidarity and survival,” he forecast optimistically.

“COVID-19 vaccines are being successfully produced across many countries, a tech investment boom is being witnessed, and digital technologies are being adopted. All of this is combining to raise the hope of a new era of progress. I want to express utmost optimism that this year the crisis caused by the COVID19 pandemic shall be mitigated and successfully reversed through committed political leadership and sustainabled global cooperation and solidarity,” said Vardhan, adding that the “COVID-19 vaccines offer a real hope – but that hope needs to reach everyone… therefore we must ensure fair and equitable distribution of the COVID vaccine.”

IFPMA – Concerns Over Speed of Access “Potentially Misleading”

Meanwhile, concerns over the lack of speedy access to coronavirus vaccines to low- and middle-income countries (LMICs) “are potentially misleading and might hinder rather than help this unprecedented effort of global collaboration and solidarity,” said the head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni, in a lengthy response to the WHO DG’s remarks. 

“Governments around the world – in industrialized as well as developing countries – have moved overnight from concern about vaccine hesitancy to high anxiety at rolling out the distribution. The political urgency is understandably, it is important recall that the roll-out of approved COVID-19 vaccines is just weeks old. In that time, events have unfolded swiftly, with a couple of other vaccines gaining approval and more to follow. 

“While there is no room for complacency, it is important to note that this is the first global-health emergency in which new vaccines are being rolled out to LMICs at about the same time as in richer ones,” said Cueni – drawing a sharp contrast with other pandemics, where it took years for vital health products to reach poor countries.

Executive Board Packed Agenda Addresses COVID Directly and Indirectly

Much of the ten-day governing board meeting will focus on debates and a flurry of initiatives that are a product of the COVID-19 pandemic’s shockwaves. Beyond the optics and the politics, the quality of debate may be a test case for whether the 34-member EB, in its current alignment representing all six WHO member state regions equally, can regain its past lustre as a technically-focused board – or also requires more serious reform in the wake of shortcomings highlighted by the pandemic – as some critics have suggested.  

Items on the table will include, an exhaustive review of WHO’s emergency response operations in general, and its COVID-19 response more specifically. 

There is also an initiative by some 46 member states for more far-reaching reforms in WHO’s emergency powers and response capacity – looking toward a formal resolution to be submitted for approval at the May World Health Assembly.

The EB will also consider a WHO request for a nearly 20% increase in its operating budget to fill out the many performance gaps that have been uncovered in the course of the pandemic; a new framework to examine how to put WHO’s shaky finances on a more sustainable footing; and foster a more efficient Organization through a series of WHO administrative reforms. 

Along with that, there are a host of other core WHO activities, initiatives and issues, now being re-examined through a COVID “lens.” These range from topics like patient safety and medicines access – to non-communicable diseases and mental health.   

Improving WHO’s Emergency Response
Even as high-tech vaccines are rolled out in some countries, other essential COVID-19 supplies like oxygen remain in short supply in many others, notes the report by the Independent Panel for Pandemic Preparedness, under EB review. this week

Responding to the shortcoming already identified in WHO’s often delayed and wavering responses, the European Union, United States, Canada, Australia and Japan, are among the 46 countries seeking an EB mandate to develop a reform-minded WHA resolution that would sharpen WHO’s emergency response capacity. Behind the scenes, the resolution’s backers want to see much stronger enforcement mechanisms built into the legally-binding International Health Regulations that WHO administers – requiring countries that identify a new disease outbreak or pathogen risk to report on it more transparently and promptly – and enabling stronger action if they fail to do so. The proposal would be anchored in the findings of three independent investigative committees currently underway, the initiatives sponsors, led by Australia and Canada state.

The first gleanings of one such review by the Independent Panel on Pandemic Preparedness and Response will also be under the spotlight at the meeting. The review by an expert team led by the former prime ministers of New Zealand and Liberia concludes that the global pandemic alert system was “not fit for purpose” and the WHO was “underpowered” to do the job expected of it. (See related Health Policy Watch story)

NCDs, Mental Health & Patient Safety – Also Being Examined In the COVID Lens

Other items on the marathon EB agenda include a wide range of items relating to WHO’s pre-pandemic “Triple Billion” programme of work for 2019-2023, which also aims to improve the health of 3 billion people worldwide through wider access to universal health coverage as well as more action on preventive health issues, including social and environmental risks, such as poor diets, physical inactivity, and air pollution. But these items, as well, are being looked at with new eyes in light of the pandemic.   

For instance, a World Health Assembly proposal for a Global Action Plan on Patient Safety 2021-2030  states: 

“Patient safety issues such as personal protection, health worker safety, medication safety and patient engagement have become key areas of the COVID-19 response globally. Patient safety interventions must be urgently implemented in order to respond effectively to this global public health emergency of unprecedented scale. Such interventions are also needed to improve preparedness to respond to such challenges in the future.”  

The EB will also be asked to consider updating WHO’s 2013 Global Action Plan for the prevention and control of noncommunicable diseases, with one eye looking through a “COVID” lens – which saw the virus hit hardest against those with other chronic diseases. The updated action plan, which targets risks such as unhealthy diets, physical inactivity, smoking, alcohol consumption and air pollution, also would now include a stronger emphasis on mental health. It would be extended to the year 2030.

Transparency of Medicines Markets & Local Medicines Production 

The transparency of medicines markets and effective access to treatments for cancer and rare and orphan diseases, is another key topic on the EB agenda – resuming discussions over an earlier South African proposal to expand access to cancer treatments and another proposal on rare and orphan diseases by Peru, which the WHO had deferred until 2021. Linked to that, the EB willl also review the broader topic of medicines and vaccines access, in light of a WHO resolution on transparency in medicines markets, which was approved by the World Health Assembly in 2019. 

In another COVID-inspired move, some EB member states also are reportedly preparing a WHA resolution that aims to strengthen local production of medicines, vaccines and other health products, according to a Zero draft of the proposed resolution, obtained by Health Policy Watch. This has surfaced as an issue in light of the severe supply chain interruptions seen over the past year as a result of the pandemic – which left countries rich and poor facing dire shortages of basic medicines  – from antimalarials in some parts of Africa  to certain common antibiotics in Europe. 

Still other issues being considered involve WHO’s actions to address longstanding problems with fake and substandard medicines and a plan for operationalizing the new “Immunization Agenda 2030” that was approved by the World Health Assembly in August 2030. Both issues are even more important now, in light of the rollout of COVID vaccines underway, and the ongoing quest for reliable treatments. 

WHO Proposes 20% Budget Increase for 2022-2023
WHO proposal to Executive Board for some US $ 447 million in new allocations for 2022-23

A proposal to sharply increase the WHO budget for 2022-23 by nearly 20% or US$447 million is also on the table, raising the two-year budget level to US$4.478 billion.

A big chunk of the added funds would go to strengthening WHO capacity at the country level. WHO also promises to use the funds to integrate the “lessons learned” from COVID into other WHO initiatives; and “mainstream” WHO polio eradication teams – which have often serviced as the “backbone” of WHO vaccine support overall for developing countries – into other functions: 

“In the past, because of limited resources, the human resources and operational infrastructure built through the polio programme has been the backbone of the WHO Secretariat’s technical and public health operational support to countries,” states the budget proposal, “this proved to be critical in WHO’s effective emergency response in immunization campaigns and in surveillance, especially in fragile, conflict-affected and vulnerable settings.”

Under the proposal, rather than staff positions being cancelled in the phase-out of polio activities, polio eradication teams would be reassigned to other functions that, de facto, they already perform anyway, supporting overall immunization goals and general primary health care provision.  

A companion proposal to the budget would establish an intergovernmental working group on Sustainable Financing for WHO. The working group would examine ways to ensure more stable contributions from member states or other sources – easing the reliance on unpredictable  voluntary contributions from member states and other donors for many core programme activities.  The reliance on such contributions is widely acknowledged as a factor leading to gaps in more strategic, long-term Organizational staffing.    

WHO Reform

The EB will also consider advancing a controversial proposal to curtail formal presentations by civil society and other non-State actors at official WHO meetings, including the EB and the World Health Assembly – while facilitating new fora for technical exchanges with WHO technical teams and WHA member states. Civil society groups have objected to the proposals – saying that the new venues for interaction will not be as fruitful since they are outside the formal channels where dialogue with member states takes place. Nonetheless, the EB proposal suggests the approach be tested at the 74th World Health Assembly in May. Other reform proposals would sunset nearly 50 WHO resolutions that are more than six years old – and which WHO argues have since been replaced by other initiatives. The sunsetting would cover resolutions as wide ranging as health responses in nuclear war to the elimination of tropical diseases – which still often entail bulky reporting requirements, WHO says. A more systematic rationale for the declaration of World Health Days is part of yet another reform proposal.

Image Credits: WHO, Independent Panel for Pandemic Preparedness – Second Progress Report. .

Johnson & Johnson vaccine research laboratory. The J&J vaccine is one of the COVID-19 vaccines in the pipeline that WHO’s COVAX facility is planning to procure, but COVAX urgently needs US$ 8 billion to cover its commitments, says WHO special adviser Dr Bruce Aylward.

“Escalating bilateral deals” between pharmaceutical companies and World Health Organization (WHO) member states have complicated the global body’s vaccine delivery platform, the COVAX Facility, a number of top WHO officials told the WHO’s Executive Board yesterday in the opening day of the  EB’s 148th session, which focused largely on the pandemic.

“Countries with bilateral deals are urged to be transparent with COVAX so we know what vaccines are going where and we can be sure the unserved are getting served rather than some countries getting double served,” reported Dr Bruce Aylward, special adviser to WHO’s Director-General, urging wealthier countries to ensure that COVAX gets access to the vaccines.

“The unmet demand now for vaccines, evolving viral mutations and escalating bilateral deals, all require us to adjust our strategy and needs for 2021,” Aylward stressed, flagging that while COVAX is ready to distribute vaccines it urgently needs at least US$8 billion to cover its current commitments.

A brand new report released this week by the Independent Panel for Pandemic Preparedness and Response, however, has made a number of scathing observations about the global handling of the pandemic by countries as well as WHO, including that the response has “deepened inequalities”, the global pandemic alert system “is not fit for purpose”, and that WHO has been “underpowered to do the job expected of it”.

The Independent Panel for Pandemic Preparedness and Response said that it was struck by how WHO was “underpowered to do the job expected of it”, and that “inequalities both within and between nations have worsened” as marginalised communities are locked out of healthcare.
WHO Powers To Validate Disease Outbreaks Gravely Limited – Incentives For Countries’ Cooperation ‘Too Weak’ – Says Independent Panel

“The Panel is struck that the power of WHO to validate reports of disease outbreaks for their pandemic potential and to be able to deploy support and containment resources to local areas is gravely limited,” the panel, which is chaired by ‘two former prime ministers, Liberia’s Ellen Johnson Sirleaf and New Zealand’s Helen Clark, reported.

“The incentives for cooperation are too weak to ensure the effective engagement of states with the international system in a disciplined, transparent, accountable and timely manner,” it added.

The report by the panel of 11 international experts also observed that “inequalities both within and between nations have worsened as vulnerable and marginalized people in a number of countries have been left without access to health care, not only to treat COVID-19 infection, but also because health systems have been overwhelmed, shutting many out of basic care and services”.

To address this, it stated that “fundamental and systemic change in preparedness” is necessary to introduce a new global framework “to support the prevention of and protection from pandemics”.

But this will need the global community to “come together with a shared sense of purpose and to leave no actor outside the circle of commitment to transformative change”, it acknowledged.

Trends in vaccine access by the Independent Panel for Pandemic Preparedness & Response (The Independent Panel) to the 148 Executive Board.

As of 17 January, 50 countries have started administering vaccines. 40 of these were high-income countries, and 95% of the estimated 40 million vaccine doses that have been dispensed so far were done so in only 10 countries.

Numerous member states including Australia, Bangladesh, China and New Zealand expressed their concern about the inequitable access to the vaccine.

Representing the African region, Botswana called for “global solidarity to prioritize investment in affordable and safe COVID-19 vaccines and equitable allocation, based on the principle of fairness”.

Lemogang Kwape, Botswana Minister of International Affairs and Cooperation, described the “great inequality in COVID-19 vaccine availability” as a public health concern. It said that Africa’s response to the pandemic had already been affected shortages in personal protective equipment, ventilators and other essential medical items.

Brazil, currently facing rising COVID-19 infections and deaths as part of its second wave, called for action to ensure equitable access of COVID-19 products and technologies.

“At this critical juncture, this Executive Board should make a strong call for members, WHO, other international entities, and pharmaceutical companies to deliver in full and as a matter of urgency on their pledges and commitments to the fair and equitable distribution of COVID vaccines everywhere,” said Ambassador Maria Nazareth Farani Azevêdo, Permanent Representative of Brazil to the UN Office in Geneva.

Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, warned that “case and cluster investigations, contact tracing and support the quarantine of context remain underpowered in almost every country” and “we haven’t expanded the use of rapid diagnostic tests as much as we would like”.

China Appeals for Origin Research Not to Be Politicized

Meanwhile, China appealed for research into the origin of the virus not to be politicized, stressing that the country had “always been open, transparent and responsible”.

After months of delay, A WHO-led investigative team arrived on 14 January in Wuhan to begin what is supposed to be an independent query into the origins of the virus, which first emerged among clusters of people working around a wildlife market in Wuhan.

Leading up to the team’s arrival, however, China has launched an extensive media campaign to try to shift the narrative about the origins of the virus elsewhere – suggesting most recently that it could have come from Southeast Asia. This is despite pre-pandemic research indicating that the SARS-CoV-2 family of viruses pre-pandemic circulates in bats in the Hunan region of south-central China – an area to which Beijing has recently barred access.

The WHO team investigating the origins of the COVID-19 pandemic arrived in Wuhan on Thursday. The US representative to the board said the team’s investigation would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”.

In light of China’s clear interest in shaping the virus origins narrative, leading European, American and western Pacific governments have expressed concern about whether the investigative team could really do its work. Last week, WHO’s Dr Ryan clarified that the investigation is not a matter of assigning blame, but “is about finding the scientific answers”.

Even so, Garrett Grigsby, Director of the Office of Global Affairs in the Department of Health and Human Services, said today the WHO expert team currently in China to investigate the origin of the virus would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”. This includes animal tests from in and around Wuhan, environmental samples from the markets, comparative analysis of animal and human genetic data and samples.

This message was echoed by the representatives from Japan, Canada, Australia, and Austria, on behalf of the EU.

“We wish to reiterate the importance of the international expert team to be able to access all the necessary studies and information to achieve a scientific, objective and transparent investigation,” said the EB representative for Japan.

“We welcome that the international expert team was finally allowed to travel to China to start their investigation in cooperation with Chinese counterparts. We hold great importance to this investigation, which requires transparency, access to locations and data, and full cooperation. We request to be regularly briefed on the progress,” said Ambassador Elisabeth Tichy-Fisslberger, Permanent Representative of Austria to the UN Office in Geneva.

Image Credits: Independent Panel on Pandemic Preparedness, Johnson & Johnson, CGTN.