Vaccine
COVID-19 vaccine sales have netted Pfizer and Moderna around $100 billion in revenue.

A new study published in the BMJ has found that the United States invested at least $31.9 billion in public funds directly into the development, production and purchasing of mRNA COVID-19 vaccines through channels ranging from the National Institutes of Health to the Department of Defense. 

That vast pool of U.S. public funding was indispensable to the development of mRNA vaccines that have netted Moderna and Pfizer over $100 billion in sales revenues since their launch, an amount is 20 times greater than the budget of the World Health Organization (WHO) for 2020-21.

The study is based upon an extensive analysis of US  government research grants and procurement contracts related to mRNA vaccines or technologies issued between 1985 and March 2022. 

The study covered contracts issued by the National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense.  

Most funds invested in vaccine procurement

Vaccine
Researchers identified 34 NIH research grants directly related to mRNA covid-19 vaccines.

While the overwhelming majority of the $31.9 billion in funds was invested in the heat of the pandemic, at least $337 million was invested in mRNA related science before SARS-CoV2 emerged. 

That research, conducted between 1985 and 2019, resulted in the discovery of indispensable precursor technologies to mRNA vaccines including lipid nanoparticles, mRNA modification and synthesis, pre-fusion spike proteins, and mRNA vaccine biotechnology.

Pre-pandemic, the NIH invested $116m (35%) in basic and translational science related to mRNA vaccine technology, and the Biomedical Advanced Research and Development Authority (BARDA) ($148m; 44%) and the Department of Defense ($72m; 21%) invested in vaccine development.  

“The pre-pandemic investments are conservative and likely much higher than $337 million,” said Dr Hussain Lalani, lead author of the study.

Altogether, the study identified 34 NIH research grants directly related to mRNA COVID-19 vaccines.  

An additional $5.9 billion in U.S. financing contributed indirectly to the development of mRNA technology. The resulting vaccines are recognized as among the most effective jabs against the SARS-CoV2 virus.

After the onset of the pandemic, $29.2bn (92%) of US public funds went to vaccine procurement, $2.2bn (7%) supported clinical trials, and $108m (<1%) supported manufacturing plus basic and translational science. 

“[This is] the largest public investment for a disease ever,” Lalani said.

Risks were socialized while financial rewards were privatized 

A network analysis of COVID-19 mRNA vaccine patents.

The speed of vaccine development in response to the COVID-19 threat is unprecedented in vaccine science. In their first year alone, COVID-19 vaccines are estimated to have prevented 20 million deaths globally, including 1.1 million in the US. 

“In making health and protection possible amid a deadly pandemic, the mRNA COVID-19 vaccines have been a remarkable achievement,” writes Victory Roy, a fellow at Yale Medical School who authored the BMJ editorial that accompanied the study. 

“However, their development also serves as a cautionary tale of a system in which the risks of pursuing innovation were socialized while the lion’s share of rewards became privatized to corporate shareholders … who risked little of their capital in the development process.”

Both Moderna and Pfizer plan to sell their vaccines at over $110 per dose in the U.S. once freed of their government contracts. Their estimated production cost is just $1-3 per dose.

Research or share buy-backs? 

A significant portion of the vaccine-derived profits, Roy points out, are not being reinvested into medical research and development. Between 2021 and 2022, Moderna has announced or executed $7 billion in share buybacks – $3 billion more than it has spent on research and development.

Pfizer, meanwhile, spent $115 billion on shareholder payouts in the decade before the pandemic, $34 billion more than it invested in its R&D division. 

“Without public investment, there would be no mRNA vaccines,” said People’s Vaccine Alliance policy co-lead Mogha Kamal-Yanni in reaction to the study. “Pharmaceutical companies have sold a false narrative to the public: that it was their investment which gave us mRNA vaccines, and that they deserve the $75 billion profit made from COVID-19 vaccines.

“As this research shows, that claim is a total myth,” she said. 

What’s the counter?

The UN World Intellectual Property Organization’s 2022 report estimates the social benefit of COVID-19 vaccines – which includes the value of lives saved, health problems avoided, and economic costs of mitigation measures – at $70.5 trillion annually, or 887 times estimated private sector revenues of $130.5 billion. 

Pharmaceutical companies also point to the significant risk that came with following the mRNA route. Now seen as a game changer, the technology was unproven heading into the pandemic. Smaller companies like BioNtech, which had accumulated over $400 million in debt since its founding in 2008, ran the risk of collapsing if its vaccine did not succeed.

And that risk was real. Of the four largest pre-pandemic vaccine companies, three of them – GSK, Sanofi and MSD – failed to produce a successful vaccine by 2021. Novavax, whose vaccine was approved for emergency use in December 2021, raised doubts this week about its ability to remain in business, highlighting the boom-or-bust nature of vaccine development. 

The medical upside of mRNA

The risk taken in pursuing mRNA technology for developing COVID-19 vaccines has also played a significant role in mainstreaming mRNA as a platform. The medical upside, some researchers believe, could be revolutionary.

“Some experts believe that we are entering a new era with mRNA technology and the promise of regenerative medicine and personalized cancer vaccines on the horizon,” the BMJ study on U.S. vaccine spending said. “Hundreds of new products incorporating this technology using mRNA synthesis and lipid nanoparticles are being tested.”

The world’s first universal mRNA influenza vaccine, for example, which would be effective against all known types of influenze, is already being tested in animals and has shown promising results. In late 2022, researchers at Moderna and Merck announced they would move forward with efforts to pursue a personalized mRNA cancer vaccine for high-risk melanoma patients.

“Today’s results are highly encouraging for the field of cancer treatment,” said Stéphane Bancel, Moderna’s Chief Executive Officer said of the December Phase 2 trial. “mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma.”

Asked about Moderna’s proposed 130$ price point for its COVID-19 vaccine by the Wall Street Journal, Bancel said of the 400% price hike, “I would think this type of pricing is consistent with the value.”

Image Credits: Ajay Suresh, NIH, Nature Biotechnology.

Outgoing Africa CDC Director Ahmed Ogwell Ouma meets WHO Director General Tedros Adhanom Ghebreyesus in Geneva during the May 2022 World Health Assembly.

No date has yet been set for the recently-elected Director General of the Africa Centres for Disease Control and Prevention (Africa CDC) Jean Kaseya to take over his new tasks, said acting director Dr Ahmed Ogwell Ouma on Thursday.

But he promised that the transition period would be a smooth one, saying: “After the decision by the African Union summit, there are internal processes that continue to be done. And as soon as those have been completed, you will be hearing from us. 

“Suffice to say that we are in a transition period and Africa CDC continues to work until the incoming leadership is in place,” Ouma told Health Policy Watch at a press briefing on Thursday.

Kaseya was electeed as Africa CDC’s new head, in late February on the sidelines of the 36th session of the African Union.  A Democratic Republic of Congo national with a seasoned international health career, he beat 179 other candidates, including Ouma,  who had been appointed as acting director following the departure of John Nkengasong in May 2022, to head the US President’s Emergency Plan For AIDS Relief (PEPFAR). 

Africa CDC pivots COVID-19 vaccine campaign to broader aims 

Vials of Pfizer´s COVID-19 vaccine.

Meanwhile, Ouma said that the agency has also extended its COVID-19 vaccination acceleration campaign, the Bingwa Initiative,  which was due to end in April, until the end of 2023. 

That comes even as multiple countries in eastern and southern Africa battle a prolonged cholera outbreak, which WHO has blamed on excessive flooding. 

Launched in April 2022, the COVID-19 vaccine acceleration campaign originally aimed to have 100 million African citizens vaccinated by April 2023. But as that goal remains far from being achieved, Africa CDC is now also striving to expand the initiative’s scope, Ouma said.

Going forward, the initiative, supported by the MasterCard Foundation, the German Development Cooperation Project, UNICEF and others, will not only be utilized to promote COVID-19 vaccination but to promote immunization against other vaccine-preventable diseases, harnessing the energies of a new Africa CDC youth advisory team, he said.

“We are extending the Bingwa initiative at least until the end of the year. In fact, we are not only going to utilize this initiative for COVID-19 vaccination, which is the primary objective, but we are going to utilize it for health in general. It is part of the reason why I set up the youth advisory team for health so that we can be able to bring the youth into our work, our strategizing as Africa CDC.” 

Training of the initiative’s ambassadors is set to begin in South Sudan, in addition to central and western African regions in the coming weeks, he added. “We want to be sure that the youth are firmly part of all our community-based activities going forward as far as leadership is concerned,” he added. 

Floods exacerbate cholera risks, but poor WASH and vaccine shortages also to blame

Dr Matshidiso Moeti, Africa Regional Director at WHO

Meanwhile, in a separate briefing, WHO’s Regional Director for Africa said that extreme weather leading to excessive flooding is prolonging the multi-country cholera outbreak in southern and eastern Africa – despite falling case rates over the past week. 

Addressing journalists on Thursday, Dr Matshidiso Moeti noted that even though weekly cholera cases in the affected African countries are declining, heavy rains in southern Africa continue to raise the risk of disease spread – exacerbating peoples’ exposure to contaminated food and water.

“In southern Africa, cholera outbreaks are occurring amid seasonal rains and tropical storms that have caused heavy flooding. 

While climate change is a key factor, poor water and sanitation more generally, and lack of vaccine access are other critical drivers of the outbreaks, global health experts say.  

Due to a shortage of cholera vaccines, WHO last year recommended that countries move from a two-dose to one-dose regimen to allow for more people to get at least one jab. And WHO says it has helped facilitate Malawi’s access to some 4.9 million doses since May 2022.  But public health officials lament the fact that preventative campaigns were not conducted prior to last year. 

South Africa, Tanzania and Zimbabwe latest to detect cases

Cholera flourishes in dirty water.

According to the WHO, 12 African countries are currently reporting cases, with South Africa, Tanzania and Zimbabwe the latest to detect cholera cases. 

The number of new cholera cases fell to 2880 in the week ending on 26 February, a 37% decline compared with the week before when 4584 cases were recorded. The number of deaths in the same period however remained nearly unchanged, declining marginally from 82 to 81.

In Malawi, where cholera has so-far killed 1500 people over the last year, increased rainfall is slowing outbreak control efforts in some areas, with response teams facing difficulty reaching people in need of assistance due to inaccessible roads and infrastructure damage. Some cholera treatment units have been flooded and there has been an increase in cases reported in some locations following the heavy rainfall,” Moeti stated.

In Mozambique, WHO’s regional director noted that Tropical Storm Freddy, which made landfall on 24 February, has caused widespread infrastructure damage with over 44,000 people affected, 55 health facilities damaged or destroyed and nearly 3500 km of road damaged.

Six out of Mozambique’s 11 districts have been affected by cholera outbreaks and the country has seen a sharp increase in cases since December 2022 amid the ongoing rainy season. 

“Countries have stepped up cholera control measures and early indications are promising. However, the heavy flooding and cyclonic events in parts of southern Africa risk fuelling the spread of the disease,” said Moeti. “We’re reinforcing our support to countries to increase disease detection capacity, providing medical supplies and stepping up readiness in regions at risk of flooding.”

Image Credits: Ahmed Ogwell/Twitter , Photo by Mat Napo on Unsplash, L Pezzoli/ WHO.

Social distancing squares marked out during the COVID-19 pandemic.

As World Health Organization (WHO) member states get into line-by-line negotiations on a proposed pandemic accord to guide the world’s approach to future pandemics, there are growing calls for independent monitoring to ensure that the terms of such an accord are implemented. Layth Hanbali explains.

Health Policy Watch:  You and other colleagues have noted that the zero draft of the WHO’s Pandemic Accord “contains little on holding countries accountable for the obligations they sign up to” and that it implies that the governing body of the accord would need to “agree to accountability measures after the accord is implemented”. You propose that the accord itself needs to include a mechanism to monitor countries’ compliance, particularly on the legally-binding elements. What should this look like?

Layth Hanbali: An independent monitoring committee should consist of a group of experts from a broad range of disciplines who would assess countries’ compliance with their obligations under the pandemic accord and the timeliness, completeness, and robustness of their reporting on these obligations. They would meet regularly (for example, quarterly) to review the available evidence on countries’ compliance, which would include countries’ own reports, shadow reports by non-state actors, and confidential reports. They would be supported by a dedicated secretariat who would work on behalf of the committee to collect and collate data and prepare analyses and reports.

HPW: Who would this “independent committee of experts” report to, and how would it be financed?

LH: The independent monitoring committee should report to a high-level political body; that means it should consist of, or represent, heads of state. This could, for example, be the proposed Global Health Threats Council or the UN Secretary-General or UN General Assembly.

Financing should be through an international or multilateral mechanism or body, such as the UN Secretary-General’s office or the General Assembly or the Pandemic Fund. The important thing is that the funding enables the committee to operate while firewalled from the influence of any political or commercial actors with a vested interest in pandemic preparedness nnd response (PPR). That also means the funding should be ring-fenced, unconditional, up-front, and sustained.

HPW: Isn’t this the job of the WHO?

LH: The WHO has struggled in the past with calling out countries for failing to fulfil their obligations, such as under the International Health Regulations (IHR). This is partly because it needs to maintain good relations with its members to continue to provide them with the technical support that only WHO can provide. It is therefore not best suited for this kind of function, where it would sometimes be necessary to criticize countries transparently. An independent monitoring mechanism taking on this responsibility would therefore allow the WHO to fulfil its responsibilities and dedicate its resources and expertise to the tasks that it is best placed to do. This will include supporting countries to fill the gaps identified by the independent monitoring committee.

HPW: Some member states fear that the pandemic accord will undermine their sovereignty. How would an implementation mechanism address this?

LH: The pandemic accord can only come into existence if it is agreed upon by member states and there remains a high level of commitment to maintaining state sovereignty in the negotiations of the accord. An accountability mechanism would therefore only assess countries’ compliance with the obligations that they themselves would agree to take on.

HPW: The WHO Director-General has proposed a Global Health Emergency Council, described as a “high-level body on global health emergencies, comprising Heads of State and other international leaders”. Could this council oversee the implementation of the accord, and do you envisage that this could oversee your proposed independent monitoring committee? 

LH: The Director-General’s commitment to secure high-level political commitment to global health emergencies is welcome. There are three main issues with his proposal for such a council to be based at WHO, however. First, the WHO has historically struggled to call out countries for failing to meet obligations, for example under the International Health Regulations. An accountability mechanism should be removed from those dynamics.

Second, his proposal would have the council report to the World Health Assembly, which is traditionally seen as an arena for ministers of health. It is therefore unrealistic to expect heads of state to agree to report to ministers of health.

Third, keeping oversight over the pandemic accord at WHO may undermine the accord’s aim of adopting a whole-of-government approach to pandemic prevention, preparedness, response and recovery while the WHO remains focused on the health sector.

HPW: The Independent Panel for Pandemic Preparedness and Response (IPPPR), co-chaired by Helen Clark and Ellen Sirleaf, has proposed a Global Health Threats Council. Could this be the appropriate body to oversee the accord’s implementation?

LH: The IPPPR’s proposal for a Global Health Threats Council fulfils what we envision as a body that the independent monitoring committee would report to. The proposed council would provide high-level political leadership, monitor actors’ performance, and take on accountability functions. If this comes into existence as it is currently proposed, it would be appropriate for an independent monitoring committee to report its findings to the Global Health Threats Council.

HPW: There is also the Global Preparedness Monitoring Board (GPMB), convened by the WHO and the World Bank. It is described as an “independent monitoring and accountability body to ensure preparedness for global health crises” that is comprised of “globally recognized leaders and experts”, which is “tasked with providing an independent and comprehensive appraisal for policy makers and the world about progress towards increased preparedness and response capacity for disease outbreaks and other emergencies with health consequences”. How does this fit in?

 LH: Our proposal is for an independent committee to monitor each country’s compliance with its individual obligations under the pandemic accord. Meanwhile, the GPMB focuses on global preparedness for pandemics, which it describes as more than the sum of each country’s preparedness. The mandates of these two bodies are therefore related but distinct.

Layth Hanbali is an analyst focusing on global health governance at Spark Street Advisors. His current work tracks developments in the governance of pandemic preparedness and response, and analysing how independent monitoring could promote compliance and accountability in the proposed pandemic accord. He is also an Assistant Researcher in community health at Birzeit University in Palestine, and has worked as a researcher, public health practitioner and doctor; volunteered as a civil society organizer; and taught for several global health programmes. He has a master’s degree in Health Policy, Planning and Financing, a medical degree, and a bachelor’s degree in Global Health. 

 * Kerry Cullinan asked the questions.

 

Image Credits: Shahin Khalaji/ Unsplash.

Chinese Foreign Ministry Spokesperson Mao Ning

A US intelligence chief has claimed that COVID-19 most likely originated in a laboratory in China, a claim that was promptly dismissed by the Chinese government. 

“The FBI has for quite some time now assessed that the origins of the pandemic are most likely a potential lab incident in Wuhan,” Christopher Wray, the head of the US Federal Bureau of Investigation (FBI) told Fox News on Monday.

He said that the FBI had teams of experts spanning across topics that assess the threats posed by various actors. “…and here we’re talking about a potential leak from a Chinese- government-controlled lab that killed millions of Americans”.

However, on Tuesday China dismissed his comments as “political manipulation”, and urged the US to respect “science and facts”

“The origins-tracing of SARS-CoV-2 is about science and should not be politicised,” said Chinese Foreign Ministry Spokesperson Mao Ning.

“China has always supported and participated in global science-based origins-tracing,” she stressed, adding that a laboratory origin of the pandemic was considered to be “extremely unlikely” according to the “science-based, authoritative conclusion reached by the experts of the WHO-China joint mission after field trips to the lab in Wuhan and in-depth communication with researchers”.

Certain parties should stop rehashing the “lab leak” narrative, stop smearing China and stop politicizing origins-tracing, she added.

“Based on the poor track record of fraud and deception of the US intelligence community, the conclusions they draw have no credibility whatsoever,” added Mao.

‘Low confidence’ assessment 

The FBI chief’s statement comes close on the heels of the US Department of Energy’s (DoE) “low confidence” assessment that the pandemic was the result of an unintended laboratory leak in China, as reported in the Wall Street Journal (WSJ) over the weekend. 

The WSJ report stated that the DoE’s claim is a result of new classified intelligence in its possession, which has been submitted to the US Congress. This is reportedly an update to its 2021 document which said that the department was “undecided” on the origins of the pandemic. 

Apart from the FBI and DoE, other members of the US Intelligence community have attributed the origins of the pandemic to various other causes, such as zoonotic spillover. Two of the agencies are undecided. 

According to a US National Intelligence Overview document published by the Office of the Director of National Intelligence (ODNI), a low confidence level indicates that “the information used in the analysis is scant, questionable, fragmented, or that solid analytical conclusions cannot be inferred from the information, or that the Intelligence Community has significant concerns or problems with the information sources”. 

Lack of concrete evidence 

The claims from the FBI and the DoE have evoked a barrage of responses from the scientific communit

Pointing out that the latest statements from the FBI and the DoE are based on classified information, Dr Angela Rassmussen, a virologist and a research scientist at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan, tweeted that there is still no publicly available evidence to suggest that the COVID-19 pandemic was caused by a lab accident.

She emphasized that the “low confidence” level attributed to the latest statement by the DoE raises doubts about the strength of the evidence in its possession. 

“However, given the “low confidence” rating and the DOE’s failure to persuade any other IC, I’m extremely sceptical that this intel comprises any such evidence,” she tweeted. 

Dr Stephen Griffin, a virologist and associate professor at the University of Leeds, too echoed Dr Rasmussen’s thoughts on the lab leak theory. 

“If there’s something that’s changed in the evidence base, let’s hear it. Otherwise, there remains not a shred of meaningful evidence that SARS2 was engineered or leaked. End of,” he tweeted. 

WHO demands more Chinese cooperation

However, the origins of the pandemic are far from conclusive and the World Health Organization (WHO) has been at the forefront of investigations, demanding more cooperation from China to help the world better understand how the pandemic originated. 

In January 2023, Dr Maria Van Kerkhove, the COVID-19 Technical lead at the WHO, said that the agency was working with China to fill some “very important information gaps”. 

“We have requested further information to have those sequences be shared publicly so that a deeper analysis and more phylogenetic analysis can be done so that we could look mutation by mutation to really assess what is circulating there,” she added. 

In February 2020, as the SARS-CoV-2 started spreading across the world, the WHO set up a team of 25 national and international experts to visit China to understand the origins of the COVID-19 pandemic. The report released by the WHO after the mission stated that the possibility of the pandemic originating from a lab accident in China is low. 

“Prior to December 2019, there is no evidence of circulation of SARS-CoV-2 amongst people globally and the surveillance programme in place was limited regarding the number of samples processed and therefore the risk of accidental culturing SARS-CoV-2 in the laboratory is extremely low,” the report said. 

However, the independent team that visited China had limited access to various sites and patient medical records, leading to the WHO repeatedly demanding more cooperation from China to enable better understanding of the origins of the pandemic. 

The WHO’s Intergovernmental Negotiating Body’s fourth meeting is underway in Geneva.

Although the drafting of the proposed global pandemic accord will happen behind closed doors, civil society organisations want a say as they’re often on the ground dealing with health emergencies.

This emerged during the second day of the meeting of the World Organization’s (WHO) intergovernmental negotiating board (INB), which is just starting to discuss the zero draft of the accord.

Health Action International stressed “the legitimacy of public interest civil society to participate in this and other international processes, not only as providers of expertise and knowledge but as recipients of a mandate to transmit the voice and grievances of communities, individuals and parties too often overlooked, persecuted or taken for granted by far too many governments and organisations”.

The Office of the United Nations High Commissioner for Human Rights (OHCHR) urged the INB to include civil society in the drafting of the pandemic, saying that “we have a successful example of that sort of participation in the development of the Convention on the Rights of Persons with Disabilities”. 

The OHCHR emphasised the important role of civil society organisations played in “resolving difficult questions and identifying priorities”, particularly during pandemics and other crises.

Transparency

Key access to medicines advocates including Medecins sans Frontieres, Knowledge Ecology International (KEI), and Medicines Law & Policy called for the accord to give attention to transparency, particularly in regard to research and development (R&D) and public funding.

“Transparency will be essential for addressing future pandemic risks and implementing the agreement including monitoring compliance,” added Medicines Law & Policy’s Ellen ‘t Hoen

She added that the sharing of intellectual property (IP), know-how and technology could be mandatory during a pandemic, and that new legal obligations “can be created in compliance with existing international law including the World Trade Organization TRIPS Agreement”. 

Ellen t’Hoen

KEI described article 7.4 B of the zero draft as “the most important intellectual property proposal in the text”.

This clause states that, in the event of a pandemic, member states “will apply the full use of the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration”.

However, KEI warned that the clause “should avoid a closed list of exceptions or specific references to the TRIPS agreement” as, in the event of a pandemic, “the mandatory obligations to use exceptions” were often needed in country’s domestic IP laws.

“Parties should also be required to review and modify domestic laws to ensure that there are sufficient exceptions to exclusive rights and intellectual property in order to respond to a pandemic,” KEI added.

Vision is limited

Meanwhile, the Independent Panel for Pandemic Preparedness and Response (IPPPR)’s co-chair, Helen Clark, said that the draft’s vision was lacking as it assumed pandemics would take place – yet the political decisions taken by member states “can avert devastating pandemics”.

“The International Health Regulations and the pandemic instrument should together set the rules that ensure an outbreak does not result in a devastating pandemic,” said Clark in a statement.

Clark added that “accountability must include independent monitoring, which should be explicitly built into this draft. We would welcome an independent expert group for continuous monitoring, which could, for example, be modelled on the IPCC, associated with the climate convention”.

Closed sessions

The afternoon session of the INB was closed for member states to be guided through a reading of the draft to ensure that all parties had the same understanding of the clauses, said co-chair Roland Driece.

Much of the rest of the week is also likely to be closed as the drafting of clauses will follow. However, the INB co-chairs have promised to hold open information sessions from time to time.

Image Credits: WHO.

INB co-chair Precious Matsoso and Dr Tedros at the opening of INB4.

Concerns about equity and financing dominated day one of the negotiations on a global pandemic accord’s zero draft at the World Health Organization’s (WHO) Geneva head office on Monday.

Opening the fourth meeting of the intergovernmental negotiating body (INB) that is steering the process, WHO Director-General Dr Tedros Adhanom Ghebreyusus noted that various people had remarked about emerging “divisions between North and South” during negotiations. He then appealed to member states “not to repeat the same mistakes” made during the COVID-19 pandemic.

Tedros also notified the INB that the two United Nations ambassadors from Morocco and Israel, who are facilitating the UN summit on pandemic prevention, preparedness and response in New York in September, were observing the proceedings to “listen to all the stakeholders”.

“They believe in an inclusive and transparent process, which is very, very crucial,” added Tedros.

The meeting moved into a closed session for the rest of the morning to discuss the modalities of negotiations for this meeting and the next, being held from 3 to 5 April.

Equity concerns

During the afternoon session, a number of member states including India, Namibia and Indonesia raised concerns about how equity was not mainstreamed throughout the document.

According to Namibia, it appeared as though equity was “voluntary”, while Indonesia appeals for equity to be considered both between and within countries.

Mexico, speaking for Latin America, was concerned about the lack of “binding language” and incentives to encourage equity.

Meanwhile, for the US “commitment to equity must address inequities not only between countries but also within them, not just protecting populations from pandemics but also from illness, death and disrupted access to essential health care services during pandemics, including sexual and reproductive health services”. 

The US, Japan and India expressed disquiet about the accord prescribing “specific allocations of domestic budgets or GDP” to pandemic preparedness and response.

“We would like to know from the Bureau the basis of determining 5% of member states current expenditure on health to be dedicated for pandemic preparedness, response and health system recoveries as this tool seems unnecessarily prescriptive,” said India.

Japan said that it could not be a party to an instrument “with a percentage GDP financial commitment”, adding that intellectual property issues should be addressed at the World Trade Organization and the World Intellectual Property Organization.

China at INB4

Climate change inclusion

Fiji on behalf of the Western Pacific, asked for consideration of the “multi-dimensional vulnerabilities such as geographical remoteness and the particular context of small island developing states that may be an impediment in pandemic response” and “specific recommendations in recognition of the impacts of climate change”. 

Along with countries including Australia and the UK, Fiji also supported the “integration of a One Health approach.. working collaboratively across the human, animal, environment and food sectors”.

Both China and Russia were concerned that a pandemic accord should not undermine their sovereignty.

China called for a “more flexible and effective dialogue mechanism so as to fully and widely consult and incorporate the opinions and needs of different parties in whole process and reflect the principles of respecting national sovereignty, respecting diversity and differences, equity, solidarity, coordination and inclusion”.

Various European states and the EU used the meeting to condemn Russia’s invasion of Ukraine, with Russia retaliating that they were attempting to “politicize” the INB process.

The meeting continues until Friday, although most of the sessions will be for member states only.

The antiviral of Merck’s key competitor, Pfizer’s Paxlovid, received full approval in January 2022. Now the company is fighting to catch up.

Merck will appeal the recommendation by the Europe Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) that the European Medicines Agency (EMA) rejects its COVID-19 antiviral, Lagevrio (molnupiravir).

The decision comes after months of deliberation by European regulators, who began looking at Lagevrio, in November 2021. The CHMP said there was a lack of evidence to support its efficacy in patients. There have also been previous concerns that the benefits of Merck’s drug do not outweigh its cost.

In its response to European regulators, Merck highlighted that more than 25 countries have authorized the use of the antiviral, including the US and the United Kingdom, which was the first country to authorize the drug in November 2021, the same month the CHMP started its review process.

Deaths from COVID-19 applied pressure on regulators to get Lagevrio and its competitor, Paxlovid (Pfizer), available as fast as possible.

But doubts about the side effects of the pill have been present from the start, and even countries that approve Lagevrio place restrictions on its use. The US Food and Drug Administration (FDA) advises that it should only be used “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.” It also cannot be given to patients under the age of 18, or to pregnant women due to the potential for birth defects.

“More than four million patients worldwide have been treated with Lagevrio,” Dr Dean Li, president of Merck Research Laboratories said. “We remain confident that Lagevrio has an important role to play in the COVID-10 treatment landscape.”

Merck provided the CHMP with data from a trial of 1,400 unvaccinated adults, which the company said provided “compelling evidence” from real-world use, and demonstrates the “positive impact that Lagevrio can provide for patients by reducing the risk of hospitalisation and death among adults at increased risk for severe disease.”

But the CHMP was unimpressed, and its decision unambiguous: “The clinical benefit of Lagevrio could not be demonstrated.”

“Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalisation or death or shorten the duration of illness or time to recovery in adults at risk of severe disease,” the agency said. “Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.”

Lagevrio made Merck over $5.7 billion in sales last year. Merck and its development partner Ridgeback Therapeutics said they expect to make around $1 billion from the antiviral in 2023.

Image Credits: Creative Commons.

The working group on amending the IHR met in Geneva last week (20-24 Februar 2023).

After five days of discussions last week on how to amend the World Health Organization’s (WHO) International Health Regulations to make them more able to combat future pandemics, the international working group has “agreed on a way forward”, according to the WHO.

WHO member states have proposed 307 amendments, and much of last week’s meeting was taken up by explanations of these.

While the regulations set out common approaches and obligations for countries to prepare for, and respond to, disease outbreaks, the COVID-19 pandemic exposed many weaknesses.

Behind closed doors

Much of last week’s meeting, the second of the working group, was behind closed doors, but agreement was reached on “next steps to tackle more in-depth negotiations on the proposed amendments, and plans for its next meeting running from 17-20 April”, according to WHO.

Co-Chair of the IHR Working Group, Dr Ashley Bloomfield, said in discussing amendments to the Regulations, governments focused on making their countries, and the international community, better prepared for future emergencies.

“COVID-19 showed us that having a good, strong set of International Health Regulations is essential, and showed where the current regulations need to be improved,” said Dr Bloomfield, former Director-General of Health in New Zealand, and working group co-chair. 

“The tone of the discussions and progress made during this week’s meeting clearly show that countries understand the responsibility they have to ensure this process is successful.”

Better detection

Co-chair Dr Abdullah Assiri, Saudi Arabia’s deputy health minister, said that updated regulations “will enable the world to better detect outbreaks early, and prevent them from developing into public health emergencies of international concern”. 

“Countries are in the driving seat of this process as they need to implement the IHR, deliver on the obligations, and make the key decisions needed to respond to public health threats,” said Assiri. 

“During the pandemic, the world faced the urgent need for functioning international instruments, and placed increasing importance in international organizations, such as WHO. Alongside the IHR amendments discussions, member states are also negotiating the drafting of a pandemic accord to address prevention, preparedness and response, and the fourth meeting of the inter-governmental board to consider the zero draft of the accord began on Monday and will run until 3 March.

Bloomfield described the two processes as complementary: “The efforts to update the IHR and draft a pandemic accord share a number of common themes, including the importance of equity in access to health, collaboration and capacity building,” he said. “It is important that there is consistency and alignment across the two processes.”

The IHR are legally binding on member states and create rights and obligations for countries, including the requirement to report public health events with risk of international spread to the WHO. 

They also outline the criteria for a public health emergency of international concern, WHO’s highest level of alarm under the IHR, which in turn triggers specific response actions for countries to prevent the further spread of the epidemics.

Image Credits: WHO.

Avian flu
The death of an 11-year-old girl in Cambodia has sparked new worries about the potential for human transmission of deadly avian influenza (H5N1).

World Health Organization (WHO) officials have sounded alarm bells following the death of an 11-year-old girl in Cambodia from the deadly H5N1 strain of avian influenza, the first such death in the country in nearly 10 years. 

At least 12 people in Cambodia have now been tested for infection with H5N1 following the girl’s death, WHO officials said at a press briefing on Friday. 

WHO officials said the organization was in direct contact with Cambodian public health authorities at the time of the briefing. Cambodia is closely watching the girl’s father, who was also infected, as well as her other contacts, in an effort to determine if person-to person transmission of the deadly virus may have occurred.

The H5N1 strain of Avian influenza has only occasionally infected humans, and mostly as a result of animal-to-human contact. 

But public health officials have long been concerned that a new strain of the virus, harbored by poultry and other birds around the world, could eventualy emerge that is more easily transmissible between people.   

‘Worrying’ says WHO official

“The situation is worrying,” said Dr Sylvie Briand, WHO’s director of epidemic and pandemic preparedness and prevention. The press conference was supposed to provide an update on the composition of seasonal flu vaccines, but was largely taken over by concerns about the more deadly and unpredictable H5N1 pathogen.

The virus has had a fatality rate of over 53% among the 868 cases recorded worldwide between 2003 and November 2022. 

But so far documented cases of human-to-human transmission have been exceedingly rare, and there is no evidence of sustained human transmission of the virus, according to WHO officials.   

“So far, it is too early to know if it’s human-to-human transmission or exposure to the same environmental conditions,” Briand said.

Case in Cambodia follows one in China last year  

The case in Cambodia follows a similar case of H5N1 in China in September 2022, also in an infected girl who ultimately succumbed to the virus.  It was the first case of avian influenza to be recorded in China since 2015.  

The disease is spreading rapidly among bird populations. Since the start of last year, over 200 million birds worldwide were culled or died as a result of the disease, according to the World Organisation for Animal Health.

Genomic sequence not yet known, but vaccines are on hand

The genomic sequence of the exact strain that infected the girl is still unknown. But it is most likely one of two clades, said Dr Richard Webby, Director of WHO’s Collaborating Centre for Studies on the Ecology of Influenza in Animals. 

The two dominant clades of the virus reported by Cambodian authorities in recent years include Clade 2344B, which has ravaged bird flocks across Europe, Africa and the Americas, and Clade 2321C, circulating in Cambodia and the surrounding South Asia region.  

Many of the tools needed to respond to the H5N1 threat already exist, including multiple vaccines and antivirals, said Dr Wenqing Zhang, Head of WHO’s Global Influenza Programme at the briefing. He said that in addition to five vaccines, nearly 20 products are licensed for pandemic use.

WHO has recommended an update the existing reference vaccine, which will begin production in the coming weeks. While it will take some time before the newest vaccine is deployed, Zhang said the vaccines contained in pre-existing international stockpiles built up after an H5N1 outbreak in 2003 stoked fears of a pandemic, have also produced promising clinical trial results against circulating strains. 

If an outbreak occurs, “there is going to be a period of time when the perfectly matching vaccine won’t be available,” Webby said. “That’s when the stockpiled vaccines could perhaps come into play and probably offer offer protection from more severe disease.”

But Webby noted that the trials were not definitive proof of real world efficacy.

“We need to separate in vitro reactivity of people’s antibodies from vaccine effectiveness,” he said.

Image Credits: Roee Shpernik.

Two residents stand in the ruins of residential apartments in Borodianka in the Kyiv region

On the first anniversary of Russia’s invasion of Ukraine, the international community is grappling with how to hold Russia accountable for war crimes, while many Ukrainians are struggling mentally and physically. 

“Ukraine is a crime scene,” Karim Khan, Prosecutor of the International Criminal Court (ICC), told a United Nations (UN) session on the war in Ukraine on Wednesday.

ICC Prosecutor Karim Khan addressing the UN this week.

The ICC had been asked to investigate Russia’s invasion of Ukraine, which started a year ago on 24 February 2022, and Khan visited various Ukrainian cities last May. There he saw civilians being bombed and body bags, and heard testimony from girls and women who had been raped and ex-prisoners of war who had been tortured by Russian soldiers.

Khan said that there were “reasonable grounds” for prosecution under the Rome Statute – the treaty that established the ICC to investigate genocide, crimes against humanity, war crimes, and the crime of aggression.

Late Thursday, the United Nations General Assembly adopted a resolution reiterating its demand that Russia “immediately, completely and unconditionally withdraw all of its military forces from the territory of Ukraine and called for a cessation of hostilities”. Only seven member states – Belarus, North Korea, Eritrea, Mali, Nicaragua, Russia and Syria – voted against the resolution, with 141 states in favour and 32 abstentions including China, India, Pakistan and large parts of Africa.

Back in September, the Independent International Commission of Enquiry on Ukraine, established by the UN Office of the High Commissioner of Human Rights (OHCHR), also reported that there were “reasonable grounds to conclude that an array of war crimes, violations of human rights and international humanitarian law have been committed in Ukraine”. 

The Commission reported “summary executions, unlawful confinement, torture, ill-treatment, rape and other sexual violence committed in areas occupied by Russian armed forces across the four regions on which it focused”. 

Given the gravity of the identified violations, there is an “undeniable need for accountability”, the commission added.

While Russian soldiers are responsible for the “vast majority of the violations identified, including war crimes”, Ukrainian forces had also violated international humanitarian law in some cases, including two incidents that qualify as war crimes, the commission reported.

The UN resolution on Ukraine also calls for “accountability for the most serious crimes under international law committed on the territory of Ukraine through appropriate, fair and independent investigations and prosecutions at the national or international level”.

Collecting evidence of war crimes

However, ensuring accountability is not going to be easy. The ICC has been assisted by forensic investigators from the Netherlands who are helping to “collect evidence to the highest international standards”, said Khan.

The ICC is also working with the European Union (EU) Agency for Criminal Justice Cooperation (Eurojust), which has set up a joint investigative team to investigate war crimes in Ukraine, as well as the Genocide Network, a European network of jurists specialising in international crimes.

“There is no space for spectators in this battle of conscience… It is imperative that the law is rendered effective in this critical moment of world affairs,” said Khan.

However, ensuring that Russian war criminals are tried and convicted will be almost impossible unless there is a regime change. Russia withdrew from the Rome Statute in 2016 after the ICC ruled that its activity in Crimea amounted to an “ongoing occupation”. Travel bans on key leaders make it unlikely that the culprits will leave Russia.

Access to abortion for refugees in Poland

A year into the war, the physical and mental suffering of Ukrainians is immense. By the end of 2022, 18 million Ukrainians needed humanitarian help, with 14.5 million people needing health assistance.

About eight million Ukrainians are refugees, dependent primarily on neighbouring countries for their survival.

This week, a number of Members of the European Parliament expressed concern for Ukranian women who had fled to Poland, which does not allow abortion except if a woman’s life is in danger, or in cases of rape or incest.   

“According to the UN, more than one and a half million Ukrainians have fled to Poland. Ukrainian women and girls who have been raped by Russian soldiers are among the millions of people who have fled to Poland. Now they find themselves in a country that harshly restricts access to reproductive healthcare, including abortion,” the MEPs noted.

They asked the European Commission how it would “ensure that Ukrainian women and girls who have become pregnant as a result of rape have access to reproductive healthcare, including abortion, in accordance with Polish law”.

Kyiv residents queue for water in the street after water infrastructure was destroyed by Russian bombings.

Health, power and water facilities bombed

By the end of 2022, 763 healthcare facilities had been attacked, and half of the health facilities in Donetska, Zaporizka, Mykolaivska and Kharkivska oblasts are either partially or completely non-functional, according to the WHO Surveillance System, 

The continual bombing has destroyed power and water supplies, making it difficult for hospitals to function as well as undermining people’s health.

Approximately 9.6 million people in Ukraine may have a mental health condition, according to the WHO. This is based on previous research on those caught in war and conflict, which shows that almost a quarter (22%) develop depression, anxiety, post-traumatic stress disorder, bipolar disorder or schizophrenia. 

“From overcoming war trauma, to social isolation, to daily struggles without power and heating, to displacement-related challenges and more, the consequences of the war are expected to cause mental health problems for at least five years after the war ends,” says the global health body.

Retreating Russian forces have also mined land, and Ukraine estimates that 30% of the country’s land is contaminated by mines. 

Future geopolitical relations

The war has caused a global realignment, with an isolated Russia working hard to win new allies. India’s trade with Russia has increased by 400%, largely fueled by the sales of discounted crude oil while many African countries are being courted by Russia, including South Africa which has hosted Russian warships in the past few months in violation of US-imposed sanctions.

Ukraine is actively seeking membership of the European Union and has to satisfy an EU seven-point checklist of anti-corruption and judicial reforms – which explains the recent government investigations and dismissals.

Meanwhile, Europeans are increasingly anxious about the war, according to a recent Eurobarometer survey Some 85% of Germans and 82% of French are “very concerned” about the situation in Ukraine, while almost 80% of Poles believe that the war threatens their security.

However, US President Joe Biden’s visit to Kyiv this week to show solidarity with Ukraine, Europe’s discussion of joint arms procurement for the country, and Russian President Vladimir Putin’s decision to pull out of a nuclear pact with the US, point to a hardening of attitudes, and the likelihood that the war will drag on.

Image Credits: Oleksandr Ratushniak/ UNOCHA, Matteo Minasi/ UNOCHA.