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.

Without this fund, the world’s poorest countries would have to pay out legal claims made by people who might suffer serious side-effects after receiving their COVID-19 vaccination.

The global COVID-19 vaccine access platform, COVAX, plans to impose a US 10-cent levy on each vaccine dose to fund a compensation scheme for people who suffer from severe adverse reactions to any of the vaccines it supplies.

The “no-fault” compensation fund is crucial for countries who join COVAX, as one of the conditions of membership is that they agree to indemnify pharmaceutical manufacturers from any legal claims from people who might suffer serious side-effects.

Without the fund, the world’s poorest countries – defined as COVAX’s advance market commitment (AMC) countries – would have to pay out citizens’ claims themselves.

In the past two weeks, the US Centers for Disease Control and Prevention (CDC) reported several cases of people suffering from anaphylactic shock as a result of taking the Pfizer-BioNTech and Moderna vaccines. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination, according to the CDC.

In the case of the Pfizer-BioNTech vaccine in the US, by 23 December, some 4,393 adverse events had been reported out of 1,893,360 (0.2%). Of these, 21 cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a history of allergies or allergic reactions.

In Moderna’s case, by 19 December, 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the US, with 1,266 adverse events reported (0.03%). Of these, 10 cases were determined to be anaphylaxis, nine of whom had a history of allergies or allergic reactions.

COVAX published an indemnification proposal in November, which states that “each country receiving COVID-19 Vaccines through the COVAX Facility, whether distributed under an emergency use authorization or recently licensed, will be required to indemnify manufacturers, donors, distributors, and other stakeholders against any losses they incur from the deployment and use of those vaccines”.

A spokesperson for GAVI, the Vaccine Alliance, which manages COVAX, told Health Policy Watch that the facility had been working with all stakeholders to establish “a comprehensive solution addressing the need for indemnification and the financial obligations this may impose on middle- and low-income countries”.

The compensation fund will be financed “from a $0.10 per dose levy charged by GAVI on the doses to be distributed to AMC countries through the COVAX Facility,” said the spokesperson. “We will be announcing more details, including specific terms around the principles governing indemnity, in the coming days.”

COVAX has also facilitated a common template agreement for AMC-eligible economies, that has been negotiated with, and agreed upon by all manufacturers which will “greatly reduce the legal burden on AMC participants”.

All Medicines Contain ‘Some Risk’ But Not An Excuse For Sub-Par Product, Experts Remind

Professor Brook Baker, an access to medicines expert at Northeastern University in Boston, said that “there are credible arguments for some degree of indemnification, but it should not be a blanket indemnification for harms caused by manufacturer neglect”.

“All medicines contain some risk of known and unanticipated adverse side effects or reduced efficacy. The risks of vaccines in particular are considered significant, not because vaccines don’t meet heightened safety requirements, but because they are given to large populations of otherwise healthy people,” explained Baker.

“Some risks of vaccine administration are unavoidable. Most of them are rare and listed, but others may be truly rare and unexpected. It makes some sense for governments and payers to indemnify against these predictable and inevitable risks – otherwise vaccine manufacturers might charge much higher prices or avoid vaccine R&D and sales altogether,” added Baker.

However, he said manufacturers should not have a “free pass” against adverse outcomes that they could have prevented, such as a sub-standard batch of vaccines or if the manufacturer failed to monitor and report significant side-effects adversely affected particular populations.

COVAX is also proposing a “no-fault, lump-sum compensation” for an adverse event as a “full and final settlement of any claims”, but this won’t preclude a local claim.

However, Baker cautioned that “a lot of people suffer health effects after vaccination that are not causally related to the vaccine – there is correlation but not causation”.

For this reason, some no-fault schemes “get hung up on long, drawn-out investigations of causation”, making the compensation process slow.

In addition, “no-fault compensation schemes can be overly bureaucratic and costly to maintain and administer”, warned Baker. “Resource poor countries with weak regulatory capacity would have particular difficulty setting up and running a no-fault compensation mechanism at the national level.”

Image Credits: CIO Look/Flickr, Bret Bostock/Flickr.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at Monday’s Executive Board session.

COVID-19 has led to the suspension of polio campaigns in more than 30 countries, and has underscored the importance of the mission to eradicate it, tackle antimicrobial resistance, and ensure the timely sharing of pathogens, said WHO member states at Monday’s Executive Board session. 

Throughout the morning and afternoon sessions, member states reviewed and discussed the Director General’s reports on poliomyelitis eradication, polio transition planning, antimicrobial resistance (AMR), and the public health implications of the implementation of the Nagoya Protocol. 

Afghanistan and Pakistan have already reported outbreaks of both types of polioviruses, making them the last two remaining polio endemic countries. Although polio outbreaks impacted three of WHO’s six regions in 2020, with almost 1,000 cases recorded, 30% of the emergencies were stopped during the year, demonstrating the ability to stop polio outbreaks even in the midst of a pandemic. The pandemic has also disrupted routine immunisation programmes, increasing outbreaks of both wild and vaccine-derived polioviruses.

“Polio is still considered an emergency, and rightly so, because it could become a major international problem again if we’re not careful,” said WHO Regional Director for the Eastern Mediterranean, Ahmed Al-Mandhari. “So we need the resources that are required to keep the public health situation under control and make sure that all countries of our region are doing what needs to be done as it needs to be done.

“This requires resource mobilisation across the region…We’ve got children at risk of being paralysed for life and we must save them from that. That means intensifying our efforts as we get close to the finishing line of efforts to eradicate poliomyelitis.” 

Despite the disruptions of efforts to combat vaccine-preventable diseases, along with projections that the African region could see a 200% increase in the number of districts with polio cases by the end of 2020, WHO officials highlighted the opportunities brought along by the SARS-CoV2 virus. This could particularly be the case for polio transition, which is the adaptation of polio infrastructure for disease surveillance, social mobilisation, vaccine delivery, and care for hard-to-reach populations to other programme areas. 

“Firstly, COVID-19 is accelerating programmatic integration…We are now leveraging the full technical expertise to align polio transition activities with other programmatic priorities and the planning processes,” said Zsuzsanna Jakab, WHO Deputy Director-General. “Secondly, COVID-19 has once again demonstrated the value of the polio network, especially at the community level…Thirdly, COVID-19 underlines the importance and the need for strong and resilient health systems. In countries where there is a strong polio footprint, the polio network is a core component of the essential public health workforce.”

Zsuzsanna Jakab, WHO Deputy Director-General.

The contributions of polio staff, networks, resources and expertise to COVID-19 actions assisted in the pandemic responses in over 50 countries. In the African region, two polio personnel at the national and district levels in country offices in the region are spending more than half of their time on the COVID-19 response. 

In addition, “polio colleagues are the main frontline workers [in the African region] responding to outbreaks of cholera, yellow fever, and meningitis,” said Matshidiso Moeti, WHO Regional Director for the African Region. 

Australia’s delegation echoed some of WHO’s messages, “acknowledg[ing] the ongoing role the GPEI [Global Polio Eradication Initiative] will have in supporting the delivery of COVID-19 health interventions, including vaccinations.”

Polio Eradication Efforts Face “Precarious Financing”

Meanwhile, member states expressed concern regarding the “precarious financing situation” of the Global Polio Eradication Initiative, a public-private partnership with six core partners – WHO, Rotary International, the US Centers for Disease Control and Prevention, UNICEF, the Gates Foundation, and GAVI. 

“We’re concerned at the slow pace with which polio transition plans are being finalised. Given current funding constraints, this work needs to be expedited now more than ever,” said the UK’s delegate. 

“We share concern with regard to the financial gap in GPEI’s budget this year. The way forward is looking for new financial resources, but also focusing on increasing efficiency,” said the delegate representing Germany. 

Burkina Faso, speaking on behalf of the 47 WHO member states of the African region, called upon stakeholders to strengthen the financial mechanisms to fight polio, particularly given the “fragile financial situation.”

Burkina Faso’s delegate at the Executive Board session on Monday.

With the announcement in the Director General’s report of the likely scaling back of resources and presence in countries where poliomyelitis is not endemic, the African region emphasised the need to “mobilise long term financing to allow the region to continue its elimination activities” and “ask[ed] WHO to add financing for poliomyelitis and put it in one of the priorities of the program budget for 2022-2023 and following budgets,” said Burkina Faso’s delegate. 

In an effort to reassure member states, Jakab recognised the need for long term financing to sustain polio assets. “We would like to assure [member states] that this remains a priority for WHO’s programme budget 2020-2023 and beyond.”

“The draft budget presented to the EB reflects our commitment to sustainable financing for the polio network and we are working closely with GPEI and other development partners to develop comprehensive resource mobilisation efforts for future financing,” she added. 

“I encourage partners and donors to continue to support WHO in order to sustain our core functions where polio infrastructure can make the most impact,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General. “These functions are central to reaching the 13th General Programme of Work (GPW) goals of promoting health, keeping the world safe and serving the vulnerable.” 

Antimicrobial Resistance

Also on the Executive Board agenda was AMR, a growing global threat. Essential antimicrobial drugs used to treat common infections are becoming ineffective globally, but the highest rates of resistance are in low- and lower-middle-income countries, found WHO’s progress report on the implementation of the Global Action Plan on Antimicrobial Resistance. 

A risk assessment conducted by the Secretariat indicated that COVID-19 has disrupted planned and ongoing national AMR activities and has heightened the risk of resistance emerging due to the irrational use of antimicrobials to treat patients infected with SARS-CoV2. 

The EU and the Philippines laid out the interplay between COVID-19 and AMR, which included supply chain disruptions of antibiotics, interruptions in the delivery of routine immunisation services, and the misuse and overuse of antibiotics in managing COVID-19 patients. 

“These developments, if not addressed, can push back all the gains in our fight against infectious diseases,” said the delegate representing the Philippines. 

Philippines’ delegate at the Executive Board session on Monday.

“Within the context of the pandemic, implementing the relevant programmes to mitigate and control AMR, such as infection prevention, surveillance, antimicrobial stewardship, and WASH [water, sanitation, and hygiene] have become even more crucial,” said Dr Tedros. “As we continue to tackle the COVID-19 pandemic, we must simultaneously ensure that efforts to stop the spread of AMR are accelerated to control this silent tsunami together.” 

WHO Collaboration to Address AMR

Following the establishment of the Tripartite Joint Secretariat on AMR, a collaboration between WHO, the Food and Agriculture Organisation (FAO), and the World Organisation for Animal Health (OIE), the tripartite Antimicrobial Resistance Multi-Partner Trust Fund was launched in 2019 to support One Health action in low- and lower-middle-income countries.

“In Brazil’s view, the collaboration between WHO and other agencies within the United Nations system [such as through the Tripartite Joint Secretariat on AMR] will be as legitimate and successful as they perform their respective mandates and are accountable to their respective governing bodies,” said Brazil’s delegation. “We also see room for improvements in the way that AMR-related high level bodies connect their work, the wealth of needs and context to member states.”

The Trust Fund was supported by Zambia at the Executive Board session, as “this will ensure sufficient and sustainable AMR funding” through the utilization of multi-fund streams. 

“134 countries have established national plans [on AMR], but a lot of countries lack the necessary financing. As a result, plans won’t have a real impact. We can’t be successful if we don’t have the necessary financing in place to implement activities at the national, regional and local level,” said Professor Hanan H. Balkhy, WHO Assistant Director-General of Antimicrobial Resistance. 

Professor Hanan H. Balkhy, WHO Assistant Director-General of Antimicrobial Resistance.

“We call upon all member states to take the necessary measures to fight AMR by establishing these national action plans and establishing the financing so that they can be implemented in the context of Universal Health Coverage and primary health care,” she added. 

WHO and member states agree upon the need for a holistic and multi-sectoral approach – a One Health approach – to AMR and several announced their support for the One Health Global Leaders Group on Antimicrobial Resistance, a key global governance structure comprised of members states, civil society and the private sector. 

“We applaud the many initiatives that are putting the one health approach in practice at the global level….Germany welcomes the recent establishment of the One Health Leaders Group and is happy to be represented in this group,” said Germany’s delegate. “We trust that it will keep AMR high on the political agenda.”

Mechanisms for Pathogen Sharing in Health Emergencies

Subsequently, member state discussions on practices in the sharing of pathogens and genetic sequencing data commenced, largely focusing on actions taken in relation to the SARS-CoV2 virus and highlighting the importance of rapid pathogen sharing in the context of public health emergencies.

Austria, speaking on behalf of EU member states, underscored the “confusing situation” and legal uncertainty that surrounds the timely access to pathogens in health emergencies. This uncertainty “could cause delays in access to diagnostics, therapeutics and vaccines,” said the Austrian delegate.

Ambassador Elisabeth Tichy-Fisslberger, Permanent Representative of Austria to the United Nations Office at Geneva.

Current arrangements lack clarity, as the distinction between the sharing of biological pathogen samples and genetic sequences is blurry and the implementation of certain provisions of the Nagoya Protocol – an international legal agreement on the fair and equitable sharing of genetic resources – is limited, according to the Austrian delegation.

By contrast, India’s delegate recounted the benefits of the Protocol revealed by the pandemic. “[The Nagoya Protocol] facilitated the rapid sharing of information about the COVID-19 virus and helped in establishing a systematic, organised method of data exchange to prevent any potential breaches in the country’s jurisdiction related to sharing and use of biological data and resources,” said the delegate representing India.

The Chinese delegation recognised the urgent need to establish a fair and equitable benefit sharing mechanism and highlighted China’s efforts to fulfill its obligations to promote access to genetic data under the Nagoya Protocol.

Both China and the US delegations drew attention to the actions of their respective countries during COVID-19.

“Concerning the sharing of the SARS-CoV2 virus, since the outbreak, China immediately mobilised high level, biological security labs with leading experts to conduct a parallel testing for cases and samples. Within a record breaking time period, they identified SARS-CoV2 as the pathogen and immediately shared this genome sequencing,” said China’s delegate.

China’s WHO Executive Board delegate at the session on Monday.

“The genome sequencing shared immediately by China provided the world with important basic information to be used in clinical diagnostics,…vaccine research, origin tracing, [and] virus evolution studies,” he added.

In the US, “the National Institute of Allergy and Infectious Diseases has shared these [SARS-CoV2 virus samples] more than 4,500 times…with diverse stakeholders in at least 49 countries, including government scientists, academics, and private sector companies for any legitimate purpose required to study, rapidly detect, prepare for, and respond to COVID-19,” said the delegate from the US.

The discussion on pathogen sharing practices and pathways to increase the capacity for the sequencing and analysis of genomes globally will resume on Tuesday, prior to the closure of the 148th session of the Executive Board.

Image Credits: WHO / Christopher Black, WHO.

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.

Manufacturing Pfizer/BioNTech’s COVID-19 vaccine

Pfizer/BioNTech will join the WHO-co-sponsored COVAX vaccine facility, providing up to 40 million vaccines at cost to the Facility for use in low-income countries around the world – in what signals a breakthrough for the facility that only a week ago appeared to be teetering on the verse of irrelevance – as more low- and middle-income countries raced to sign bilateral contracts with pharma manufacturers for vaccine supplies.   

The joint announcement by Pfizer CEO Albert Bourla and WHO’s Dr Tedros Adhanom Ghebreyesus at a WHO press conference on Friday evening puts a bookend on a week of good-news developments for the WHO and its global health partners in COVAX – following on from moves by the new US administration of President Joe Biden to rejoin WHO and join the COVAX facility as well. 

Albert Bourla, CEO Pfizer, announces vaccine procurement deal with COVAX, Friday 22 January 2021

Psychological Turning Point For COVAX

While 40 million doses is still a relatively a small initial amount, to begin with, it is also psychologically important to COVAX.  It makes a statement that the even the most expensive, cutting edge mRNA vaccine technologies will be a part of the global vaccine pool made available to low and middle-income countries  – which has already stocked up pre-orders for 2 billion doses of cheaper, and more conventional COVID vaccines.  Together with the AstraZeneca vaccine, the commitment by Pfizer also ensures that at least some vaccine supplies will be ready to roll out almost immediately; other vaccines in the COVAX portfolio include products by Johnson & Johnson, Novavax and Sanofi – which are still in Phase 3 trials and thus haven’t yet been approved by any regulatory agency.   

The Pfizer move is also important because it provides a signal to other vaccine developers that COVAX has a broad base of industry support. This now leaves Moderna, the other producer of an already-approved mRNA vaccine, as the COVAX “outsider”. Moderna was among the first pharma companies to declare that it would not enforce its patent rights on its vaccine technology during the pandemic. But it has not signed a contract with COVAX – yet.   

“Pfizer and BioNTech have reached an advance purchase agreement with the COVAX facility for up to 40 million initial doses of our COVAX vaccine,” said Bourla, in annoucing the agreement at the WHO briefing. “We expect that the first doses will be delivered in the first quarter of this year, once we finalize agreements with UNICEF … we are coordinating procurement to support the delivery of these vaccines.

UNICEF is mounting the COVAX logistics effort on the back of its enormous existing global infrastructure in transport, logistics and cold chain management – which distributes and administers childhood vaccines worldwide every year.  GAVI, The Vaccine Alliance, and the other key  COVAX partner, is mediating the contractual arrangements with vaccine manufacturers as well as COVAX members, including 92 low-income  countries that regularly receive vaccines free or at preferential prices through a donor supported “Advance Market Commitment” scheme. 

WHO Director General Dr Tedros Adhanom Ghebreyesus announces COVAX vaccine procurement deal with Pfizer/BioNTech Friday 22 January

“Since the very beginning of our vaccine development program Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world,” added Bourla. “We fully support, and we are in alignment with the guiding principles of the COVAX facility

“GAVI’s coordination of the COVAX Advanced Market Commitment that supports the participation of 92, lower-middle and low-income economies, is an important tool that will help ensure developing countries have the same access to vaccines as the rest of the world,” said Bourla. “And we will provide the vaccine coverage for these countries, not for profit,” said Bourla.” 

Bourla said that the doses would “support COVAX efforts to vaccinate healthcare works at high risk of exposure, and other vulnerable communities.” 

He added, “this is just one step in our commitment to support developing countries. As we work to deliver these doses, we are also bringing resources and expertise that will help to strengthen the global health infrastructure, building on our recent innovations in packaging and cold chain requirements, and ensuring that solid systems are in place. 

“Establishing the infrastructure needed to deliver breakthrough mRNA vaccine in ow income countries will not also will not only help us fight the pandemic, but make us more prepared for the next pandemic,” Bourla said. “We believe that this is a collective responsibility that calls for highly coordinated and collaborative actions by public and private stakeholders.”

COVAX Deals with Pfizer and AstraZeneca Mean Facility is Ready To Rollout Supplies 
Pfizer COVID-19 vaccine delivery – in ultra-cold chain storage in special containers designed by the company.

Some 150 million doses of the AstraZeneca vaccine will also be available in the first quarter of 2021, said Dr Tedros, speaking at the press briefing.  Those doses are primed and ready to go, pending only WHO review and approval of the safety and efficacy of the AstraZeneca vaccine and its production facilities at the Serum Institute in India and in the Republic of Korea. 

“Together, these announcements mean COVAX could begin delivering doses in February, provided that we can finalize a supply agreement for the Pfizer biotech vaccine and emergency use listing for the AstraZeneca Oxford vaccine,” he said.  

“This agreement also opens the door for countries who are willing to share doses of the Pfizer BioNTech vaccine, to donate doses to COVAX and support rapid rollout,” the WHO Director General said.  A handful of high income countries have purchased or pre-ordered even more COVID19 vaccine doses than they have people to immunize – with Canada topping the list with pre-orders or purchases of multiple  vaccines per capita. 

UNICEF’s Executive Director Henrietta Fore, said that her organization was in the process of securing logistics and supply chain arrangements for the new contract with Pfizer/BioNTech as well as for others in the COVAX pipeline. Those are arrangements will be particularly sensitive because the Pfizer vaccine requires -70C storage conditions – although innovative new packaging developed by the company can help keep the vaccine cold for at leat a week without an electricity supply.  

“In the coming weeks UNICEF will begin transporting vaccines, together with syringes and safety boxes to countries around the world. And we are working with airlines and freight and logistics providers to ensure safe and timely delivery,” said Fore at the briefing.

“UNICEF and our partners are working with governments around the clock to ensure that countries are ready to receive the vaccines that there is appropriate cold chain equipment in place, and that health workers are trained to dispense them,” said Fore, adding that UNICEF is also playing a lead role in efforts to foster trust in the vaccine, tracking and addressing vaccine misinformation.”

United States Expected to Play Critical Role in COVAX Global Vaccine Rollout

The fact that the United States has rejoined WHO and is also playing an active role in COVAX, will also help ensure the kind of global solidarity needed to ensure success in the vaccine rollout effort, said Bourla and all three agency heads at the briefing.

“Last year, we saw a truly unique human ingenuity at work to successfully develop effective and safe vaccines in record time. This year, we turn to the biggest logistical challenge the world has ever seen. And we need all hands on deck,” said Fore. “With that in mind,  I join everyone to say how pleased I am that the United States is has joined the COVAX facility, and confident that with its expertise and resources, the United States will give this global effort, and UNICEF’s role in it, a major boost.” Her comments referred to the leading role the US has played as a funder and supporter of the UN agency whose main mission is the children’s and adolescent health in the world’s poorest countries.

Tedros, for his part, said he spoke with Vice-President Kamala Harris by phone on what was her first full day in office: “The United States has long played a vital role in global health. The US was a founding member of WHO, and has been a leader in the fight against many diseases from smallpox to polio, and malaria to HIV. The US contributes an enormous amount to global health, but it also benefits from WHO’s work on a range of both infectious and non communicable diseases,” he added, noting that a healthier, safer world is a healthier, safer America.”

Added Bourla, whose company is headquartered in the United States: “I couldn’t avoid the temptation to say that I’m very glad this press conference is happening the day that the United States is rejoining the WHO organization. I think it is a symbolic great day for us.

Global Vaccine Capacity Increasing 
Seth Berkley, CEO GAVI, The Vaccine Alliance

Seth Berkley, CEO of GAVI, said that with the rapid approval of new vaccines, the world could be positioned to roll out as much as 6 or 7 million vaccine doses in 2021. 

While Dr Tedros said that the COVAX was on track to rollout out at least 2 billion doses this year, Berkley said that the number could rise to 2.3 billion doses  – “with the right level of funding in place”

“This would equate to close to 1.8 billion doses for the 92 lower income counties in the COVAX advanced market commitment, or AMC,” said Berkley.  “That’s enough to protect about  27% of the population in those low and lower-middle income countries, which is in excess of the initial tartlets we laid out to protect those at highest risks. And we have the prospect of more doses to come through other deals and sharing principles that we announced in December.”

While initial deliveries “will be small, but they will grow quickly,” Berkley promised.  

Pfizer, for its park had initially only projected the production of 1.3 billion vaccine doses this year, but that has now increased to 2 billion Bourla said, adding that he feels “confident” about that projection.  

Reduce Virus Transmission to Preserve Vaccine Efficiency But Decision on 2021 Olympics Is Japan’s – WHO Says
WHO’s Katherine O’Brien speaking at press briefing 22 January

In a wide-ranging press briefing that covered a week packed with the WHO Executive Board meeting, WHO’s Executive Director of Health Emergencies, Mike Ryan, said that the higher rate of serious COVID19 cases now being observed in the United Kingdom doesn’t necesarily mean that the mutated SARSCoV virus variants are necessarily more deadly/.  More infectious also generate more serious hospital cases, overloading hospitals and reducing their response capacity, he pointed out.  So the dynamics of health system response have to be looked at in addition to the dynamics of the infections as such.

Katherine O’Brien, WHO’s director of Immunization, Vaccines and Biologicals, underlined that as vaccine rollouts get underway, it is more important than ever for societies to use social distancing and other measures to rein in the virus.

“The risk of virus variants relative to vacccines is even greater when transmission is very high in communities – because of the possiblility of additional [resistant]  variants emerging under the pressure of vaccines,” she explaining, stressing “the importance of really crushing transmission.”

In terms of queries over whether it would be safe to hold the 2021 Olympics, which the Japanese government is still planning to host this July – even though public opinion is more negative, Ryan said that WHO would provide advice about risk management of mass gatherings – but it doesn’t provide advice on whether to hold a mass gathering or not.  He added: “we all hope for the Olympics but we all recognize that everyone is a little afraid as we enter the new year with some uncertainties. I believe the Japanese overnment will always act in the best interest, and according to the will of its people.”

Investigation of SARS-CoV2 Virus Origins Will “Follow the Science”

With regards to Beijing’s recent media campaign suggesting that the virus may have originated somewhere other than China – just as a WHO-led team begins work in Wuhan to look for virus tracks in the city where the first clusters of infection were reported, Ryan said that it was mistaken to “start any process where the conclusions are at the start, and then we look for the evidence to support them – we’re dealing with a lot of that in the last few days.”

But Ryan declined to say whether the international team of independent experts would visit the Wuhan Virology Institute that had been conducting research into coronaviruses before the pandemic began.

There has been some speculation that the virus could have escaped accidentally from the facility. Leading experts have noted that the virus that caused the pandemic shares 96% of its genetic makeup with coronavirus variants that circulate naturally among bat populations living in caves in Yunnan Province, about 1800 kilometers southwest of Wuhan near the borders of Laos and Myanmar. But there has been no suggestion that the team would visit the Yunnan cave region either – an area in Yunnan’s Tongguan district, from which roving BBC media team was recently barred.

In terms of where the quest for the virus origins might lead, Ryan added that, “all hypotheses are on the table, and it is definitely to early to come to a conclusion, this is a big jigsaw puzzle, you’re entitled to your opinion… but that doesn’t make you right. So let’s step back and follow the science.

“Our WHO team on the ground are having a good experience working with our Chinese colleagues, working through the data; the data will lead us to the next phase, where we need to go next to look at the origins of the SARS-CoV2 virus.”

Image Credits: Flickr – Province of British Columbia, Pfizer, Flickr – Province of British Columbia.

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 .