Electron microscope image of SARS-CoV2.

Just 66 days after the SARS-CoV2 genetic sequence was shared by a Chinese scientist online, the first COVID-19 vaccines went into production – in record time for R&D that yielded the first approved vaccines less than a year later. 

But there are looming concerns that the relatively open models of data and pathogen sharing that oiled the wheels of R&D during the COVID era could turn more slowly in future pandemics if countries, scientists or research institutions decide to hold back know-how about critical genome sequences and samples in order to reap financial benefits or other concessions.

Already, the Nagoya Protocol of the Convention on Biodiversity has fostered a vast patchwork of laws and regulations, originally intended to protect countries’ indigenous biodiversity, but also extending to regulations on pathogen sharing, which vary from country to country. 

A new pandemic accord currently being negotiated could represent an opportunity to better clarify the muddied waters.  But there is a risk that accord rules could also make sharing even more difficult, said Bart Van Vooren, an European Union jurist and life sciences expert. 

Van Vooren spoke at a webinar sponsored by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) following the recent publication of an IFPMA-commissioned report on the ins and outs of pathogen sharing, by the UK-based law firm Covington, where Van Vooren is a partner.  

A growing flashpoint in negotiations

Bart Van Vooren describes the issues associated with the Nagoya Protocol on access and benefit-sharing of genetic resources

The four-part report provides a detailed review of existing networks for pathogen sample- and data-sharing, the rules governing that sharing; and perceptions of what works and does not, based upon interviews with dozens of scientists from both the public and private sector. The aim, said Van Vooren, is to inform the negotiations of the WHO pandemic accord.

Linking access to pathogen data to the sharing of benefits from drugs and vaccines developed to combat these pathogens is a growing flashpoint in the pandemic accord negotiations. 

Feelings run particularly high in developing countries that were unable to get early access to COVID-19 tests, treatments and vaccines – largely because these were hoarded by rich countries.  To make matters worse, countries like South Africa were punished by travel sanctions after reporting on the emergence of the SARS-CoV2 Omicron variant, including the publication of its genomic sequence, as the variant swept across southern Africa in late 2021, and the world in early 2022. 

At the same time, the pharmaceutical industry and many researchers have argued that rapid and transparent sharing of such data is critical to mount an effective public health response.

“When we spoke to the interviewees on a confidential basis, whether they were from the public or private sector, whether the background is North or South, everyone agrees that something has to give. This needs to be resolved. How, of course, a different question,” observed Van Vooren. 

“Honestly, it scares me because there is a very short timeline to flesh this out in the next two years, and it could be another Nagoya Protocol. Or it could be a solution to another Nagoya Protocol.  So it is concerning”, said Van Vooren, who is regarded as an international expert on the protocol.

Nagoya Protocol: 92 countries have laws; 12 have a public health emergency exception  

The core intent of the Nagoya Protocol on access and benefit sharing (ABS) of genetic resources is to regulate commercial appropriation of countries’ plant, animal species, and related genetic resources to enable countries to claim benefits for the use and development of indigenous assets.  

However, the system has led to a global patchwork of diverse rules and regulations, and 92 countries have enacted their own distinct legislation.  Only 12 of the 92 countries that have put regulations in place make provision for public health emergencies.

“There are nearly 100 ABS laws in the world,” said Van Vooren. “Nearly 100 ABS rules to deal with  77 laws applying to viruses and 39  likely to apply for genetic sequence data. Only 12 have a public health emergency exception in place.”

Obtaining a permit to use a pathogen for pharmaceutical R&D can be a long and arduous process under many national ABS systems, even when public health exceptions are in place. 

“At least five interviewees noted difficulties in getting Zika samples from Brazil, so diagnostics could not be tested against the local strain,” said Van Vooren.

During the recent Mpox outbreak, “a sample held by a European biobank could not be shared, and a national authority never responded to a request for a permit,” he added.

As a result, scientists in both the private and public sectors often look for workarounds, he said. 

“They want to avoid ABS jurisdictions, with a preference for ‘unburdened’ samples,” he said. “This often means waiting for the ‘returning traveller’”, an infected person will ‘import’ the pathogen from which samples and data can be extracted. 

“The intent of Nagoya is noble – equitable benefit sharing – but how it’s been implemented has completely missed the objective. The transactional approach of attaching value to pathogens but not to public health doesn’t seem to work.

“The problem is that politics have replaced science and common science.  Everyone agrees that something has to give.”

Networks for sharing pathogen samples are ‘like a bowl of spaghetti’ 

Complicating matters further is the fact that existing systems of pathogen data and sample sharing operate in a highly decentralized and fragmented manner. 

“It’s a very complex spaghetti bowl of how pathogens are really shared… what we found was a patchwork of practices, and not the very rigorous organization of how pathogen sharing works within disease surveillance networks.” 

As examples, he cited four leading disease surveillance networks, hosted or supported by WHO. These include: the Global Influenza Surveillance and Response System (GISRS); Global Polio Laboratory Network; the Global Outbreak Alert and Response Network (GOARN); and the Global Antimicrobial Use and Resistance Surveillance System (GLASS).   

“But there are quite a few others out there too. The animal foot and mouth networks, the arboviruses. 

”There is huge diversity and a very fragmented system of disease surveillance out there. It is due to a mixture of reasons.  There are scientific reasons – no pathogen is created equal, ….dengue has a kind of reverse seasonality when compared to influenza. And there are differing public health objectives that are also fragmented.” 

Generally, the older networks like the influenza (GISRS) and polio networks are able to share data and samples most efficiently because they represent public-private collaborations built up over decades, including personal relationships of trust between the partners involved. 

“You don’t have so much of the discussions of North versus South, or commercial versus non-commercial, private versus public,” said Van Vooren. “The global influenza system has really managed to rise above these arguably false dichotomies, and it’s the same in the Global Polio Network. Without trust, we would not be as close as we are to global polio eradication.

“With GoARN, you don’t have the all-year-round collaboration between different members of the network.  And that creates difficulties because people don’t know each other as well as they would in an all year round surveillance system.” 

Within these highly fragmented, but also interconnected networks, sharing of samples and data on pathogens may be limited within the network itself; exchanged routinely within the network, but not outside of it; or sharing may also be more open to outside institutions.

Only in the GISRS, is sharing is formalized with a “standard material transfer agreement.” obsrved Van Vooren.  In other networks, it’s much more informal and “sometimes only on a case by case basis.” 

Multiple biobanks and networks 

And that’s not the end of it. Extensive sharing of biological data and samples also takes place via a parallel universe of global and regional databases and biobanks. 

In terms of databases, leaders include, GSAID, global influenza database [also being used for SARS-CoV2], as well as GenBank, the US National Institutes of Health Genetic Sequence database.

Then there are the biobanks, which are large repositories of physical pathogen samples. 

“It’s hard to quantify but we got the impression that when a public health Institute or a company for R&D wants to get access to a pathogen, very often it will work through a network of biobanks, such as the Institut Pasteur, or the European BioBank, or the American Type Culture Collection (ATCC), or BEI. So it’s completely outside the surveillance networks, and very often just through bilateral relationships between a company and a public health Institute, a university and another university,” Van Vooren said. 

Decentralization is an asset and a limitation

While the systems in place may sound chaotic, they offer some advantages: decentralization can enable more rapid response to certain emergencies. And they offer diverse specializations and response capacities.  

“Physically decentralized structures are uniquely prepared in these early stages. They are quick to pick up a pathogen and to enable quick sharing with your R&D community. 

“What many interviewees told us is that especially these networks like European BioBank,BEI, or Institut Pasteur, that has a presence in Paris but also in Dakar and other locations, these kinds of network biobanks … that offer access to physical materials, are essential in order to respond to the early stage of an outbreak.

“I think it’s really important to keep in mind when all the participants look at what is being negotiated under the pandemic accord and the International Health Regulations. It is not really a centralized network, and as far as we are told, it also cannot be.”

Benefitting the host country is ‘insane’  

Thomas Cueni, Director General of the IFPMA.

Prior to the COVID pandemic, the intricacies of pathogen and genome data sharing were a “niche area” of interest, observed Thomas Cueni, the IFPMA’s Director-General, who also spoke at the forum about the broader policy implications of the current systems.  

“When I started to talk about the Nagoya Protocol, no one understood. The pandemic changed that. It showed how fundamental these things are. 

The fact that only 66 days after the SARS CoV2 genome sequence was first published by a Chinese scientist on an open-access platform in January 2020 clinical trials began, underlined to the broader public the significance of such data sharing.  

“And yet the sharing of data and pathogens remains voluntary, which really begs the question of how something so vital to our global health security, how can we leave that to chance?” asked Cueni. 

“During the COVID pandemic, nobody really cared about Nagoya’s ABS provisions because basically everybody agreed that public health should predominate. My concern is that this might change… countries may be tempted not to facilitate this interactive sharing of pathogens that is so much needed to respond to epidemics. 

“Conservatively COVID-19 cost us $15 trillion in economic losses, apart from the millions of lives lost. And yet based on Nagoya, you would give a benefit to the country from which SARS CoV 2 emanated, which is pretty absurd. Actually one could even say that it’s a little bit insane.

“And at the end of the day, pathogens in today’s world are travelling fast, which means that if you try to create obstacles in terms of pathogen sharing it’s just a question of days or weeks before they show up in genetic sequencing in the UK or the US, or another country, which hopefully does have a public health exception (to the Nagoya Protocol).”

COVID-19 was the ‘exception’, not the rule

Furthermore, Cueni adds, while the COVID pandemic drew multiple pharma actors into the fray of rapid-fire R&D, this is “the exception rather than the rule” when emerging diseases are concerned. 

In most other global public health emergencies recognized by the WHO over the past 15 years, it has been difficult to identify pharma partners to develop vaccines and treatments, he contended.  Not incidentally, most of those viruses also leapt from animals to humans in low- and middle-income countries where the risks of infection by communities living around degraded forests, or engaging in unsafe contact with wildlife or domestic animal production, are much higher.

“When I look at seven cases where WHO so far has declared a Public Health Emergency of International Concern – whether it was swine flu, Ebola, Zika or more recently, monkeypox, COVID was the exception rather than the rule. In most instances, basically you had to search for more than a couple of companies willing to run the risk; willing to invest. And we really need to be careful not to create obstacles, which would delay and maybe hinder our ability to have rapid countermeasures… in other important outbreaks, such as Ebola.”   

Sharing benefits – with the world

At the same time, the IFPMA director-general admits that for “common sense” to prevail in global rules around pathogen data sharing, the benefits of tests, treatments and vaccines thus developed will also have to be shared more equitably. 

But that means sharing benefits with the world, not only with the country from which the pathogen first emerged. 

“I do hope that common sense prevails,” he said with reference to language in the current “zero draft” of the treaty, which he argues risks creating more obstacles to sharing. “But I do believe that, in order for that to happen, we from the private and  the public sector need to come up with a response. 

“How can we create trust that, in the next pandemic, we will have a more equitable rollout of these vaccines, tests and treatments? We need to address that,” he admits.

The pharma industry’s recent Berlin Declaration takes a big step in the right direction, he argues:  “Industry has expressed our commitment to early access, to learn from what went wrong during the COVID pandemic, namely, companies willing to reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority population in lower-income countries and to take measures to make them available and affordable.

“But this industry commitment will not really work unless countries with manufacturing capacity, big countries such as the US or India are also willing to sign up.

“We actually wholeheartedly say that more needs to be done in the future to address the shortcomings of COVID response. Each partner in the global health space …. has a role to play in the overall social contract to address future pandemic preparedness and response and ensure equity is at the forefront.”

Image Credits: NIAID-RML (https://www.niaid.nih.gov/, Convginton , Covington, Covington .

A third of Europeans don’t meet the World Health Organization’s (WHO) guidelines for physical activity – but if they did, this would avert over 10 000 premature deaths, almost four million cases of cardiovascular disease, three and a half million cases of depression and nearly a million cases of type two diabetes by 2050.

This is according to a report launched on Friday by the WHO Europe and the Organisation for Economic Co-operation and Development (OECD), which urges policy-makers to adopt strategies to increase people’s physical activity.

The findings are based on a recent Eurobarometer survey conducted for the European Commission which found that 45% of the respondents report that they never exercise or play sport, an increase of 6% since 2009. 

People in Finland (71%), Luxembourg (63%), the Netherlands (60%), and Denmark and Sweden (both 59%) were the most likely to exercise, while people in Portugal, Greece and Poland were least likely to exercise.

“We find that it’s worse among women, with some countries having almost half of all adult women not meeting the WHO recommended guidelines on physical activity,”  OECD health policy analyst Sabine Vuik told the launch on Friday.

Meanwhile, less than a quarter of people who consider themselves to be working class exercise at least once a week, and over half of all adults surveyed said that they exercised less frequently since the COVID-19 pandemic.

Recommended activity

The WHO recommends that everyone does at least 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity every week.

“This could be a half-hour run twice a week, running about 10 kilometres per hour, but it doesn’t need to be formal exercise. It can also be walking the dog every day for half an hour,” added Vuik.

OECD health analyst Sabine Vuik

“Our analysis shows that larger countries such as Germany, France and Italy can save more than €1 billion every year if everyone were to meet the physical activity guidelines. And across the EU, we could save €8 billion every year in healthcare expenditure if everyone meets the minimum recommended guidelines.”

WHO Europe regional director Dr Hans Kluge, said that the report “provides evidence that investing in policies that promote physical activity not only improves individual well-being and population health, but also pays economic dividends”. 

“Every €1 invested in physical activity generates an almost two-fold return of €1.7 in economic benefits. We need to communicate the benefits of being active, not just the physical benefits, but the benefits to mental health, the environment and society in the WHO European Region, and we need to make sure that our systems can and will sustain these changes – as real, long-term transformation,” added Kluge, who is an avid cyclist and cycles to work and back daily.

The report calls on policymakers to step up the policy response to increase physical activity in schools, in urban and transport design and in healthcare settings and workplaces.

Since 2015, some EU countries have adopted policies to improve access to physical activity. For example, Finland adopted a resolution to promote active modes of transportation, Austria builds up co-operation between sports clubs and primary schools and Bulgaria develops a programme to help people whose jobs involve sitting for long periods. 

 

Dr Ahmed Ogwell Ouma, Acting Director of the Africa Centres for Disease Control.

The Africa Centres for Disease Control and Prevention (Africa CDC) is closely monitoring Equatorial Guinea’s first-ever Marburg virus disease outbreak, Africa CDC acting director Dr Ahmed Ogwell Ouma told a media briefing on Thursday

“One big challenge we have are test kits and we are working around the clock to try and get test kits to Equatorial Guinea and also to Cameroon and Gabon, to ensure that we have a very short turnaround time for samples being tested in the laboratory,” Ouma added.

So far, one case has been confirmed and nine deaths have been reported, while there are 16 suspected cases in quarantine, and another 15 contacts are under observation.  All cases have occurred in the province of Kie Ntem in the country’s western region.

Ouma added that a key priority is to limit the spread of the virus, as well as monitor neighbouring countries such as Cameroon and Gabon for potential cross-border spillover.

As reported by Health Policy Watch, on Tuesday, the WHO received updates from five vaccine developers who have been working on candidate vaccines.  The WHO plans to convene a working group to prioritize existing vaccine candidates, with an eye to seeing if clinical trials for any of the vaccines can be launched in real time, particularly if the outbreak expands.

Diphtheria, cholera, mpox, Lassa fever, and measles are some of the other health emergencies that African countries are also grappling with, alongside COVID-19, and Ouma, a Kenyan epidemiologist, said that his center is currently monitoring up to nine different public health events.

Nigeria reported over 600 new cases of diphtheria and several African countries reported cases of cholera, including Malawi, where three-quarters of the continent’s cases have been reported.

The continent has documented over 12 million cases of COVID-19 and 256,705 deaths, a case fatality rate of 2.1%, which is double the global average, Ouma told the media. 

While the number of new cases and deaths have decreased over the past several weeks, he emphasized the importance of continuing to encourage vaccination efforts and targeted campaigns to reach more people.

“The general trend on the continent now is quite flat with the indications that we may be seeing further decreases in numbers and also in deaths,” Ouma told journalists.

Ouma noted that Africa CDC is working with governments and health organizations to provide technical assistance and medical countermeasures as needed for these and other health emergencies. He added that the organization is also continuing to promote vaccination efforts and targeted campaigns to help prevent the spread of infectious diseases.

The producers of unhealthy commodities that contribute to NCDs will attempt to dilute WHO’s recommended policies

While WHO’s recent Executive Board meeting saw a considerable amount of sound and fury over the proposed pandemic treaty, an obscurely titled but vital appendix of updated “best buys” to combat noncommunicable diseases (NCDs) was also briefly on stage. 

This new set of cost-effective recipes to combat what are now the world’s biggest killers provides crucial guidance on how to address NCDs  Were governments to adopt the recommendations as official policies, they could significantly impact the growing trajectory of NCDs. 

Yet, this potentially powerful guidance is wrapped in a wonkily titled document called Appendix 3 of the Global Action Plan for The Prevention and Control of NCDs 2013‒2030. It’s just the kind of packaging that the food, alcohol or tobacco industry would never even dream of using to launch a new product or strategy.  

Powerful but poorly displayed, this new guidance must be packaged and communicated better to protect it from untoward corporate influences. 

For all of those reasons, and more, it deserves far more attention from health policy leaders and civil society as it winds its way to approval at the World Health Assembly in May. 

Unpacking the latest formulas to fight NCDs

The updated policies and interventions address risk factors that perpetuate NCDs such as  tobacco, alcohol and ultra-processed foods. Much in the current draft is good, such as a broader definition of “unhealthy diets”  that includes not only sodium, but also transfats, saturated fats, and free sugars; strengthening countries’ capacities for strategic, multisectoral NCD prevention; and not only enacting minimum prices for harmful products but monitoring how those prices need adjustment based on inflation and other economic factors.

It also does better at reflecting the evidence from low- and middle-income countries (LMICs). The last version in 2017 had data only from 20 LMICs, while the current draft reflects the experiences of 62 countries. 

Nevertheless, the document still does not go far enough on critical aspects of prevention – such as environmental health risk factors like traffic injuries, air pollution, climate change and biodiversity loss, and related to those, unhealthy and unsustainable food systems. It must include conflict of interest policies as recommended policy interventions.

The producers of unhealthy commodities that contribute to NCDs, including the tobacco, alcohol, and ultra-processed foods industries, have a direct stake in maintaining their markets and will attempt to dilute WHO’s recommended policies.(Coca-Cola has lobbied aggressively to remove taxes on sodas and sugary drinks – a best-buy to combat unhealthy diets – in previous versions of this document.)

That is why it is imperative that trusted parties – from civil society groups to individual researchers – carefully scrutinize the proposed revisions on their merits, offer feedback ahead of the WHA, and prevent efforts by self-interested commercial entities to undercut the proposed solutions. 

And there is still room for improvement, which is why we recommend WHO includes the following updates and commitments to its current draft of Appendix 3. These should include  a more explicit articulation of recommendations against conflict of interest, corporate influence, and a more proactive stance on integrated policies related to climate and environmental health that prevent NCDs, as follows:

Preventing corporate influence 

Corporate influence has been identified as a reason for the poor implementation of NCD policies. A global study of 194 countries identified corporate influence as one of the main reasons for the poor implementation of WHO’s recommended cost-effective solutions in Appendix 3. 

The most recent Gallup poll released by WHO and Bloomberg Philanthropies on public perception of NCDs bears this out further. Many people support policies like taxes on unhealthy commodities, particularly if the money will support public programs. 

They want labels on unhealthy foods and restrictions on advertisements that entice their kids. Therefore, removing conflicts of interest from mega-corporation must be included as a specific policy intervention, at least for tobacco control, alcohol use, and unhealthy diets. 

Tobacco control may offer a good template for initial steps towards more aggressive action given that conflicts of interest had already been listed as clear and unequivocal policy interventions in WHO’s global treaty, the Framework Convention on Tobacco Control, which went into effect way back in 2005. Indices like the Global Tobacco Industry Index provide a template for monitoring the global implementation of conflict-of-interest policies.

Argentina requires warning labels on ultra-processed products.

An integrated approach to prevention and control 

The different NCD risk factors often share a common underlying relationship. Improvements in one area can foster improvements in others. For instance, best-buy solutions that improve diets, particularly by reducing the consumption of ultra-processed products, can not only address obesity but also improve malnutrition in all its forms. 

Moreover, since food production is associated with 80% of land-use conversion and biodiversity loss, as well as 20-30% of greenhouse gas emissions, reductions in consumption of ultra-processed foods – the worst of the unhealthy dietary options – can reap environmental gains. 

These “double-duty” actions and co-benefits, concepts promoted by WHO, could be better signalled in Appendix 3. We recommend that WHO commits to a better-integrated guide of best-buy solutions for policymakers.

Appendix 3 acknowledges that a broader set of NCD risk factors must be acted upon. It stresses that cost-effective solutions for air pollution, road safety and traffic injuries, and mental and oral health, are part of complementary processes. Cost-effective solutions for these are to be published but separately from Appendix 3.

There is no mention of integrating these complementary processes within a single document. Multiple parallel processes are needlessly confusing to time-strapped policymakers. We recommend that WHO commits to creating a simple and all-encompassing guide of best-buy solutions for policymakers.

WHO’s updated guidance for NCDs is a great start. With under-resourced health systems struggling to keep up with cascading crises, countries need efficient solutions that will yield a big bang for their buck. Previously known as the “best buys,” “Appendix 3” offers just that. 

By helping governments determine where to place their efforts, Appendix 3 is a valuable document worthy of time and revision. But like any living document, it is open to interference. Global advocates must hold the process accountable. WHO leadership must welcome this committed activism and collaboration by producing a document with real potential for impact. 

Nandita Murukutla is Vice President of Global Policy, Research, Policy Advocacy and Communication for Vital Strategies

Image Credits: Wei Ding/ Unspash, Global Health Policy Incubator , Vital Strategies.

INB co-chair Roland Driece

The draft pandemic accord needs more emphasis on preventing pandemics at their source – where animal pathogens “spill over” to people – according to a number of organisations participating in a consultation on the document’s “zero draft” on Wednesday.

Negotiations between World Health Organization (WHO) member states on the draft are due to begin at the fourth meeting of the Intergovernmental Negotiating Body (INB), scheduled to take place from 27 February to 3 March.

However, Wednesday’s meeting gave WHO’s civil society stakeholders an opportunity to comment on the draft ahead of that meeting.

Only member states will take part in the actual treaty negotiations, which are likely to start behind closed doors on the second day of the month-end meeting (called INB 4), INB co-chair Roland Driece told the meeting.

INB 4 and the following INB5 meeting from 3 to 6 April would be approached as “one big meeting”, he added.

While the start of the meeting would be open to all stakeholders, “as soon as member states tell us that they accept the zero draft as the zero draft, we will move into negotiation mode, and that means that only member states can be present,” said Driece. “So that’s why it’s so important that you tell us and member states now what you feel and think about this zero draft.”

He added that he thought that the INB Bureau had done “a pretty decent job [of synthesizing stakeholders’ inputs]” but “this is an important moment for you all to share whether or not you share my optimism about that and tell us what you think is important”.

Prevent ‘zoonotic spillover’ – environmental and animal health groups

Across large swathes of Asia and Africa, wholesale markets often sell wild animals captured or bred for food consumption, and which may harbor dangerous viruses. Many scientists believe that SARS-CoV2 was transmitted to humans via live, wild animals, caged for slaughter in Wuhan’s wet market.

An unprecedented number of organisations spoke about how the draft needs to pay more attention to pandemic prevention at the source; this means addressing the social, environmental and food safety factors that lead to the spillover of pathogens from wild animal populations into human communities. These drivers range from deforestation which has prompted animal populations like bats, which harbor a range of deadly pathogens from SARS-COV to Marburg, to move closer to human habitats; to wild animal trafficking and trade, both legal and illicit; as well as industrial production, sale and slaugher of wild animal species.  

The Wildlife Conservation Society recommended that the accord commit governments to “identifying and prioritising actions to prevent pathogen spillover in the first place” by prioritising tougher regulations on “markets and trade chains and wildlife domestic and international trade”. 

“We have extensive experience and expertise with habitat degredation, deforestation, forest degradation, wildlife trade and wildlife markets,” said the WCS representative. “And this isn’t about illegal trade, its about any live trade, particularly for food but also for other purposes, birds and mammals.  We look forward to working with member states and the INB to ensure that first and foremost there are commitments by governments to avoid the spillover in the first place. And we do know how to do that, from a biodiversity perspective and in terms of markets.”

The World Wildlife Fund (WWF) appealed for the “list of drivers of pathogen emergence risks to be expanded to include not just deforestation, but ecosystem loss, fragmentation and degradation”. 

“Deforestation alone omits many of the potentially important pandemic frontiers and ignores the role of fragmentation and degradation in increasing proximity between humans and wildlife,” said the WWF.

Meanwhile, the World Organisation of Animal Health (WOAH) called for the inclusion of the full definition of “One Health” in the treaty.  Its delegate also questioned why preparedness and response were stressed whereas “preventive actions targeting activities and places that increase the risk of zoonotic spillover” were not.

Pointing to a lack of expertise to address zoonotic spillover, the Action for Animal Health Coalition said that member states needed to invest in increasing the animal health workforce.

Equity obligations

Oxfam’s Piotr Kolczynski, who also represented the People’s Vaccine Alliance.

Meanwhile, Oxfam, also representing the People’s Vaccine Alliance, said that “the accord’s language must oblige governments to take specific actions to ensure equity; otherwise it would be very difficult to implement this”.

The current zero draft also assumes that “critical public health interventions are based on the willingness of pharmaceutical companies to engage in voluntary mechanisms” but “these have proved to be largely insufficient during the current and previous pandemics,” said Piotr Kolczynski, of Oxfam and PVA.  

For this reason, it added, “the accord must require governments to invest in research and development and manufacturing capacities and to condition public funding on the sharing of technologies, knowledge and intellectual property with developers and manufacturers in the South”. 

In reference to the accord’s proposal that 20% of pandemic-related goods be allocated to the WHO for distribution, Oxfam stated that “equitable allocation of medical countermeasures cannot be achieved by reserving a 20% of production for 80% of the world’s population”. 

Medecins sans Frontieres (MSF), meanwhile, asked for a legal definition of “pandemic”, and “explicit reference to governments complying with international humanitarian law obligations in the context of pandemic preparedness, prevention and response”.

It also demanded stronger language in relation to commitments to protect “humanitarian populations of concerns” and healthcare workers during pandemics.

Private sector is a ‘critical partner’

IFPMA’s Grega Kumer, Deputy Director of Government Relations.

“The private sector should be seen as a critical partner in preparedness, response and recovery, and should have a seat at the table,” stated Grega Kumer, Deputy Director of Government Relations at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

However, it warned that some of the accord’s proposals “would jeopardise our capacity to efficiently prepare for the next pandemic.” Key concerns it cited included proposals for a waiver on intellectual property rights (IP) for health products during a pandemic, as well as proposals that would “be “transactionally linking access to pathogens and sharing of benefits”. 

It also urged the INB to “avoid unnecessary overlaps and duplications including other multilateral organisations mandate and expertise such as WTO and WIPO”. 

While there were over 200 participants online, a handful of member states were also on hand to listen in person at WHO’s Geneva Headquarters to the inputs as they prepare for INB4, when the real negotiations begin for the accord that is due to be presented by May 2024 to the World Health Assembly.

Image Credits: Peter Griffin/Public Domain Pictures.

Mpox
Dr Tedros Adhanom Ghebreyesus speaking at the media briefing on Wednesday.

The World Health Organization (WHO) declared on Wednesday that Mpox will continue to remain a Public Health Emergency of International Concern (PHEIC). The decision to continue with the status quo on Mpox was based on the recommendations made by an Mpox Emergency Committee, whose findings were published on the same day.  

“The emergency committee for the global outbreak of Mpox met to assess whether, in its view, the outbreak remains a public health emergency of international concern. The committee has advised me that, in its view, Mpox remains a global health emergency, and I have accepted that advice,” Dr Tedros Adhanom Ghebreyesus, director-general of the WHO, said at a press briefing on Wednesday.  

In its report, the Mpox committee, which met on 9 February, acknowledged the progress made in reducing the virus transmission and the sharp decline of reported cases. However, it also expressed concerns that “a few countries continued to see a sustained incidence of illness” while in other countries it’s likely that more cases are occuring under the radar.   

“More than 30 countries continue to report cases, and the possible underdetection and under-reporting of confirmed cases in some regions is concerning. Particularly in countries where animal-human transmission of Mpox has been reported before,” Tedros pointed out. 

In its report, the expert committee also expressed concerns about the possible resurgence of cases due to the expected resumption of LGBTQ social events and other mass gathering events; lack of access to vaccines and testing capacities in many lower-income countries; and the recurring zoonotic transmission in Africa.

It added that “not all countries are receiving the support they need or have structures or systems to respond to mpox, including inadequate support for marginalized groups; and general fatigue among supporting agencies.”

Returning from Syrian scenes of devastation

Tedros spoke at the briefing shortly after returning to Geneva from a visit to earthquake affected areas in Syria. The 7.8 magnitude earthquake that hit Syria and Türkiye last week is now estimated to have killed over 41,000 people. 

Describing the damage caused to Aleppo and Damascus first due to the war, and now by the earthquake, Tedros said “I saw the destruction of entire communities, the unspeakable suffering of people, and the courage and determination of survivors and responders. As we drove from Aleppo to Damascus, I saw the legacy of conflict, with town after town destroyed and abandoned.  Survivors are now facing freezing conditions without adequate shelter, heating, food, clean water, or medical care.”

While two more cross-border points between Türkiye and Syria have been opened, Tedros said he had had asked Syrian president Bashar al-Assad to open still more crossings so that relief could reach people in need more rapidly.  Humanitarian aid groups charge that the Syrian president has “weaponized aid” channeling available supplies to government controlled areas – while most of western Syria where the earthquake hit, is controlled by  Kurdish and other Syrian anti-government militias. 

“WHO remains committed to supporting all people in the Syrian Arab Republic now and in the days, weeks, months, and years ahead,” Tedros added.  

The WHO has launched an appeal for $43 million to support its response in Syria and Türkiye and expects the amount to double by this weekend. Meanwhile, UN Secretary General Antonio Guterres called upon countries to fully fund a $397 million earthquake fund for Syria, in particular, which lacks resources to mount its own response. 

Marburg disease – ramping up diagnostics and clinical trial possibilities

Touching back on the Marburg Virus Disease (MVD) outbreak in Equatorial Guinea, which has claimed nine lives, Tedros said that the WHO is working with the country’s health authorities to ramp up their diagnostic capacity. 

“So far, no confirmed cases have been reported in Cameroon and or Gabon,” he added, referring to the two countries that, along with Liberia, border Equatorial Guinea. “We’re also supporting the governments of Cameroon and Gabon to prepare to rapidly detect, isolate, and provide care for any suspected cases.” 

Following up on the Marburg Virus Vaccine Consortium (MARVAC)’s meeting on Tuesday, Tedros said that WHO is trying to accelerate talks on possibile clinical trials for Marburg virus diseaes vaccine candidates. But he reiterated that any decision on the trials of vaccines and therapeutics for Marburg needs to be taken by researchers and the national authorities of Equatorial Guinea. 

“In the meantime, WHO is convening the vaccine prioritization committee to identify which vaccine candidates should be evaluated first and prepare for potential trials. WHO is also discussing with the ministry of health, the possibility of providing access to experimental therapeutics as part of a clinical trial,” he said.     

COVID-19
Dr Maria Van Kerkhove, speaking at Wednesday’s media briefing.

A senior World Health Organization (WHO) official has emphatically denied that abandoned its investigation of the origins of the virus that caused the COVID-19 pandemic.

The comment by Dr Maria Van Kerkhove, COVID-19 technical lead, was in response to a report published on Tuesday by Nature which stated that the agency has “quietly shelved” its plans to continue with its investigation of SARS-CoV2’s origins. due to the barriers to plans to conduct further, crucial studies in China. A controversial report by a joint Chinese and international mission to Wuhan, covering the first phase of the investigation was published in March 2021,  But critics said glossed over China’s omission of key patient data from the early days of the outbreak in Wuhan. The report also declared that it was “extremely unlikely” that the virus could have escaped from a local research laboratory, without sufficient data or evidence to make such a determination, critics said. 

Subsequently, WHO laid plans for an extensive set of on-site, follow-up studies over the summer of 2021, including further assessment of Wuhan wild markets, the lab escape theory, and closer examination of early transmission patterns, based on blood samples from anonymized patient data. But China rejected those plans outright, and has remained unwilling to release further patient data or to let teams of researchers visit the country.

In the Nature report, Van Kerkhove was quoted saying that WHO had in fact abandoned its plans for a Phase II of the COVID origin studies: “There is no phase two,” she reportedly said. While WHO protocols had called for extensive follow-up studies in China, “that plan has changed”, she added, saying: “The politics across the world of this really hampered progress on understanding the origins.”

Speaking at Wednesday’s briefing, Van Kerkhove appeared to walk back on her comments, stating:

“I think we need to be perfectly clear that WHO has not abandoned studying the origins of Covid 19. We have not, and we will not.”

However, she also admitted that WHO’s “updated” plans for a second phase would have to take a more generalized approach to the origins question:  

“In a sense, phase two became the Scientific Advisory Group for the Origins of novel pathogens (SAGO),” she clarified. SAGO held its first meeting in November 2021 and was established as a permanent advisory group to work on drawing up a framework to understand the origins of not just COVID-19 but any future outbreaks. “So the creation of SAGO was in effect, our best effort to move this work forward.”

China has evaded WHO’s requests for cooperation

China continues to refuse WHO’s requests to release more data or to open its borders to scientific teams for further on-site investigations, Kerkhove also admitted.

“Studies that were recommended from the March 2021-WHO report, from the June 2022-SAGO report and studies that we’ve been recommending at the animal human interface and markets, on farms need to be conducted in China. We need cooperation from our colleagues there to advance our understanding,” she added. 

Over the past year, WHO repeatedly called on China to cooperate in further SARS-CoV2 origin studies. Last month, WHO Director General Dr Tedros Adhanom Gheyebresus also appealed to Beijing to share more data about death rates and SARS-CoV2 variants ciculating in the country as the country was swept by a fresh COVID wave after removing its controversial “zero COVID” policy measures. 

Dr Tedros added that it remains crucial to understand the origins of the pandemic for scientific and moral reasons. 

“Millions of people lost their lives and many suffered. The whole world was taken hostage by a virus. It’s morally very important to know how we lost our loved ones.

“Recently, seven weeks ago, I sent a letter to a top official in China, asking for cooperation because we need cooperation and transparency and the information we ask in order to know how this started,” he stated.

But apparently so far, there has been no return mail.

Image Credits: Megha Kaveri.

Image Credits: Abdulsalam Jarroud/TNH.

Marburg
Health workers in protective gear during the Marburg outbreak in Guinea in 2021.

Following a first-ever outbreak of deadly Marburg virus disease in Equatorial Guinea, the World Health Organization (WHO) on Tuesday called an emergency meeting of the Marburg virus vaccine consortium (MARVAC) to receive an urgent update on possible vaccine candidates for the filovirus that can have an 80% fatality rate.  

At the meeting, the agency received updates from five vaccine developers who have been working on candidate vaccines.  WHO experts said that they will soon convene a working group to prioritize existing vaccine candidates, with an eye to seeing if clinical trials for any of the vaccines can be launched in real time, particularly if the outbreak expands.  So far the virus has claimed nine lives, while there are 16 suspected cases in quarantine, and another 15 contacts are under observation.  All cases have occurred in the province of Kie Ntem in the country’s western region.

“The critical next steps include getting full sequence information on the virus, which is being detected in Equatorial Guinea to use that for a number of different purposes,” said Philip R. Krause, chair of the WHO Covid Vaccines Research Expert Group, who led the meeting.

In parallel, WHO will “rapidly” convene a vaccine prioritization committee, Krause said, to “consider updated information from vaccine developers and to simplify, which really means extract relevant sections from the vaccine clinical protocol for potentially use in Equatorial Guinea,” Krause said. He was referring to an already-approved WHO clinical trial protocol for Marburg vaccines, which would likely need adaptation to the context of the current outbreak. 

“Assuming we’ll proceed with clinical studies, and of course this is pending agreement and support from local authorities in Equatorial Guinea, assuming that such a study were to be done, it would be important to convene the prioritization committee to look at these in the context of most up-to-date information – to make decisions about which of these  should be included in in such a study,” Krause said.

Marburg
Phil Krause at the WHO-led MARVAC meeting on Tuesday.

The meeting came only a day after WHO officially confirmed the first-ever outbreak of Marburg haemorrhagic fever in Equatorial Guinea. That confirmation came a week after the country’s Health Ministry notified WHO of a suspected case that had first been reported on 7 January in the country’s Kie Ntem province.

Vaccines in the pipeline

At the meeting, the WHO experts reviewed the status of five active vaccine candidates against the virus. Two of the candidates, one developed by the Sabin Vaccine Institute and one by Janssen are in the Phase 1 clinical trials. The other three vaccine candidates being developed by International AIDS Vaccine Initiative (IAVI), Public Health Vaccines (PHV) and Auro Vaccines, are still in the pre-clinical stage of development.

Marburg
The five active vaccine candidates that are in development for Marburg disease.

Babajide Keshinro of Janssen said that the company could mobilise 3500 doses of its Marburg vaccine candidate for WHO-led trials immediately in Equatorial Guinea. However, he stressed that the trials would have to begin within the next two months. Beyond that, the company does not yet have a firm estimate on the length of time the Janssen vaccine candidate remains stable.  

Matthew Duchars, speaking on behalf of the Sabin Vaccine Institute, told the committee that the Institute has up to 20,000 doses of active vaccine ingredient, which it was already planning to use for its own Phase2/3 trials later this year. “We have quite a reasonable amount of drug substance, which has been manufactured and is awaiting to be filled, and is probably up to about 20,000 doses from the bulk that’s currently made.”

The Institute also had reserved “slots” with a number of vaccine manufacturers which could be “repurposed” to rapidly produce several hundred finished vials of the vaccine candidate for deployment in Equatorial Guinea. he added.  

Joan Fusco, of PHV, said that their vaccine candidate had just recently secured FDA approval for clinical testing and that they have around 350 vials ready for use. But they do not have further active manufacturing of the product planned at present. 

As for IAVI, Andi Kilansk said that the organization does not have “any available bulk drug, substance or field drug product.” Similarly, Auro Vaccines said it had no Clinical Trial Material (CTM) available at present, and that its own clinical trials had been planned only for later in the year.

In relation to therapeutics, Dr Simon GP Funnell from the United Kingdom’s Health Security Agency, referred to a recent study that found a combination treatment of monoclonal antibodies and remdesivir performed better against the virus than individual drug agents. “A combination of monoclonal antibodies and remdesivir was better than either alone at Day 6. And that’s going to be a theme that’s carried forward,” he said.

Index case on 7 January

The index case of Marburg virus disease occurred on 7 January 2023, Dr George Ameh, country representative of WHO to Equatorial Guinea, told the meeting. However, the Country’s Health Ministry only notified WHO of the case on 7 February, with a definitive lab confirmation of the disease from a Senegalese laboratory on 13 February.

“In total, there have been nine deaths associated with this outbreak, with established epidemiological links. Close family members, those who attended burials of these close family members…nine confirmed deaths as of today. We also have 16 suspected cases in quarantine and 15 asymptomatic contacts being closely followed up from their homes,” he said. 

Marburg
Equatorial Guinea is located in west central Africa.

Despite the month-long lag between the report of the suspected first case and notification to WHO, Dr Matshidiso Moeti, WHO Regional Director for Africa, praised the “rapid and decisive” action by Equatorial Guinean health authorities.

“Marburg is highly infectious. Thanks to the rapid and decisive action by the Equatorial Guinean authorities in confirming the disease, emergency response can get to full steam quickly so that we save lives and halt the virus as soon as possible,” said Moeti.

Marburg virus disease, also known as MVD, is a highly infectious disease that has a fatality ratio that can range between 24% and 88%. The virus, named after a town in Germany where the virus was first identified in 1967 after causing 29 infections and 7 deaths, belongs to the same family of filoviruses as Ebola. The virus is typically transmitted to humans by fruit bats, and then spread between humans through direct contact with bodily fluids of infected people, surfaces and materials.  In Africa, outbreaks have been reported peridically in the Democratic Republic of Congo, Angola, Uganda – but never before in Equatorial Guinea.

Common symptoms of Marburg disease include fever, fatigue, blood-stained vomit and diarrhoea, according to WHO.

“Efforts are also underway to rapidly mount emergency response, with WHO deploying health emergency experts in epidemiology, case management, infection prevention, laboratory and risk communication to support the national response efforts and secure community collaboration in the outbreak control,” stated a WHO press release, published on Monday.

“WHO is also facilitating the shipment of laboratory glove tents for sample testing as well as one viral haemorrhagic fever kit that includes personal protective equipment that can be used by 500 health workers.”

Image Credits: WHO, Megha Kaveri, Alvaro1984 18, Public domain, via Wikimedia Commons.

The fourth Intergovernmental Negotiating Body (INB) meeting takes place 27 February; portrayed here, WHO member states at the second meeting 18-22 July 2022.

On 27 February, World Health Organization member states will meet to commence formal negotiations on a global pandemic preparedness agreement – unofficially turning the page from responding to COVID-19 to readying ourselves for future health emergencies.

While the Intergovernmental Negotiating Body (INB) of member states have already held a series of meetings, as well as stakeholder briefings, the negotiations at the end of the month hold special significance as they follow on from the publication of the “zero draft” of the envisioned international legal instrument.

And with the aim of concluding a draft instrument by May 2024, the clock is already counting down. This is a huge undertaking, and millions of lives depend on learning the right lessons from our collective response to the COVID-19 pandemic.

The pharmaceutical industry, which played an indispensable role in defeating COVID-19, recommends focusing on five priorities.

Sustaining a thriving innovation ecosystem

R&D of COVID-19 vaccines took place in record time.

The first must be to maintain and reinforce the policies and systems that worked well these past three years – the innovation ecosystem undergirding our industry and the immediate unhindered access to pathogens and their genetic sequences.

It was no accident that we had tests and potential vaccines and treatments in development within days of the sequence of the novel coronavirus published online – a record-breaking pace that saved an estimated 20 million lives in year one of the pandemic. Everything from the viral vector or mRNA technology behind the vaccines to the global supply chains that enabled unprecedented manufacturing scale-up wouldn’t have been possible without decades of large, risky investments in the international pharmaceutical sector.

Yet today, the very system that allowed collaboration and innovation to thrive and deliver the solutions for the COVID-19 pandemic, is under attack. The World Trade Organization’s (WTO) June 2022 decision to waive international patent protections on the COVID-19 vaccines, and the ongoing discussions on extending this waiver to COVID-19 therapeutics and diagnostics, risk undermining the system, which was critical for the success in the fight against COVID-19.

Attacks on IP at the WTO or in the zero draft of the accord fail to recognize the critical role that intellectual property frameworks play to incentivize research and facilitate voluntary partnerships, business-to-business agreements, and technology transfers. Proponents of these proposals oversimplify what the notion of “tech transfer” entails, and risk undermining, rather than facilitating our collective ability to rapidly develop and scale-up countermeasures.

Furthermore, some countries seek to twist the UN’s Nagoya Protocol – a roughly decade-old pact that gives countries more rights and incentives over their native flora and fauna with the intention of protecting biodiversity – to restrict the flow of information about pathogens. The deliberate twisting of the protocol giving value to pathogens instead of protecting global health security is a bizarre and unprecedented threat to global health.

Lest we forget, the system we had in place when COVID-19 arrived created multiple safe, effective vaccines against a novel, deadly contagion in a matter of months, produced billions of doses within a year, and has now delivered at least one dose to over 69% of the world’s 8 billion people. This is a record to build on, not to attack. Innovation and immediate access to pathogens should be at the center of all pandemic preparedness and response plan.

Shaping a new ‘social contract’

Second, the world’s wealthiest nations must adopt a new framework for more equitable global distribution of vaccines and therapies. National leaders, morally accountable to their own citizens, can now nonetheless appreciate the value of global preparedness. As wave after wave of COVID-19 variants have taught wealthy nations, viruses do not respect economic advantage any more than they do geographic borders. Amidst a global contagion, none of us are safe until we all are.

The framework that best reconciles different regions’ interests is one familiar to all democracies: the social contract under which citizens balance rights with responsibilities, independence with interdependence. Under a global pandemic preparedness “social contract”, pharmaceutical companies set aside stores of vaccines, treatments, and tests, based on real time production, for priority populations in lower-income countries.

But for this to work, manufacturing countries need to allow part of what is produced in their territories to be exported to low-income countries in real-time. And of course, we need adequate funding upfront for organizations such as Gavi, the Vaccine Alliance, to sign contracts early on.

Fostering sustainable manufacturing globally

Third, Covid-19 showed how broad a global vaccine production program must be – and how much such a program depends on a stable legal and policy framework, which gives the confidence to parties to join forces, and share technology and know-how.

The record is clear. By the end of 2022, pharmaceutical companies signed 381 vaccine manufacturing and production partnerships, and 150 more to produce COVID treatments – the vast majority of both involving technology transfer. To facilitate access and equity for the developing world, those partnerships included facilities based in India, Bangladesh, Egypt, and South Africa.

The right enabling environment to attract sustainable investments and predictable demand will be critical to maintain existing capacity and introduce new capacity in other regions.

Removing trade restrictions

Fourth, the COVID-19 experience showed that when it comes to the development, manufacturing, and distribution of goods around the world, there is no substitute for free trade. Whatever arguments might exist for protectionist trade barriers in other sectors of the global economy, it is now obvious that those arguments do not apply to public health necessities in the middle of pandemics. Open trade saves lives.

Ensuring greater country readiness

And fifth, when it comes to global equity, the ability of less developed nations to absorb supplies is also paramount. These countries need help in strengthening their healthcare systems and making huge investments in health infrastructure to prevent, detect and respond to future threats while maintaining access to routine and essential services during a crisis.

Later this month, WHO negotiators will be looking at all of the above – efficacy and equity, supply and demand, economic incentives and moral responsibilities – as members work to revise the current zero draft of a global pandemic Accord.

Taking the time, here in this middle hour between crises, to get the policies and incentives right will yield the public health community the coordination, collaboration, and innovation we will need to overcome the inevitable next pandemic.

____________________

Thomas B Cueni, is the director general director general of the International Federation of Pharmaceutical Manufacturers and Associations.

Image Credits: Pfizer, IFPMA .