Chile’s easily recognisable hexagonal warning labels – mandatory for products high in salt, sugar, saturated fat and calories – have had a real impact on consumer habits.

This World Food Day (16 October), Chile provides solid evidence that mandatory warning labels that target products with high salt, sugar, saturated fat and calories have reduced consumers’ appetite for unhealthy products.

Worldwide, countries are grappling with diets increasingly composed of ultra-processed products, which are associated with obesity and other non-communicable diseases (NCDs). 

The proliferation of these highly processed, additive-rich products is accompanied by the food and beverage industry’s onslaught of inescapable marketing, with much of it directed at children.

In this rapidly changing global food environment, Chile’s progressive food policy offers new insight. Through the introduction of a comprehensive policy that instituted both front-of-package labeling regulations and marketing restrictions, Chile has continually demonstrated that policy can profoundly influence consumer behavior and improve public health.

Passed in 2016, the Law of Food Labeling and Advertising, included the introduction of mandatory, black octagonal front-of-package nutrient warning labels alerting consumers to products high in sugar, salt, saturated fat and calories; marketing restrictions aimed at protecting children from pervasive food marketing and bans on the sale of ultra-processed products in schools. 

Earlier evaluations of Phase 1 have demonstrated significant decreases in purchases of products high in ‘nutrients of concern’ as well as a 73% drop in Chilean children’s exposure to TV for regulated food and beverages.

In the years since its passage, Chile’s law has provided a roadmap for similar global healthy food policies for public health researchers, advocates and policymakers.

Growing evidence that warnings work 

New research published in PLOS Medicine from the University of Chile and the University of North Carolina, Chapel Hill showed in Phase 2 of the nutrient warning label law, Chileans are purchasing significantly less sugar, salt, saturated fat and calories. 

Researchers found that households bought 37% less sugar, 22% less sodium, 16% less saturated fat and 23% fewer total calories from products with warning labels. These figures indicate that when consumers are equipped with clear, accessible information, they can make healthier choices.

Results from Phase 2 of the nutrient warning label law (Global Food Research Program at the University of North Carolina, Chapel Hill)

They also confirm what was seen by researchers after the first phase of Chile’s law – that people bought fewer items high in nutrients of concern – and these changes were even more pronounced in Phase 2. 

Critically, the data showed that these changes were equitable across socioeconomic groups – a collective win for all Chileans.

The impact of these labels goes beyond mere numbers. They serve as vital tools for empowering individuals to take control of their health in a food environment often dominated by marketing tactics designed to entice consumers toward less healthy, ultra-processed options. 

By mandating that products high in sugar, sodium, saturated fat and/or calories carry bold warning labels, the Chilean government is not just informing consumers; it’s shifting the narrative around food consumption.

A second new study published in the American Journal of Public Health examined adherence to the mandatory front-of-package labeling provision of Chile’s historic food policy. 

In the final and most nutritionally strict phase of the law, a remarkable 94% of products required to display these labels had the appropriate labels. The results of this mandatory policy represent a stark contrast to the significantly lower uptake of voluntary labeling programs in countries like Australia and New Zealand.

This compliance showcases the effectiveness of mandatory policies—when regulations are clear and enforcement is robust, industries have no choice but to adapt.

Increased knowledge shifts social norms  

These two new studies further support the efficacy of Chile’s 2016 Law of Food Advertising and Labeling. The country has seen improvements in the nutritional quality of its food supply, a development that could better the dietary quality of the population. 

Additionally, increased knowledge about food and drinks with warning labels and shifting social norms helps consumers to make healthier choices. Furthermore, these changes have been accompanied by drops in children’s exposure to harmful food marketing, due to the law’s stringent marketing restrictions.

These impressive strides have led to newer health initiatives in Chile. Recent measures expanding warning labels to alcoholic beverages that disclose calorie counts and feature safety information indicate a commitment to tackling health issues from multiple angles.

Chile’s actions have also sparked a wave of similar initiatives for other countries looking to improve their food environments and the health of their citizens.

Throughout the Americas, eight similar policies requiring black ‘stop sign’ warning labels on foods and beverages high in nutrients of health concern were rapidly adopted, mirroring Chile’s efforts. This trend demonstrates a growing recognition that health policies can, and should, prioritize public well-being over corporate interests.

In August 2021, Argentina introduced front-of-pack warning labels for ultra-processed food products.

Mandatory labels are most effective

Global health governing bodies are taking notice. To address diet-related diseases and create enabling and supportive food environments in more countries, the World Health Organization (WHO) recently released its draft guideline on nutritional labeling policies for comment. (The deadline for comments was 11 October.)

The key tenets of the Guideline include a strong recommendation for front-of-package labeling policies and the implementation of interpretive front-of-package labels. 

WHO’s leadership and action on this issue are commendable, and their draft guideline will be an incredibly helpful blueprint for member states in formulating and implementing these policies.

However, drawing from Chile’s evidence, the Guideline could be strengthened. The evaluations of Chile’s policy clearly demonstrate the necessity of mandatory front-of-package labeling systems featuring nutrient warning labels, which have been shown to be the most effective in helping consumers identify unhealthy products. 

Research has shown that Chile’s law’s mandatory regulations can be directly linked to the policy’s observed impacts – both the decline in purchases of unhealthy products and high rates of compliance. 

The lessons are clear: evidence-supported public health policies can lead to significant changes in consumer behavior, improve nutrition and, ultimately, enhance population health.

Yet, while Chile has made impressive strides, the work is far from over. Public health experts and policymakers are working to build on these early achievements to address other issues like access to affordable, fresh fruits and vegetables and the influence of social media marketing on children.

In an era where convenience supersedes health, Chile’s commitment to enacting decisive policies that support consumers in making healthier choices in their daily lives offers a path forward. 

It’s a reminder, especially in light of World Food Day 2024’s theme, “Right to foods for a better life and a better future,” that informed choices lead to healthier lives—and that policy can be a powerful tool for change.

Lindsey Smith Taillie, PhD, is an associate professor in the Department of Nutrition at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill. She is a nutrition epidemiologist focused on designing and evaluating healthy food policies.

 

Image Credits: CIAPEC-INTA, Global Health Policy Incubator .

Ensuring high quality patient care is at the heart of the Consensus Framework.

Ten years ago, global health leaders came together to agree on the first-of-its-kind international Consensus Framework for ethical collaboration between patients’ organizations, healthcare professionals, and the pharmaceutical industry in support of quality patient care. Since then, the Framework has been adopted across countries worldwide and embedded in international initiatives.

This Global Ethics Day, under the theme ‘Ethics Empowered’, members of the international Consensus Framework celebrate 10 years of the Framework as a lighthouse for ethical collaboration for the benefit of patients. In this joint op-ed, members reflect on progress made under the Framework over the last decade and announce their commitment to ensuring it is fit-for-purpose to address unfolding new realities, including the impact of new innovations, on patients’ lives.

The very first Global Ethics Day was celebrated one decade ago. This development milestone in the ethics world was engineered for the express purpose of raising awareness and driving diverse stakeholders to address the ethics issues facing their organizations and society.

It is fitting that, in this same year, entities representing the world’s patients, healthcare professionals, hospitals, and the pharmaceutical manufacturing industry also came together to forge a novel commitment: an international Consensus Framework to foster ethical collaboration.

One decade later, on this 2024 Global Ethics Day, we are thrilled to share not only the progress we have made together but also our collective ambitions for the future. A future that must find ethical collaboration at the heart of every interaction, and of every decision taken in healthcare leadership.

Ethical collaboration to advance patient health

Our journey began with recognition that health systems around the world were evolving, and continue to evolve, towards more dynamic partnerships. When establishing partnerships with the goal of improving the health of patients, it is critical that these are built on trust.

To support this, a new transnational platform was needed that represented a shared commitment to sustain fundamental ethical principles, and to create a safe space to raise ethical risks or opportunities for collective input and alignment to deliver greater patient benefit and support high-quality care.

International Consensus Framework partners celebrate a decade of collaboration: Dani Mothci, (IAPO), Dr David Reddy (IFPMA), Dr Catherine Duggan (FIP), Howard Catton (ICN), Ronald Lavater (IHF) and Dr Otmar Kloiber (WMA).

The six international member bodies of the Framework – International Alliance of Patients’ Organizations, International Council of Nurses, International Hospital Federation, International Pharmaceutical Federation, the World Medical Association, and the International Federation of Pharmaceutical Manufacturers and Associations – have collaborated on numerous ethics issues in diverse formats, co-creating several notes for guidance as well as providing bilateral and multilateral input on emerging ethical considerations affecting one or more bodies. In so doing, we utilized the Framework to enshrine four overarching principles:

  • Putting patients first
  • Supporting ethical research and innovation
  • Ensuring independence and ethical conduct 
  • Promoting transparency and accountability.

 At the same time, we used the Framework to bring outside perspectives into our work and share our expertise with others to advance ethical decision-making in health.

From global intention to national impact

The value of this innovation in process and design cannot be understated. In 2016 Canada and Peru became the first countries to adopt national-level, consensus-based frameworks spanning major local health stakeholders. From 2017 to 2024, 12 additional national-level frameworks were adopted among leading health bodies in countries as diverse as China and the United States, Kenya and Japan, Brazil and New Zealand, underscoring that a fundamental need has surfaced in favor of ethical collaboration, irrespective of a nation’s health system.

Many countries saw their framework membership expand as time progressed, drawing new voices to the “table” to advance ethical collaboration in their healthcare systems. With the approach under active consideration in many other countries today, leading international institutions from the Asia-Pacific Economic Cooperation Forum (APEC) to the United Nations and the Organization for Economic Co-operation and Development (OECD) have taken notice. And several governments, such as those in Chile and Australia, have stepped up in support of their framework process.

The theme of this year’s Global Ethics Day is Ethics Empowered, and we believe our international Consensus Framework has done precisely this. This is true both for us and for the hundreds of health bodies across the globe participating in consensus frameworks who, in turn, represent tens of thousands of companies, millions of healthcare leaders and caregivers, and billions of patients.

Consensus Framework fit for the future

As we celebrate the 10-year milestone of the international Consensus Framework for Ethical Collaboration in health, it is also crucial to acknowledge the evolving challenges that today’s healthcare sector faces.

 The rapid rise of digital platforms and the production and use of health data, including the expansion of artificial intelligence (AI) capabilities, is transforming how each of our associations and those we represent approach healthcare delivery and patient care. These innovations offer tremendous potential as well as pose new ethical dilemmas. 

The Framework, in its current form, provides a solid foundation, but we are looking to address emerging needs through the inclusion of an additional ethical principle. If successful, such an outcome would mark the first time leading health stakeholders have come together to advance ethical collaboration in health data and AI. We are showing that ethical collaboration needs to continuously adapt to meet evolving societal expectations.

We could not be prouder to celebrate Global Ethics Day by reaffirming our commitment to the Framework and its principles. The power of ethical collaboration is, and always will be, our greatest tool for building better healthcare.  

Dani Mothci, is CEO of the International Alliance of Patients’ Organizations (IAPO)

Dr Otmar Kloiber is Secretary General of the World Medical Association (WMA)

Howard Catton is CEO of the International Council of Nurses (ICN)

Ronald Lavater is CEO of the International Hospital Federation (IHF)  

Dr Catherine Duggan is CEO of the International Pharmaceutical Federation (FIP)

Dr David Reddy is Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

 

Image Credits: CDC, Jeremy Spierer.

BERLIN – Countries worldwide, regardless of income level, can halve premature death rates by 2050, a new Lancet report presented at the closing of the World Health Summit in Berlin suggests.

Fifteen key health threats are driving premature deaths worldwide, with tobacco use leading the pack “by far”, the Lancet Commission for Investing in Health found. Targeting interventions in these areas – with over half involving maternal, newborn, child, and infectious diseases – could dramatically reduce global deaths before age 70, the Commission said.

“Sharp reductions in mortality and morbidity can be achieved by focusing on 15 priority conditions,” Dr Angela Chang from the University of Southern Denmark and lead author of the report, told a panel at the World Health Summit in Berlin on Tuesday. “Doubling down on past health investments, focusing resources on a narrow set of conditions, scaling up financing and developing new technologies can continue to have an enormous impact despite the headwinds.”

The 15 priority conditions, selected from over 17,000 internationally recognized health diagnoses, account for approximately 80% of the life expectancy gap between most regions and the North Atlantic, defined in the report as North America and Europe. 

These conditions account for 86% of the gap between China and the North Atlantic, and 74% between sub-Saharan Africa and the North Atlantic.

“There’s a 22-year gap in life expectancy between Sub-Saharan Africa and the North Atlantic, Chang explained. “Close to 80% of this gap can be explained by these 15 priority conditions, and over half of the difference can be attributed to eight infectious and maternal health conditions.”

If the global goal is met, the average premature mortality rate worldwide would fall to about 15%, matching levels currently seen in Europe and North America—today’s global benchmark.

Achieving this would mean dramatic improvements for billions, especially in low- and middle-income countries. In Sub-Saharan Africa, the worst-performing region, premature mortality sits at 52%.

Setting priorities straight

The report’s optimism is rooted in historical data. Globally, the probability of dying before 70 has halved since the 1960s, falling from 62% to 31% for individuals born in 2019.

Thirty-seven countries, including populous nations like Bangladesh, China, Japan, and Vietnam, have already halved their premature death rates in similar or shorter periods than the 26 years remaining until the 2050 target date. 

The Commission recommends public financing for essential medicines targeting the 15 key conditions driving premature mortality. It suggests mobilizing international funding and joint procurement efforts, similar to strategies used by GAVI, PEPFAR, and the Global Fund, to reduce costs for patients and governments alike.

“Inadequate access to medicines and high out-of-pocket costs are major threats to cutting premature mortality,” Chang noted. “We learned from the Global Fund’s experience how national government subsidies can steer resources towards priority interventions and reduce out-of-pocket payments.” 

While the Commission believes halving premature mortality by 2050 is globally achievable, it acknowledges this target may be “perhaps only aspirational for some countries, realistically speaking.”

“We have a tendency to focus on the new, shiny things,” Chang added. “Our message is for countries to stay focused on these priority conditions.”

‘Tobacco is the new tobacco’

Six out of ten smokers, or 750 million people globally want to quit tobacco use.

High tobacco taxes are “by far” the most crucial policy tool for reducing premature deaths, according to the report.

“You often hear about other risk factors, but we argue tobacco is the new tobacco,” Chang explained.

Recent research suggests raising excise taxes on tobacco, alcohol, and sugary drinks by 50% could yield $2.1 trillion for low- and middle-income countries over five years. This could boost healthcare spending in these nations by 40% if directed towards health initiatives.

The Commission highlights the Middle East and North Africa as an example of untapped potential in tobacco control. With 160 million smokers and rising prevalence among youth and women, the region faces a growing health crisis.

Egypt’s smoking rates doubled between 2000 and 2018, while tobacco became more affordable in conflict-affected countries like Iraq and Syria. The region’s tobacco taxes, second-lowest globally, fall far short of the World Health Organization’s recommended 70% excise tax.

“Despite wide experience with its successful use, tobacco taxation remains a policy tool that is still greatly underused,” the Commission found. “Raising taxes on tobacco can do more to reduce premature mortality than any other single health policy.”

High risk of  ‘COVID magnitude’ pandemic in next decade

The Lancet Comission estimates there is a 23% change of a COVID-scale pandemic in the next decade.

New modeling for the Commission’s report indicates a 23% chance of a pandemic as severe as COVID-19 occurring within a decade. Unprepared health systems could see progress on reducing premature deaths plummet if caught off guard again.

“There is a high risk of another pandemic of Covid-like magnitude,” Chang warned. “To put it another way, in most years there will be zero pandemic deaths, and in some years there will be millions of pandemic deaths.”

The Commission’s analysis estimates an average of 2.5 million deaths per year due to pandemics when viewed over a long time horizon. This figure is comparable to the current annual death toll from AIDS, malaria, and tuberculosis combined, and significantly exceeds even pessimistic projections for annual climate change-related deaths in coming decades.

“People should wake up at that figure,” Helen Clark, former Prime Minister of New Zealand, warned the summit. 

The warning from the Commission comes as global headwinds from conflict, climate change and debt hammer health budgets. Neglecting pandemic preparedness could have severe consequences, particularly for poorer countries less equipped to handle sudden outbreaks.

“We need to learn the lessons not just from COVID, but from Mpox, Ebola … and avoid this panic-neglect cycle,” said Dr Seth Berkley, former CEO of Gavi, the Vaccine Alliance. “Unfortunately, I don’t think we’re doing a very good job.” 

From 1993 to Berlin 

A figure from the World Bank’s 1993 report making the case for health as an economic investment.

The Lancet Comission report is the latest in a line of studies that traces its lineage back to a pivotal World Bank report that changed the landscape of global health finance.

The World Bank’s 1993 report, Investing in Health, the only report on health ever published by the Bank, was the first to make an argument still used by health advocates and ministers across the globe: health is an investment. 

“The World Bank saying investing in health is no just a cost to society, but an investment that was justified on pure economic grounds … was revolutionary,” Berkley recalled. “Prior to this, people saw it as a cost – if you get richer, you can afford health, but this really changed the thinking.” 

The Commission’s work has expanded on the World Bank’s initial calculations, incorporating factors such as the impact of out-of-pocket health costs on economies and personal livelihoods. This broader perspective has significantly increased the estimated economic benefits of maintaining healthy societies, from the World Bank’s initial 11% to 24%.

“The important thing is that each one of these reports, including this one, says the case is better than ever for investing in health, and we need to keep talking about that, particularly at a time when the headwinds are so strong,” Berkley emphasizes.

The latest report continues this tradition, reaffirming that health investment remains one of the most effective strategies for improving both individual and societal outcomes.

“Today, the case is better than ever for going for mortality reduction,” said Dr Gavin Yamey, director of Duke University’s Center for Policy Impact in Global Health and lead author of the commission report “It’s a prize within reach. It will have extraordinary health, welfare and economic benefits.”

Image Credits: Sarah Johnson.

BERLIN – The World Health Organization secured $1 billion in pledges at a landmark fundraising event in Berlin on Monday, kickstarting a major campaign by the UN agency to overhaul its funding model and enhance its ability to tackle global health emergencies.

The billion-dollar total includes $700 million in new pledges from European nations and philanthropies at the World Health Summit. The remaining $300 million comes from previous commitments by the European Union and African Union.

German Chancellor Olaf Scholz, speaking alongside European health ministers from the German capital, stressed the importance of sustainable financing for WHO.

“The WHO’s work benefits us all. What it needs for this work is sustainable financing that gives it the certainty to plan ahead and the flexibility to react,” Scholz said. “With the money we collect at this pledging event today, we can enable many women, men, and above all children to live healthier lives.”

For WHO, long plagued by financial uncertainty, this funding marks a first step toward sustainability as the agency – and the world – faces overlapping health threats from conflicts, poverty, pandemics, noncommunicable diseases, antimicrobial resistance, and climate change.

“For far too long, WHO has operated with unpredictable, inflexible, unsustainable funding,” said Director-General Dr Tedros Adhanom Ghebreyesus. “That prevents us from delivering the long-term support that countries need.”

The $1 billion, however, is just the start. WHO aims to raise $7.4 billion by next May’s World Health Assembly to address the budget gap in its $11.15 billion strategy for 2025-28, known as the General Programme of Work 14 (GPW-14).

This four-year plan could save over 40 million lives through progress on health-related Sustainable Development Goals, stronger health systems, and enhanced emergency responses, WHO figures project. 

“Meeting these complex and overlapping challenges requires a clear plan, and the resources to implement it,” Tedros said. “Tonight, we have taken a huge step toward mobilizing the resources we need to implement that plan.”

As the echoes of applause fade from the ballroom in Berlin, the work to raise the remaining $6.4bn the agency needs to operate through 2028 begins.

“Saving as many lives as possible is what the World Health Organization aspires to,” Scholz said. “One number reflects just how lofty this aspiration is: 40 million lives. That is how many lives the WHO will be able to save over the next four years.”

Major donors yet to commit

The “investment rounds” format aims to foster competition among nations, encouraging increased stakes in the agency’s operations. Several key European players, including Spain, the United Kingdom and France, have yet to make commitments, indicating they will announce their contributions later this year.

Further WHO funding appeals are planned in Asia, the Middle East and the Americas. Potential donors from Australia, Japan and South Korea to oil-rich Gulf states are expected to help the organization edge closer to its $7.4 billion goal.

Behind Monday’s success, concerns loom about the potential impact of the US elections on contributions from Washington, traditionally one of WHO’s largest donors. During his previous term, former President Donald Trump, once again a candidate in the November race, formally disavowed the WHO and moved to suspend US funding during his previous term. 

President Joe Biden reversed this decision upon taking office in January 2021, but the potential for another policy shift worries WHO officials.

“That’s a huge fear factor,” Catharina Boehme, who leads the WHO investment round. “We would go into a dramatically bad crisis” if U.S. support were withdrawn again in January, she told Health Policy Watch.

A step towards financial stability

Member states’ vote to reform WHO’s funding last year, championed by nations like Germany seeking more stable financing for the UN global health body, led to the current “investment round” approach.

In May, the 194 member states of the World Health Assembly agreed to incrementally increase their membership fees to fund up to 50% of WHO’s annual budget by the 2030-31 cycle, up from the current 30%. This commitment requires renewal in future WHA resolutions to take full effect.

“This strategy is designed to mobilize upfront the predictable and sustainable funding we need over the next four years,” Tedros said. “It’s also designed to put WHO on a more stable financial footing, so we are less reliant on a handful of large donors.”

In 2022-23, only 4.1% of voluntary donations, about $320 million, were fully flexible. Just 14 funders contributed flexible funding, with the UK being the largest contributor at $230,000.

Germany led Monday’s pledges with $360 million, followed by the European Union with $250 million, Norway with $100 million, and Ireland with $30 million. The combined unrestricted funds from Germany and Norway alone surpassed WHO’s entire 2022-2023 budget for self-directed initiatives addressing urgent global health priorities.

“This is an investment in the future of health and in the future generations to come,” said German Health Minister Karl Lauterbach. “In a time of wars, civil wars, epidemics, pandemics, climate change and catastrophes, it is important that WHO can rely on funding which is up to the ever-increasing tasks [asked] of the agency.”

Smaller nations step up

Smaller nations and emerging economies also joined the WHO’s funding drive. Montenegro made its first-ever donation to the agency, contributing $80,000.

“From a receiver, we are becoming a contributor,” Montenegro Prime Minister Milojko Spajic said. “It’s not always the population size or the GDP size that matters – it’s also a country’s actions that matter.”

WHO has found similar enthusiasm elsewhere. Seventeen African countries habr pledged a total of $47 million, with Niger committing $2 million despite significant economic challenges. Mauritania’s president announced new African Union funds from Berlin on Monday, adding more African countries are expected to follow.

“We know that we are making this ask at a time of competing priorities and limited resources,” Tedros said. “Every contribution counts.”

Philanthropies join the effort 

Philanthropies and foundations also contributed to the WHO’s fundraising drive, with Wellcome Trust and Sanofi Foundation each pledging $50 million.

“It is member states that have the core responsibility for ensuring sustainable financing for WHO. However, as a philanthropy, we also have a role to play,” said Jan Arne Rottingen, Executive Director of the Wellcome Trust. “Given the scale and the urgency of impacts on climate change on health, we urge other philanthropies and member states to invest in WHO’s critical work.”

Some donors designated funds for specific issues, including noncommunicable diseases, mental health, and substance abuse. These targeted contributions, while less flexible, aim to bolster WHO programs in traditionally underfunded areas.

“We maintain that one of the soundest investments in global health is in WHO,” Tedros and health ministers from across Europe said in an op-ed as the summit began. “Countries are doing so, already, through their regular contributions. But there is a clear understanding that in times of crisis, this is not sufficient.”

‘Budget of a mid-size hospital’ 

The World Health Organization flag above its headquarters in Geneva.

The investment round comes against a backdrop of long-standing financial constraints that have hindered WHO’s operations for years, despite its responsibility for advancing the health of 8 billion people worldwide.

In 2022-2023, WHO’s annual budget for its operations in over 150 countries was only $6.7 billion — a mere 33 cents per person globally. The Gates Foundation spent more than $15 billion during the same period.

“WHO has the annual budget of a mid-size hospital,” said Boehme, who is leading the WHO investment round. “Two and a half billion is not enough given our reach in basically all countries in the world.”

Even if funding goals are reached, the agency’s 2025-28 budget won’t be any larger. Yet it might be more predictable, flexible, and equitably distributed if member states cooperate.

In 2022-23, 88% of WHO’s funding came from voluntary contributions, with 60% of the agency’s budget controlled by just nine donors.

WHO’s expanding role

Despite its limited budget, WHO’s roles and responsibilities have expanded over the decades. It operates as a de facto second health ministry in many impoverished regions, financing primary-care clinics, managing vaccine programs, and providing training to local health authorities.

Conflict and climate change-driven natural disasters have forced WHO to take on larger emergency response roles in more affected countries – from Ukraine to Gaza, Sudan and the Democratic Republic of Congo.

As WHO continues its fundraising efforts, the challenge remains to secure not just more funding, but more flexible funding that allows the agency to independently address global health priorities.

“The COVID-19 pandemic demonstrated that when health is at risk, everything is at risk,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus at the close of the pledge announcements. “Investments in WHO are therefore investments not only in protecting and promoting health, but also in more equitable, more stable and more secure societies and economies.”

Tedros has personally campaigned for more reliable, long-term and flexible funding since taking over the helm of the organization in 2017. Even so, he seemed satisfied with the outcomes of the first salvo of the new funding drive.

“The COVID-19 pandemic made it definitely clear that an outbreak of infectious disease anywhere in the world affects us all,” Scholz said. “Pandemics do not stop for borders. This represents a global challenge that we can only properly tackle together.”

Image Credits: US Mission in Geneva / Eric Bridiers via Flickr.

GPMB co-chair Joy Phumaphi

While the next pathogen with pandemic potential may be lurking in a faraway creature, human behaviour will drive it to become a pandemic, according to the Global Preparedness Monitoring Board (GPMB), which issued its first comprehensive pandemic risk report on Monday.

The four riskiest human behaviours involve our global mobility, agricultural and farming practices, mis- and disinformation and a lack of trust – in science, in governments and between countries – according to the GPMB.

In 2024, there have already been 17 outbreaks of dangerous diseases, including H5N1 that has spilt over from cattle to humans and a new strain of mpox in East Africa. 

“The high likelihood that they will spread further should be a wake-up call for the global community,” said the board.

“Pandemics are not random events,” GPMB co-chair Joy Phumaphi told a media briefing before the launch. “The factors contributing to pandemics are deeply intertwined with how humans interact with the environment, animals and trade.

“Human and animal interconnections, including the trade and proximity of animal products, play a significant role in the transmissions of pathogens,” noted Phumaphi, Botswana’s former health minister.

“The increasingly rapid movement of people across countries and continents accelerates the spread of disease,” she noted. So too does the spread of misinformation and disinformation as it “undermines public trust and hampers collective efforts”. 

“Trust is a cornerstone [that is] central to pandemic response. Distrust can contribute to the emergence of new viruses and exacerbate outbreaks whereas trust between stakeholders and nations strengthens international collaboration and response efforts,” said Phumaphi.

The report also identifies “climate change, individualism, economic inequality, and conflict and instability” as key drivers of  pandemics.

We are ‘always at risk’

Kolinda Grabar-Kitarović, GPMB co-chair and former President of Croatia.

“We are always at risk. Pandemic drivers evolve rapidly, and if we don’t stay ahead, we’ll be unprepared for what comes next,” said Kolinda Grabar-Kitarović, the other co-chair and former President of Croatia.

“We need to focus on preparing for the next crisis, not just reacting to the last one. While we cannot predict exactly which pathogen will emerge, we can assess our risks and vulnerabilities and develop strategies to address them. Pandemics bring fear and uncertainty, and being unprepared only highlights that fear,” Grabar-Kitarović told a discussion on the report at the World Health Summit in Berlin on Monday.

Phumaphi stressed that collaboration and equity mitigate pandemic risks – and are also the best way to rebuild trust between countries that was broken during the COVID-19 pandemic.

However, cooperation and collaboration are “most difficult” to develop during a crisis – which is why frameworks like the WHO’s International Health Regulations and the pandemic agreement, currently being negotiated, are important, she stressed.

Weak pandemic agreement poses threat

Phumaphi told the media briefing that the release of the report had been timed to coincide with what might be the last meeting of the International Negotiating Body (INB) drafting the pandemic agreement, set for the first two weeks of November.

“We are aware of the direction that the negotiations are taking, and what we are concerned about is that this direction is actually going to fuel the spread of the next pandemic,” said Phumaphi. 

She described reports that the agreement’s commitment to equity had been watered down, as “a serious threat to our readiness”. 

WHO Director-General Dr Tedros Adhanom Ghebreyusus told the summit that the board’s report “highlights many of the key components that the pandemic agreement is designed to address: a One Health approach, equitable access to medical countermeasures, research and development, and most importantly, and most relevant for this world summit, trust”. 

Tedros added: “The global response to the COVID-19 pandemic was undermined by the lack of a coherent and coordinated approach, based on equity and solidarity. We can only face shared threats with a shared response.”

‘Adapt, protect, connect’

Board member Prof Ilona Kickbusch, chair of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.

The report advocates three measures to counter pandemic threats: “adapt, protect and connect”.

GPMB member Prof Ilona Kickbusch told the summit that, with adapt, the board wants countries  to assess their pandemic risk drivers, involving all sectors of society.

The key to protection is strong primary health care, equity, social protection for the most vulnerable, and boosting international cooperation, added Kickbusch, who is chair of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.

“Connect” relates to international cooperation and intersectoral cooperation, supported by dedicated funding. But it also relates to digital connection – which has helped with the spread of information but also fueled disinformation.

Without trust, innovation is ‘useless’

Victor Dzau, board member and President of the US National Academy of Medicine

Board member Victor Dzau said that while science has great progress with, for example, the rapid development of mRNA vaccines during COVID, “we’re foolish to think that science  alone will protect us”.

Scientific innovations are “useless if people don’t trust them”, said Dzau, who is also President of the US National Academy of Medicine and vice-chair of the US National Research Council.

“Whatever we do, we must address issue of trust. That means that we need to understand the root cause, including social inequity as social inequity fosters mistrust.”

Dzau said trust needs to be build “way before pandemic begins” to ensure that there is a “reservoir of goodwill, of trust, that can be relied upon when the crisis take place”. 

“During a pandemic, we need much better communication to listen more to people’s fears and fears and questions real time.”

Better ‘One Health’ tools

Panel of GPMB board members: Sir Mark Lowcock, Dr Victor Dzau, Prof Ilona Kickbusch and Christopher Elias

Board member Sir Mark Lowcock, former head of United Nations Office for the Coordination of Humanitarian Affairs (OCHA),   addressed the need for a One Health approach “linking human, animal and environmental health”.

“Those risk areas are particularly found where we have new hotspots, where there’s high levels of interaction between humans, animals and environmental stresses. We need better tools to identify those hot spots and understand the risks involved. The entry point for many countries actually is improvements to their animal health system and their food safety services,” said Lowcock, who is a former UK Permanent Secretary of the Department of International Development.

Climate change is “an amplifier of all these risks”, he added, and this needs to be addressed by “early detection, strong primary health care and overcoming the barriers to access to medical countermeasures” – and “underpinned by strong international cooperation”.

Mobility of people – and pathogens

Dr Chris Elias, president of Global Development at the Bill and Melinda Gates Foundation

“Human mobility today through trade, travel, immigration, or refugees who are fleeing conflict or climate disasters, plays in a very important role in spreading diseases, because when people move, the pathogens move with them, and that can bring novel or reemerging diseases into populations that don’t have any prior immunity,” said board member Dr Chris Elias.

“Take the example of the Omicron variant, which was initially identified in South Africa and reported promptly in late November of 2021. Within three weeks, by the middle of December, it had spread to over 70 countries, and that was in the middle of a pandemic where we were reducing the amount of movement,” said Elias, who is president of Global Development at the Bill and Melinda Gates Foundation.

Urbanisation has “skyrocketed” since the 1960, with two-thirds of people projected to live in cities by 2050, he added.

“Cities have higher population density, they have frequent commuting, and they create ideal conditions for the rapid spread of disease,” he noted.

“We have to build trust so that we can objectively assess those risks and take steps to mitigate without overreacting and causing harm to individual economies or the supply chains and creating the kind of inequity that we saw during the COVID pandemic.”

Elias concluded by noting that “one of the best ways for us to repair that trust is to have the kind of agreement we reached as a global community last year with the [amended] International Health Regulations, and to do that with the pandemic treaty, and to continue to build that sense of science driving preparedness and response.”

At a HIVR4P’s press conference: Jeremy Nuttall, Elizabeth Irungu, Mark Marzinke, Alessandro Grattoni, William Hahn and Colleen Kelley.

LIMA, Peru – The infection-prevention potential of Lenacapavir,  the long-acting anti-HIV injectable administered just twice a year, took centre stage at the fifth HIV Research for Prevention Conference (HIVR4P) held last week.

However, several other important studies were also unveiled, including an injectable that combines contraception and HIV protection, results from a three-month vaginal ring, and real-world findings from Zambia’s rollout of long-acting injectable cabotegravir. 

Lenacapavir in diverse populations

Lenacapavir reduced HIV infections by 96% in a gender-diverse population, according to results from the PURPOSE 2 trial, which enrolled over 3,200 participants from Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US between June 2021 and December 2023. 

Participants were randomly assigned to one of two groups: one receiving lenacapavir injections every six months and the other taking daily oral pills for pre-exposure prophylaxis (PrEP) with matched placebos.

The average age of participants was 28, with over one-third under the age of 25. Around 70% identified as non-white, and the gender breakdown featured cisgender men, transgender men, transgender women, and non-binary individuals who have sex with partners assigned male at birth.

At 39 weeks, only two HIV cases occurred in the lenacapavir group of 2,179 individuals, translating to a 96% reduction in HIV incidence, according to Dr Colleen Kelley from Emory University. 

In contrast, there were nine new HIV cases among the 1,087 participants taking daily oral TDF pills (comprising tenofovir disoproxil fumarate and emtricitabine and marketed as Truvada). This makes lenacapavir 89% more effective than oral PrEP.

The findings echoed earlier results from the PURPOSE 1 trial, which showed 100% efficacy in preventing HIV among cisgender women in Africa. With regulatory filings expected to begin globally by the end of 2024, lenacapavir has the potential to be a transformative HIV prevention tool. Future phases of the study will focus on other groups, including women in the US (PURPOSE 3) and people who inject drugs (PURPOSE 4).

The twice-yearly injectable, lenacapavir (marketed as Sunlenca in the US) could make a huge difference to HIV prevention is widely accessible.

Injectable contraceptive and HIV prevention in one 

For millions of young women worldwide, two major health concerns often intersect: HIV acquisition and unintended pregnancy. 

Many have expressed a preference for a method that protects against both. At the conference, Melissa Peet from CONRAD presented results from a promising solution—a silica-based hydrogel injectable that combines HIV antiretroviral drugs with contraception in a single shot.

In designing this dual-purpose method, researchers selected long-acting cabotegravir (CAB-LA) as the HIV prevention drug and levonorgestrel (LNG) as the contraceptive. 

The hydrogel injectable they developed is a silica-biodegradable material comprising two compartments, one for each medication. The injectable is capable of delivering both drugs with a single injection offering dual protection for three months.

Preclinical tests in rats showed sustained drug levels in the bloodstream without significant interactions or safety concerns, and the researchers are now conducting additional studies in non-human primates to fine-tune dosing and asses the duration of protective drug concentration.

No interactions between Cabotegravir and contraceptives

One concern with combining HIV prevention and contraception has been the potential for drug interactions, particularly between long-acting HIV medications like cabotegravir (CAB-LA) and commonly used contraceptives. 

To address this, Dr. Mark Marzinke from Johns Hopkins University presented results from a sub-study within the HPTN 084 trial to explore any potential interactions.

The study included 170 participants from South Africa with a median age of 23. A total of 80 women were randomised to the CAB-LA arm and 90 in the oral PrEP arm. Participants used three types of hormonal contraceptives: etonogestrel implants, injectable norethindrone, or medroxyprogesterone acetate (MPA), alongside either CAB-LA or oral PrEP. 

Researchers measured drug concentrations at enrolment and again at weeks 25, 49, and 73 to determine if there were any drug interactions. The results were reassuring: plasma concentrations of the contraceptives remained high enough to prevent pregnancy in both the CAB-LA and oral PrEP groups. 

CAB-LA concentrations were also consistent across contraceptive types, indicating that CAB-LA does not interfere with contraceptive effectiveness. However, tenofovir concentrations were unquantifiable for most participants, regardless of contraceptive type, due to low adherence to oral PrEP.

New data on the three-month vaginal ring

For women seeking long-term HIV prevention, the dapivirine vaginal ring, sometimes called the PrEP ring, has been a promising option. This is a flexible silicone ring that is placed in the vagina that releases the anti-HIV drug, dapivirine, over a month.

Delegates at the conference heard results from a South African study comparing the bioavailability of the standard one-month dapivirine ring with a new three-month version.

The study enrolled 124 women, but only 104 completed the trial. This was a crossover trial with two treatment phases: half the group started with the one-month ring (containing 25 mg of dapivirine) and then switched to the three-month ring, containing 100 mg of dapivirine. The other group followed the reverse order; they began with the three-month ring and later switched to the one-month ring.

The three-month ring was identical to the one-month version in silicone, dimensions, and appearance. Plasma and vaginal fluid samples were collected throughout the study to measure drug levels.

Based on dapivirine concentrations in plasma, results showed that the three-month ring provided greater overall drug exposure than the one-month version, indicating equal or possibly higher efficacy in preventing HIV.

Jeremy Nuttall from the Population Council’s Center for Biomedical Research, who presented the findings, noted that the reduced frequency of ring changes might increase acceptability and adherence, potentially improving overall effectiveness. 

He also highlighted that the estimated cost of the three-month ring is $16, making it a potentially more affordable option, projecting that the three-month ring could become available on the market by 2026.

Roxana Bretoneche protesting about the lack of community participation at HIVR4P.

Real-world results from Zambia’s CAB-LA rollout

Zambia became the first country in sub-Saharan Africa to roll out long-acting injectable PrEP (CAB-LA) beyond clinical trials, sharing results from their first three months (February to April 2024) in real-world settings. 

A total of 609 individuals with a median age of 24 were enrolled across six health facilities in two districts. Among the clients, 55% were female, 20% were adolescent boys and young men, 7% identified as key populations, and 40% as other high-risk populations.

Adamson Ndhlovu from Zambia’s JSI USAID DISCOVER-Health Project shared that over 90% of participants due for their second injection received it on time. 

A total of 24 participants (about 4%) discontinued CAB-LA. Most discontinuations were due to hepatitis B (20 cases), with two participants stopping due to pregnancy, one due to a severe rash, and one because of severe pain at the injection site. Those who discontinued were switched to oral PrEP.

During a press briefing at the conference, Professor Lloyd Mulenga from Zambia’s Ministry of Health stated that four of those enrolled had acquired HIV, explaining that they likely had undetected HIV at the time they started PrEP.

The real-world implementation of CAB-LA is anticipated to expand, as ViiV Healthcare, the manufacturer, announced at the conference its plans to triple the supply of cabotegravir that will be available for low- and middle-income countries in 2025-2026 to at least two million doses.

 

Image Credits: Nicole Bergman / IAS, Gilead, Nicole Bergman / IAS.

WHO Director-General Dr Tedros Adhanom Ghebreyesus speaks about trust and partnerships at the opening day of the World Health Summit in Berlin.

BERLIN — The World Health Organization is kicking off its first European “investment round” Monday at the World Health Summit, seeking to secure backing for its $11.1 billion four-year strategic plan.

The Berlin summit, a marquee event on the global health calendar, draws thousands of health leaders, researchers, and advocacy groups. On the agenda: pandemic preparedness, artificial intelligence in healthcare, climate change’s health impacts and pharmaceutical intellectual property rights.

The fundraising push is the centrepiece of the WHO-led summit. The plan? Putting the world’s leading health agency on a firmer financial footing with long-term, secure, flexible funding commitments from European nations, philanthropies and foundations.

“COVID was really the trigger for this journey towards sustainable financing,” WHO Assistant Director-General Catarina Boehme told Health Policy Watch in an interview Sunday evening. “Member states realised what’s wrong with WHO’s funding – it’s about the resilience of funding, the lack of diversification and the lack of flexibility.”

The publicly broadcast event will feature prominent speakers including German Chancellor Olaf Scholz, philanthropist Bill Gates and Wellcome Trust CEO John-Arne Rottingen, alongside health ministers from France, Germany, Greece, Norway and Switzerland.

Boehme, a German national and former chief of staff to WHO Director-General Tedros Adhanom Ghebreyesus, is spearheading the new funding initiative. The effort aims to find new formulas for voluntary funding critical to filling chronic budget shortfalls left by member states’ regularly assessed contributions.

For decades, member fees have covered only 20%-30% of WHO’s regular budget. A 2022 decision aims to increase that to 50% by 2030, but significant funding gaps remain.

WHO funding drive hits Europe

WHO ADG General Catherine Boehme, (center), now heading up the WHO investment round initiative.

Europe is neither the first nor the last stop for WHO’s pledging drive. On Oct. 7, South East Asian countries pledged $345 million in voluntary donations to the global health agency’s operations during a closed-door event coinciding with WHO’s South East Asia Regional Committee meeting.

Following the Berlin event, investment rounds are planned in WHO’s remaining four regions: the Americas, Eastern Mediterranean, Africa and Western Pacific.

Loosely inspired by successful fundraising drives of multilateral health organizations like The Global Fund and Gavi, the Vaccine Alliance, WHO’s approach, approved by member states in May, appears more restrained.

While The Global Fund’s “replenishment drives” have featured heads of state sharing stages with rock stars to boost visibility, WHO is working through potential donors region by region.

The focus is on broadening the base of member states who supplement their “assessed” contributions and changing the culture of giving to foster long-term funding commitments with fewer restrictions.

‘COVID was the trigger’

WHS draws thousands of attendees worldwide from civil society, academic and government ranks.

“COVID was really the trigger for this journey towards sustainable financing,” Boehme said. “It was through the pandemic that member states realized what’s wrong with WHO’s funding.”

“It’s about the resilience of funding. It’s about the lack of diversification. It’s about the lack of flexibility,” Boehme said, noting that more than 70% of WHO’s funding comes from just 10 donors.

Boehme hopes that pledges obtained at the event and in its aftermath will include fewer “earmarked” donations, which tie funds to specific programs or projects — a common feature of voluntary contributions to the UN health body to date.

“We are super ineffective because 80% of our funding is earmarked,” Boehme said. “It’s really narrowly defined what we can spend it on, which is terrible, for example, for health emergencies. We basically cannot direct our funding where we need it.”

She added that predictability is also a major issue, with 50% of WHO’s voluntary donations made as one-year grants. This leaves the organization heavily reliant on short-term staff “with no job security.”

“It’s not even about elevating the baseline. It’s actually more about making funding more predictable, more flexible,” Boehme said. “Then we can use the baseline to pay for the core stuff we need to then be able to react to emergencies.”

Trust and health

‘There’s no health without trust’ says WHO Director General Tedros

In his opening remarks Sunday evening, WHO Director-General Dr Tedros Adhanom Ghebreyesus, linked the fund-raising drive to the conference theme of “trust”, saying that building trust between WHO and its member state partners is critical to improving the organization’s credible response to fast-evolving disease outbreaks and conflict-driven emergencies.

“Trust itself does not make people healthy, but no one can be healthy without trust,” said Tedros, pointing to examples of outbreaks, from Ebola to the COVID-19 pandemic, where public confidence in advice on issues ranging from safe burial to vaccination was critical to getting diseases under control.

“Strong partnerships – like strong relationships – are built on trust,” he added, saying “Everything we do depends on the trust of the communities we serve, the partners with whom we work, and the Member States who set the global health agenda, and entrust us with the resources to deliver it.”

“At this year’s World Health Assembly, Member States adopted a new and ambitious strategy to save 40 million lives over the next four years: the 14th General Programme of Work,” he added, referring to the objectives of the 2024-2028 budget plan.

“Delivering that strategy requires a strong and sustainably financed WHO, which is why we have launched the first WHO Investment Round, to mobilize upfront the predictable funding we need to do our work over the next four years.

“We know that we are making this ask at a time of competing priorities and limited resources. But as the COVID-19 pandemic demonstrated, when health is at risk, everything is at risk.  Investments in WHO are therefore investments not only in healthier populations, but also in more equitable, more stable and more secure societies and economies.

“They’re investments in the vision countries had when they established WHO in 1948: the highest attainable standard of health for all people, as a fundamental right.”

Image Credits: Stefan Anderson/HPW, LinkedIn.

A laboratory technician at Afrigen in South Africa.

A recent article published by HPW based on research by Matthew Herder and Ximena Benavides made several criticisms and observations about the mRNA programme. HPW asked the mRNA co-leaders, the MPP and WHO, to respond to the issues raised and this is their response. 

The mRNA Technology Transfer Programme, established by the World Health Organization (WHO) in partnership with the Medicines Patent Pool (MPP), was launched in July 2021 in response to the COVID-19 pandemic to address the global inequities in vaccine manufacturing. Its primary aim is to build mRNA vaccine manufacturing capacity in low- and middle-income countries (LMICs), thus bolstering health security through local and regional production.

A key component of the Programme is the South African Consortium, which consists of Afrigen, Biovac, and the South African Medical Research Council (SAMRC). The consortium, with the contribution of other research organizations in South Africa, is responsible for developing an mRNA-based technology platform (with Afrigen focusing on pre-clinical and early clinical scales and Biovac handling late clinical and commercial scales) and vaccine candidates tailored to the needs of LMICs, with the objective being to transfer them to a network of technology recipients called Programme Partners within LMICs.

Alongside the South African Consortium, the Programme brings together a range of international and local partners who are critical players in developing and transferring vaccine technology to LMICs. The initiative receives support from donors such as Belgium, Canada, the European Commission, France, Germany, Norway, South Africa, and the ELMA Foundation.

The Programme’s four primary objectives are:

  1. Establishing sustainable mRNA vaccine manufacturing capacity in regions with limited production ability;
  2. Introducing new technologies and promoting research and development (R&D) in LMICs;
  3. Strengthening regional biomanufacturing capacity through knowledge-sharing and workforce development;
  4. Developing regulatory capabilities to support the approval and distribution of vaccines in LMICs.

 Establishment and structure 

The Programme emerged from a critical need recognized during the COVID-19 pandemic, as it became evident that LMICs lacked the capacity to produce medical countermeasures, particularly vaccines. 

France suggested establishing a fifth ACT Accelerator (ACT-A) pillar to address this gap. Following discussions within ACT-A, and given the urgency of vaccine production, the initiative translated into a Vaccines Manufacturing Taskforce established under ACT-A’s vaccine pillar, COVAX, with three workstreams. Workstreams 1 and 2 focused on addressing immediate challenges, such as supply bottlenecks, while Workstream 3 took on the longer-term goal of establishing vaccine production in LMICs.

Due to its expertise in licensing and legal matters, WHO asked the UN-backed Medicines Patent Pool to co-facilitate Workstream 3. Following guidance from WHO’s Product Development for Vaccines Advisory Committee, Workstream 3 focused on mRNA technology, ultimately evolving into the mRNA Technology Transfer Programme. 

With the completion of Workstreams 1 and 2, the Vaccines Manufacturing Taskforce was sunset, and the Programme moved into WHO’s Access to Medicines and Health Products division.

Every company that applied to the Expression of Interest launched by WHO in November 2021 to be a recipient of mRNA technology through the WHO selection process was accepted, barring any technical issues. In the Pan-American region, the Pan-American Health Organization led its own selection process, resulting in the choice of one company each from Argentina and Brazil. 

All companies were required to have the backing of their respective governments. With two recipients in South America, six in Africa (including Biovac), two in Eastern Europe, and five in Asia, the Programme ensures broad mRNA production capacity across LMICs globally.

Governance

Charles Gore (MPP), Afrigen CEO Petro Terreblanche, Dr Tedros Ghebreysus, Director-General the WHO, Dr. Joe Paahla, SA Minister of Health, and Anne Tvinnereim, Norwegian Minister of International Development, formally launched the mRNA project in Cape Town in April, 2023.

Oversight of the Programme rests with WHO, which regularly engages with its Member States through meetings to provide updates and gather input. Additionally, quarterly meetings are held with Programme funders and civil society.

To assist in decision-making, WHO established the Scientific and Technical Review Committee (STeRCo), which provides advisory support to the WHO secretariat on critical technical matters. The STeRCo consists of independent experts and stakeholders, including representatives of the Civil Society, who guide WHO on areas essential to achieving the Programme’s objectives, such as:

  • Strategic direction, including the evaluation of technologies for implementation and transfer;
  • Pre-clinical and clinical development plans for relevant mRNA technologies;
  • Adherence to regulatory guidelines;
  • Value for money in fund allocation;
  • Other critical issues to ensure the successful execution of the Programme.

From the outset, the South African Government and Africa CDC have been integral members of the STeRCo, ensuring their perspectives are included in decision-making. This inclusive approach is central to fostering local ownership and keeping the Programme responsive to the needs of LMICs.  Additionally, MPP convened an mRNA Scientific Advisory Committee (mSAC), comprising internationally recognized experts in mRNA vaccine development, to provide top-tier scientific input into the Programme.

Knowledge sharing and empowerment of LMIC partners

A cornerstone of the programme is knowledge sharing and empowerment of LMIC partners. For instance, Afrigen and Biovac, both part-owned by the South African government, play a central role in developing and transferring the mRNA technology platform, developed with a specific COVID-19 vaccine variant as proof of concept, to 14 companies across multiple regions. The South African Medical Research Council (SAMRC) shares knowledge with the network of partners on second-generation mRNA technologies and vaccine candidates targeting other diseases.

All partners benefit from MPP’s licensing model, which ensures consistency across the Programme by offering non-exclusive royalty-free licenses in LMICs, allowing equitable access to the developed technologies.

In addition to the core governance framework, it is important to highlight the continuous engagement and collaborative efforts between the partners. These include regular calls with all partners, and participation in significant global conferences, such as the Developing Countries Vaccine Manufacturers Network (DCVMN), and other major conferences.

The partners frequently present their progress during various meetings, including Clinical Study (CS) meetings and Research & Development (R&D) events. Additionally, WHO carries out government engagement missions as an integral part of this collaborative process. These efforts ensure that all stakeholders are aligned and informed of the programmes work.

Role of WHO and MPP in supporting the Programme

The role of WHO and MPP, the co-facilitators of the Programme, is to support and empower. An example of this are the research and development consortia, whose creation amongst the entities involved in the Programme is being supported by WHO and MPP, and each consortium  is each being led by a research organisation also includes one or more Programme Partners.

These consortia are completely autonomous in deciding where to focus their efforts. In addition, as part of the Programme, WHO launched a bio-manufacturing training programme for people in LMICs to ensure availability of skilled local workforce in the manufacturing and regulatory fields to sustain the production of biologic countermeasures both during and between pandemics.

Afrigen CEO Dr Petro Terreblanche and some of her scientific team.

 Licensing and intellectual property (IP) strategies

Because the role of WHO and MPP is to support and empower rather than control, the Programme imposes as few conditions on the participants as possible. The major conditionality is the requirement for partners to license the intellectual property they develop to MPP, allowing MPP to sub-license it to other Programme Partners.

This model, which MPP has used for other products, encourages competition, ensuring affordability while maintaining sustainability for manufacturers. A notable example of this approach is the first-line HIV treatment regimen, which MPP sub-licensed to manufacturers, enabling the Global Fund to procure it at less than $40 per person per year—the lowest price ever achieved for such a regimen. This price reduction was driven by competition and innovation, particularly in manufacturing process optimization.

Technology transfer and capacity building

MPP’s technology transfer team plays a central role in providing technical advice, project management, and oversight during the various phases of technology development and transfer.

While MPP does not engage directly in laboratory work, it facilitates the transfer of expertise, evaluates infrastructure needs, engages with external entities supporting analytical work, and assesses workforce training requirements. A multilateral staggered technology transfer approach was adopted to expedite the process, allowing partners to access essential information as it became available.

This early access provided the Partners with the opportunity to familiarize themselves with the fundamentals of mRNA technology while Afrigen continued its initial development. MPP’s role is to support Afrigen and Biovac in developing the mRNA platform (processes and analytics) and act as an intermediary, fielding numerous requests from partners about facility designs, equipment and material specifications, process descriptions, and troubleshooting. 

By doing so, MPP ensures that Afrigen and Biovac can focus on technology development while still addressing the needs of the manufacturing Partners. This approach has been successful, so far.

Afrigen has now established an mRNA manufacturing platform at a 1 litre IVT scale and initiated the transfer of the technology to Biovac earlier this year by providing an on-site technology platform demonstration. The remaining technology platform demonstrations at Afrigen to the Programme Partners are set to begin in Q4 2024 and continue into 2025.

An Afrigen laboratory technician works on making an mRNA vaccine against SARS-Co-V2.

 Sustaining the Programme

The primary goal of the mRNA Technology Transfer Programme is to ensure that LMICs have the mRNA capacity and capability to respond to the next pandemic. To achieve this, however, it is necessary to keep manufacturing facilities ‘warm’ by producing mRNA products between pandemics. 

Since the timing of the next pandemic is unknown, and there is little appetite for indefinite subsidies, these products must have viable markets and generate a constant stream of adequate revenues. 

This was a critical lesson from WHO’s earlier influenza technology transfer initiative. Just as important to sustainability is the role of government in each of the Programme Partner’s countries. Policies must be adapted to favour the investment being made, and this includes strengthening the National Regulatory Authority, which will require an investment of time and resources. 

Changes in procurement practices across countries and regions may need to be made along with data sharing to estimate demand. Building a robust ecosystem in LMICs is an area of urgent priority. From the outset, Programme Partners and recipient countries were informed that they would need to secure their own financing, as the Programme itself would not be providing funding. 

However, France and Canada made additional funding available for specific countries. This extra funding has not influenced or distorted the Programme’s overall direction. All partners will eventually receive some level of support. However, the extent of this support may vary depending on donor preferences and whether the recipient is a public or private entity.

Additionally, the Programme has not encountered any high-income countries (HICs) unwilling to support the development or transfer of upstream inputs, such as novel lipid nanoparticles (LNPs) and antigens. 

A laboratory technician at Afrigen.

Currently, the Programme is funded until 2026. While additional funding is required to complete the year, the goal is to complete the transfer of technology to the majority of partners by that time. The Programme coordinators are working with partners to develop sustainable business models and explore new funding sources to ensure operations can continue beyond 2026.

A major part of this sustainability strategy is the creation of R&D consortia focused on developing vaccines for diseases relevant to LMICs. These consortia bring together Programme Partners, companies, research centers, and universities to collaborate on the development of vaccines and therapeutics using the mRNA platform. 

So far, four consortia have been established in Southeast Asia, working to develop preventive mRNA vaccines against dengue, Plasmodium Vivax malaria and human hand, foot and mouth disease and a therapeutic human papillomavirus mRNA vaccine. 

Ongoing R&D work is also focused on RSV, Rift Valley Fever, gonorrhoea, HIV, and tuberculosis. In a recent meeting in Brazil, three more consortia were proposed, focusing on influenza (pandemic and seasonal), leishmaniasis, and novel lipids.

Conclusion

The mRNA Technology Transfer Programme is a landmark initiative aimed at addressing the inequities in global vaccine production by empowering LMICs to develop and produce their own vaccines. 

Through a combination of technical support, knowledge-sharing, and innovative licensing strategies, the Programme is creating a sustainable model for mRNA vaccine production that will enable LMICs to respond to future public health challenges. 

As it looks beyond 2026, the Programme remains focused on ensuring its long-term viability and expanding its impact across LMICs, contributing to global health security for the years to come.

Image Credits: WHO, WHO , Kerry Cullinan, WHO.

In Dwazark Community, Freetown, Sierra Leone, students at St. Augustine School receive the HPV vaccine to protect them against cervical cancer.

On the International Day of the Girl Child, new HPV vaccine is hailed as a lifesaver

Across Africa, too many women are still dying from cervical cancer – a disease that is almost entirely preventable with HPV vaccines.  

For too long, these vaccines have been out of reach for many girls across the continent.  

But in early October, the World Health Organization (WHO) announced a decision that will help countries around the world reach more girls with these lifesaving vaccines.

The decision adds a new vaccine, Cecolin, that can be given in just one dose – in addition to two existing vaccines– helping countries vaccinate more girls with fewer resources. 

This could have a particularly big impact in Africa, which is home to 19 of the top 20 countries with the highest burden of cervical cancer. In many of these countries, access to screening and treatment for cervical cancer is limited. 

Critical preventative tool

Most cases of cervical cancer are treatable, but too many women don’t know they have cancer until it’s too late. Even when it’s caught early enough, these women may not live close enough to a hospital with the resources and specialists needed to treat cervical cancer, let alone have the funds to afford care. 

That’s why vaccines are a critical preventative tool. Vaccines that protect girls against HPV infection – the main cause of cervical cancer – are highly effective at preventing them from developing cervical cancer later in life.

For years, organizations like PATH, Gavi, the Vaccine Alliance and many others have strived to raise awareness about how HPV vaccines can improve the lives of the people in their communities.  

Thanks to these efforts, and the commitment of many African leaders to protect future generations of women against cervical cancer, we’ve made impressive progress on HPV vaccination. In 2023, 40% of girls in the African Region had received a dose of HPV vaccine, compared to only 21% in 2020. Still, vaccine coverage rates are far below what they should be if we are going to eliminate cervical cancer by 2030.  

More choice to address supply shortages

A young girl receives a single dose of HPV vaccine at Lisawo primary school in Chiradzulu, Malawi.

While many African countries are ready to introduce HPV vaccines or scale up programs, vaccine supply shortages are hindering progress.  

Every day that vaccination programs are delayed places more girls at risk of cervical cancer as they grow up. Since HPV vaccination programs mainly target girls aged 9-14, delays mean that many girls will miss out on lifesaving protection if countries are not able to reach them within this narrow window.  

Additional vaccine supply that can be given on a one-dose schedule can help countries reach more girls with these lifesaving vaccines.  

Previously, HPV vaccination has followed a two-dose regimen, but according to WHO, just one dose is sufficient to protect against cervical cancer.

Nearly 60 countries have decided to follow a one-dose schedule, from high-income to low- and middle-income countries. Countries that made the switch in 2023 increased HPV vaccine coverage by an average of 8%, vaccinating an estimated six million additional girls. 

African countries are leading efforts that could protect more girls by using a one-dose schedule – 17 African countries have already switched. 

WHO’s decision offers a new path for countries that want to introduce HPV vaccines or expand their programs using a one-dose schedule. This could be especially helpful for countries supported by Gavi, the Vaccine Alliance, which helps governments by co-financing immunization programs and helping them procure vaccines for subsidized prices. Now all three HPV vaccines on the Gavi menu can be used with a one-dose schedule. 

 Having a variety of HPV vaccines to use with a one-dose schedule means countries don’t have to wait as long to introduce vaccines.

If one manufacturer has issues, like delays or shortages, countries can rely on other options to keep HPV vaccination programs running smoothly, ensuring girls don’t have to miss out on the opportunity to get vaccinated.

Several countries in Asia and Africa are already considering what WHO’s decision could mean for their HPV vaccination efforts.   

WHO’s decision is more than just an update to a technical document; it is an opportunity for African countries to commit to safeguarding the health and future of the next generation of women.

Cervical cancer elimination is within reach, in Africa and beyond. By seizing this moment and embracing the one-dose HPV vaccine schedule, governments and leaders can ensure that no girl is left behind.

Cathy Ndiaye is Director of HPV Vaccine Programs at PATH. PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialities, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.

Image Credits: Gavi, Nadia Marini/ MSF .

Dr Jean Kaseya, Africa CDC Director General, accused the US of creating panic around Rwanda’s Marburg outbreak.

The Africa CDC has slammed the US government’s recent Level 3 travel advisory for Rwanda as unfair and baseless, arguing it undermines Rwanda’s proactive efforts to contain a Marburg outbreak. With rapid testing, vaccinations, and coordinated emergency response measures in place, Rwanda’s leaders insist the country poses no international threat and warn that travel restrictions could stoke panic and discourage transparency in future health crises.

Dr Jean Kaseya, Director General of Africa CDC, called the US decision “unfair” during a press briefing Thursday, accusing Washington of creating unnecessary panic. On October 7, state department increased the advisory level from 2 to 3, with the caveat to “reconsider travel in Rwanda due to an outbreak of Marburg Virus Disease”.

New US travel advisory on Rwanda, issued 7 October 2024.

Kaseya emphasized that Rwanda had taken a transparent and comprehensive approach to controlling the Marburg outbreak, which was declared on September 27.

“Rwanda collaborated with all partners, including the U.S., to show that there is no risk of spreading this disease,” he stated. He pointed to the country’s proactive measures, such as stringent screening processes at Kigali International Airport, effective contact tracing, and cross-border surveillance, as evidence of Rwanda’s commitment to preventing international transmission.

The press conference also featured remarks from Rwanda’s Minister of Health, Dr. Sabin Nsanzimana, who detailed the country’s rapid response efforts, which include intensive testing, vaccination campaigns targeting healthcare workers and high-risk groups, and the use of multiple therapeutic options. “We are working closely with partners across the world… although this is the most dangerous virus in the world, we came up stronger to respond,” said Nsanzimana.

Marburg outbreak, mapping both cases and location of contacts as of 2 October.

Rwanda has so far confirmed 58 cases of Marburg virus disease, with a case fatality rate (CFR) of 22%.  While that is four to five times higher than the average CFR of COVID in the first six months of the pandemic, it is significantly lower than the fatality rate of previous Marburg outbreaks in other parts of the Africa region, Nsanzimana contended.

Historically, the case fatality rate of Marburg has averaged 50%, according to WHO, although it has varied between 24-88% in different outbreak contexts.  The virus, which causes haemorrhagic fever, is in the same family as the virus that causes Ebola virus disease. Bats are regarded as a key virus reservoir.  

Rwanda’s use of advanced therapeutics and vaccine trials

Nsanzimana attributed the relatively low fatality rate to the country’s early detection of cases, rapid isolation protocols, and the administration of supportive treatments, such as antiviral drugs and monoclonal antibodies, administered to critically ill patients.

“The earlier you detect, the better the outcome,” he noted, underscoring the importance of prompt diagnosis and immediate response.

Marburg Rwanda
Rwandan Minister of Health, Sabin Nsanzimana speaking at the Africa CDC press briefing on Thursday.

Rwanda has also already administered over 200 doses of an investigational Marburg vaccine developed by the Sabin Vaccine Institute, he revealed. The vaccination campaign, which began this week, prioritizes healthcare workers and individuals in close contact with confirmed cases. The minister announced plans to expand the vaccination effort to additional high-risk groups in collaboration with international partners. “Our aim is to vaccinate as many people at risk as quickly as possible,” he added.

Despite the positive strides made, Nsanzimana acknowledged the need for more vaccine doses and indicated that Rwanda is actively working to secure additional supplies to protect healthcare workers and communities.

Rwanda has adopted an open-label approach to the vaccine trial to expedite protection for at-risk groups, Nsanzimana said. But due to the deadly nature of the disease, the initial protocol does not include a delayed-arm trial, but plans are in place to expand the study and consider alternative methodologies as more data becomes available.

“Our focus now is on saving lives and preventing transmission. We can explore more complex trial designs as we move forward,” he said.

Criticism of travel bans

Amid growing concerns about travel restrictions, both Kaseya and Nsanzimana argued that imposing travel bans is counterproductive during outbreaks, as they may deter transparency and international collaboration. “Let us be guided by facts and science,” Nsanzimana stated, pointing out that Rwanda’s efforts to contain the virus should be viewed as a model rather than grounds for punitive measures. Kaseya added that the country’s centralized emergency response system and comprehensive cross-border surveillance demonstrate its preparedness and should be encouraged, not penalized.

The Africa CDC chief emphasized that travel advisories based on limited evidence could harm not only the affected country but also the global community by discouraging other nations from reporting outbreaks in a timely manner. He disclosed that following discussions, the U.S. government had agreed to consult with Africa CDC before issuing any future travel-related advisories regarding the continent. “We need to ensure that decisions are based on evidence and consultation with local health authorities,” Kaseya said.  US officials have also praised Rwanda’s rapid outbreak response, in comments like one from Rwanda’s US Amassador Eric Kneedler on X, who called it a “model” for the region. 

Strengthening cross-border cooperation and surveillance

Kaseya and Nsanzimana also highlighted the need for cross-border cooperation and surveillance efforts aimed at containing the Marburg virus and preventing regional spread. Kaseya announced that Africa CDC is deploying rapid diagnostic testing and bolstering surveillance capabilities in neighboring countries to ensure that any potential cases are quickly identified and isolated. He revealed that more than 5,000 test kits have already been distributed to high-risk areas, and plans are underway to establish rapid testing stations at key border points.

Rwanda also revealed it has set up a centralized emergency response center that integrates all relevant services, including health workers, the military, police, and ambulance services. This coordinated approach, the minister said, allows for rapid deployment of medical personnel and other resources across the country. “The mechanism they put in place is impressive,” Kaseya said. “When a call comes in, they can locate an ambulance anywhere in the country, not just in Kigali, and deploy personnel quickly.”

Ongoing mpox outbreak: a public health concern

Roundup of mpox cases in the African region.

At the briefing, Kaseya also stressed that the ongoing mpox outbreak remains a significant public health issue across the continent, with 3,186 new cases and 53 deaths recorded during the last week of September across Africa. The Democratic Republic of Congo (DRC), Nigeria, Uganda, and other nations are grappling with the virus, which continues to spread due to limited testing capabilities and low vaccination rates. Neighboring Republic of Congo, reported its first mpox case in the capital of Brazzavile, after six weeks of no case reports.. 

The lack of sufficient laboratory infrastructure was highlighted as a major challenge in countries like Liberia and the DRC, where low testing rates hinder accurate tracking of the outbreak. “The outbreak is still there, still increasing, and we need to stay focused to stop it,” Kaseya warned, urging affected countries to prioritize improving laboratory capacity and access to diagnostics.

Mpox vaccination campaigns underway in DRC

During the briefing, officials provided updates on the mpox vaccination rollout in the DRC, where a campaign targeting high-risk regions commenced on October 5. The first phase has seen 1,654 individuals vaccinated in DRC’s eastern regions such as North Kivu, South Kivu, where M23 militias control much of the territory. Kaseya acknowledged the logistical challenges faced during the rollout, particularly the distribution of vaccines to remote and conflict-prone regions. He commended the DRC government for prioritizing vaccination in areas with the highest burden of cases and reiterated Africa CDC’s commitment to supporting similar efforts in other affected countries, including Nigeria and the Central African Republic.

Calls for solidarity

Calling for greater regional and global solidarity in the fight against disease outbreaks, Kaseya and Nsanzimana both emphasized that health crises in one region can quickly affect others. 

In addition to pressing the US to lift its Level 3 travel advisory, the Africa CDC director repeated his commitment to working with the WHO and other partners to strengthen outbreak response systems across the continent.

This includes pushing for the finalization of a global pandemic agreement that would accelerate knowledge transfer, ease intellectual property restrictions on developing countries’ use of new and patented drug formulations, and facilitate local manufacturing of vaccines and therapeutics in Africa.

“The travel ban is not a solution,” Kaseya stated, calling for continued collaboration and evidence-based decision-making. “Let us continue to work in solidarity. We are one planet, and we must face these challenges together.”

Image Credits: Africa CDC, US State Department , WHO, Africa CDC .