pandemic

Should the corporate sector be allowed to engage in negotiations around the new binding instrument on pandemic prevention, preparedness and response that is being developed by World Health Organization member states? This week’s closed-door debate by WHO member states to decide who should get a seat around the table risks opening a Pandora’s box of vested interests. 

Twenty years ago the WHO Tobacco Convention (FCTC) initiative, the first treaty negotiated at the WHO in response to the globalization of the tobacco epidemic, set very clear ground rules. Governments included a specific statement that tobacco companies should neither participate in the negotiations of the convention nor in national tobacco policy-setting. 

Yesterday, some of the leading member state delegates gathered in Geneva for a week of deliberations on a first working draft text for a new legal instrument to govern global pandemic preparedness and response, steered by the International Negotiating Body (INB) nonchalantly hinted that business actors are welcome. Advocating for an all of society approach in the drafting process, the European Union, the USA and the United Kingdom, among others, trumpeted the need for the participation of corporate entities in the treaty’s early formulation and vision. 

The issue of which non-state actors can interact formally on the INB negotiations – beyond those already in official relations with WHO – is due to be discussed in detail this week on the basis of a short-list already submitted to member states in March outlining “proposed modalities of engagement for relevant stakeholders.” 

This list already recognizes a new and wider range of international and multilateral groups with direct corporate interests, in addition to the existing “non-state actors in official relations with WHO”.

Some 220 non-state actors already holding the coveted status of “official relations with WHO” include the International Federation of Pharmaceutical Manufacturers and Associations, as well as  agro-business foundations such as CropLife International, and private sector outliers, such as the International Air Transport Association, and the World Plumbing Council. 

Strikingly, only a few environmental health NGOs, notably the International Society of Doctors for Environment (ISDE), are recognized by WHO. None of the global environmental advocacy groups, such as Health Care Without Harm, the Global Climate and Health Alliance, or the Wildlife Conservation Society’s health programme, have been accredited so far – despite efforts to win a seat at the table.   

Expanding INB stakeholders list – who will win the prize? 

WHO member states at the INB meeting taking place 18-22 July 2022 in Geneva

WHO member states are now set to expand the list of stakeholders in the INB negotiations even further, adding an as yet-to-be defined list of new actors as a proposed Annex E of the current list of recognized groups. This Annex E , effectively, is a blank check for the entry of still-more vested interests to the INB talks.  

Astonishingly, the WHO member state discussion and decision on these added non-state actors will be held behind closed doors – away from media scrutiny and without much possibility for intervention by existing CSOs.  

So will even more powerful pharma, agri-business and other vested interests be invited to join the talks, while environmental actors concerned with One Health issues critical to pandemic prevention, remain locked out of the room? 

The risks of this are high. And it is a looming question critical to the future direction of the talks. 

Post-democratic complacency sweeping public institutions 

The issues at stake here are but one more reflection of the post-democratic complacency sweeping across state and multilateral institutions, gradually transforming the relationship between public institutions and the corporate world. 

This is not happening only at the WHO. The global multilateral arena is visibly occupied by imaginations of sustainable development that maximize new market futures through the tropes of inclusiveness, transparency and innovation. 

In the context of the WHO, the proposed modalities for engagement for relevant stakeholders do not in fact propose any safeguards against corporate political interference in the pandemic treaty and its making. 

In fact, they pave the way to an ever-increasing range of entities to gain a foothold of status  with the organization – beyond the pharma and agribusiness interests, like CropLife International, already in recognized WHO relations.

Pervasiveness of pharma groups in disguise 

Pharma continues to grow in global health.

In the meantime, the dominance of pharma continues to grow, unregulated. 

We are referring here to the powerful public and private partnerships created by the philanthropic sector – mostly the Bill and Melinda Gates Foundation – over the last two decades, including groups such as Gavi The Vaccine Alliance, The Global Fund, and Coalition for Epidemic Preparedness Innovations (CEPI).  

During the pandemic, these Gates-funded hybrid organizations collaborated in the creation of a new ‘super public-private partnership’ the Act Accelerator (ACT-A), and its vaccine component, COVAX. This new structure was tasked with orchestrating the international response to the COVID pandemic – with governments’ complacent consent.   

Legally, these institutions constitute largely inaccessible jurisdictions of private foundations deeply inhabited by corporate logics, interests and staff. Although a “transition” of the Act-A and COVAX functions back to Gavi and its partners was recently announced, it remains to be seen if and how this prototype architecture of the early phases of pandemic crisis will give rise to new ‘super’ entities or functions, as part of the WHO pandemic legal accord. 

A COVAX vaccine delivery prepared for shipment in April 2021

Several relevant stakeholders are advocating in support of this scenario. Whatever the future holds, during the recent pandemic we were confronted with a text-book example of global health privatization that ran counter to the obvious need for a strong public sector role in countering the crisis. 

So it should be no surprise that, despite early warnings, the INB continues to sideline concerns from civil society about the ambitions of the private sector in the tailoring of the treaty – as well as the need for more transparent discussions about who should be recognized as stakeholders, based on WHO constitutional principles.

Protecting from vested interests? 

While member states hold free-wheeling, closed-door discussions this Thursday and Friday, about their final list of INB stakeholders, the task of watchdog will pass to the WHO Secretariat and its legal team – also tasked with protecting the world’s public health agency from undue corporate capture along the lines of the Framework of Engagement with Non-State Actors (FENSA), approved by the World Health Assembly in 2016.  

How can WHO, the sole international institution mandated to achieve the highest possible standard of health for everyone on this planet, protect an in-house treaty–making process, and the negotiated norms on future pandemics, from the viral  influence of vested interests in their corporate and philanthropic variants? 

How will WHO member states safeguard this complex process from the power strategies that corporate lobbyists commonly exercise in the multilateral arena – in line with their mandate as duty bearers vis a vis the right to health? 

Big Pharma and Big Food are not Big Tobacco? 

Testing bio-pesticides in a Moroccan fruit orchard – alternatives yet to be taking up at scale by agribusiness worldwide.

The reluctance, when not outright opposition, to consider strict safeguards against corporate interference in managing future pandemics may be founded on one simple assumption: Big Pharma and Big Food are not  ‘Big Tobacco’. Pharmaceutical corporations save lives. Agribusiness provides food supplies. Tobacco corporations destroy health and lives. But this premise is profoundly mistaken and neglects three important facts wholesale. 

Firstly: pharmaceutical and agribusiness corporations, like any corporation, including tobacco, are primarily – and indeed statutorily – geared to profit-making. This is a reality that can, and indeed often does, produce tricky contradictions with policy-making purposed to improving the health of the largest public possible. 

The fact that COVID-19 vaccines were not initially made accessible to millions of people globally to protect the intellectual property rights of pharmaceutical corporations is a particularly germaine example of this. Pharma’s animal health branches, together with agri-business, are meanwhile making gigantic profits from the sale of antibiotics dedicated to the intensive production of livestock and pesticides that spur antimicrobial resistance and the risks of new pathogen emergence. 

Secondly: the pharmaceutical industry, like tobacco, has a troubling track record of market abuses and violations of international law that seriously undermined public health. Just a taste, to remind pandemic treaty negotiators? From Pfizer to AstraZeneca, some of the world’s largest vaccine manufacturers have paid hundreds of millions to billions of dollars to settle lawsuits on claims ranging from bribery and fraud to off-label drug promotion. In February, four leading pharma firms, including Johnson & Johnson agreed in US courts to pay out $26 billion on claims that their business practices fueled the opioid epidemic, which has caused rampant addiction, suffering, and death. Do we seriously want to treat entities like this as “partners” in crafting the vision and implementation of a pandemic treaty, after Covid-19?

The tobacco industry continues to expand, with one of the world’s largest cigarette manufacturers owning a stake in COVID vaccine manufacturer Medicago.

Thirdly: the officially stigmatized tobacco industry is not giving up and expanding its reach into the pharma sector, now under the cover of the response to the COVID-19 pandemic. Tobacco industry interests in pharmaceutical corporations are widespread and growing, with corporations even holding intellectual property rights to life-saving vaccines and treatments.

One of the world’s largest cigarette manufacturers, Philip Morris International (PMI), owns a significant stake in COVID vaccine manufacturer Medicago. To make matters worse, the Canadian government, in contravention of the WHO FCTC, has partnered with PMI to produce the Medicago Inc. vaccine. This sparked a public outcry; Canada was not only violating its international commitments but deepening one epidemic through its response to another.

British American Tobacco (BAT), another global tobacco actor, has likewise been involved in supporting development of a COVID vaccine through a subsidiary, Kentucky BioProcessing (KBP). Thanks to the WHO FCTC, approval for global distribution of these vaccines will be premised on Big Tobacco divesting from these ventures.

Big Food and Agribusiness also threaten treaty’s integrity 

Antimicrobial resistance resulting from increasing use of antibiotics in farming and particularly livestock production has been described as a ‘silent pandemic’.

In the aftermath of the pandemic, Big Tech, Big Food, Big Agribusiness are increasingly jumping on the expanding market of global health products as well as the supply chain risks management.  

The intersection of these powerful interests – which promote spiraling use of antibiotics and pesticides in unsustainable methods of farming and intensive livestock production – ultimately threatens a balanced, reality-based approach to AMR and One Health in the INB negotiations. 

Yet, while many member states this week have underlined AMR as the silent pandemic that calls for One Health as the vital approach to pandemic prevention, others have questioned whether these issues are getting too much emphasis, saying that One Health is not well understood and lies outside of the range of WHO’s usual mandates. 

Given the growing systemic pandemic risks associated with unsustainable food chains and biodiversity destruction, focusing almost exclusively on surveillance and pharmaceutical solutions for the pandemic response iterates the disease-specific reductionistic approach that industry has thrived on for the last two decades. This must change in the pandemic treaty discussion.  

But  while there are active CSO groups, recognized by WHO, advocating for medicines access issues, as already noted, hardly any planetary health players are to be seen  in the pandemic negotiations, to pose cogent counter-arguments and perspectives on the human-animal-environment interface that One Health addresses.

Trends in animal antimicrobial sales correspond with growing AMR hotspots – ETH Switzerland

Rhetoric aside, this means that the final outcome, whether its a treaty, convention or other legal instrument, may end up lacking any meaningful teeth to address the systemic determinants of zoonotic spillover events – related to unsustainable development, unhealthy and unsafe food production, and anthropogenic colonization of ecosystems. The WHO Secretariat and the INB will be dragged into merely enabling yet another new and splendid round of private-sector driven biomedical solutions.

The INB must set convincing and transparent criteria 

WHO delegates should not forget that, if they are serious about being inclusive, credible ground rules need to be created to bring transparency and order to today’s unregulated scene where conflict of interest policies render the multilateral landscape a confusing free-riding space. 

Since the WHO Secretariat and the INB point to the FCTC as their model for treaty-making, they should be mindful that the FCTC’s success has been largely attributed to member states’  precedent-setting controls against corporate manipulation. 

The INB must set convincing and transparent criteria to ensure that those negotiating, observing negotiations, and subsequently implementing the new treaty, convention or other legal instrument do not have conflicts of interest. Declaring those conflicts is not enough, if we are to build trust.

Negotiators should ensure any and all consultations with vested industries in developing the pandemic accord are publicly and immediately disclosed. This helps guard against self-serving industry influence over public health policy or the perception thereof.  

The COVID-19 pandemic has illustrated the centrality of universal public health systems in the management of a pandemic, and the inapplicability of market rules and principles in handling such an immense crisis in each country. We do not want to see future pandemics, and the global agreement supposed to prevent and respond to them, pave the way to new modes of exploitative health care marketization. Humanist ideals in global justice cannot be used to enhance the very practices that subvert it. 

It’s important that these and other strict guideposts be adopted for success. This will require less lip service be paid to the FCTC and more meaningful consultation with those WHO officials and civil society organizations intimately familiar with the Convention. There’s a lot to learn from that process that is relevant to the current one.

The success of the treaty and global pandemic response depends on it. Public health practitioners and human rights advocates the world over recognize as much. We implore the INB and the WHO delegates to do the same. 

Ashka Naik

Ashka Naik serves as the Research Director at Corporate Accountability, leading strategic research and equity-centered analysis of corporate power across issues, from public health to food systems. She is also pursuing her doctorate at the University of Massachusetts, where she explores the intersectionality of food security, women’s empowerment, and neoliberalism. 

Nicoletta Dentico

Nicoletta Dentico, journalist and writer, serves as Director of the Global Health Justice Program at the Society for International Development (SID). She is co-chair of the CSO independent platform Geneva Global Health Hub (G2H2). 

 

Image Credits: Jernej Furman/Flickr, Max Pixel, WHO, FAO, Chris Vaughan, Flickr: Paul van de Velde, Van Boeckel et al, ETH Zurich.

genomics inb
Precious Matsuso, moderator for the July 2022 INB talks on a pandemic treaty, convention or other legal instrument.

The question of whether pathogens’ genomic sequences should be shared freely – or in exchange for a clear benefit – as well as the role ‘One Health’ should play in any new Pandemic Convention or legal accord were key points of emerging dispute among member states on Day 2 of the Intergovernmental Board Meeting (INB). 

Those debates, aired publicly in the first two days of the week-long meeting that aims to draw the broad outlines of a pandemic treaty, offered a good taste of the rough road ahead. 

In sharp contrast, Wednesday and Thursday are set to be closed-door sessions. There, in private, member states will make two critical decisions. 

They will decide on the legal position of the new accord under the WHO Constitution – which in turn will reflect how legally binding the agreement really will be; 

They will also decide if the negotiations should be thrown open to an as yet undefined list of more civil society and private sector groups – beyond the nearly 300 entities already recognized as “stakeholders” in the talks.  

Genomics – a hot spot

Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, US delegate

On the genomics issue, the United States delegate Colin McIff fired off the opening shots in what is sure to be a prolonged and painful debate, saying that countries’ agreement to grant access to pathogen sequences, should not be addressed in a “transactional way” – hinged to promises of sharing benefits from the medicines or vaccines that are later produced. 

The US concern has been echoed for months by pharmaceutical companies as well – which were able to rapidly map out vaccines for the SARS-CoV2 virus because the virus sequence was shared early on. 

However, that free tap of information could be turned off if the December meeting of the parties to the Convention on Biodiversity opts to includes “genetic information” into its existing  Nagoya Protocol on Access to Genetic Resources – initially developed to protect countries IP on indigenous plant and animal species from uncontrolled development – but now being applied to pathogens as well. 

“The sharing of benefits can be seen as a means to achieving equitable pandemic preparedness and response,” said McIff. “But our concern is that … if we continue to link access and benefits in a transactional way, that’s not really conducive to meeting public health needs, and improving pandemic preparedness.” 

The US position was quickly countered by a wide range of developing countries, including Indonesia, Malaysia and the African group of 47 countries.  

‘Fair, equitable and timely access and benefit sharing’ 

“Fair, equitable and timely access and benefit sharing is an important provision as we have clearly seen the benefits of genetic sequence sharing, like the Nipah virus, that provided a valuable contribution to the development of mRNA technology,” said Malaysia’s delegate to the talks. “Hence, we propose to strengthen this concept [in the text]….  which reads ‘measures to ensure access to pathogens and genomic sequence information as well as fair and equitable sharing of benefits arising from the utilization of pathogens and genomic sequence information to one or more standardized real time platforms available to all parties.’’

Namibia, meanwhile stressed that as long as the benefit sharing mechanism is defined up front and automatically, it would not hinder rapid pathogen sharing, saying:

“The instrument should be balanced, inclusive, global, effective and legally binding, respecting the sovereign rights of states to control access to their genetic resources and ensuring fair and equitable sharing of benefits arising from the utilization of genetic resources. 

“We also note that providing timely access to pathogens is absolutely fundamental to PPR [pandemic preparedness and response] and we therefore consider that regular upfront benefit sharing by the pharmaceutical industry from their current ongoing uses of pathogens is required to ensure that timely access to new and emerging pathogens is provided. 

“In this regard, we stress that providing access to pathogens by showing genetic sequence data must be treated as equivalent to access provided through sharing biological samples, and must therefore trigger the same benefit sharing obligations on strengthening and sustaining health systems resilience and capacities.” 

‘One Health’ not mature enough – environmental health beyond WHO’s competence 

Researcher explores evidence around the wildlife-trade- pandemic nexus

Strikingly, Namibia and other African and developing country member states expressed reluctance to incorporating so-called “One Health” concepts deeply into the new legal instrument, saying that the term has not been well defined, and 

“Regarding the emphasis some member states and regional groups have placed on the One Health approach Namibia is of the view that that this concept is not yet mature enough for it to have a central role in the instrument,  seeing as we have about 22 months until May 2024. There may indeed be further discussions and the relevance spaces in that time on One Health that may bring us to position to support its inclusion with the primacy that is being proposed.

“The issue for us is that the concept does not enjoy international consensus and has not been discussed sufficiently by member states for them to have ownership on it. As it stands, we have very grave concerns. 

“”We also think there is an overemphasis on AMR [antimicrobial resistance] and not enough consideration on food safety, for instance,” the Namibian delegate continued.. 

“Furthermore, we see animal, plant and environmental health as being beyond the competence of the WHO and that they should be thoroughly considered in the appropriate international organizations by their member states before being brought together at a global level and included as a central pillar of the instrument we are discussing.”

Canada, EU and others say One Health Should be Central

one health
EU delegate at INB meeting.

Those viewpoints, also echoed by Kenya, Botswana and South Africa, contrasted sharply with statements by Canada, the European Union and other developed countries about the centrality One Health approaches should play in the new accord – to prevent the spillover of  zoonotic diseases into human communities and food chains. 

The United States took a middle-of-road view, with Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, saying,  “On One Health. We recognize the critical role that One Health plays in preventing future pandemics. We would appreciate further member state discussions with input from non governmental stakeholders to understand the specific commitments being sought from member states that will make a meaningful difference in advancing pandemic prepared prevention preparedness and response. 

“For example, we imagine that additional discussions are needed on how to improve interoperability of [human and environmentally-based] bio-surveillance and reporting systems, the role of non governmental stakeholders; measures that would help prevent and detect pandemics and reduce opportunities for zoonotic spillover, and how the WHO instrument will relate to other key actors such as FAO OIE [World Organization for Animal Health) and UNEP.”

Civil society calls for pandemic treaty that won’t ‘waste their time’

Medicus Mundi International

Civil society groups attending the public INB session, meanwhile, reiterated the need for a substantive, meaningful pandemic treaty –  that strengthens transparency, funding and equity for marginalized groups in the global health landscape. 

“The relevance of the substantive elements of the pandemic treaty will finally determine if all of us currently take part of a historic process, or if you just waste our time with the compilation of an uninspirational and encyclopedic document,” said the delegate from advocacy group Medicus Mundi International.

“[A document] that will not change any realities, that will keep people sick, keep health systems vulnerable, and keep national health authorities depending on national charity, instead of having the needs for caring for the health and wellbeing of their people.”

Transparency for R&D and clinical trial costs 

Knowledge Ecology International (KEI) called for an item on transparency to be included, specifically for R&D and clinical trial costs, as well as information on the research itself and the outcomes.

The medicines access advocacy group also proposed measures to incentivize persons or entities to openly share access to biological data, resources, and know-how as a public good, and also noted a need to fund such research in the first place.

“[We would also like to see] measures for norms for the funding of R&D by national governments that provide flexibility in terms of methods, management and control, funding consistent with transparency and best incentives to collaborate,” said KEI’s director, Jamie Love. 

Thorny question of private sector participation 

Another issue of concern is the role the private sector may play in negotiations over, and governance of, the pandemic agreement, Love added.  

“The United States made this mention of including other actors, including the private sector in the conversation. And I think from our point of view, we would have concerns if you had drug companies, vaccine manufacturers, and people that manufacture diagnostic tests involved in the governance in different ways. Because of the conflicts of interest they present. And so I wanted to flag that.” 

He also protested against the outsized influence wielded by the Gates Foundation in debates over technology sharing and intellectual property rights – which are also emerging as thorny points in the INB deliberations.  

“If you look at the Global Fund, or UNITAID, some committees created by the World Bank, Gavi and CEPI, you see, the Gates Foundation playing the central role in all these institutions as the largest non-actor state and sometimes the largest discretionary funder, period, to the WHO.    

“And yet, they play a controversial role, particularly on the issues of sharing of technology and technology transfer and intellectual property rights. And so I just don’t know if it’s helpful to have one institution run by you know, one guy or you know, his family or whatever, you know, having an excessive amount of influence on these decisions. 

“We’re more comfortable with, with something that did not give, for example, the Gates Foundation or its surrogates a role in the governance.” 

IFPMA offers to set aside fixed amounts of pandemic products in ‘real-time’ for poor countries  

James Anderson, IFMPA Executive Director for Global Health

As one solution to ongoing controversies over IP rights and, related to that, equitable access to medicines and vaccines,  International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) pledged to set aside an “allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable”.

The IFPMA’s  ‘Berlin Declaration’ unveiled at Tuesday’s INB meeting, aims to overcome the huge inequities seen during the COVID crisis by rich countries’ pre-purchase and stockpiling of vaccines and health products – before poorer countries could get in line.   

See related story here:

Big Pharma Offers to Reserve Pandemic Products for Poorer Countries in Future – Albeit With Prerequisites

The joint declaration by major pharma innovators – Biopharmaceutical Industry Vision for Equitable Access in Pandemics – 

However, this commitment will only succeed “if other stakeholders also play their parts,” said IFPMA’s James Anderson, executive director for global health. The declaration calls upon the G7 and G20 to contribute more to strengthening health systems in low- and middle-income countries so they can absorb new health products.  

“Without robust plans to deliver pandemic vaccines, treatments, or diagnostics, and ongoing care to populations in all countries,” said Anderson, “attempts to improve equity will not succeed.” 

Equity must be prioritized 

Women in Global Health delegate Shubha Nagesh

Other groups, such as Women in Global Health and Sightsavers highlighted the need for equity in the treaty for marginalized groups.

“Too often women from the global south are marginalized in health leadership,” Shubha Nagesh, the delegate from Women in Global Health. “Women have made an exceptional contribution during COVID-19, but are often clustered into lower or unpaid roles with reduced status.”

Sightsavers strongly supported the right to health and human rights, with an emphasis on equity, to be embedded in the treaty, particularly for individuals and groups disproportionately at risk, including persons with disabilities and those in vulnerable situations. 

“To achieve equity, instruments should really affirm human rights obligations to those that are at higher risks from pandemics,” said Sightsavers’ delegate.

Image Credits: Wildlife Conservation Society, Wildlife Conservation Society .

Major pharmaceutical companies have offered to reserve a “real-time allocation” of vaccines and treatments upfront for “priority populations in lower-income countries” in future pandemics – providing the G7 and G20 also help low-income countries finance and make effective use of the products.

Launching its Berlin Declaration on Tuesday, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acknowledged that there has been an inequitable distribution of COVID-19 products, which it attributed to “inadequate financing mechanisms upfront and a lack of country readiness”.

It calls for  “strong, fully funded international procurement mechanisms”  for pandemic vaccines, therapeutics and diagnostics (VTD) for lower-income countries that can forecast demand and sign advanced purchase agreements with industry early in a pandemic. 

“Each company will take measures, in partnership with governments, to help ensure that authorized pandemic vaccines and treatments are available and affordable in countries of all income levels, including via donations, not-for-profit supply, voluntary licenses or equity-based tiered pricing based on countries’ needs and capabilities, or any other innovative mechanism as during COVID-19,” according to the IFPMA.

Stronger health systems

However, a “prerequisite” for the success of more equitable access rests on improving health systems in lower-income countries to ensure that they “are better prepared to absorb and deliver vaccines and treatments”  – and the willingness of high-income countries to “provide the necessary political and financial support” to achieve this, says the IFPMA. 

The IFPMA also says that the success of its declaration depends on “a strong innovation ecosystem, grounded in intellectual property rights, and the removal of trade and regulatory barriers to export”.

“Intellectual property rights should be respected since society depends on them to stimulate innovation and the scale-up of supply,” according to the declaration, which has been named “Berlin” in recognition of Germany’s leadership role as President of the G7.

The pharmaceutical industry has lobbied vehemently against any relaxation of IP rights for COVID-19 products, putting it at loggerheads with health activists and a number of governments in low and middle-income countries.

Better protected

The IFPMA’s future pandemic preparedness plan, which it aims to sell to world leaders in upcoming meetings, is based on “innovation, manufacturing scale-up, and planning ahead for equitable access”.

“With all stakeholders collaborating and playing their part, we can make sure that the efforts, investments, learnings and losses seen during COVID-19 are not in vain, but rather help shape a future where everyone is better protected from the threat of pandemics,” said Thomas Cueni, Director General of IFPMA.

“Our proposal is just a first step along the way to what I believe has the potential to be a transformational solution for future pandemics.” 

The declaration commits pharma to three key issues:

  • working with regulators and other stakeholders to establish streamlined approaches to develop and deliver new quality, safe and effective vaccines and treatments even faster in the future;
  • supporting collaborations, a geographically diverse sustainable manufacturing footprint and mechanisms for rapidly scaling-up supply in a future pandemic; 
  • planning ahead to ensure equitable access and delivery of pandemic products, including identifying priority groups such as health workers and high-risk individuals, who “should be vaccinated first, regardless of the country they live in”.

“We will build on existing manufacturing partnerships, business-to-business agreements set up in advance, ongoing capability development and voluntary licensing and/ or early, voluntary technology transfer where this will facilitate rather than impede scale up and global supply,” says the IFPMA. 

It also appealed to governments to commit to unrestricted trade, no export bans across the vaccine-treatments-diagnostics supply chain and expedited processes for import and export during a pandemic.

 Pharma proposes to work with G7 and G20 on a joint solution for better access to vaccines and treatments around the world for future pandemics 

Jean-Christophe Tellier, IFPMA President and CEO of UCB, said “we applaud Germany’s leadership of the G7’s pandemic response and trust that our declaration is seen by world leaders as a practical proposal to build greater equitable access into future pandemic response. 

“For this potentially life-saving concept to become reality, we will need to work with G7, and later this year in Bali with G20 to flesh out how to make it work. The reward if successful will help shape a future where everyone has a chance to be better protected from the threat of pandemics from the outset, no matter where they live.”

José Manuel Barroso, Gavi chair and co-chair of COVAX, the global COVID vaccine access platform, applauded the IFPMA and industry leaders for “seizing the initiative”. 

“We saw effective innovation and manufacturing scaling up with this pandemic; but we also saw the challenges we had to overcome to get the vaccines to all those who needed them,” said Barroso.

“The industry’s commitment to reserve part of production of vaccines and treatments at real time for vulnerable populations in low-income countries provides an opportunity to work together strategically to forge a new social contract. I hope that political leaders will do their part and engage with industry on how to make this work.”

Image Credits: Glsun Mall/ Unsplash.

member state
WHO member states meet to discuss details of a proposed international pandemic convention or other legal accord 18 July 2022 in Geneva

The first day of WHO member state talks on a proposed new Pandemic Convention or Treaty opened with broad agreement that the new legal instrument should complement – but not repeat – provisions of the existing International Health Regulations – while respecting national sovereignty in terms of public health responses. 

But the hours of debate over the definitions, principles and scope of an initial “working draft” developed by a “Bureau” of six member states from every WHO region, reflected the enormity of the task they face in reaching beyond high-minded rhetoric about how the new instrument  should align to principles of equity, preparedness and “One Health”, to binding rules and obligations acceptable to all 194 WHO member states. 

Member states are meeting under the auspices of the second meeting of the WHO Intergovernmental Negotiating Body (INB) to try move along the initial framing of the new legal accord – which is expected to take two years or more to actually negotiate.

“The new instrument should seek to address clearly identified gaps that cannot be resolved through IHR amendments…  Otherwise there would be no need for a new instrument,” said Kenya’s delegate at the outset of the meeting – echoing a point that had wide agreement among member states. 

Other points that won wide agreement included the importance of linking the new accord to the fight against antimicrobial resistance as well as better application of “One Health” principles of preserving ecosystem balances that can also limit the spillover of animal pathogens into human communities.   

However fissures on other simmering issues, such as rights over R&D related to pandemic response as well as national rights to genomic sequences of pathogens, soon became apparent.  A range of Asian, African and Latin America  member states, including South Africa, stressed that public health responses to the pandemic, as well as “investments in research and development for countermeasures” should be “treated as public goods and accounted for as such.”

Genomic ‘information’ also sure to be a hot topic

Delegate from Malaysia at INB meeting, 18 July 2022.

South Africa, as well as other countries, including Malaysia, also stressed that pathogens’ genomic sequence data – or as Malaysia requested “genomic information” – should be shared in exchange for the promise of benefits from those entities, primarily pharma, which make use of such data to develop new vaccines and treatments then sold commercially. 

“It is critical for us to specify from the outset that data, and genomic sequencing sharing and benefits will be shared equitably,” South Africa’s delegate stated at the meeting. 

Those statements cut to the heart of a smoldering controversy over pending revisions in the Nagoya Protocol to the Convention on Biodiversity – to be considered at the Montreal Conference of Parties 5-15 December.  Those revisions could see the genomics information of pathogens included as part of a country’s biodiverse natural resources – entitling national governments to demand benefits if they share that genomics sequences or similar data with researchers for medicines and vaccines development. 

On the other end of the spectrum, a number of developed countries, including the European Union, stressed the importance of strengthening references to “better collaboration, surveillance and early detection”  – as key pillars of any new agreement.   

How legally ‘binding’ will the new instrument really be? 

China’s delegate to the INB

At this week’s meeting member states have been asked to decide whether the new legal instrument would be formally positioned as a legally-binding convention under Article 19 of WHO’s Constitution, or new, legally binding regulations under Article 21. The implications of those choices are outlined in a WHO background document, made available to member states last week. 

Regardless of which route is chosen, the final document could still include a mix of “both legally binding and non-legally binding provisions, with the non-binding provisions being, for example, recitals, principles, recommendations or aspirations,” stated the background document, drafted by WHO’s legal team, noting that, “This practice is, in fact, standard both in WHO1 and with other international instruments.”

Speaking at the meeting, both Russia and China said that the final stance of member states on many of the articles contained in the working draft, may be based upon the final decision by member states of “how legally binding” the new instrument will indeed be. 

“Whether it’s under Article 19 or 21, should the nature of the instrument be a Framework Convention, containing only guidance in principle or a regulation with detailed and implementable actions?” China asked in Monday morning’s session.  

Added Russia, in the afternoon session.  “We must decide by the first of August what kind of document this will be,” although it added that “we see a general trend or direction that we’re moving in, looking at the structure of the document, which is a reminder of the Framework Convention on Tobacco Control.

“But all the same, we need some clarification.  Will there be another opportunity to comment on the content of the document after we adopt the decision on the fate of this document – of the kind of Article of the WHO Constitution that will be applied here?”

In terms of defining the new agreement’s scope, Beijing also recommended that the “Bureau conduct an in-depth investigation of the deficiencies found in the current pandemic and to past emergencies, and to analyze existing international instruments such as the IHR to clarify the issues to be addressed by the pandemic treaty.. In other words, the scope of work.”

That demand seemed to ignore the fact that no less than three external review bodies, including and IHR review committee, a WHO health emergencies review committee and the Independent Panel, have already conducted such reviews over the past two years. 

Wordsmithing – a massive task 

What remains clear is that the INB “Bureau” together with the WHO legal team face a massive task of redaction – not only of thorny substantive issues – but also of countless ‘editorial’ issues ‘related to definitions, organization and wordsmithing of the draft text – before it is submitted to member states as a “Zero Draft” over which countries would begin formal negotiations.   

Over the course of Monday, delegates from several dozen states went  paragraph by paragraph with proposed textual changes to what has been drafted by the INB “Bureau” as a preliminary, working draft.  

Many delegates requested extensive new framing terminology in the documents’  initial sections – to make stronger reference to equity, human and gender rights, for instance. 

At the same time, others pointed out that the lengthy preliminaries – which include both a Preamble, a Vision statement, followed by an Introduction – with a set of as yet incomplete definitions of terms including what constitutes a ‘Pandemic’ – was unduly bulky.

The document, its WHO drafters acknowledged, incorporated numerous texts and references not only from the WHO documents including the: IHR, FCTC, and Pandemic Influenza Preparedness Framework (the PIP), but also from the Paris Climate Agreement, the UN Framework Convention and Climate Change (UNFCCC) and the Convention on Biological Diversity, and the CBD’s related Nagoya Protocol.  

Loyce Pace, US Assistant Secretary for Global Affairs

“It’s nice to have a living document.  It’s not quite a Zero draft,” said US Assistant Secretary for Global Affairs Loyce Pace, who attended the meeting along with Colin McIff, Deputy Director, of the US Health And Human Services Office of Global Affairs.  “The Preamble, vision Parts 1 and 2  overlap and risk being repetitive,” she added.  

“‘There is a saying that ‘less is more’ and we are inclined to think that a shorter and more targeted preamble could work better,” said New Zealand’s delegate, noting that some of the best known UN instruments like the UN Convention on the Law of the Sea include a preamble of less than a dozen paragraphs. 

The African Union executive council meeting has selected Rwanda to host the AMA.

Rwanda has been selected to host the headquarters of the African Medicines Agency (AMA) by the Executive Council of the African Union (AU) at a meeting held in the Zambian capital of Lusaka on Saturday.

The council agreed that AMA will enhance the capacity of AU state parties and the continent’s Regional Economic Communities (RECs) to regulate medical products, and to improve Africa’s access to quality safe, and efficacious medical products.

“AMA will also support the creation of an enabling environment for pharmaceutical manufacturing on the continent,” AU announced, describing the agency as the second specialized health agency of the AU after the Africa Centres for Disease Control and Prevention (Africa CDC).

Rwanda had submitted an expression of interest in hosting the AMA headquarters along with Uganda, Algeria, Egypt, Morocco, Tanzania, Tunisia and Zimbabwe, as Health Policy Watch reported in June.

The World Health Organization’s (WHO) Director General, Dr Tedros Adhanom Ghebreyesus, congratulated Rwanda and pledged the WHO’s support for the AMA.

“Congratulations Rwanda on the selection to host the African Medicines Agency (AMA). WHO will continue to provide technical & financial support to the AMA to ensure all people across the continent have equitable access to safe, quality medicines & medical products,” he tweeted.

Nuur Mohamud Sheekh, Spokesperson for the Executive Secretary of the Intergovernmental Authority on Development (IGAD), a regional development organization in East Africa, described hosting the AMA Headquarters as the latest achievement for Rwanda, which is already a leading technology destination on the continent.

Valens Munyabagisha, former president of Rwanda’s Olympic Committee, also attributed the selection of Rwanda as host country for AMA Headquarters as “good news and undoubtedly [the] result of good leadership”.

But Dr Ereck Chakauya, network manager of the AUDA NEPAD Southern Africa Network for Biosciences, noted that the priority should now be on delivering the promises of the initiative which includes boosting Africa’s manufacturing capacities for vaccines, drugs and others products.

“Congratulations Rwanda. Lets get on with making stuff. We have gone round the mountain for too long, now is the time to make vaccines for ourselves. Let’s give ourselves five years to make five drugs for the top five diseases of importance in Africa,” he said.

Next step: Finances and staff

 

“It’s encouraging to see progress made in the operationalisation of the AMA, and we must build on this momentum to ensure that more countries ratify the treaty establishing the agency. The next step is to ensure the AMA has the financial resources and is adequately staffed to deliver on its ambition,” said Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

“Africa’s 55 nations and nearly 1.4 billion people need to benefit from a harmonized regulatory system for medical products – vaccines, treatments, diagnostics and other healthcare products. The AMA can make good on that promise,” he added.

“The AMA will facilitate collaboration, work-sharing and the use of reliance procedures between regulators that will enable faster approval processes, allowing a better allocation of resources and cutting down on the waiting time for patients to access medicines and ensuring a steady supply of medicines.”

The IFPMA  is part of the African Medicines Agency Treaty Alliance (AMATA), and works with regulatory authorities, the pharmaceutical industry in Africa, and relevant regulatory stakeholders to encourage greater harmonization and convergence of regulatory requirements.

Meanwhile, AMATA said the COVID-19 pandemic has “highlighted the importance of regulatory harmonisation in the context of public health emergencies and the need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner”.

“The AMA will reduce the complexity of regulatory frameworks and hence enable all patients in Africa to have timely access to quality medicines that are safe and effective. We now call upon the remaining African Union Member States who have yet to ratify and deposit their AMA Treaty instruments to do so urgently so we can build on the current momentum gained with this major milestone,” said AMATA.

Thirty-one of the African Union’s 55 member states have now signed and/or ratified the AMA Treaty, with Ethiopia the latest to sign as of May 2022.

As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance.

Africa CDC granted autonomous status

The AU’s Executive Council also adopted the amended statute of the Africa Centres for Disease Control and Prevention as an autonomous health body

Prof Stanley Okolo, CEO of the West African Health Organization (WAHO), described the development as “a milestone which enhances Africa CDC’s ability to safeguard the health of the African population and contribute to global health security.”

Dr Matshidiso Moeti, WHO’s Regional Director for Africa,– also congratulated the Africa CDC on the adoption of its amended statute.

“A big congratulations to Africa CDC for their statute as an autonomous health body. I look forward to our continued collaboration in support of health security on the continent, as well as many other pressing health issues,” she tweeted.

Previously, Health Policy Watch reported that the WHO expressed concerns regarding the inclusion of power to declare a Public Health Emergency of Continental Security in Africa CDC’s amended statute.

Ahmed Ogwell Ouma, Africa CDC’s Acting Director, spoke at the AU’s recently held Executive Council meeting

However, Ahmed Ogwell Ouma, Africa CDC’s Acting Director, said the move is necessary to ensure that the Africa CDC does not have to wait for a long time for a public health emergency of international concern (PHEIC) pronouncement to be made by the WHO before swinging into full action. 

“That is our expectation indeed. And that is the expectation of the African Union. That is why this request has been made,” Ouma said.

See our coverage on the development of the African Medicines Agency and the countdown for AU member states to formally ratify the AMA Convention here:

African Medicines Agency Countdown

vaccinations
Healthcare workers in Nigeria fight to maintain routine childhood vaccination services during the COVID-19 pandemic.

The World Health Organization and UNICEF have sounded the alarm on the largest sustained decline in global childhood vaccinations in approximately 30 years, with 25 million infants missing out on lifesaving routine vaccines. 

The percentage of children who received three doses of vaccine against diphtheria, tetanus and pertussis (DTP3) – a marker for immunization coverage within and across countries – continues to decline, falling 5 percentage points between 2019 and 2021 to 81%. 

As a result, 25 million children missed out on one or more doses of DTP through routine immunization services in 2021 alone. This is 2 million more than those who missed out in 2020 and 6 million more than 2019, highlighting that there are a growing number of children at risk from devastating but preventable diseases. 

“This is a red alert for child health. We are witnessing the largest sustained drop in childhood immunization in a generation. The consequences will be measured in lives,” said Catherine Russell, UNICEF Executive Director, in a joint WHO and UNICEF news release. 

The decline has been attributed to many factors, including an increased number of children living in conflict and fragile settings where immunization access may be difficult; increased misinformation; and COVID-19 related issues such as service and supply chain disruptions. 

Russel acknowledged the disruptions caused by COVID-19, but stated that this “was not an excuse.”

“We need immunization catch-ups for the missing millions or we will inevitably witness more outbreaks, more sick children and greater pressure on already strained health systems.”

Majority of children who missed DTP doses from low- and middle-income countries 

18 million of the 25 million children did not receive a single dose of DTP during the year, the vast majority from low- and middle-income countries. India, Nigeria, Indonesia, Ethiopia, and the Philippines recorded the highest numbers of unvaccinated children. 

Myanmar and Mozambique are among countries that recorded the largest relative increases in the number of children who did not receive a single vaccine between 2019 and 2021. 

Overall, vaccine coverage has dropped in every region, with the East Asia and Pacific region recording the steepest reversal in DTP3 coverage, falling 9% in just two years. 

While many thought that 2021 would be a year of recovery in which strained immunization programmes would rebuild and those children missed in 2020 immunizations would be caught up, instead, DTP3 coverage was set back to its lowest levels since 2008. 

This has pushed the world off-track to meet global goals, including the immunization indicator for the Sustainable Development Goals. 

HPV vaccine coverage progress lost in 2021 

A young girl gets vaccinated against HPV in Sao Paulo, Brazil.

In addition to declining DTP vaccinations, over a quarter of the global coverage of HPV vaccines that was achieved in 2019 has been lost. 

3.5 million children had missed the first dose of the HPV vaccine, which protects girls against cervical cancer, in 2021. 

This has grave consequences for the health of women and girls, as global coverage of the first dose of human papillomavirus (HPV) vaccine is only 15%, despite the first vaccines being licensed over 15 years ago.

Uganda and Pakistan resisted coverage declines 

Children in Pakistan show proof of vaccination against polio.

However, some countries were able to hold off declines in vaccination coverage. Uganda maintained high levels of routine immunization programs whilst rolling out a targeted COVID-19 vaccination programme to protect priority populations, including health workers.

Pakistan also returned to pre-pandemic levels of coverage thanks to high levels of commitment and significant catch-up immunization efforts. 

“To achieve this in the midst of a pandemic, when healthcare systems and health workers were under significant strain, should be applauded,” the joint WHO and UNICEF press release reads. 

Avoidable outbreaks of measles and polio result from inadequate coverage 

Health worker vaccinates young child against measles

In the past twelve months, avoidable outbreaks of measles and polio have occurred as a result of inadequate coverage levels, underscoring the vital role of immunization to keep children, adolescents, adults, and societies healthy. 

First dose measles coverage had dropped to 81% in 2021, also the lowest since 2008, which meant 24.7 million children missed their first measles dose in 2021, 5.3 million more than 2019. 6.7 million children had also missed a third dose of the polio vaccine in 2021. 

The drop in measles coverage had led to declaration of a measles outbreak in the southern African country of Malawi in March. In response, WHO had launched a mass vaccination campaign in order to reach 23 million children across five countries – Malawi, Mozambique, Tanzania, and Zambia, and Zimbabwe.

“Planning and tackling COVID-19 should also go hand-in-hand with vaccinating for killer diseases like measles, pneumonia and diarrhea,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “It’s not a question of either/or, it’s possible to do both”.

WHO and UNICEF are working with Gavi, the Vaccine alliance, and other partners to deliver the global Immunization Agenda 2030 (IA2030), a strategy for all countries and global partners to achieve set goals on preventing diseases through immunization and vaccines for everyone. 

Gavi had also launched a $100 million initiative to identify and reach zero-dose children – those without a single routine shot, earlier in June 2022. 

“It’s heart-breaking to see more children losing out on protection from preventable diseases for a second year in a row,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.

“The priority of the Alliance must be to help countries to maintain, restore and strengthen routine immunization alongside executing ambitious COVID-19 vaccination plans, not just through vaccines but also tailored structural support for the health systems that will administer them,”

Image Credits: Twitter: @WHOAFRO, WHO PAHO, UNICEF Pakistan, WHO/John Kisimir.

Methicillin-Resistant Staphylococcus aureus (MRSA), a notorious bacteria resistant to many antibiotics.

Researchers worldwide are searching for ways to reduce dependence on antibiotics to preserve these life-saving medicines in the face of the rise in antibiotic-resistant bacteria.

Drug resistance is currently implicated in 700,000 deaths each year, and the World Health Organization (WHO) raised the red flag last month over the lack of new antibacterial treatments being developed to address the mounting threat of AMR.

A new study conducted at Israel’s Ben-Gurion University and published recently in the peer-reviewed journal Pharmaceutics, showed that a substance found in broccoli called 3,3′-diindolylmethane (DIM) can reduce resistance to certain antibiotics.

The study was led by Prof Ariel Kushmaro and Dr Karina Golberg of BGU’s Avram and Stella Goldstein-Goren Department of Biotechnology Engineering.

What is DIM?

DIM is a natural substance that is already used in high doses in the treatment of some cancers. The new study found that DIM in low concentration can disrupt “quorum communication” among bacteria and prevent them from doing human harm.

Quorum communication allows bacteria to share information about cell density and adjust their gene expression accordingly, forming bacterial biofilms that protect bacteria from being eradicated by antibiotics.

“Drug-resistant biofilm-forming bacteria are known to pose an even greater threat once they have already infected and damaged healthy tissue, therefore the addition of an anti-biofilm compound to traditional antibiotic treatments may improve treatment outcomes,” the researchers wrote in their paper.

DIM could help, they showed.

Pharmaceutics 14 00967 g001
Figure 1. Prevention of the formation of biofilm by A. baumannii (A) and P. aeruginosa PA01 (B) in a flow system during 48 h of incubation with continuous supplementation of 50 μM DIM. Biofilms were stained with the live/dead bacterial viability kit. Quantification of live, dead, and total bio-volumes (μm3/μm2) based on image analysis and data from the IMARIS software together with % biofilm inhibition. Images were acquired from three different areas in each treatment, three independent repetitions. Asterisks indicate significant differences compared to control (independent samples t-test; *** p < 0.001).

The research findings show that the biofilm formation of two of the most prioritized bacterial pathogens, Acinetobacter baumannii and Pseudomonas aeruginosa, was inhibited by 65% and 70% respectively.

When tested in combination with the antibiotic Tobramycin, it was found that the DIM improved its ability to work and helped eliminate the bacterial resistance to it, suggesting that DIM may play a role in salvaging antibiotic potency. Specifically, combining the antibiotic with DIM enabled a 94% inhibition of P. aeruginosa biofilm.

Finally, the study also showed that DIM has an anti-inflammatory effect.

Effective on wounds

In a separate experiment, the scientists used DIM on infected wounds in an animal model and found that the wounds healed faster and more effectively than with antibiotics.

“When you are using antibiotics, your aim is to kill the bacteria,” Kushmaro told Health Policy Watch. “When we are using other materials, like DIM, we are only blocking the communication… If you are using antibiotics you will eventually have resistance. If you use materials that are just jamming communication, then you are more likely to have less resistance to this material.”

He said that what is also important is that DIM is already a known material that has passed all the necessary clinical safety trials in human beings, so developing it as a treatment or a food additive will be faster than other drugs or materials.

“Drug repurposing, involving the identification of new applications of an approved medication beyond the scope of its original specification, is gaining considerable attention in recent years,” the researchers wrote in their paper.

For animals first

Further development and commercialization of the technology is being done by a startup company, LifeMatters. Kushmaro said the business model is to get DIM approved first as a food additive and treatment in the agriculture arena, such as an additive to chicken, goat and cow feed, which could improve animal health. Only afterwards would they work towards approval for use in humans.

Presently, animals are the largest consumers of antimicrobial drugs – and thus the leading factor driving antimicrobial resistance, Health Policy Watch reported in May.

Kushmaro believes DIM could be approved for animal use within the next five years, and human use in the next 10 to 15.

“Today, after many years of research, we are confident that in the future DIM and other microbial communication disruptors will completely replace antibiotics,” Kushmaro said. “Our findings show promise for other avenues of research in addition to known classes of antibiotics.”

Image Credits: NIAID.

Young men under 40 are most at risk of harm after drinking more than a mere 10th of a standard drink

Alcohol has no benefits for people under the age of 40, but drinking a small amount of alcohol by healthy people over 40 might have some health benefits, according to a study conducted by the Global Burden of Disease study, published in The Lancet on Friday.

The study – the first to report alcohol risk by region, age and sex – suggests that the strictest drinking guidelines should be targeted at young men, who are at the greatest risk of harmful alcohol consumption worldwide.

Around 60% of alcohol-related injuries occur in people under 50, including motor vehicle crashes, suicides and homicides. 

For those over 40, consuming a small amount of alcohol (for example, less than two small glasses of red wine per day) can provide some health benefits, such as reducing the risk of cardiovascular disease, stroke, and diabetes.  

Using estimates of alcohol use in 204 countries, researchers calculated that 1.34 billion people consumed harmful amounts in 2020. In every region, and the group drinking the most unsafe amounts of alcohol were men aged 15–39.

Young men could only consume one-tenth of a standard drink and young women a quarter of a standard drink before incurring health risks, according to the study. It defines a standard drink as 10 grams of pure alcohol – the equivalent of a 100ml glass of red wine (13% alcohol by volume), a 375ml can of beer (3.5% alcohol volume), or a single 30ml shot of spirits (40% alcohol by volume).

“Our message is simple: young people should not drink, but older people may benefit from drinking small amounts,” said senior author Dr Emmanuela Gakidou, from the University of Washington’s Institute for Health Metrics and Evaluation (IHME).

“While it may not be realistic to think young adults will abstain from drinking, we do think it’s important to communicate the latest evidence so that everyone can make informed decisions about their health.”

Risk calculations from 204 countries

The researchers looked at the risk of alcohol consumption on 22 health outcomes, including injuries, cardiovascular diseases, and cancers using 2020 Global Burden of Disease data for males and females aged 15–95 years and older between 1990 and 2020, in 204 countries and territories. 

From this, they could estimate the average daily intake of alcohol that minimises risk to a population, as well as how much alcohol a person can drink before taking on excess risk to their health in comparison to someone who does not drink any alcohol.

There were substantial variations in risk across regions. For example, for people aged 55–59 years in North Africa and the Middle East, 30.7% of alcohol-related health risks were due to cardiovascular disease, 12.6% were due to cancers, and less than 1% were due to tuberculosis. 

In this same age group in central sub-Saharan Africa, 20% of alcohol-related health risks were due to cardiovascular disease, 9.8% to cancers, and 10.1% to tuberculosis. 

Overall, the recommended alcohol intake for adults remained low, at between zero and 1.87 standard drinks per day, regardless of geography, age, sex, or year.

“Even if a conservative approach is taken and the lowest level of safe consumption is used to set policy recommendations, this implies that the recommended level of alcohol consumption is still too high for younger populations,” said lead author Dana Bryazka, a researcher at IHME.

“Our estimates, based on currently available evidence, support guidelines that differ by age and region. Understanding the variation in the level of alcohol consumption that minimises the risk of health loss for populations can aid in setting effective consumption guidelines, supporting alcohol control policies, monitoring progress in reducing harmful alcohol use, and designing public health risk messaging.”

Image Credits: Taylor Brandon/ Unsplash.

Vaccine manufacturers are in a race to develop or tweak COVID-19 vaccines to address the Omicron variants that are sweeping through the globe – and get them ready for use as boosters when the weather cools in the northern hemisphere.

More infectious Omicron strains BA.4 and BA.5 have become dominant in many parts of the world and while they appear less virulent, they have mutated to be more capable of evading neutralizing antibodies generated by vaccinated people.

BA.4/5 showed 4.2-fold more resistance to sera from vaccinated and boosted people according to research from Qian Wang, David Ho and colleagues published in a recent preprint article.

Pfizer and Moderna dominate 

Nine candidate vaccines are in the pipeline that offer “multi-variant vaccines, booster vaccines, or vaccines targeting Omicron”, according to UNICEF’s COVID-19 Vaccine Market Dashboard.

But market leaders Pfizer-BioNTech and Moderna have the upper hand and are racing ahead with tweaks to their vaccines to ensure Omicron-ready boosters can be manufactured and ready within months.

In late June, Pfizer-BioNTech announced preliminary results for their vaccine tweaked to combat Omicron BA.1 that “elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1” – and was also effective in neutralising BA.4/BA.5 – but “with titers approximately three-fold lower than BA.1”. 

Moderna booster targets Omicron BA.4 and BA.5 

This week, Moderna announced preliminary results from trials of its Omicron candidate booster vaccine – mRNA-1273.214  – which showed a 6.3-fold rise in neutralizing antibodies against BA.4 and BA.5 strains in comparison to a 3.5-fold increase elicited by the original vaccine.

“One month after booster, BA.4/5 neutralizing titers were 776 for mRNA-1273.214 and 458 for the currently authorized booster,” according to Moderna, which is also working on a second booster called mRNA 1273.222, that specifically targets BA.4/ 5.

“This superior breadth and durability of immune response following a bivalent booster has now been shown in multiple Phase 2/3 studies involving thousands of participants,” said Moderna CEO Stephane Bancel. “We are working with regulators to advance two bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants, clinical data requirements, and urgency of starting fall booster campaigns for vulnerable populations.”

The race to develop Omicron-specific boosters accelerated after the US Food and Drug Administration (FDA) recommended the inclusion of an Omicron component in COVID-19 booster vaccines after a meeting of its Vaccines and Related Biological Products Advisory Committee on 28 June.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” said the FDA.

The “overwhelming majority” of independent experts on the FDA advisory committee had voted in favour of boosters including an Omicron component to be ready for use in the US in fall 2022, it added.

“We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022,” added the FDA.

However, it has not advised manufacturers to modify vaccines for primary vaccination.

India and South Korea approve local vaccines 

A COVID-19 vaccine developed by SK bioscience in South Korea, in partnership with GlaxoSmithKline and the University of Washington, was been approved in South Korea.

Among the candidate vaccines targeting Omicron are two Chinese vaccines, one from the Beijing Institute of Biologic Production, and the other from Sinocell.

Meanwhile, three new vaccines have been approved in various parts of the world. On Wednesday, the US finally approved Novavax which was approved in the European Union late last year. Novavax is also in the process of testing a booster to deal with Omicron.

Meanwhile, India approved the first mRNA vaccine developed by an Indian company, Gennova, in late June. 

At the same time, South Korea approved a recombinant protein-based vaccine, SKYCovione, developed by local company SK bioscience in partnership with GlaxoSmithKline (GSK) and the University of Washington’s School of Medicine.

SK bioscience has already signed an advance purchase agreement with the Korea Centers for Disease Control and Prevention for 10 million doses of the two-dose SKYCovione.

SK bioscience announced on Wednesday that its candidate booster had proven to be effective against Omicron in a small Phase I/ II trial involving 81 adults who received the booster seven months after completing primary vaccination.

“Neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titres right after the second dose, and 72 times the titres seven months after the second dose,” according to the company.

Meanwhile, SK bioscience was recently approved to manufacture Novavax for European Union markets.

Image Credits: Pixabay.

hepatitis
Distribution of probable cases of severe acute hepatitis of unknown aetiology in children by country, as of 8 July 2022 (n=1010), 5 PM CEST

Over 1000 probable cases of severe acute hepatitis of unknown cause in children have been reported across 35 countries in five World Health Organization (WHO) regions as of 8 July 2022, including 22 deaths.

Since the previous WHO Disease Outbreak News, published on 24 June 2022, 90 new probable cases and four additional deaths have been reported, bringing the new total of probable cases to 1010. The Disease Outbreak News provides updates on the epidemiology of the outbreak, as well as updates on the response to the event

Two new countries, Costa Rica and Luxemburg, have also been added to the list of countries with probable cases. 

Hepatitis is an inflammation of the liver, and acute hepatitis is a sudden onset of hepatitis. While the disease usually passes on without the need for special treatment, according to WHO, in rare cases, it can result in severe liver failure or even death.

Of the probable cases, 46 (5%) of children have required transplants. 

Between 5 April (when the outbreak was initially detected) and 8 July 2022, almost half of the probable cases have been reported from the WHO’s European Region (21 countries reporting 484 cases), including 272 cases from the United Kingdom. 

The second highest number of cases have been reported from the WHO Americas region (435 cases), including 334 (33%) of global cases from the US. This is followed by the Western Pacific region (70 cases), the Southeast Asia region (19 cases), and the Eastern Mediterranean region (2 cases).

Age and gender distribution of reported probable cases of severe acute hepatitis of unknown aetiology with available data, as of 8 July 2022 (n=479) 5 PM CEST

The majority of cases (76%, 364 cases) involve children under six years old. 

However, the Disease Outbreak News does note that “the actual number of cases may be underestimated, in part due to the limited enhanced surveillance systems in place.”

“The case count is expected to change as more information and verified data become available,” it reads. 

The WHO has assessed the global risk level to be moderate, which has been the case since May 2022. 

Adenovirus and SARS-COV-2 detected in some hepatitis cases 

Distribution of probable cases of severe acute hepatitis of unknown aetiology in children by WHO Region since 1 October 2021, as of 8 July 2022

Pathogens such as adenovirus and SARS-COV-2 have been detected by PCR testing in a number of cases, with the adenovirus the most frequently detected pathogen among cases with available data. 

In the European region, adenovirus was detected by PCR in 52% of cases (193/368). In Japan, adenovirus was detected in 9% of cases (5/58) with known results.

SARS-COV-2 has also been detected in 16% (54/335) cases in the European region, and 8% of cases in the US (15/197). In Japan, 8% (5/59) of cases also had SARS-COV-2.

Most cases did not appear to be epidemiologically linked, although there have been epidemiologically linked cases reported in Scotland and the Netherlands.  

Launch of global online survey 

The WHO has also launched a global online survey with an aim to estimate the incidence of severe acute hepatitis of unknown aetiology in 2022 compared to the previous five years, in order to understand where cases and liver transplants are occurring at higher-than-expected rates. 

Until more is known about the aetiology of these cases, WHO advises implementation of general infection prevention and control practices, including frequent hand washing, avoiding crowded spaces and ensuring good ventilation when indoors. 

“Efforts to communicate with empathy in a timely and transparent way, acknowledging what is known and unknown and what is being done to investigate will help to reassure parents and caregivers, maintaining trust in health authorities and interventions,” according to the WHO.

Image Credits: F1000research.com, WHO.