While very low-income countries have experienced relatively low mortality rates from COVID-19, they can expect higher mortality caused by the knock-on effects of the pandemic on their fragile health systems, according to the Executive Director of the Global Fund to Fight AIDS, TB and Malaria.

Since the pandemic first overwhelmed health systems in early 2020, countries across the globe have reported a reduction in referrals and diagnoses for various diseases.

Peter Sands, Executive Director of Global Fund

“It’s a perfect storm of concurrent social crises which are disrupting health interventions: programmes to fight diseases like HIV, tuberculosis (TB) and malaria,” Peter Sands, Executive Director of the Global Fund, said during a session of the  World Economic Forum in Davos today.

Last year, India, Indonesia, the Philippines — three high-burden countries for TB — reported a 25-30% drop in its case notifications. A Lancet study predicted a 25% reduction in antimalarial drug coverage in 2020 in malaria-endemic African countries, potentially doubling mortality.

And although the pandemic has affected health systems in low- and high-income countries alike, poorer countries with weaker health infrastructure, greater disease burdens, and generally worse access to COVID-19 treatments and vaccines will have the hardest time recovering.

“Particularly, the lowest income countries have very young populations. This kind of demographic means that the mortality rate from COVID is relatively low,” he said. In the poorest countries, the life expectancy is about 18 years lower than the richest.

But these countries could be more vulnerable to the “collateral damage” of the SARS-CoV-2 pandemic, rather than the direct impact of the virus. 

“You’re going to see relatively low mortality from COVID itself, and relatively high mortality from these knock-on consequences,” added Sands.

Diagnosis Deficit: Lower Diagnoses Globally

The COVID-19 pandemic risks shattering countless disease elimination targets, many of which have been set by the World Health Organization (WHO).

Diagnoses and interventions for communicable and non-communicable diseases (NCDs) have both been impacted in 2020, with COVID-19 and related lockdowns affecting patients’ ability to get access to treatment.

The World Hepatitis Alliance found that last year 94% of respondents in its 32-country survey had had their hepatitis services closed. In addition, half of respondents in lower- and middle-income countries (LMICs) could not get their medication, with respondents in India and Nigeria citing pandemic-related travel restrictions as the cause.

“The Task Force for Global Health and the World Hepatitis Alliance [have] all come up with the same figures,” said Charles Gore, Executive Director of the Medicines Patent Pool.

“Diagnosis and treatment are the key areas in [WHO’s] Global Strategy where the world is lacking,” he added. “And unfortunately, the hit is even bigger in LMICs.”

Where access to treatment for a given disease might have been reduced by 40-60% in a high-income country, “we’re talking 60-90% in LMICs”.

“There’s an estimate that a one-year hiatus in [a country’s] national programs from hepatitis elimination will lead to an extra 45,000 liver cancers and 72,000 deaths by 2030,” he said.

The reduction in access to treatments is similarly stark for NCDs.In the UK, lung cancer referrals in August 2020 were down by 26% from the previous year. During the April lockdown — when much of the Western world experienced its first COVID wave — referrals for lung cancer from doctors’ surgeries dropped by 72%.

“Even if they are referred, it’s very difficult to get patients through the system, and get respiratory symptoms investigated so they can start treatments quickly,” said Michelle Mitchell, chief executive of Cancer Research UK.

“This is a time of great worry for patients with lung cancer or other types of cancer.”

Patients will have a much better prognosis if they are diagnosed early. Data observed by Cancer Research UK indicates that nearly 90% of patients diagnosed at Stage 1 survived the disease for at least one year, compared to just 19% for those diagnosed at Stage 4.

“It’s too early to know the impact yet,” she said. “But we do expect there to be a huge impact.”

Build Back Better: ‘Not Ambitious Enough’

The process of ‘building back better’ does not go far enough, Harvard T.H. Chan School of Public Health’s Dean, Michelle Williams, said.

Building back better refers to a process of economic recovery from COVID-19 that avoids destructive investment patterns: namely, investments that endanger biodiversity, which is linked to zoonotic diseases jumping species.

“What COVID has done is really show how weak global public health infrastructure can bring us to our knees,” she said.

“To build back better is [to] first recognise the importance and value of public health and invest accordingly. That means properly investing in global governance of public health leadership [and] making the structure nimble and equipped.”

An interim report by the Independent Panel on Pandemic Preparedness and Response, published last week, determined that WHO’s COVID-19 response was too slow, and was hampered by a lack of resources and a damning lack of authority among its member states.

“We’re not being remotely ambitious enough,” Sands said. “This year we are deploying about US$4.7 billion on HIV, TB and malaria to mitigate the collateral damage … we need another $5 billion. And that’s the Global Fund alone.”

And the global ambition for economic recovery, which is “currently shaped as getting back to [a] pre-pandemic” scenario, is “not good enough”, Mitchell added. “Because we weren’t doing well enough before COVID.”

Image Credits: The Global Fund.

WHO is yet to grant the Moderna vaccine Emergency Use Listing (EUL), but its advice for use is still significant as many member states rely upon these vaccine recommendations as a global reference point.

The Moderna COVID-19 vaccine is safe for most people including those with a wide range of underlying medical conditions, according to the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on immunizations.

However, the vaccine is not recommended for pregnant women or children as it has not been tested on these groups, according to interim recommendations published today by WHO.  The issue of the vaccine in pregnancy is emerging as a bigger issue in light of recent evidence, including from the US Centers for Disease Control, that pregnant women are at higher risk of serious COVID-19, and as new variants of the SARS-CoV2 virus infect more young people, including those of childbearing age.

The WHO approval may also pave the way for Moderna to contribute vaccines to the global COVAX facility, following a final WHO “Emergency Use Listing” approval for the vaccine.

Last Friday, Pfizer announced it was contributing 40 million doses of its vaccine to the WHO co-sponsored COVAX, weeks after WHO approved the vaccine.

People who have severe allergic reactions to any of the vaccine’s components should not receive it, and it should also not be used in countries that do not have the capacity to treat anaphylactic shock, according to SAGE. It also advises caution about administering the vaccine to frail, elderly people near the end of their lives.

The vaccine needs to be administered in two doses 28 days apart, although “the interval between the doses may be extended to 42 days”, SAGE said. All those vaccinated should be observed for “at least 15 minutes after vaccination”, and anyone experiencing an immediate severe allergic reaction should not receive the additional dose.

No Word On Emergency Authorization From WHO

The WHO has not yet issued an Emergency Use Listing (EUL) for the Moderna vaccine, but it has undergone review by the European Medical Agency (EMA), which has authorized its use in the European Union. It has also been approved in the United States, Canada, the United Kingdom and Swissmedic.

Regardless, the WHO advice is significant as many member states – especially low- and middle-income countries (LMICs) – also rely upon WHO for vaccine recommendations as a global reference point.

Dr Kate O’Brien, WHO’s Director of Vaccines, told a media briefing today that the global body was still in discussions with Moderna about the information it needed to issue an EUL, and so did not comment about if or when this would be issued.

O’Brien did add, however, that SAGE’s advice was important as some member states had already made arrangements to procure the vaccine from Moderna.

Dr Kate O’Brien, WHO’s Director of Vaccines.

Moderna and Pfizer/BioNTech are both mRNA-based vaccines, but the Moderna vaccine does not need to be stored at the extremely cold temperatures required by the BioNTech-Pfizer vaccine, which makes it more suitable for LMICs.

In trials, the Moderna vaccine showed an efficacy of approximately 92% in protecting against COVID-19, starting 14 days after the first dose.

Moderna claimed yesterday that its candidate appears to retain its efficacy against the B.1.1.7 and South Africa-identified (B.1.351) variants. In the study, which is yet to be peer-reviewed, researchers looked at blood samples from eight participants who had previously received the recommended two doses during Phase 1 trials.

In the case of the B.1.1.7 variant, they reported the mutated virus posed no significant impact on titers: a means for measuring the amount of antibodies in a blood sample. Tests on B.1.351 showed a “six-fold reduction in neutralizing titers” although “neutralizing titer levels with B.1.351 remain above levels that are expected to be protective”, according to the company media release.

Meanwhile, Moderna also announced that it will “test an additional booster dose of its COVID-19 Vaccine (mRNA-1273)” to see whether it can further increase neutralizing antibodies against emerging strains “beyond the existing primary vaccination series”.

Despite this, O’Brien said that clinical evidence was needed to support this report, and that the blood sera of people who have antibodies against COVID-19 was currently being tested against these variants.

She welcomed how prepared vaccine manufacturers were to “potentially make modifications to the vaccines that they are continuing to develop”.

“The preponderance of evidence at hand, albeit small, is that the vaccines in hand are extremely valuable as part of the toolbox for fighting the pandemic and really crushing this virus, but we will continue to respond to as new scientific evidence comes in,” concluded O’Brien.

Image Credits: Moderna.

Björn Kümmel, Vice Chair, WHO Executive Board.

Discussions on WHO’s state of financing were addressed by member states during the on-going Executive Board meeting. As we reported last week, WHO is keen on defining independence and sustainability of its financing to be better prepared to address emergencies in the future.

We spoke to Björn Kümmel, Deputy Head of Unit, Global Health, German Federal Ministry of Health and Vice Chair of the WHO Executive Board, who has been actively involved consistently in raising these issues on the organization’s finances. He was also a part of the consultations on the Open-ended Intergovernmental Working Group on Sustainable Financing at the EB last week.

Geneva Health Files: Germany has emphasized the importance of assessed contributions for improving the finances of WHO. Can you please share your reasoning behind an increase in assessed contributions for all member states?

Björn Kümmel: Strengthening of the World Health Organization (WHO) is a key priority for the German Federal Government. In the new Global Health Strategy of the German Federal Government, which has been adopted by the Cabinet of Ministers last October, there is a clear focus on enabling WHO to play its mandated role as the leading and coordinating authority in global health.

The WHO’s budget has grown over the past decades. However, the assessed contributions have remained practically stable since the year 2000. Today, WHO’s overall budget volume foresees roughly 5 billion USD for two years. While in past history, the entirety of the membership fee, the assessed contributions was the main part of WHO’s budget, since 2000, the voluntary contributions have outgrown the assessed contributions.

It is essential to realize, that today, the vast majority of  financial resources (currently roughly 83 %) are contributed on a voluntary and largely unpredictable basis. These funds are provided and steered by a very limited number of generous individual donors on a purely voluntary basis. These donors decide, for which concrete goals WHO may use the funding, and they are free to withdraw the funding as they please. This financial dependency on a very limited number of key donors is seen as one of the key risks for WHO as this leads also to political dependency. Some argue that WHO is often used by donors like an implementing agency, implementing the goals that are a priority for the generous donors.

With only 17 % purely predictable and flexible sustainable finances (assessed contributions), it is practically impossible for WHO to play its envisaged role as a guardian of global health. Through the COVID-19 pandemic it has become obvious: The expectations of the 194 Member States vis-à-vis WHO by far outweigh WHO’s de facto abilities. And while in the WHO governing bodies, Member States keep on adding concrete tasks for WHO, not only but including through adopting World Health Assembly Resolutions that have wide financial implications, within the past decades, the WHO Member States have failed to properly address the key challenge of sustainable financing for WHO. One lesson that will most likely be pointed out in the current lessons-learnt-processes that assess the reaction towards the COVID-19 pandemic will be: This financing challenge needs to be tackled if  WHO should in the future continue to be expected to lead and coordinate the international prevention, detection and response to pandemics.

GHF: Based on the deliberations at the EB, what is your assessment of WHO’s proposal for sustainable financing?

Björn Kümmel: Through its resumed session in November 2020, the World Health Assembly has asked the WHO Secretariat to prepare a paper on sustainable financing for discussion at the Board`s meeting in January. The Secretariat’s report (EB148/26) provides a clear picture about the different sources of financing for WHO with regards to the question whether this financing is sustainable or not. The Secretariat proposed to set up a Member State working group to assess the situation with regards to the sustainability of financing for WHO. Based on this assessment, the working group is supposed to discuss and explore options in order to address this challenge. However, it is clear, that it is not the role of the working group to take final decisions. These would have to be taken by the entire membership of WHO, all 194 Member States together.

The proposed process is promising as it may help to address one of the key structural challenges that has been hindering WHO to fulfil its mandate. During the yearly meetings of the Executive Board in January, the implementation of the current Programme Budget is being discussed. In the relevant discussions, all Member States complain about the fact, that the different programme areas of the WHO are unevenly financed with many so called “pockets of poverty”. These are predominant throughout all WHO’s programme areas and have severe implications for WHO’s day to day work.

It is important to understand: When WHO’s programme budget is being approved by the 194 Member States, it is a largely unfunded budget. The only financing source that is purely certain is the 17 % share of the assessed contributions and some already secured grant agreements by voluntary donors. Therefore, WHO has to raise the vast majority of the needed finances after the approval of the programme budget.

This has led to the fact, that many departments need to spend major parts of their work on fund-raising efforts to make sure that envisaged activities are enabled and staff positions can be paid for. Since the vast majority of WHO’s funding is unpredictable and non-sustainable, many WHO staff members do not work on a long-term basis but even based on contracts covering shorter periods than half a year. In addition, this situation has led to a major increase of the use of “non-staff” contracts, in particular consultants and other agreements that are perceived to be more flexible and cover shorter periods of time. Obviously, this financial reality is hardly reconcilable with the need to ensure the best talent in public and global health in order to be able to lead global health by excellence. Attracting and retaining the needed talents will be a growing challenge due to the human resources consequences of the current financing model of WHO.

The discussion that will evolve based on the Secretariat’s report on sustainable financing and the future work of the working group is of highest importance to make all WHO Member States and the broader public health community aware of this financing challenge. We hope that the different ways that have been tried in the past years to ease this challenge will be assessed including why these options have failed to properly address the given challenge. It would be a great step forward, if, through this process, the WHO’s governing bodies would devote adequate focus on potential future options for long-term solutions.

It is clear, that this will be a lengthy and very complex endeavour. However, the COVID-19 crisis may serve for a new political understanding among the entire membership of WHO, that more sustainable investments are needed to enable WHO to fulfil its mandated role.

GHF: What steps have been taken, or will be taken, in the near future to revitalise the role of the governing bodies?

Björn Kümmel: Germany has been a member of the Executive Board for the past three years. From the start, we shared the view that the role of the governing bodies and in particular the Executive Board indeed needs to be revitalized. The Executive Board has been criticized not to allow for adequate interaction between its members and sometimes not being able to more flexibly shift the focus of its deliberations on the most pressing and decisive questions. It is a fact, that the Executive Board has become to some extent a small World Health Assembly.

While this transparency is a great merit as it allows for full inclusiveness and at least theoretically ensures that the Assembly is well prepared through a consensual process, some argue that this setting sometimes limits the interaction in between the original members of the Executive Board. This leads to reading out only prepared statements and thus reduces the role of the Executive Board to serve as an exclusive steering board.

During the COVID-19 pandemic, some EB members have raised their concern, that the EB has not played its mandated role to provide oversight and guide the work of the Secretariat throughout the pandemic. In order to reflect on this and more generally the role that the Executive Board sees for itself, a retreat of the Executive Board has been proposed. Taking into account the limitations for such a retreat during the ongoing pandemic, members of the Executive Board have called for such a retreat at the earliest possible timing.

Priti Patnaik is the founding editor of Geneva Health Files – a reporting initiative that tracks power and politics in global health.

This interview is a part of a series under a new collaboration arrangement between Geneva Health Files and Health Policy Watch.  

Image Credits: C Black, WHO.

Michael Osterholm – a leading member of the United States President’s coronavirus transition team – has said he is “convinced” by data indicating the UK COVID-19 variant is more deadly, even as United Kingdom officials downplay the limited and “uncertain” evidence.

Meanwhile, Moderna announced today that it will “test an additional booster dose of its COVID-19 Vaccine (mRNA-1273)” to see whether it can further increase neutralizing antibodies against emerging strains “beyond the existing primary vaccination series”.

Late on Friday evening, UK Prime Minister Boris Johnson announced that the SARS-CoV-2 variant, also known as B.1.1.7, “may be associated with a higher degree of mortality”: potentially by up to 30%.

But the government’s chief scientific adviser, Sir Patrick Vallance, was quick to flag that the current data available – published by Nervtag, a government advisory committee – was “not yet strong”.

The report concluded there was “a realistic possibility” that infection with B.1.1.7 “is associated with an increased risk of death”.

Vallance noted: “There’s a lot of uncertainty around these numbers and we need more work to get a precise handle on it, but it obviously is a concern that this has an increase in mortality as well as an increase in transmissibility.”

The variant, which was first detected in September 2020, was previously understood to be around 30-70% more transmissible than the Wuhan strain.

Vallance explained that around 10 in 1,000 men in their 60s infected with the Wuhan strain would be expected to die with the virus. “With the new variant,” he said, “for 1,000 people infected, roughly 13 or 14 people might be expected to die.”

Despite this, Michael Osterholm – epidemiologist and a member of President Joe Biden’s coronavirus transition team – has said he is “convinced” that B.1.1.7 is deadlier after reviewing the UK report.

Osterholm, who has also reviewed other unpublished data, said: “The data is mounting — and some of it I can’t share — that clearly supports that B.1.1.7 is causing more severe illness and increased death.”

The US Centers for Disease Control and Prevention (CDC) has begun reviewing the data, it confirmed to CNN on Saturday: “The CDC has reached out to UK officials and is reviewing their new mortality data associated with variant B.1.1.7.”

The Nervtag report collected data from three independent analyses, led by University of Exeter, Imperial College London, and London School of Hygiene & Tropical Medicine.

Moderna Latest To Claim Vaccine Effective Against Key Variants

Moderna’s clinical development manufacturing facility in MA, USA.

Given this uncertainty, questions have naturally been directed toward those organizations developing COVID-19 vaccines, notably as to whether these candidates can protect against these variants.

As of Monday morning, Moderna — whose mRNA vaccine has so far been approved for emergency use in at least 10 blocs including the UK, the US and the European Union — has claimed its candidate appears to retain its efficacy against the B.1.1.7 and South Africa-identified (B.1.351) variants.

In the study, which is yet to be peer-reviewed, researchers looked at blood samples from eight participants who had previously received the recommended two doses during Phase 1 trials.

In the case of the B.1.1.7 variant, they reported the mutated virus posed no significant impact on titers: a means for measuring the amount of antibodies in a blood sample.

Tests on B.1.351 showed a “six-fold reduction in neutralizing titers” although “neutralizing titer levels with B.1.351 remain above levels that are expected to be protective”, according to the company media release. But the sample size is surprisingly low, with only eight participants and the study is based on an in-house, un-peer reviewed study,

Last week, Pfizer made a similar claim after testing only 16 blood samples: a startlingly low number given the number of participants involved in their clinical trials. Critics had said Pfizer had been overly optimistic in its interpretation of the data.

Meanwhile, Moderna is also “advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in South Africa”.

It aims to test the candidate in preclinical studies and a Phase 1 study in the US “to evaluate the immunological benefit of boosting with strain-specific spike proteins” and “expects that its mRNA-based booster vaccine will be able to further boost neutralizing titers in combination with all of the leading vaccine candidates”.

Image Credits: Moderna.

Vaccine
The economic cost to the world’s advanced economies in the absence of global vaccine access could be up to US$5 trillion, a report has found, compared to the $38 billion cost of funding WHO’s ACT Accelerator.

Wealthy countries that pursue ‘vaccine nationalism’ when their trading partners don’t have access to the COVID-19 vaccine will pay a far higher economic price than if they invest in ensuring all countries have access to vaccines, according to a comprehensive economic modelling study released today by the World Health Organization (WHO).

The study, commissioned by the International Chamber of Commerce (ICC) Research Foundation, projects that the economic cost to the world’s advanced economies in the absence of global vaccine access could be up to US$5 trillion.

In contrast, the entire cost of funding the Access to COVID-19 Tools (ACT) Accelerator, the WHO-led global platform to ensure equitable access to COVID-19 vaccines, tests and treatments, is $38 billion.

“Strikingly, a $27.2 billion investment on the part of advanced economies – the current funding shortfall to fully capitalize the ACT Accelerator and its vaccine pillar COVAX – is capable of generating returns as high as 166x the investment,” according to the ICC.

The researchers looked at the production and trade networks of 65 countries across 35 sectors, modelling three different vaccine access and lockdown scenarios. They concluded that the global loss to GDP if vaccines are not widely available “is higher than the cost of manufacturing and distributing vaccines globally”.

“Our estimates suggest that up to 49 percent of the global economic costs of the pandemic in 2021 are borne by the advanced economies even if they achieve universal vaccination in their own countries,” states the report, which was produced by the Centre for Economic Policy Research.

The study explains that the advanced economies are “tightly connected to unvaccinated trading partners which consist of a large number of emerging markets and developing economies”.

“Thus, the devastating economic conditions in these countries under the ongoing pandemic can cause a non-negligible drag on the advanced economies as well,” according to the study.

Demand for goods would fall in countries badly affected, and their production capacity would be weakened, thus affecting their ability to supply goods and materials needed by advanced economies.

Ṣebnem Kalemli-Özcan, Professor of Economics and Finance at the University of Maryland and an author of the report, said: “No economy can fully recover until we have global equitable access to vaccines, therapeutics and diagnostics. The path we are on leads to less growth, more deaths, and a longer economic recovery.”

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

Meanwhile, WHO Director General Dr Tedros Adhanom Ghebreyesus said that “this research shows a potentially catastrophic economic failure”.

“The progress made by the ACT Accelerator shows solidarity in beating this virus. The longer we wait to provide vaccines, tests, and treatments to all countries, the faster the virus will take hold, the potential for more variants will emerge, the greater the chance today’s vaccines could become ineffective, and the harder it will be for all countries to recover. Truly, no-one is safe until everyone is safe.”

ICC Secretary General John WH Denton added that the research shows that  “ensuring equitable access to COVID-19 tests, treatments and vaccines is not only the right thing to do – to do otherwise is economically irresponsible. International business needs a fully funded ACT Accelerator”.

“This is not an act of charity. This is economic common sense,” said Denton. “If you want to ensure a durable recovery in your economies, you need to step up and actually pay up.”

Countries with open economies stand to lose the most, particularly Belgium, France, Germany, the Netherlands, Norway, Switzerland, the United Kingdom and the US, “who might lose up to 3.9% of their GDPs”.

“No economy is an island,” the report concluded, paraphrasing the John Donne poem. “The economic losses of the pandemic can only be mitigated through a multilateral coordination ensuring the equitable access of vaccines, tests and therapeutics.”

COVAX Deal With Pfizer Is Small But ‘Opens the Door’

Meanwhile, WHO Special Advisor Dr Bruce Aylward defended a small 40 million COVAX deal reached with Pfizer, which had been announced on Friday. The European Union has reserved 600 million doses, with the US securing 200 million.

Alyward said the small number was “a start”, but that the Pfizer vaccine was already recommended by WHO “so this could be launched very, very rapidly and earlier possibly than some of the other products”.

45 out of 50 of the countries rolling out COVID-19 vaccines are using the Pfizer vaccine.

“45 out of 50 of the countries rolling out vaccines are using the Pfizer vaccine,” said Aylward. “Even with a relatively small number of doses …  it was clear that we could make a real difference in protecting some of the most highly exposed, highly at risk health care workers, particularly in some of the [low- and middle-income countries (LMICs)] that the facility serves.

“The other big advantage by putting the framework agreement in place, is that we can then open the door to donations in a much more potentially seamless manner with other countries that currently have contracts with and substantial quantities of the Pfizer vaccine.”

Rapid COVID Tests Ensured For LMICs As Costs Halved

Fragile health systems, remote or decentralised populations, and reliance on global provision in LMICs have created obtrusive barriers to achieving mass rapid testing for SARS-CoV-2.

However, more than 250 million antigen-detecting rapid diagnostic tests (Ag RDTs) will be made available to LMICs for approximately US$2.50 each following a July 2020 call for interest.

The open call for Expressions of Interest (EOI) was launched by Unitaid — a WHO partner — and global nonprofit Foundation for Innovative New Diagnostics (FIND), on behalf of the ACT-Accelerator: WHO’s platform for providing equitable COVID medicines and treatments

Up to 120 million tests will be produced by Premier Medical Corporation, India, in 2021, with a further 130 million tests secured through other, unannounced agreements.

The ACT-Accelerator has estimated that 500 million COVID tests will be needed in LMICs over the next 12 months, with three-quarters necessarily deployed via primary health care.

Image Credits: WHO Afro region, WHO, Pfizer.

Activism against Gender-Based Violence at the National University of Lao, Dong Dok campus. During the pandemic, violence against women had increased by 25% as early as April in countries with formal reporting systems in place.

WHO needs to focus more work on limiting gender-based violence, increase its programmatic emphasis on healthy diets and lifestyles, and contribute to renewed momentum on climate action, said WHO member states at Friday’s Executive Board session.

The member states were reviewing the WHO Director General’s report on “social determinants of health” – in light of the added health impacts of the ongoing global COVID-19 pandemic.

Social determinants of health is a broad umbrella term referring to a range of socio-economic and environmental drivers that can help prevent diseases from ever occurring – or conversely accelerate more disease if neglected. They range from poverty, which can foster more communal violence and addictions, to unhealthy diets leading to malnutrition and obesity, or air pollution that contributes to the development of cardiovascular and respiratory diseases as well as cancers.

COVID-19’s Gender Gap

Amid mounting evidence that the social and economic toll of the COVID-19 pandemic is to being disproportionately paid by women, member states flagged WHO’s need to do more to assist countries’ attempts to limit gender-based violence and discrimination, WHO member states suggested.

A delegate from Kenya highlighted “increased teenage pregnancies, gender-based violence and substance abuse” as results of pandemic related lock-downs and economic stagnation. He called on WHO for an inter-agency plan to support its Member States, as they struggle to mitigate the “severe social shocks of the pandemic”.

A United Nations report, published as early in the pandemic, highlighted that “many women are being forced to ‘lock down’ at home with their abusers” even as support services typically available for victims continue to be “disrupted or made inaccessible”.

That same report flagged that violence against women had increased by 25% in countries with formal reporting systems in place.

Beyond gender-based abuse, the pandemic-related gender impacts also are evident in the greater difficulties when have had accessing healthcare. And the pandemic has exacerbated pre-existing employment inequalities, member states reflected.

“Gender is a key social determinant of health given the impact of gender roles, norms and behaviours, on how people access health services and information,” a delegate from the United Kingdom said. Similarly, gender also determines how health systems respond to individual patients.

With regards to the pandemic, as such, the WHO report staed that the Organization is developing advocacy and engaging with other UN agencies and actors on “on human rights-based approaches” to gender and COVID-19- although it didn’t provide further details.

The report also notes that internally at WHO: “The Gender, Equity and Human Rights team at headquarters and the regional office network are spearheading efforts to mainstream gender issues across the Organization.” In other comments this past week to the EB, Dr Tedros Adhanom Ghebreyesus has noted that while WHO has gender parity among the ranks os its senior management – but male professionals still well outnumber women in certain WHO regional  and country offices – with the most imbalance in the African region.

Diet and Nutrition

During the board meeting, the UK also flagged diet and nutrition as key social determinants: topics scarcely mentioned in the WHO report.

“Healthy diets and malnutrition are an important element of determinants of health,” the delegate said.  “Action is needed to address unhealthy diets and malnutrition in all its forms.”

The WHO report refers to nutrition only vaguely, listing “food insecurity” alongside “poor-quality housing … insecure employment, and poorly regulated care for the elderly” as “examples of social determinants with devastating impacts on individuals and communities affected by COVID-19”.  However, a growing body of evidence, including other recent WHO reports, point to the double burden many low-and middle-income countries are now seeing from undernutrition and malnutrition- the latter related to an over reliance of fast-urbanizing communities on fast or processed foods, cheap starches, and sugar-  and fat-heavy diets.

Despite arguments that addressing diet would help to improve health outcomes and prevent future pandemics, the WHO report on social determinants of health scarcely mentioned nutrition.

Those forms of malnutrition – leading to micronutrient deficiencies as well as to obesity –  are responsible for a significant portion of the Global Burden of Disease, the UK delegate said.  He reminded the EB that “obesity has shown to significantly increase the severity of COVID-19”.

Meaningfully addressing poor diet, the UK argued, would help to improve health outcomes and enter future pandemics better prepared.

The Climate Crisis & Biodiversity

In the decade before the pandemic, awareness of the health impacts of climate change and loss of biological diversity were growing global health concerns, including at WHO. But the sudden and overwhelming emergence of SARS-CoV-2, however, has meant climate-related health policy has mostly been left to stagnate, some delegates observed.

Pedestrians in Bangladesh cover their faces to keep from breathing in dust and smog. Despite significant advancements before the pandemic, environmental health has largely taken a back seat in policymaking.

While there have been a few significant steps made since the first COVID-19 death — such as the UN including climate measures on its Human Development Report, or the UK registering the first death due to air pollution — there is evidence that the pandemic has led national health ministers to push  environmental health risks to the background of their agendas.

This is despite the fact that environmental risks, notably from air pollution, also contribute directly to more chronic cardiovascular and respiratory health conditions, and thus more COVID-related deaths.

The WHO report acknowledges this, indirectly, stating that “increasing urbanization and climate change risk [as] entrenching existing inequalities and further widening the gap in health outcomes”.

However, delegates noted that more attention needs to be given to the routes by which climate change, biodiversity loss and urbanization are contributing to ill health during the pandemic – as well as increasing future pandemic risks.

In the case of SARS-CoV2, for instance, while the exact route by which the virus reached Wuhan and its seafood market where the first human clusters of infection appeared, most scientists agree that the virus hails from a bat coronavirus that leaped the species barrier. In the past, that has happened when wild animals are hunted, captured, caged, transported and sold alive in crowded urban food markets across Asia.

Similar leaps of animal diseases to humans have led to the rise of Ebola and HIV in Africa, where the capture and consumption of  wild animals as “bushmeat” is a traditional practice that became even more common in conditions of conflict and food insecurity, where wildlife areas also are more vulnerable to poaching and plunder by black marketeers.

“The [COVID-19] crisis we are facing is not only a health crisis, but also a social and economic crisis,” the Austrian delegate told the board. But, vitally, she added that “it cannot be fully understood without considering the ongoing ecological crisis.”

“The poorest and most vulnerable have been disproportionately hit,” she said, “and further action to foster health equity and moving beyond the health sector is urgently needed.”

This was also underlined by the UK delegate, who stated it “will also welcome more attention on to the impact of climate change both on people’s health and on national health systems”.

Image Credits: DANHO/Daniel Hodgso, Sven Petersen/Flickr, Rashed Shumon.

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.