Praise and Criticism as Talks to Amend International Health Rules Near Conclusion 22/04/2024 Kerry Cullinan WGIHR co-chairs Ashley Bloomfield, Abdullah Assiri and Dr Tedros The penultimate meeting of a World Health Organization (WHO) working group to amend the International Health Regulations (IHR) began in Geneva on Monday amid stakeholder praise and criticism for the latest 64-page draft. The IHR are legally binding and sets out countries’ rights and obligations in handling public health events and emergencies that have the potential to cross borders. But they were found lacking during the COVID-19 pandemic and the Working Group on Amendments to the IHR (WGIHR) has been considering over 300 amendments over the past two years. WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the draft “reflects the patience, flexibility and commitment” of the WGIHR. He also expressed appreciation for the inclusion “pandemic emergency” within the process of declaring a Public Health Emergency of International Concern (PHEIC). Amazingly, the current IHR neither mention nor define a pandemic. However, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) described the “pandemic emergency” along with several other new definitions as “excessively vague”, which made it “very difficult for industry to assess the overall instrument”. Other terms condemned for vagueness include “early action alerts”, stages in the PHEIC process, and “references to health products”, said the IFPMA’s Grega Kumer. The IFPMA also believes the process of declaring the early action alerts and PHEIC leaves room for “discretion and interpretation” instead of being “based on science and evidence-based criteria”. Article 13 attracts the most attention The IHR’s amended Article 13, dealing with the “public health response, including access to health products”, attracted the most attention from stakeholders. Knowledge Ecology International (KEI) welcomed the” transparency mandate” contained in Article 13 (9C). This calls on state parties to publish “relevant terms of government-funded research agreements for health products needed to respond to a public health emergency of international concern as well as information where relevant on pricing policies regarding these products and technologies to support equitable access”, said KEI’s Thiru Balasubramaniam. “Article 13.7 envisions that WHO plays a coordinating role among state parties during public health emergencies of international concern. This coordinating role involves the facilitation of equitable access to health products, including through technology transfer on mutually agreed terms,” added Balasubramaniam. KEI suggested two options to encourage technology transfer and know-how to facilitate the development of drugs, vaccines and other countermeasures. One would “create incentives for parties to share some rights acquired from publicly funded R&D or procurements in a reciprocal manner with parties that also share”. The other would “provide money or other incentives to acquire rights to patented inventions, know-how and other inputs from private rights holders”. The Coalition for Epidemic Preparedness Innovations (CEPI) described as “commendable” that Article 13 made provision for state parties to allocate sustainable financing, but added that “they should have the support of the WHO in building, strengthening and maintaining core capacities” and in public health emergency, this should extend to “local production capacity development”. “Equally, in this article, we would like to see broader requirements for embedding equitable access terms in public funding contracts, including data sharing, affordable and sustainable pricing, manufacturing scale-up and technology transfers,” said CEPI. Third World Network (TWN), an alliance of non-profit organisations from the Global South, welcomed the proposed language on WHO’s role in equitable access to deliver health products, but said “specific methods for achieving this remain absent, particularly in Article 13.7.” TWN also that Article 4.2 bis and 13.1 shift the “implementation burden to state parties, contradicting the common but differentiated responsibilities principle and abandoning support for developing countries”. Health Action International’s Senior Policy Advisor, Jaume Vidal, condemned attempts by some countries to “water down and remove suggested amendments seeking to scale up production, diversify manufacturing and guarantee a steady supply of health technologies”. The IFPMA said that some recommendations in Article 13 lack balance and pre-empt the outcome of the pandemic agreement negotiations, “in particular, the WHO-coordinated mechanisms and networks”. Threat of avian flu Although the WGIHR meeting is set to close on Friday to enable the intergovernmental negotiation body (INB) on the pandemic agreement to resume next week, Tedros encouraged the group to “take more sessions together if you need them”. But WGIHR co-chair Dr Ashley Bloomfield urged member states to “work towards Friday this week as a firm deadline”. “We are all aware the INB process remains live with another two weeks of intense negotiations scheduled following this meeting,” said Bloomfield. “We continue to work closely with the INB co-chairs and the Bureau to ensure our work is aligned. “One reason it is important for us to complete our work this week is so that there can be a full focus on the INB negotiations in the following two weeks to maximise the chance of success in that crucial process.” Bloomfield added: “You will all be aware of the growing concern about the threat of H5N1 bird flu highlighted by the WHO just last week. We have the opportunity to ensure that the world is better prepared both individual countries and collectively to address that thread through strengthening core capacities in all states parties.” World Bank Launches Ambitious Plan to Expand Health Services 19/04/2024 Kerry Cullinan World Bank president Ajay Banga (centre) addresses an event to announce the new focus. He is flanked by Shakuntala Santhiran and WHO’s Dr Tedros. The World Bank aims to support countries to deliver “quality, affordable health services” to 1.5 billion people by 2030, it announced during its ‘spring’ meeting in Washington this week. It will expand its current focus from maternal and child health to include “coverage throughout a person’s lifetime, including non-communicable diseases”; hard-to-reach areas, including remote villages, cities, and countries; and working with governments to “cut unnecessary fees and other financial barriers to health care”, the Bank announced on Thursday. “The Bank has been working in 100 countries for a while on a maternal and neonatal effort to improve the delivery of care to women and young babies,” said World Bank president Ajay Banga at an event to announce the Bank’s new focus. .@WorldBank aims to improve health care services to include coverage throughout a person’s lifetime. Together with @WHO and partners, we're targeting to reach 1.5 billion people by 2030. Watch the event replay: https://t.co/NmjAo6f4pp #WBGMeetings pic.twitter.com/CTKDLxA7m0 — World Bank (@WorldBank) April 19, 2024 “We want to widen our aperture to include the diseases across adults, adolescents and old age.” Banga said that the Bank intended to “really reach them… actually touching the person with a medical appointment, either physical or telehealth, working on this expanded range of noncommunicable diseases, that’s the effort we’re going to try and put in by now in 2030”. World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus said that around 4.5 billion people lacked adequate health coverage, while two billion face financial hardship trying to get health services, some “descending into poverty” as a result. The task is complicated by what the Bank describes as “intertwined challenges, such as climate change, pandemics, conflicts, societal ageing, and a projected shortfall of 10 million healthcare workers by 2030”. How will this be achieved? “A lot of hard work, a lot of knowledge, a lot of financing, and a lot of partnerships,” is how the aim will be realised, said Banga. “Financing is the obvious one. We’re a money bank and a knowledge bank. But even the money we can put to work will never be enough. We’re talking about putting to work 50% more money per year than what we used to spend on health care, pre- the pandemic,” he said. But governments and the private sector would also have to invest in the effort. Low-income countries spend an average of $21 per person, per year on health care. “That’s not going to get to health care workers in remote areas. So we have to give them share financing, concessional and grant financing,” said Banga. Middle-income countries have more money available, but “may not have the right regulatory policies to create the multiplier that you want to create” – which could be done through private sector involvement. “We can help with incentivizing them to create the right regulatory platforms and the right policies.” This could involve private sector involvement in manufacturing essential medicines, or fortifying basic foods with vitamins. Discussions with countries would involve identifying what they need to do to break through their barriers to deliver their share of the 1.5 billion – skills, infrastructure, medicines. “We bring a diversification of knowledge. We understand water, we understand climate, we understand agriculture. We understand how those connect to health challenges. “We can bring that knowledge as a partner, not just our financing, not just our ability to advise governments on regulatory policy, but our ability to help understand the intersections between these different causes of healthcare problems in the intertwined challenges that we are going through,” Banga concluded. New WHO Terminology to Clear Confusion over ‘Airborne’ Pathogens 19/04/2024 Kerry Cullinan The World Health Organization (WHO) has published a new technical report including updated terminology to describe pathogens that are transmitted through the air, following “an extensive, multi-year, collaborative effort”. It follows confusion and contestation between scientists during the COVID-19 pandemic because of the “varying terminologies” and “gaps in common understanding”, said the WHO. These “contributed to challenges in public communication and efforts to curb the transmission of the pathogen”. However, a number of scientists called out the WHO itself for being slow to acknowledge that SARS-CoV2 could be transmitted in the air. “Together with a very diverse range of leading public health agencies and experts across multiple disciplines, we are pleased to have been able to address this complex and timely issue and reach a consensus,” said Dr Jeremy Farrar, WHO’s Chief Scientist. “The agreed terminology for pathogens that transmit through the air will help set a new path for research agendas and implementation of public health interventions to identify, communicate and respond to existing and new pathogens.” Experts and four major public health agencies – the Africa Centres for Disease Control Prevention, Chinese Center for Disease Control and Prevention, European Centre for Disease Prevention and Control and US Centers for Disease Control and Prevention – were consulted between 2021 and 2023. Away with ‘aerosols’ and ‘droplets’ Instead of ‘aerosols’ and ‘droplets’, the report uses the new descriptor, ‘infectious respiratory particles’ (IRPs), describing these as existing “on a continuous spectrum of sizes, and no single cut-off points should be applied to distinguish smaller from larger particles”. This facilitates a “away from the dichotomy of previously used terms: ‘aerosols’ (generally smaller particles) and ‘droplets’ (generally larger particles)”. These IRPs are transmitted by people infected by a respiratory pathogen “through their mouth or nose by breathing, talking, singing, spitting, coughing or sneezing”. ‘Through the air’ Under the umbrella of ‘through the air’ transmission, the report advises the use of two descriptors. The first is “airborne transmission or inhalation” for cases when IRPs are expelled into the air and inhaled by another person, who could be at quite a distance from the infected person. The second is “direct deposition” for cases when IRPs are expelled into the air from an infectious person, and are then directly deposited on the exposed mouth, nose or eyes of another person nearby. The pathogens covered include those that cause respiratory infections, such as COVID-19, influenza, measles, Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and tuberculosis. Image Credits: Towfiqu Barbhuiya/ Unsplash. Bed Nets Treated With Two Insecticides Instead of One Are Much More Effective Against Malaria 19/04/2024 Zuzanna Stawiska A resident of Ifakara tucked into a mosquito net Bed nets treated with an additional insecticide are between 20% and 50% more effective in preventing malaria than those treated with the standard single pyrethroid insecticide, according to pilots in 17 sub-Saharan Africa. The New Nets Project successfully piloted nets impregnated with a new generation pyrrole insecticide in combination with pyrethroid in response to growing resistance by the malaria-carrying Anopheles mosquitoes to pyrethroid. Between 2019 and 2022, the New Nets Project supported the deployment of 38.4 million nets across sub-Saharan Africa. In parallel, the Global Fund and US President’s Malaria Initiative (PMI) supported the deployment of millions of additional nets under an internal initiative. As a result, 56 million mosquito nets were introduced in 17 countries across sub-Saharan Africa. Two clinical trials and five pilot studies, delivered through the New Nets Project found the new nets could improve malaria control by approximately 20-50% in countries reporting insecticide resistance in sub-Saharan Africa, compared to standard nets. The intervention has the potential to avert about 13 million malaria cases and save 24,600 lives, according to its funders, Unitaid and the Global Fund, and the lead implementer, the Innovative Vector Control Consortium (IVCC). The epidemiological evidence built throughout the project led the World Health Organization (WHO) to publish new recommendations supporting pyrethroid-chlorfenapyr nets instead of pyrethroid-only nets in countries facing pyrethroid resistance. “We are delighted to see that the dual active ingredient insecticide-treated nets have demonstrated exceptional impact against malaria,” said Peter Sands, executive director of the Global Fund. Unitaid’s executive director, Dr. Philippe Duneton, said “The New Nets Project has made a massive contribution to malaria control efforts, helping to accelerate the introduction of next-generation bed nets – a critically important tool for reducing malaria cases and deaths. “ Global burden of malaria. Most DALYs in Sub-Saharan Africa. Malaria is a life-threatening infectious disease with an estimated 249 million cases and 608 000 deaths in 2022, according to the World Malaria Report. It is present in 85 countries, with 95% of cases in the African region. Children under the age of five account for as much as about 80% of malaria deaths. While some malaria cases are mild, others prove deadly, progressing to severe illness and death within 24 hours. Symptoms range from fever, chills and headache to seizures, confusion and difficulty breathing. As it is transmitted through mosquito bites, much of the malaria control efforts go into vector control, that is protection against mosquitoes through insecticide-treated bed nets and indoor residual spraying to prevent mosquitoes from staying on the house roof or walls. Yet, as malaria-carrying mosquitoes adapt to insecticides, a new chemical is likely only a short-term solution. Malaria control requires broad action with multiple solutions implemented. Next to bed nets, many public and private actors concentrate on vaccines, treatments, preventive doses for risk groups and other measures. “The findings of the New Nets Project demonstrate the value of investments into state-of-the-art tools in the fight against malaria. We always say that there is no silver bullet to eliminating malaria and we cannot rely on single interventions but rather invest in a suite of tools, which when combined, will have the biggest impact on defeating this disease,” said Dr. Michael Charles, CEO of the RBM Partnership to End Malaria. Image Credits: Peter Mgongo, IHME. Sudan Gets Donor Boost As First Anniversary of War is Marked by Famine and Mass Displacement 19/04/2024 Sophia Samantaroy UNICEF screening for malnutrition in the River Nile state A year into one of the most brutal conflicts in decades, the war in Sudan has triggered the world’s largest displacement crisis and left the country’s healthcare system in tatters. Nearly 25 million people need immediate humanitarian assistance, according to the United Nations (UN) and over 18 million people face acute food insecurity, with the World Food Programme (WFP) warning that the situation could quickly slip into “catastrophic” food insecurity levels. In light of this accelerating humanitarian crisis, governments, donors, and aid organizations met in Paris on the first anniversary of the war, aiming to “break the silence surrounding this conflict and mobilize the international community,” said French Foreign Minister Stéphane Séjourné said in his opening remarks. The Sudanese people have suffered not only from the catastrophe of war, but also from international “indifference,” said Séjourné, while international organizations struggled to meet key funding needs. “The scale of this catastrophe far outstrips the international community’s attention,” said World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus. The conflicts in Gaza and Ukraine have garnered most of the international community’s attention, and funding. Only 6% of the UN’s emergency funding appeal was met before the Paris conference. Similarly, only 7% of the $1.4 billion Regional Refugee Response Plan for the Sudan Crisis was funded. Donors responded to pleas for humanitarian funding, pledging 2.13 billion in aid for Sudan. Top contributors were the European Union (EU), co-sponsors France and Germany, the US and the UK. “We can manage together to avoid a terrible famine catastrophe, but only if we get active together now,” German Foreign Minister Annalena Baerbock said, adding that, in the worst-case scenario, one million people could die of hunger this year. Tedros echoed this sentiment, calling for access across borders and humanitarian corridors, the cease of attacks on healthcare facilities, funding for both health-related aid and for the UN in general: “This is a health crisis that could reverberate across generations.” Heavy fighting persists “People in Sudan are suffering immensely as heavy fighting persists, including bombardments, shelling and ground operations in residential urban areas and in villages, and the health system and basic services have largely collapsed or been damaged by the warring parties,” said Jean Stowell, Medecins sans Frontieres (MSF) head of Sudan mission. “Only 20-30% of health facilities remain functional in Sudan, meaning that there is extremely limited availability of health care for people across the country.” The number of operational healthcare facilities has decreased even further since February 2024. Healthcare facilities themselves have been subject to attacks. The World Health Organization (WHO) reports 62 confirmed attacks, but notes that these numbers are most likely underestimates. In the 12 months of conflict the warring sides repeatedly and intentionally blocked humanitarian and medical aid. A United Nations graphic of the humanitarian crisis in Sudan The disruption of basic needs has meant that routine immunizations, care for pregnant women and babies, and chronic disease care has “dropped precipitously.” In the Darfur region alone, only 30% of children have received routine immunizations, according to the United Nations Children’s Fund (UNICEF.) The country has seen outbreaks of measles, malaria, dengue fever, cholera, and other water-borne illnesses. Since March, the country has reported over 5,000 cases of measles and 106 deaths. While a nationwide “catch up” measles vaccination campaign was successfully conducted across seven Sudanese states in January 2024, the campaign was unable to cover the Darfur or Kordofan states. Both regions have seen some of the heaviest fighting; no immunizations have been possible since the conflict began. Children bear the brunt of these healthcare disruptions. “After 365 days of conflict, the children of Sudan remain at the sharp end of a horrific war,” said UNICEF Deputy Executive Director, Ted Chaiban this week. “If immediate steps are not taken to halt the violence, facilitate humanitarian access and provide lifesaving aid to those in need, an even worse catastrophe is likely to impact children for many years to come.” The threat of malnutrition Acute food insecurity in Sudan have soared in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions Since violence erupted on 15 April 2023 between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF), the country has experienced the highest levels of food insecurity in its history. More than 710,000 children face severe acute malnutrition, “representing the highest number of people in need of nutrition assistance ever recorded in Sudan,” according to the WHO. Without humanitarian assistance, the number could rise to 3.5 million children before the end of 2024. These levels surpass the WHO’s emergency thresholds for acute malnutrition, and raise concerns for an expected famine. For the first time since the crisis began, displacement in the Darfur states is now being driven by hunger rather than violence, according to the most recent WHO public health situation analysis. This acceleration of widespread severe food insecurity is most prominent in rural households, where up to 59 percent face moderate or severe food insecurity. The states of West Kordofan, South Kordofan, and Blue Nile have seen the highest levels, according to a new study from United Nations Development Programme (UNDP) and the International Food Policy Research Institute (IFPRI). The study warns that a famine in Sudan is expected in 2024, particularly in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions. Key food sources disrupted Food insecurity is now driving displacement in the Darfur states The conflict has affected cereal production in particular, pushing more people into hunger, according to the Food and Agriculture Organization of the United Nations (FAO). The situation requires “urgent and at-scale agricultural support ahead of the planting season starting in June,” said Rein Paulsen, Director of the FAO Office of Emergencies and Resilience. The production output of key cereal crops in 2023 decreased 46 percent from the previous year, and 40 percent below the average from the previous five years. “This is a very practical manifestation of the impact of clashes, conflict and violence on food production. We clearly have a context that requires urgent and appropriate support. This is why FAO’s interventions are so incredibly important at this point in time,” said Paulsen, who is currently on a field mission to the country to evaluate the food security situation on the ground. Preventing a looming famine requires an immediate ceasefire, unhindered humanitarian access, and increased support for humanitarian needs, concludes the report. Image Credits: UNICEF/UNI530171/Mohamdeen, Integrated Food Security Phase Classification, United Nations Office for the Coordination of Humanitarian Affairs (OCHA). To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
World Bank Launches Ambitious Plan to Expand Health Services 19/04/2024 Kerry Cullinan World Bank president Ajay Banga (centre) addresses an event to announce the new focus. He is flanked by Shakuntala Santhiran and WHO’s Dr Tedros. The World Bank aims to support countries to deliver “quality, affordable health services” to 1.5 billion people by 2030, it announced during its ‘spring’ meeting in Washington this week. It will expand its current focus from maternal and child health to include “coverage throughout a person’s lifetime, including non-communicable diseases”; hard-to-reach areas, including remote villages, cities, and countries; and working with governments to “cut unnecessary fees and other financial barriers to health care”, the Bank announced on Thursday. “The Bank has been working in 100 countries for a while on a maternal and neonatal effort to improve the delivery of care to women and young babies,” said World Bank president Ajay Banga at an event to announce the Bank’s new focus. .@WorldBank aims to improve health care services to include coverage throughout a person’s lifetime. Together with @WHO and partners, we're targeting to reach 1.5 billion people by 2030. Watch the event replay: https://t.co/NmjAo6f4pp #WBGMeetings pic.twitter.com/CTKDLxA7m0 — World Bank (@WorldBank) April 19, 2024 “We want to widen our aperture to include the diseases across adults, adolescents and old age.” Banga said that the Bank intended to “really reach them… actually touching the person with a medical appointment, either physical or telehealth, working on this expanded range of noncommunicable diseases, that’s the effort we’re going to try and put in by now in 2030”. World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus said that around 4.5 billion people lacked adequate health coverage, while two billion face financial hardship trying to get health services, some “descending into poverty” as a result. The task is complicated by what the Bank describes as “intertwined challenges, such as climate change, pandemics, conflicts, societal ageing, and a projected shortfall of 10 million healthcare workers by 2030”. How will this be achieved? “A lot of hard work, a lot of knowledge, a lot of financing, and a lot of partnerships,” is how the aim will be realised, said Banga. “Financing is the obvious one. We’re a money bank and a knowledge bank. But even the money we can put to work will never be enough. We’re talking about putting to work 50% more money per year than what we used to spend on health care, pre- the pandemic,” he said. But governments and the private sector would also have to invest in the effort. Low-income countries spend an average of $21 per person, per year on health care. “That’s not going to get to health care workers in remote areas. So we have to give them share financing, concessional and grant financing,” said Banga. Middle-income countries have more money available, but “may not have the right regulatory policies to create the multiplier that you want to create” – which could be done through private sector involvement. “We can help with incentivizing them to create the right regulatory platforms and the right policies.” This could involve private sector involvement in manufacturing essential medicines, or fortifying basic foods with vitamins. Discussions with countries would involve identifying what they need to do to break through their barriers to deliver their share of the 1.5 billion – skills, infrastructure, medicines. “We bring a diversification of knowledge. We understand water, we understand climate, we understand agriculture. We understand how those connect to health challenges. “We can bring that knowledge as a partner, not just our financing, not just our ability to advise governments on regulatory policy, but our ability to help understand the intersections between these different causes of healthcare problems in the intertwined challenges that we are going through,” Banga concluded. New WHO Terminology to Clear Confusion over ‘Airborne’ Pathogens 19/04/2024 Kerry Cullinan The World Health Organization (WHO) has published a new technical report including updated terminology to describe pathogens that are transmitted through the air, following “an extensive, multi-year, collaborative effort”. It follows confusion and contestation between scientists during the COVID-19 pandemic because of the “varying terminologies” and “gaps in common understanding”, said the WHO. These “contributed to challenges in public communication and efforts to curb the transmission of the pathogen”. However, a number of scientists called out the WHO itself for being slow to acknowledge that SARS-CoV2 could be transmitted in the air. “Together with a very diverse range of leading public health agencies and experts across multiple disciplines, we are pleased to have been able to address this complex and timely issue and reach a consensus,” said Dr Jeremy Farrar, WHO’s Chief Scientist. “The agreed terminology for pathogens that transmit through the air will help set a new path for research agendas and implementation of public health interventions to identify, communicate and respond to existing and new pathogens.” Experts and four major public health agencies – the Africa Centres for Disease Control Prevention, Chinese Center for Disease Control and Prevention, European Centre for Disease Prevention and Control and US Centers for Disease Control and Prevention – were consulted between 2021 and 2023. Away with ‘aerosols’ and ‘droplets’ Instead of ‘aerosols’ and ‘droplets’, the report uses the new descriptor, ‘infectious respiratory particles’ (IRPs), describing these as existing “on a continuous spectrum of sizes, and no single cut-off points should be applied to distinguish smaller from larger particles”. This facilitates a “away from the dichotomy of previously used terms: ‘aerosols’ (generally smaller particles) and ‘droplets’ (generally larger particles)”. These IRPs are transmitted by people infected by a respiratory pathogen “through their mouth or nose by breathing, talking, singing, spitting, coughing or sneezing”. ‘Through the air’ Under the umbrella of ‘through the air’ transmission, the report advises the use of two descriptors. The first is “airborne transmission or inhalation” for cases when IRPs are expelled into the air and inhaled by another person, who could be at quite a distance from the infected person. The second is “direct deposition” for cases when IRPs are expelled into the air from an infectious person, and are then directly deposited on the exposed mouth, nose or eyes of another person nearby. The pathogens covered include those that cause respiratory infections, such as COVID-19, influenza, measles, Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and tuberculosis. Image Credits: Towfiqu Barbhuiya/ Unsplash. Bed Nets Treated With Two Insecticides Instead of One Are Much More Effective Against Malaria 19/04/2024 Zuzanna Stawiska A resident of Ifakara tucked into a mosquito net Bed nets treated with an additional insecticide are between 20% and 50% more effective in preventing malaria than those treated with the standard single pyrethroid insecticide, according to pilots in 17 sub-Saharan Africa. The New Nets Project successfully piloted nets impregnated with a new generation pyrrole insecticide in combination with pyrethroid in response to growing resistance by the malaria-carrying Anopheles mosquitoes to pyrethroid. Between 2019 and 2022, the New Nets Project supported the deployment of 38.4 million nets across sub-Saharan Africa. In parallel, the Global Fund and US President’s Malaria Initiative (PMI) supported the deployment of millions of additional nets under an internal initiative. As a result, 56 million mosquito nets were introduced in 17 countries across sub-Saharan Africa. Two clinical trials and five pilot studies, delivered through the New Nets Project found the new nets could improve malaria control by approximately 20-50% in countries reporting insecticide resistance in sub-Saharan Africa, compared to standard nets. The intervention has the potential to avert about 13 million malaria cases and save 24,600 lives, according to its funders, Unitaid and the Global Fund, and the lead implementer, the Innovative Vector Control Consortium (IVCC). The epidemiological evidence built throughout the project led the World Health Organization (WHO) to publish new recommendations supporting pyrethroid-chlorfenapyr nets instead of pyrethroid-only nets in countries facing pyrethroid resistance. “We are delighted to see that the dual active ingredient insecticide-treated nets have demonstrated exceptional impact against malaria,” said Peter Sands, executive director of the Global Fund. Unitaid’s executive director, Dr. Philippe Duneton, said “The New Nets Project has made a massive contribution to malaria control efforts, helping to accelerate the introduction of next-generation bed nets – a critically important tool for reducing malaria cases and deaths. “ Global burden of malaria. Most DALYs in Sub-Saharan Africa. Malaria is a life-threatening infectious disease with an estimated 249 million cases and 608 000 deaths in 2022, according to the World Malaria Report. It is present in 85 countries, with 95% of cases in the African region. Children under the age of five account for as much as about 80% of malaria deaths. While some malaria cases are mild, others prove deadly, progressing to severe illness and death within 24 hours. Symptoms range from fever, chills and headache to seizures, confusion and difficulty breathing. As it is transmitted through mosquito bites, much of the malaria control efforts go into vector control, that is protection against mosquitoes through insecticide-treated bed nets and indoor residual spraying to prevent mosquitoes from staying on the house roof or walls. Yet, as malaria-carrying mosquitoes adapt to insecticides, a new chemical is likely only a short-term solution. Malaria control requires broad action with multiple solutions implemented. Next to bed nets, many public and private actors concentrate on vaccines, treatments, preventive doses for risk groups and other measures. “The findings of the New Nets Project demonstrate the value of investments into state-of-the-art tools in the fight against malaria. We always say that there is no silver bullet to eliminating malaria and we cannot rely on single interventions but rather invest in a suite of tools, which when combined, will have the biggest impact on defeating this disease,” said Dr. Michael Charles, CEO of the RBM Partnership to End Malaria. Image Credits: Peter Mgongo, IHME. Sudan Gets Donor Boost As First Anniversary of War is Marked by Famine and Mass Displacement 19/04/2024 Sophia Samantaroy UNICEF screening for malnutrition in the River Nile state A year into one of the most brutal conflicts in decades, the war in Sudan has triggered the world’s largest displacement crisis and left the country’s healthcare system in tatters. Nearly 25 million people need immediate humanitarian assistance, according to the United Nations (UN) and over 18 million people face acute food insecurity, with the World Food Programme (WFP) warning that the situation could quickly slip into “catastrophic” food insecurity levels. In light of this accelerating humanitarian crisis, governments, donors, and aid organizations met in Paris on the first anniversary of the war, aiming to “break the silence surrounding this conflict and mobilize the international community,” said French Foreign Minister Stéphane Séjourné said in his opening remarks. The Sudanese people have suffered not only from the catastrophe of war, but also from international “indifference,” said Séjourné, while international organizations struggled to meet key funding needs. “The scale of this catastrophe far outstrips the international community’s attention,” said World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus. The conflicts in Gaza and Ukraine have garnered most of the international community’s attention, and funding. Only 6% of the UN’s emergency funding appeal was met before the Paris conference. Similarly, only 7% of the $1.4 billion Regional Refugee Response Plan for the Sudan Crisis was funded. Donors responded to pleas for humanitarian funding, pledging 2.13 billion in aid for Sudan. Top contributors were the European Union (EU), co-sponsors France and Germany, the US and the UK. “We can manage together to avoid a terrible famine catastrophe, but only if we get active together now,” German Foreign Minister Annalena Baerbock said, adding that, in the worst-case scenario, one million people could die of hunger this year. Tedros echoed this sentiment, calling for access across borders and humanitarian corridors, the cease of attacks on healthcare facilities, funding for both health-related aid and for the UN in general: “This is a health crisis that could reverberate across generations.” Heavy fighting persists “People in Sudan are suffering immensely as heavy fighting persists, including bombardments, shelling and ground operations in residential urban areas and in villages, and the health system and basic services have largely collapsed or been damaged by the warring parties,” said Jean Stowell, Medecins sans Frontieres (MSF) head of Sudan mission. “Only 20-30% of health facilities remain functional in Sudan, meaning that there is extremely limited availability of health care for people across the country.” The number of operational healthcare facilities has decreased even further since February 2024. Healthcare facilities themselves have been subject to attacks. The World Health Organization (WHO) reports 62 confirmed attacks, but notes that these numbers are most likely underestimates. In the 12 months of conflict the warring sides repeatedly and intentionally blocked humanitarian and medical aid. A United Nations graphic of the humanitarian crisis in Sudan The disruption of basic needs has meant that routine immunizations, care for pregnant women and babies, and chronic disease care has “dropped precipitously.” In the Darfur region alone, only 30% of children have received routine immunizations, according to the United Nations Children’s Fund (UNICEF.) The country has seen outbreaks of measles, malaria, dengue fever, cholera, and other water-borne illnesses. Since March, the country has reported over 5,000 cases of measles and 106 deaths. While a nationwide “catch up” measles vaccination campaign was successfully conducted across seven Sudanese states in January 2024, the campaign was unable to cover the Darfur or Kordofan states. Both regions have seen some of the heaviest fighting; no immunizations have been possible since the conflict began. Children bear the brunt of these healthcare disruptions. “After 365 days of conflict, the children of Sudan remain at the sharp end of a horrific war,” said UNICEF Deputy Executive Director, Ted Chaiban this week. “If immediate steps are not taken to halt the violence, facilitate humanitarian access and provide lifesaving aid to those in need, an even worse catastrophe is likely to impact children for many years to come.” The threat of malnutrition Acute food insecurity in Sudan have soared in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions Since violence erupted on 15 April 2023 between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF), the country has experienced the highest levels of food insecurity in its history. More than 710,000 children face severe acute malnutrition, “representing the highest number of people in need of nutrition assistance ever recorded in Sudan,” according to the WHO. Without humanitarian assistance, the number could rise to 3.5 million children before the end of 2024. These levels surpass the WHO’s emergency thresholds for acute malnutrition, and raise concerns for an expected famine. For the first time since the crisis began, displacement in the Darfur states is now being driven by hunger rather than violence, according to the most recent WHO public health situation analysis. This acceleration of widespread severe food insecurity is most prominent in rural households, where up to 59 percent face moderate or severe food insecurity. The states of West Kordofan, South Kordofan, and Blue Nile have seen the highest levels, according to a new study from United Nations Development Programme (UNDP) and the International Food Policy Research Institute (IFPRI). The study warns that a famine in Sudan is expected in 2024, particularly in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions. Key food sources disrupted Food insecurity is now driving displacement in the Darfur states The conflict has affected cereal production in particular, pushing more people into hunger, according to the Food and Agriculture Organization of the United Nations (FAO). The situation requires “urgent and at-scale agricultural support ahead of the planting season starting in June,” said Rein Paulsen, Director of the FAO Office of Emergencies and Resilience. The production output of key cereal crops in 2023 decreased 46 percent from the previous year, and 40 percent below the average from the previous five years. “This is a very practical manifestation of the impact of clashes, conflict and violence on food production. We clearly have a context that requires urgent and appropriate support. This is why FAO’s interventions are so incredibly important at this point in time,” said Paulsen, who is currently on a field mission to the country to evaluate the food security situation on the ground. Preventing a looming famine requires an immediate ceasefire, unhindered humanitarian access, and increased support for humanitarian needs, concludes the report. Image Credits: UNICEF/UNI530171/Mohamdeen, Integrated Food Security Phase Classification, United Nations Office for the Coordination of Humanitarian Affairs (OCHA). To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
New WHO Terminology to Clear Confusion over ‘Airborne’ Pathogens 19/04/2024 Kerry Cullinan The World Health Organization (WHO) has published a new technical report including updated terminology to describe pathogens that are transmitted through the air, following “an extensive, multi-year, collaborative effort”. It follows confusion and contestation between scientists during the COVID-19 pandemic because of the “varying terminologies” and “gaps in common understanding”, said the WHO. These “contributed to challenges in public communication and efforts to curb the transmission of the pathogen”. However, a number of scientists called out the WHO itself for being slow to acknowledge that SARS-CoV2 could be transmitted in the air. “Together with a very diverse range of leading public health agencies and experts across multiple disciplines, we are pleased to have been able to address this complex and timely issue and reach a consensus,” said Dr Jeremy Farrar, WHO’s Chief Scientist. “The agreed terminology for pathogens that transmit through the air will help set a new path for research agendas and implementation of public health interventions to identify, communicate and respond to existing and new pathogens.” Experts and four major public health agencies – the Africa Centres for Disease Control Prevention, Chinese Center for Disease Control and Prevention, European Centre for Disease Prevention and Control and US Centers for Disease Control and Prevention – were consulted between 2021 and 2023. Away with ‘aerosols’ and ‘droplets’ Instead of ‘aerosols’ and ‘droplets’, the report uses the new descriptor, ‘infectious respiratory particles’ (IRPs), describing these as existing “on a continuous spectrum of sizes, and no single cut-off points should be applied to distinguish smaller from larger particles”. This facilitates a “away from the dichotomy of previously used terms: ‘aerosols’ (generally smaller particles) and ‘droplets’ (generally larger particles)”. These IRPs are transmitted by people infected by a respiratory pathogen “through their mouth or nose by breathing, talking, singing, spitting, coughing or sneezing”. ‘Through the air’ Under the umbrella of ‘through the air’ transmission, the report advises the use of two descriptors. The first is “airborne transmission or inhalation” for cases when IRPs are expelled into the air and inhaled by another person, who could be at quite a distance from the infected person. The second is “direct deposition” for cases when IRPs are expelled into the air from an infectious person, and are then directly deposited on the exposed mouth, nose or eyes of another person nearby. The pathogens covered include those that cause respiratory infections, such as COVID-19, influenza, measles, Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and tuberculosis. Image Credits: Towfiqu Barbhuiya/ Unsplash. Bed Nets Treated With Two Insecticides Instead of One Are Much More Effective Against Malaria 19/04/2024 Zuzanna Stawiska A resident of Ifakara tucked into a mosquito net Bed nets treated with an additional insecticide are between 20% and 50% more effective in preventing malaria than those treated with the standard single pyrethroid insecticide, according to pilots in 17 sub-Saharan Africa. The New Nets Project successfully piloted nets impregnated with a new generation pyrrole insecticide in combination with pyrethroid in response to growing resistance by the malaria-carrying Anopheles mosquitoes to pyrethroid. Between 2019 and 2022, the New Nets Project supported the deployment of 38.4 million nets across sub-Saharan Africa. In parallel, the Global Fund and US President’s Malaria Initiative (PMI) supported the deployment of millions of additional nets under an internal initiative. As a result, 56 million mosquito nets were introduced in 17 countries across sub-Saharan Africa. Two clinical trials and five pilot studies, delivered through the New Nets Project found the new nets could improve malaria control by approximately 20-50% in countries reporting insecticide resistance in sub-Saharan Africa, compared to standard nets. The intervention has the potential to avert about 13 million malaria cases and save 24,600 lives, according to its funders, Unitaid and the Global Fund, and the lead implementer, the Innovative Vector Control Consortium (IVCC). The epidemiological evidence built throughout the project led the World Health Organization (WHO) to publish new recommendations supporting pyrethroid-chlorfenapyr nets instead of pyrethroid-only nets in countries facing pyrethroid resistance. “We are delighted to see that the dual active ingredient insecticide-treated nets have demonstrated exceptional impact against malaria,” said Peter Sands, executive director of the Global Fund. Unitaid’s executive director, Dr. Philippe Duneton, said “The New Nets Project has made a massive contribution to malaria control efforts, helping to accelerate the introduction of next-generation bed nets – a critically important tool for reducing malaria cases and deaths. “ Global burden of malaria. Most DALYs in Sub-Saharan Africa. Malaria is a life-threatening infectious disease with an estimated 249 million cases and 608 000 deaths in 2022, according to the World Malaria Report. It is present in 85 countries, with 95% of cases in the African region. Children under the age of five account for as much as about 80% of malaria deaths. While some malaria cases are mild, others prove deadly, progressing to severe illness and death within 24 hours. Symptoms range from fever, chills and headache to seizures, confusion and difficulty breathing. As it is transmitted through mosquito bites, much of the malaria control efforts go into vector control, that is protection against mosquitoes through insecticide-treated bed nets and indoor residual spraying to prevent mosquitoes from staying on the house roof or walls. Yet, as malaria-carrying mosquitoes adapt to insecticides, a new chemical is likely only a short-term solution. Malaria control requires broad action with multiple solutions implemented. Next to bed nets, many public and private actors concentrate on vaccines, treatments, preventive doses for risk groups and other measures. “The findings of the New Nets Project demonstrate the value of investments into state-of-the-art tools in the fight against malaria. We always say that there is no silver bullet to eliminating malaria and we cannot rely on single interventions but rather invest in a suite of tools, which when combined, will have the biggest impact on defeating this disease,” said Dr. Michael Charles, CEO of the RBM Partnership to End Malaria. Image Credits: Peter Mgongo, IHME. Sudan Gets Donor Boost As First Anniversary of War is Marked by Famine and Mass Displacement 19/04/2024 Sophia Samantaroy UNICEF screening for malnutrition in the River Nile state A year into one of the most brutal conflicts in decades, the war in Sudan has triggered the world’s largest displacement crisis and left the country’s healthcare system in tatters. Nearly 25 million people need immediate humanitarian assistance, according to the United Nations (UN) and over 18 million people face acute food insecurity, with the World Food Programme (WFP) warning that the situation could quickly slip into “catastrophic” food insecurity levels. In light of this accelerating humanitarian crisis, governments, donors, and aid organizations met in Paris on the first anniversary of the war, aiming to “break the silence surrounding this conflict and mobilize the international community,” said French Foreign Minister Stéphane Séjourné said in his opening remarks. The Sudanese people have suffered not only from the catastrophe of war, but also from international “indifference,” said Séjourné, while international organizations struggled to meet key funding needs. “The scale of this catastrophe far outstrips the international community’s attention,” said World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus. The conflicts in Gaza and Ukraine have garnered most of the international community’s attention, and funding. Only 6% of the UN’s emergency funding appeal was met before the Paris conference. Similarly, only 7% of the $1.4 billion Regional Refugee Response Plan for the Sudan Crisis was funded. Donors responded to pleas for humanitarian funding, pledging 2.13 billion in aid for Sudan. Top contributors were the European Union (EU), co-sponsors France and Germany, the US and the UK. “We can manage together to avoid a terrible famine catastrophe, but only if we get active together now,” German Foreign Minister Annalena Baerbock said, adding that, in the worst-case scenario, one million people could die of hunger this year. Tedros echoed this sentiment, calling for access across borders and humanitarian corridors, the cease of attacks on healthcare facilities, funding for both health-related aid and for the UN in general: “This is a health crisis that could reverberate across generations.” Heavy fighting persists “People in Sudan are suffering immensely as heavy fighting persists, including bombardments, shelling and ground operations in residential urban areas and in villages, and the health system and basic services have largely collapsed or been damaged by the warring parties,” said Jean Stowell, Medecins sans Frontieres (MSF) head of Sudan mission. “Only 20-30% of health facilities remain functional in Sudan, meaning that there is extremely limited availability of health care for people across the country.” The number of operational healthcare facilities has decreased even further since February 2024. Healthcare facilities themselves have been subject to attacks. The World Health Organization (WHO) reports 62 confirmed attacks, but notes that these numbers are most likely underestimates. In the 12 months of conflict the warring sides repeatedly and intentionally blocked humanitarian and medical aid. A United Nations graphic of the humanitarian crisis in Sudan The disruption of basic needs has meant that routine immunizations, care for pregnant women and babies, and chronic disease care has “dropped precipitously.” In the Darfur region alone, only 30% of children have received routine immunizations, according to the United Nations Children’s Fund (UNICEF.) The country has seen outbreaks of measles, malaria, dengue fever, cholera, and other water-borne illnesses. Since March, the country has reported over 5,000 cases of measles and 106 deaths. While a nationwide “catch up” measles vaccination campaign was successfully conducted across seven Sudanese states in January 2024, the campaign was unable to cover the Darfur or Kordofan states. Both regions have seen some of the heaviest fighting; no immunizations have been possible since the conflict began. Children bear the brunt of these healthcare disruptions. “After 365 days of conflict, the children of Sudan remain at the sharp end of a horrific war,” said UNICEF Deputy Executive Director, Ted Chaiban this week. “If immediate steps are not taken to halt the violence, facilitate humanitarian access and provide lifesaving aid to those in need, an even worse catastrophe is likely to impact children for many years to come.” The threat of malnutrition Acute food insecurity in Sudan have soared in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions Since violence erupted on 15 April 2023 between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF), the country has experienced the highest levels of food insecurity in its history. More than 710,000 children face severe acute malnutrition, “representing the highest number of people in need of nutrition assistance ever recorded in Sudan,” according to the WHO. Without humanitarian assistance, the number could rise to 3.5 million children before the end of 2024. These levels surpass the WHO’s emergency thresholds for acute malnutrition, and raise concerns for an expected famine. For the first time since the crisis began, displacement in the Darfur states is now being driven by hunger rather than violence, according to the most recent WHO public health situation analysis. This acceleration of widespread severe food insecurity is most prominent in rural households, where up to 59 percent face moderate or severe food insecurity. The states of West Kordofan, South Kordofan, and Blue Nile have seen the highest levels, according to a new study from United Nations Development Programme (UNDP) and the International Food Policy Research Institute (IFPRI). The study warns that a famine in Sudan is expected in 2024, particularly in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions. Key food sources disrupted Food insecurity is now driving displacement in the Darfur states The conflict has affected cereal production in particular, pushing more people into hunger, according to the Food and Agriculture Organization of the United Nations (FAO). The situation requires “urgent and at-scale agricultural support ahead of the planting season starting in June,” said Rein Paulsen, Director of the FAO Office of Emergencies and Resilience. The production output of key cereal crops in 2023 decreased 46 percent from the previous year, and 40 percent below the average from the previous five years. “This is a very practical manifestation of the impact of clashes, conflict and violence on food production. We clearly have a context that requires urgent and appropriate support. This is why FAO’s interventions are so incredibly important at this point in time,” said Paulsen, who is currently on a field mission to the country to evaluate the food security situation on the ground. Preventing a looming famine requires an immediate ceasefire, unhindered humanitarian access, and increased support for humanitarian needs, concludes the report. Image Credits: UNICEF/UNI530171/Mohamdeen, Integrated Food Security Phase Classification, United Nations Office for the Coordination of Humanitarian Affairs (OCHA). To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Bed Nets Treated With Two Insecticides Instead of One Are Much More Effective Against Malaria 19/04/2024 Zuzanna Stawiska A resident of Ifakara tucked into a mosquito net Bed nets treated with an additional insecticide are between 20% and 50% more effective in preventing malaria than those treated with the standard single pyrethroid insecticide, according to pilots in 17 sub-Saharan Africa. The New Nets Project successfully piloted nets impregnated with a new generation pyrrole insecticide in combination with pyrethroid in response to growing resistance by the malaria-carrying Anopheles mosquitoes to pyrethroid. Between 2019 and 2022, the New Nets Project supported the deployment of 38.4 million nets across sub-Saharan Africa. In parallel, the Global Fund and US President’s Malaria Initiative (PMI) supported the deployment of millions of additional nets under an internal initiative. As a result, 56 million mosquito nets were introduced in 17 countries across sub-Saharan Africa. Two clinical trials and five pilot studies, delivered through the New Nets Project found the new nets could improve malaria control by approximately 20-50% in countries reporting insecticide resistance in sub-Saharan Africa, compared to standard nets. The intervention has the potential to avert about 13 million malaria cases and save 24,600 lives, according to its funders, Unitaid and the Global Fund, and the lead implementer, the Innovative Vector Control Consortium (IVCC). The epidemiological evidence built throughout the project led the World Health Organization (WHO) to publish new recommendations supporting pyrethroid-chlorfenapyr nets instead of pyrethroid-only nets in countries facing pyrethroid resistance. “We are delighted to see that the dual active ingredient insecticide-treated nets have demonstrated exceptional impact against malaria,” said Peter Sands, executive director of the Global Fund. Unitaid’s executive director, Dr. Philippe Duneton, said “The New Nets Project has made a massive contribution to malaria control efforts, helping to accelerate the introduction of next-generation bed nets – a critically important tool for reducing malaria cases and deaths. “ Global burden of malaria. Most DALYs in Sub-Saharan Africa. Malaria is a life-threatening infectious disease with an estimated 249 million cases and 608 000 deaths in 2022, according to the World Malaria Report. It is present in 85 countries, with 95% of cases in the African region. Children under the age of five account for as much as about 80% of malaria deaths. While some malaria cases are mild, others prove deadly, progressing to severe illness and death within 24 hours. Symptoms range from fever, chills and headache to seizures, confusion and difficulty breathing. As it is transmitted through mosquito bites, much of the malaria control efforts go into vector control, that is protection against mosquitoes through insecticide-treated bed nets and indoor residual spraying to prevent mosquitoes from staying on the house roof or walls. Yet, as malaria-carrying mosquitoes adapt to insecticides, a new chemical is likely only a short-term solution. Malaria control requires broad action with multiple solutions implemented. Next to bed nets, many public and private actors concentrate on vaccines, treatments, preventive doses for risk groups and other measures. “The findings of the New Nets Project demonstrate the value of investments into state-of-the-art tools in the fight against malaria. We always say that there is no silver bullet to eliminating malaria and we cannot rely on single interventions but rather invest in a suite of tools, which when combined, will have the biggest impact on defeating this disease,” said Dr. Michael Charles, CEO of the RBM Partnership to End Malaria. Image Credits: Peter Mgongo, IHME. Sudan Gets Donor Boost As First Anniversary of War is Marked by Famine and Mass Displacement 19/04/2024 Sophia Samantaroy UNICEF screening for malnutrition in the River Nile state A year into one of the most brutal conflicts in decades, the war in Sudan has triggered the world’s largest displacement crisis and left the country’s healthcare system in tatters. Nearly 25 million people need immediate humanitarian assistance, according to the United Nations (UN) and over 18 million people face acute food insecurity, with the World Food Programme (WFP) warning that the situation could quickly slip into “catastrophic” food insecurity levels. In light of this accelerating humanitarian crisis, governments, donors, and aid organizations met in Paris on the first anniversary of the war, aiming to “break the silence surrounding this conflict and mobilize the international community,” said French Foreign Minister Stéphane Séjourné said in his opening remarks. The Sudanese people have suffered not only from the catastrophe of war, but also from international “indifference,” said Séjourné, while international organizations struggled to meet key funding needs. “The scale of this catastrophe far outstrips the international community’s attention,” said World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus. The conflicts in Gaza and Ukraine have garnered most of the international community’s attention, and funding. Only 6% of the UN’s emergency funding appeal was met before the Paris conference. Similarly, only 7% of the $1.4 billion Regional Refugee Response Plan for the Sudan Crisis was funded. Donors responded to pleas for humanitarian funding, pledging 2.13 billion in aid for Sudan. Top contributors were the European Union (EU), co-sponsors France and Germany, the US and the UK. “We can manage together to avoid a terrible famine catastrophe, but only if we get active together now,” German Foreign Minister Annalena Baerbock said, adding that, in the worst-case scenario, one million people could die of hunger this year. Tedros echoed this sentiment, calling for access across borders and humanitarian corridors, the cease of attacks on healthcare facilities, funding for both health-related aid and for the UN in general: “This is a health crisis that could reverberate across generations.” Heavy fighting persists “People in Sudan are suffering immensely as heavy fighting persists, including bombardments, shelling and ground operations in residential urban areas and in villages, and the health system and basic services have largely collapsed or been damaged by the warring parties,” said Jean Stowell, Medecins sans Frontieres (MSF) head of Sudan mission. “Only 20-30% of health facilities remain functional in Sudan, meaning that there is extremely limited availability of health care for people across the country.” The number of operational healthcare facilities has decreased even further since February 2024. Healthcare facilities themselves have been subject to attacks. The World Health Organization (WHO) reports 62 confirmed attacks, but notes that these numbers are most likely underestimates. In the 12 months of conflict the warring sides repeatedly and intentionally blocked humanitarian and medical aid. A United Nations graphic of the humanitarian crisis in Sudan The disruption of basic needs has meant that routine immunizations, care for pregnant women and babies, and chronic disease care has “dropped precipitously.” In the Darfur region alone, only 30% of children have received routine immunizations, according to the United Nations Children’s Fund (UNICEF.) The country has seen outbreaks of measles, malaria, dengue fever, cholera, and other water-borne illnesses. Since March, the country has reported over 5,000 cases of measles and 106 deaths. While a nationwide “catch up” measles vaccination campaign was successfully conducted across seven Sudanese states in January 2024, the campaign was unable to cover the Darfur or Kordofan states. Both regions have seen some of the heaviest fighting; no immunizations have been possible since the conflict began. Children bear the brunt of these healthcare disruptions. “After 365 days of conflict, the children of Sudan remain at the sharp end of a horrific war,” said UNICEF Deputy Executive Director, Ted Chaiban this week. “If immediate steps are not taken to halt the violence, facilitate humanitarian access and provide lifesaving aid to those in need, an even worse catastrophe is likely to impact children for many years to come.” The threat of malnutrition Acute food insecurity in Sudan have soared in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions Since violence erupted on 15 April 2023 between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF), the country has experienced the highest levels of food insecurity in its history. More than 710,000 children face severe acute malnutrition, “representing the highest number of people in need of nutrition assistance ever recorded in Sudan,” according to the WHO. Without humanitarian assistance, the number could rise to 3.5 million children before the end of 2024. These levels surpass the WHO’s emergency thresholds for acute malnutrition, and raise concerns for an expected famine. For the first time since the crisis began, displacement in the Darfur states is now being driven by hunger rather than violence, according to the most recent WHO public health situation analysis. This acceleration of widespread severe food insecurity is most prominent in rural households, where up to 59 percent face moderate or severe food insecurity. The states of West Kordofan, South Kordofan, and Blue Nile have seen the highest levels, according to a new study from United Nations Development Programme (UNDP) and the International Food Policy Research Institute (IFPRI). The study warns that a famine in Sudan is expected in 2024, particularly in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions. Key food sources disrupted Food insecurity is now driving displacement in the Darfur states The conflict has affected cereal production in particular, pushing more people into hunger, according to the Food and Agriculture Organization of the United Nations (FAO). The situation requires “urgent and at-scale agricultural support ahead of the planting season starting in June,” said Rein Paulsen, Director of the FAO Office of Emergencies and Resilience. The production output of key cereal crops in 2023 decreased 46 percent from the previous year, and 40 percent below the average from the previous five years. “This is a very practical manifestation of the impact of clashes, conflict and violence on food production. We clearly have a context that requires urgent and appropriate support. This is why FAO’s interventions are so incredibly important at this point in time,” said Paulsen, who is currently on a field mission to the country to evaluate the food security situation on the ground. Preventing a looming famine requires an immediate ceasefire, unhindered humanitarian access, and increased support for humanitarian needs, concludes the report. Image Credits: UNICEF/UNI530171/Mohamdeen, Integrated Food Security Phase Classification, United Nations Office for the Coordination of Humanitarian Affairs (OCHA). To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Sudan Gets Donor Boost As First Anniversary of War is Marked by Famine and Mass Displacement 19/04/2024 Sophia Samantaroy UNICEF screening for malnutrition in the River Nile state A year into one of the most brutal conflicts in decades, the war in Sudan has triggered the world’s largest displacement crisis and left the country’s healthcare system in tatters. Nearly 25 million people need immediate humanitarian assistance, according to the United Nations (UN) and over 18 million people face acute food insecurity, with the World Food Programme (WFP) warning that the situation could quickly slip into “catastrophic” food insecurity levels. In light of this accelerating humanitarian crisis, governments, donors, and aid organizations met in Paris on the first anniversary of the war, aiming to “break the silence surrounding this conflict and mobilize the international community,” said French Foreign Minister Stéphane Séjourné said in his opening remarks. The Sudanese people have suffered not only from the catastrophe of war, but also from international “indifference,” said Séjourné, while international organizations struggled to meet key funding needs. “The scale of this catastrophe far outstrips the international community’s attention,” said World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus. The conflicts in Gaza and Ukraine have garnered most of the international community’s attention, and funding. Only 6% of the UN’s emergency funding appeal was met before the Paris conference. Similarly, only 7% of the $1.4 billion Regional Refugee Response Plan for the Sudan Crisis was funded. Donors responded to pleas for humanitarian funding, pledging 2.13 billion in aid for Sudan. Top contributors were the European Union (EU), co-sponsors France and Germany, the US and the UK. “We can manage together to avoid a terrible famine catastrophe, but only if we get active together now,” German Foreign Minister Annalena Baerbock said, adding that, in the worst-case scenario, one million people could die of hunger this year. Tedros echoed this sentiment, calling for access across borders and humanitarian corridors, the cease of attacks on healthcare facilities, funding for both health-related aid and for the UN in general: “This is a health crisis that could reverberate across generations.” Heavy fighting persists “People in Sudan are suffering immensely as heavy fighting persists, including bombardments, shelling and ground operations in residential urban areas and in villages, and the health system and basic services have largely collapsed or been damaged by the warring parties,” said Jean Stowell, Medecins sans Frontieres (MSF) head of Sudan mission. “Only 20-30% of health facilities remain functional in Sudan, meaning that there is extremely limited availability of health care for people across the country.” The number of operational healthcare facilities has decreased even further since February 2024. Healthcare facilities themselves have been subject to attacks. The World Health Organization (WHO) reports 62 confirmed attacks, but notes that these numbers are most likely underestimates. In the 12 months of conflict the warring sides repeatedly and intentionally blocked humanitarian and medical aid. A United Nations graphic of the humanitarian crisis in Sudan The disruption of basic needs has meant that routine immunizations, care for pregnant women and babies, and chronic disease care has “dropped precipitously.” In the Darfur region alone, only 30% of children have received routine immunizations, according to the United Nations Children’s Fund (UNICEF.) The country has seen outbreaks of measles, malaria, dengue fever, cholera, and other water-borne illnesses. Since March, the country has reported over 5,000 cases of measles and 106 deaths. While a nationwide “catch up” measles vaccination campaign was successfully conducted across seven Sudanese states in January 2024, the campaign was unable to cover the Darfur or Kordofan states. Both regions have seen some of the heaviest fighting; no immunizations have been possible since the conflict began. Children bear the brunt of these healthcare disruptions. “After 365 days of conflict, the children of Sudan remain at the sharp end of a horrific war,” said UNICEF Deputy Executive Director, Ted Chaiban this week. “If immediate steps are not taken to halt the violence, facilitate humanitarian access and provide lifesaving aid to those in need, an even worse catastrophe is likely to impact children for many years to come.” The threat of malnutrition Acute food insecurity in Sudan have soared in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions Since violence erupted on 15 April 2023 between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF), the country has experienced the highest levels of food insecurity in its history. More than 710,000 children face severe acute malnutrition, “representing the highest number of people in need of nutrition assistance ever recorded in Sudan,” according to the WHO. Without humanitarian assistance, the number could rise to 3.5 million children before the end of 2024. These levels surpass the WHO’s emergency thresholds for acute malnutrition, and raise concerns for an expected famine. For the first time since the crisis began, displacement in the Darfur states is now being driven by hunger rather than violence, according to the most recent WHO public health situation analysis. This acceleration of widespread severe food insecurity is most prominent in rural households, where up to 59 percent face moderate or severe food insecurity. The states of West Kordofan, South Kordofan, and Blue Nile have seen the highest levels, according to a new study from United Nations Development Programme (UNDP) and the International Food Policy Research Institute (IFPRI). The study warns that a famine in Sudan is expected in 2024, particularly in the states of Khartoum, Aj Jazirah, and in the Darfur and Kordofan regions. Key food sources disrupted Food insecurity is now driving displacement in the Darfur states The conflict has affected cereal production in particular, pushing more people into hunger, according to the Food and Agriculture Organization of the United Nations (FAO). The situation requires “urgent and at-scale agricultural support ahead of the planting season starting in June,” said Rein Paulsen, Director of the FAO Office of Emergencies and Resilience. The production output of key cereal crops in 2023 decreased 46 percent from the previous year, and 40 percent below the average from the previous five years. “This is a very practical manifestation of the impact of clashes, conflict and violence on food production. We clearly have a context that requires urgent and appropriate support. This is why FAO’s interventions are so incredibly important at this point in time,” said Paulsen, who is currently on a field mission to the country to evaluate the food security situation on the ground. Preventing a looming famine requires an immediate ceasefire, unhindered humanitarian access, and increased support for humanitarian needs, concludes the report. Image Credits: UNICEF/UNI530171/Mohamdeen, Integrated Food Security Phase Classification, United Nations Office for the Coordination of Humanitarian Affairs (OCHA). To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
To End AIDS, We Must Reclaim Our Unyielding Pursuit of Equity 18/04/2024 Bience Gawanas Young women at an information and prevention campaign coupled with HIV testing conducted by Alliance Côte d’Ivoire. As HIV practitioners gather this week in Yaoundé for AFRAVIH, the largest international Francophone conference on HIV/AIDS, and a few months before the 25th International AIDS Conference in Munich, the Vice-Chair of the Global Fund Board urges renewed focus on promoting equity in the fight against HIV particularly for groups that continue to suffer a disproportionate proportion of HIV infections. Every step we make in the fight against HIV today is going to be painstaking – we must press harder for progress. In the early years of the fight against this virus, our gains were often rapid and immense because everywhere you looked, there was great need. Those were devastating times: The disease killed three million people in 2000, more than 2.4 million of them in Africa. In the southern tip of the continent, where I am from, the disease was threatening to disintegrate the very fabric of society. When the world came together to form partnerships like that of the Global Fund and PEPFAR, it was to challenge the injustice that only the rich could get HIV treatment. It was to stop the possibility of losing a generation of people in many low- and middle-income countries as well as those who were stigmatized and discriminated against because they were considered “different”. I am proud to say that we have since come a long way. From less than 50,000 people on treatment for HIV in Africa in 2000 to more than 20 million today, HIV prevention innovations have proliferated, reducing HIV infections dramatically. And yet, more than 1.3 million people were infected with the virus in 2022. These infections are now happening primarily amongst the most marginalized: Men who have sex with men, people who inject drugs, trans women and sex workers. More so, their voices are increasingly silenced, and they are under constant threat of violence and abuse, as discriminatory legislation directed against LGBTI people is surging around the world. Among these groups, young people aged 15-24 years old bear a disproportionate burden of HIV and are even more vulnerable, facing greater barriers to accessing health services. Long road remains In Francophone African countries (24 countries – 373.3 million people), the HIV burden is lower than in the rest of the continent. However, they accounted for 16% of all new HIV infections in sub-Saharan Africa in 2022. Thanks to concerted efforts from the Global Fund and other partners, the AIDS-related mortality rate in Francophone African countries has declined by 82% between 2000 and 2022. In the same time period, the AIDS-related mortality rate fell by 95% in Burundi, by 91% in Rwanda, and by 90% in Côte d’Ivoire and Burkina Faso. The number of new HIV infections in Francophone Africa also decreased, from 325,000 in 2000 to 108,000 in 2022. Between 2001 and 2022, HIV incidence rates declined by 92% in Burundi and Rwanda, and by 91% in Côte d’Ivoire and Burkina Faso. Through Global Fund-supported programs, antiretroviral therapy coverage in Francophone Africa significantly increased from 4% in 2005 to 72% in 2022. Still, a long road lies ahead to achieve key objectives, such as elimination of AIDS in children. As many Francophone countries still have high rates of vertical transmission, it is of the utmost importance to improve both prevention and pediatric care simultaneously. Another key objective is to reduce stigma and discrimination as barriers to HIV prevention, care and treatment. The West Africa regional Stigma Index 2.0 report, based on data from 10,910 people living with HIV in seven countries in the region, found that, among key populations, people who inject drugs and transgender women had the biggest difficulties in accessing testing, care and treatment. HIV challenge is one of equity, not science The fight against HIV is no longer a challenge of science, but one of equity. For us to accelerate progress once again, we must reclaim that strong spirit of equity that animated us two decades ago. That means focusing on the communities most affected by HIV. In Africa, the focus on adolescent girls and boys is an urgent imperative. Adolescent girls play in a school yard at a boarding school in Karongi district in Rwanda. Keeping girls in school greatly reduces their risk of contracting HIV. Although HIV incidence in adolescent girls and young women has greatly declined in the past decade, 4,000 girls and young women still get infected with HIV every week across the world, mainly in sub-Saharan Africa. This is unacceptable. This group continues to suffer conditions that are the most iniquitous of all, with structural injustices that predispose them to diseases. If we are to prevent HIV infections in this population, we must bring together diverse partners to invest in long-term efforts to keep girls in schools. Education turns girls into women with the possibility of more equal opportunities, and protects them from diseases such as HIV. Educated girls register lower rates of teenage pregnancies, sexual violence, early marriages, and ultimately lower HIV infections. We must also accelerate investments in programs that support comprehensive sexual and reproductive health and rights, particularly for adolescent girls and young women. And we must ensure that young women and girls are front and center of projects that seek to engage them. These are some of the goals the Global Fund partnership is seeking to achieve with projects such as Voix EssentiELLES and the HER Voice Fund, which strive to meaningfully engage young women and girls in key health programs and decision-making forums in their communities. To end the HIV infections in young women and girls, we must also reduce infections amongst their sexual partners. That means investing in efforts to transform cultural and social norms that predispose men and boys to HIV and that shape their engagement with girls and women in their communities. It also means that men at high risk of HIV infection are tested and supported to start and stay on treatment. Protecting heterosexual men and boys from HIV can also help protect women and girls from HIV. We must seek to renew our focus on promoting equity. We know how to do this. We did it at the turn of the millennium with our drive for equity in HIV treatment. Let us now move forward and end this unfinished fight by reducing HIV infections among the most affected communities. To get there, we can be reenergized by the goals and the unyielding spirit of those golden years of progress in the fight against HIV. Bience Gawanas is a Namibian lawyer, advocate and vice-chair of the Global Fund Board. She was appointed as the first Commissioner for Social Affairs by the African Union Assembly of Heads of State and Government, and in her home country of Namibia she served as Public Service Commissioner, Ombudsperson and Special Advisor to the Minister of Health and Social Services and to the Minister of Poverty Eradication and Social Welfare. Gawanas also recently served as the United Nations Under-Secretary General and Special Advisor for Africa. Image Credits: JB Russel/ The Global Fund/ Panos, Vincent Becker/ The Global Fund. Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Study Finds Adult Vaccination Programs Deliver 19x Returns 18/04/2024 Maayan Hoffman A medical assistant gives a flu vaccination at the Arzthaus in Zurich, Switzerland, on January 30, 2015. (KEYSTONE/Gaetan Bally) Amidst the anticipated increase in vaccine-preventable diseases as the global population ages, a first-of-its-kind study has underscored the dual benefits of adult immunization programs. Beyond saving lives and preventing severe illnesses, the study found these programs offer substantial financial advantages to nations by reducing the need for costly hospitalizations and emergency medical interventions and avoiding expensive productivity losses. The research, carried out by the Office of Health Economics (OHE) and funded by IFPMA, revealed that adult vaccination programs can deliver a return of up to 19 times the investment. When considering the comprehensive range of benefits and using the most widely accepted valuation approach for each program, these programs translate into billions of dollars in net monetary gains for society. On an individual level, this equates to approximately $4637 in net benefits for a complete vaccination course, according to the study. “The high-level results are overwhelmingly positive and offer so much value – much more value than the cost of delivering the vaccines,” Prof Lotte Steuten, deputy CEO of OHE and co-author of the report, told Health Policy Watch. “Government decision-makers should rest assured that this is a good idea, high value, and you will get more in return.” Prof Lotte Steuten, deputy CEO of OHE Promoting Health, Productivity, and Equity Specifically, the study looks at adult immunization programs targeting four diseases, three life-threatening illnesses and one causing severe pain and hospitalizations: influenza (flu), pneumococcal disease (PD), herpes zoster (HZ), and respiratory syncytial virus (RSV). These programs were examined across 10 countries: Australia, Brazil, France, Germany, Italy, Japan, Poland, South Africa, Thailand, and the United States of America. Steuten said the 10 countries were chosen to provide a balanced mix of societies regarding income level, demographics, disease incidents and availability of adult vaccination programs. She said that the goal was to ensure that decision-makers globally could relate to the list of countries and find resonance with the study’s findings. The study’s findings came from reviewing published research about how these diseases affect adults and the benefits of vaccines for health, hospitals, and society. The researchers also used a method called health economic modeling to figure out the costs versus the benefits and the money saved by using adult vaccination programs in the 10 countries. Steuten pointed out two additional important discoveries from the study: first, expanding vaccination programs for adults can help people and their caregivers be more productive. Second, these programs can also promote fairness in health and economics within countries, especially helping those who are at risk or don’t have enough access to healthcare. “People can stay active, and that’s very important, particularly for an aging society—for people with paid and unpaid work, such as caring for their loved ones or their grandchildren,” Steuten said. PAHO is supporting vaccinations of indigenous people Actionable Recommendations The report was released ahead of World Immunization Week, and its authors noted that the findings support major global initiatives like the United Nations Sustainable Development Goals, the UN’s Decade of Healthy Aging (2021-2030), and the World Health Organization’s Immunization Agenda 2030. The latter focuses on encouraging vaccinations for all ages, stressing the importance of understanding the benefits of adult immunization and the need for national strategies that cover immunization throughout a person’s life. The authors provide actionable recommendations for countries based on the study’s results. These recommendations include embracing a prevention-focused approach, allocating sufficient funding to enhance adult immunization programs and accessibility, and further developing the evidence supporting the value of these programs for adults. “Increasing pressures on ailing healthcare systems, such as aging populations, are driving an urgent need to shift to a prevention-first mindset. Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention,” concluded Steuten. “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs. “These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules.” Image Credits: Unsplash, KEYSTONE/Gaetan Bally, Office of Health Economics, PAHO. Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Latest Pandemic Agreement Draft Keeps Equity Hopes Alive – But Defers Key Operational Decisions 17/04/2024 Kerry Cullinan The South Sudan Minster of Health, Elizabeth Chuei, receives a COVID-19 vaccine at Juba Teaching Hospital in March 2021. The latest draft of the pandemic agreement, while deferring many operational issues, keeps equity hopes alive in many aspects – including by cementing in-principle agreements on a pathogen access and benefit-sharing (PABS) system, a global supply chain and logistics network and geographically diverse “capacities and institutions” for research and development. READ: WHO Pandemic Agreement draft_16 April 2024 The streamlined 23-page draft was sent to World Health Organization (WHO) member states on Tuesday night ahead of the final meeting of the intergovernmental negotiations body (INB) on 29 April. The “minimum” components of the envisaged PABS system – one of the most contentious aspects of the negotiations – include the reservation of 20% of pandemic-related health products for the WHO for distribution to those most in need, and “annual monetary contributions from PABS System users”. The basis for the PABS system, to be administered by the WHO, is “the fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS material and information”. But the “modalities, terms and conditions, and operational dimensions” of the PABS system will be “further defined in a legally-binding instrument, that is operational no later than 31 May 2026”, according to the draft. Ditto the mechanisms for a One Health approach, also to be decided in future and operational by 31 May 2026. As reported earlier by Health Policy Watch, the WHO’s 194 member states’ obligations to secure themselves against pandemics are codified in the draft – particularly in Articles 4,5 and 6. Meanwhile, some of the international obligations are there – but are still aspirational rather than practical. ‘Differences are not huge’ Ambassador Amanda Gorely, Australia’s representative to the UN in Geneva, told an event in the city on Wednesday that all delegations “need to come together and focus on finding consensus on these high level commitments, and on the institutional structures and further processes”. “We have been working closely with our Ethiopian colleagues on Article 12 negotiations, which have been amongst, I think, the most intractable in terms of divergent positions. So we really appreciate and acknowledge the fact that the Bureau has been working very hard and indeed circulated a revised text last night, which we’re all now trying to digest and prepare to engage on in the next session,” Gorely told a high-level discussion at the Geneva Graduate Institute’s Global Health Centre. While Australia is generally aligned with the western bloc of countries, it has been working to resolve differences between the key power blocs. “Negotiators who have been listening carefully to each other for many, many months, and know where common ground can be found, need to be empowered to make the agreement that we need to see happen. “It’s really up to the negotiators and our governments, to enable them to be able to navigate where the landing zones are and of course, the Bureau has an essential role to play in that,” Gorely told the meeting, convened by the Geneva Graduate Institute’s Global Health Centre, the, Global Preparedness and Monitoring Board (GPMB) and Pandemic Action Network (PAN) to assess progress in the pandemic negotiations. Ethiopian Ambassador Tsegab Kebebew Daka told the same event that “the differences are in the text are not huge”. They are mainly differences of ideas and they’re not that many. So we can come to an agreement,” said Daka, a key negotiator for the Africa group. What next? So who takes this further? Once the draft has been agreed on, hopefully by the end of the INB’s ninth meeting on 10 May, it goes to the WHO’s World Health Assembly (WHA) which convenes from 27 May to 1 June. Once the draft and its accompanying resolution are passed by the WHA, some of the outstanding issues will need to be finalised. The WHA draft resolution proposes creating working groups on the key outstanding issues – namely the PABS system, One Health and financing – particularly to help low-and middle-income countries to implement all the provisions. The draft’s Article 21 makes provision for a Conference of the Parties (COP) to be convened by the WHO “not later than one year after the entry into force of the WHO Pandemic Agreement”. The COP will determine the venue and timing of subsequent regular sessions at its first session, and shall “regularly” take stock of the implementation of the agreement, and review its functioning every five years. Nina Schwalbe, head of Spark Street Advisors, who has been closely monitoring the negotiations, notes that the text “has no provision for monitoring compliance or details on state reporting requirements other than ‘periodically’,” and that also “notably missing is a working group for accountability or any type of Compliance Committee”. 🚨The proposed WHO #PandemicAccord is released. 💥It has no provision for monitoring compliance or details on state reporting requirements other than “periodically.” 🛑This leaves Member States with no accountability for any of their treaty commitments (weak or strong). 🧵 pic.twitter.com/bbAJxJMA7r — Nina Schwalbe (@nschwalbe) April 17, 2024 Reduction in transparency Meanwhile, James Love, director of Knowledge Ecology International (KEI), said that “there has been a significant reduction in the transparency obligations, although a few important provisions have survived, for example, on the terms in government funding agreements”. The article Love referred to is in Article 9 (research and development), which states that: “Each party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms.” Transparency about how public money is spent on pharmaceutical R&D has long been a demand by medicines access activists. The clause elaborates on the types of provisions that could access, listing them as “licensing and/or sublicensing, preferably on a non-exclusive basis; affordable pricing policies; technology transfer on mutually agreed terms; publication of relevant information on research inputs and outputs; and/or adherence to product allocation frameworks adopted by WHO.” Love also pointed to the removal of some wording related to using TRIPS flexibilities to enable access to medicines, which he described as “unfortunate”. Image Credits: ULISES RUIZ / Getty Imageses Contributor, UNICEF. World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
World Health Assembly is Likely to See Basic ‘Consensus’ Pandemic Agreement as Hard Decisions are Deferred 16/04/2024 Kerry Cullinan Negotiations underway for a pandemic agreement at the WHO headquarters in Geneva. While the next draft of the World Health Organization’s (WHO) pandemic agreement is due to be sent to member states by Thursday (18 April), it is likely to be stripped of contentious clauses. Instead, the draft – and indeed, the pandemic agreement to be put to the World Health Assembly (WHA) at the end of May – will be an “instrument of essentials”; a basic text that will be fleshed out by further talks in the next couple of years, as reported recently by Health Policy Watch. After the WHA has adopted the framework, more details will be fleshed out over the next 12 to 24 months. Thereafter, a Conference of Parties has been proposed, but sources close to the discussions say this is only likely to convene in the latter half of 2026 – so fingers crossed that there’s no pandemic before that! The ninth intergovernmental negotiating body (INB) meeting, from 18-28 March, was due to be the last before the WHA. But there was little agreement between the key power blocs: the European Union, UK, Japan and US; the 34-strong Group of Equity (headlined by Bangladesh, India, Brazil and Indonesia) and the Africa Group. After days of circular negotiations and countries’ loss of patience with one another and the INB Bureau, parties resolved that the agreement to be put to the WHA would focus on areas of convergence. This has seen the text slim from a completely unwieldy 100-page draft on 26 March, with multiple opposing clauses contained in brackets, to the current 20-pager, according to insiders. Country obligations in, international obligations out Likely to be in the latest draft are many of the countries’ obligations to prevent and prepare for pandemics (for example, Articles 4,5 and 6). But many of the articles that deal with international co-operation will be delayed. For example, the operating mechanism of the contested pathogen access and benefit-sharing (PABS) system – Article 12 – is likely to be “further defined in a legally binding instrument that is operational no later than 31 May 2026”, according to a proposal made to parties by INB deputy chair Viroj Tangcharoensathien of Thailand. "PABS Operational Modalities – Terms, conditions and operational modalities of the PABS – System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026." pic.twitter.com/f5MVNNQHzB — Balasubramaniam (@ThiruGeneva) April 10, 2024 What has survived in Article 12, however, is the proposal that the WHO will get 20% of pandemic-related health goods (10% as a donation and 10% at affordable prices) to allocate to those most in need. At least that will go some way to securing a little stash of vaccines for poor countries should another pandemic sweep through the world soon. The “modalities, terms and conditions, and operational dimensions” of a One Health approach have also been kicked down the line, to become operational no later than 31 May 2027, according to Geneva Health Files. Also missing is are financial commitments to fund countries’ pandemic prevention, preparedness and response. However, even the section on research and development (Article 9) has been pared down, with no obligations placed on public-funded research although there seemed to be broad consensus on that, according to a draft published by Politico Europe. Why has Article 9 been so pared down when it was one of the only points of consensus? Access to research knowledge & publishing of terms of govt-funded research gone when there was little objection. These were necessary provisions toward equity. #INB #PandemicAccord pic.twitter.com/rWbpyw7ShW — Samantha Rick (@hellosamrick) April 16, 2024 The ninth INB meeting resumes from 29 April to 10 May where member states will iron out further issues with the slimmed-down agreement. “Civil society continues to call for access to the resumed negotiations, while pushing for a successful conclusion to the negotiating process, a meaningful agreement, and a human rights-based approach,” according to the Pandemic Action Network. Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Moderna’s ‘Disappointing’ Pull Back from Kenya Highlights Complexity of Expanding Vaccine Manufacturing in Africa 16/04/2024 Kerry Cullinan The Moderna vaccine was unavailable in Africa for most of the COVID-19 pandemic. “Disappointed” is how the Africa Centres for Disease Control and Prevention phrased its response to pharmaceutical company Moderna “pausing” its Kenyan mRNA vaccine manufacturing facility. Moderna’s decision is yet another example of how complex it is to kickstart vaccine manufacturing on the continent – an essential component to safeguard Africans against future pandemics on the continent that was simply unable to procure COVID-19 vaccines until way after developed nations. “The demand in Africa for COVID-19 vaccines has declined since the pandemic and is insufficient to support the viability of the factory planned in Kenya,” Moderna announced in a statement last Thursday. Back in March 2022, Moderna and then Kenyan president Uhuru Kenyatta signed a memorandum of understanding, with the company aspiring to produce up to 500 million vaccine doses a year with a focus on drug substance manufacturing. But Moderna disclosed last week that it “has not received any vaccine orders for Africa since 2022 and has faced the cancellation of previous orders, resulting in more than $1 billion in losses and write-downs”. Moderna’s experience mirrors that of South African generic drug company Aspen, which spent millions of dollars expanding its production facilities to make Johnson and Johnson vaccines – yet it never sold a single vial, as reported previously by Health Policy Watch. “Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Stavros Nicolaou, Aspen’s head of strategic trade, said at the time. However, Moderna is estimated to have made $18.4 billion in profits from COVID-19 vaccines in 2022 alone in other markets. Moderna was a latecomer to African COVID-19 market In its response, Africa CDC reminded Moderna that it entered the African COVID-19 vaccine market late – some time after various calls by African leaders and the African Union (AU) for “equitable and timely access to, and receipt of, vaccines”, which “in many instances went unanswered by the international community and industry”. The @AfricaCDC's Statement on @moderna_tx Plan to reassess commitment to African vaccine manufacturing. This is in response to Moderna's decision to put its plans on hold for establishing vaccine manufacturing in Kenya. Read more: https://t.co/0BRuUbSW9r — Jean Kaseya (@JeanKaseya2) April 15, 2024 When the AU’s African Vaccine Acquisition Trust (AVAT) eventually managed to acquire 400 million COVID-19 vaccines from manufacturers for the continent, none were from Moderna “simply because Moderna vaccines were not made available, despite attempts to buy [them],” said the Africa CDC, adding that less than 5% of the COVID-19 vaccines administered in Africa were from Moderna. “Therefore, to blame Africa and Africa CDC for lack of demand for COVID-19 vaccines and therefore the reason to put on hold plans to manufacture vaccines in Africa, only serves to perpetuate the inequity that characterised the response to the COVID–19 pandemic,” said Africa CDC. “While other vaccine manufacturers are progressing with their plans and construction in Africa, Moderna is abandoning a commitment to build highly needed and relevant vaccine manufacturing capabilities in Africa, in truth, demonstrating that Moderna’s commitment is in fact not to vaccine equity and access to vaccine, through building manufacturing in Africa.” Moderna’s clinical development manufacturing facility in the USA. While pulling back from COVID-19 vaccines, Moderna stated that it is” actively working on the development of public health vaccines, including those for diseases that predominantly affect the African continent, such as HIV and malaria”, using mRNA technology. “However, these investigational vaccines are at an early development stage. Given this, and in alignment with our strategic planning, Moderna believes it is prudent to pause its efforts to build an mRNA manufacturing facility in Kenya. This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa,” said the company. Gavi’s ‘Accelerator’ is a game-changer Africa CDC said that it would continue to advocate, and support the establishment of a strong local vaccine manufacturing ecosystem as part of its “continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040”. But it acknowledged that “building vaccine manufacturing infrastructure and capabilities is complex, takes a long time, and requires significant investment”. Vaccine platform Gavi’s decision to establish a new innovative financial mechanism, the African Vaccines Manufacturing Accelerator (AVMA), is such an investment. Through the AVMA, Gavi plans to make up to $1 billion available over the next 10 years to “support the sustainable growth of Africa’s manufacturing base”. Making the announcement last December, Gavi put the current value of Africa’s annual vaccine demand at over $1 billion. “Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.2% of global supply,” said Gavi. “A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response.” The AMVA will be launched on 20 June at a high-level event in Paris co-hosted by the French government, AU and Gavi, with support from Team Europe partners. AVMA will offer two types of incentive payments to offset some of the initial high costs of production. The first type of payment, known as a ‘milestone payment’, will be available to manufacturers that produce one of the vaccines included in the Gavi priority vaccine market group when they succeed in obtaining WHO pre-qualification (PQ). “PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this pre-qualification and production,” according to Gavi. Top-up payments per dose The second type of payment, termed an ‘accelerator payment’, will be paid as a per-dose top-up, in addition to the market price that manufacturers receive for doses on winning Gavi-UNICEF tenders. These payments will be highest for the “end-to-end manufacture of priority market vaccines , and vaccines produced using ‘pandemic ready’ technology platforms”, while lower tiered incentives will be paid for lower-cost ‘fill and finish’ manufacturing. “The need to ensure regional diversification of vaccine manufacturing was a key learning from the COVID-19 pandemic, when a lack of local manufacturing capacity in Africa and other parts of the world meant these countries had to wait longer for vaccines to become available,” according to a recent media release from Gavi. “Our determination to promote equitable access to global health and the health sovereignty of our African partners is growing further,” said Chrysoula Zacharopoulou, French Minister of State for Development and International Partnerships. Gavi will also use the event to make the case for donors to invest in a “new era of immunisation for enhanced equitable access to health care” as well as pitching its 2026-2030 funding needs to the government leaders, partner organisations, civil society and business who are invited to the event. Image Credits: Gavi , Moderna. Posts navigation Older postsNewer posts