Schools have to been directed  to build gender-segregated toilets and to keep stocks of menstrual hygiene products by India’s Supreme Court .

In January, India’s Supreme Court has ruled that menstrual health is a fundamental right, directing states and schools to take measures to facilitate menstrual health and sanitation.

The laws of the world’s most populous country are now in line with the United Nations (UN) stand on menstrual health taken in 2024, and one that is also echoed by the World Health Organization. 

India’s Supreme Court directed state governments and schools in the country to build gender segregated toilets, hold menstrual health awareness sessions for both boys and girls, and stock schools with menstrual hygiene products.  

After the ruling, Megha Desai, president of the Desai Foundation,  said she and her team jumped for joy. The foundation works across eight states in India on menstrual health and hygiene awareness, 

“Up until this ruling came through, the responsibility of managing menstruation was left to a 12-year-old girl,” said Desai. “With the Supreme Court ruling, what it has done is shifted that responsibility to the community, and in this case, the infrastructure of the school.”

Megha Desai, president of the Desai Foundation, that works on menstrual health.

The court relied on research that showed only half of the girls surveyed were aware of menstruation before puberty, toilets were scarce, and menstruation led to a high level of absenteeism. 

The issue is not restricted to India alone. A 2021 survey by global children’s non-profit Plan International done in the United Kingdom found that 64% of girls aged 14-21 missed part or a full day of school due to their period, and 13% of girls missed an entire day of school at least once a month.

The UN children’s organisation, UNICEF, has long raised the issue of girls staying out of school due to their monthly periods in several continents, such as Africa, apart from Asia.

Precedent for the developing world?

A community open session on menstrual health and hygiene in Jahelipatti village of Bihar state in India conducted by World Neighbors’ partner Ghoghardiha Prakhand Swarajya Vikas Sangh.

In many parts of the world, especially in rural areas, menstruation is still a taboo subject. Women can be labelled “unclean” and subjected to social isolation. Blood stains due to the periods are perceived to be shameful. 

“This is a very bold move by the Indian government, and I really hope other countries learn from that and decide to do more about it,” said Rannia Elsayed, regional portfolio director for South Asia, the Middle East, and North Africa at Pathfinder International, a non-profit that focuses on women’s health.

Elsayed, who is based in Egypt, said that talking about menstruation is taboo in many rural parts of Egypt and Jordan. 

India may have set a precedent in the developing world with its court ruling.

“In Kenya, there’s been a ruling that mandates free sanitary pads for public schools. Again, but there’s no constitutional rights framing for it,” she said. 

The ruling comes at a time when climate change is making heatwaves more intense and changing rainfall patterns in India as well as the rest of the world. A policy like this will help girls become more resilient to the impact of climate change on menstrual health, Elsayed said.  

Also read: Climate Change Driving India’s Unseasonably Severe Heat Wave

Slew of recent measures to improve health

India has built millions of new toilets in the past decade.


Over the past decade, the Indian government’s Swachh Bharat Mission has focused on building millions of new toilets in the country with an eye on improving health, sanitation, and women’s lives. 

Despite this, less than half of the schools researchers surveyed in India have gender segregated toilets. The Indian government  claims that 100 million toilets were built by 2019, but the reality is more complex than that. 

“In some of the schools I’ve seen [that the] toilet is there but no water, or the situation of toilets is in such a pathetic condition that you wouldn’t step in,” said Srijana Karki, who oversees the projects in India and Nepal for the international development organisation, World Neighbors.

But in communities where access to toilets has improved, this has also translated into increased mobility of women as they feel more confident about managing their periods, she added.

More toilets are just one of the many requirements to improve menstrual equity, however.

“You have to have awareness [on menstrual health], you have to be educated, and there has to be a functional toilet, not just a toilet, but a functional toilet… clean, have enough water, and then use of sanitary napkins or clean cloths, and knowledge about how to safely dispose the napkins or safely reuse the cotton cloths,” Karki said. 

But the Indian government’s campaign to build more toilets has started a conversation about the relationship between more toilets and improved women’s health. It has also created an appetite for such infrastructure among families, especially from women who are now pushing for it from within families.

“That wonderful campaign with beautiful intentions did change the mindset of communities and community leaders,” Desai said. 

Impact depends on implementation

A menstrual health awareness session in progress in India’s Tamil Nadu, organized by the Desai Foundation.

The immediate impact of the ruling is to provide impetus for development organizations working in this area to speed up their work. 

“Having the support of a ruling allows us to eliminate the debate. So, for me, I can tell you that time is now being saved on the ground where I am now saying, okay, now that we all agree that this is the way forward, let’s work together for the best way to implement,” Desai said. 

She also said that the government can play a big role in the implementation by supporting new infrastructure, and that it is likely that we will see more girls finish school as a result of this ruling.

The ruling has been welcomed by development organizations working in the region, while the non-profit International Planned Parenthood Federation’s South Asia team has called for such a ruling to be extended to workplaces.  

If India does get the implementation part right in the coming years, it could set an example for the rest of the developing world, Desai said.   

Image Credits: Desai Foundation, Yogendra Singh/ Unsplash, World Neighbors, Ignas Kukenys/ Openverse/ Flick.

Woman standing in front of formula options
Nestlé is the largest transnational food corporation in the world, and a documented violator of the International Code of Marketing of Breast-milk Substitutes.

The United Nations University Institute for Water, Environment and Health (UNU-INWEH) announced a “strategic partnership” with Nestlé to establish the World Food Academy 4 Sustainable Food Systems on 26 March. 

The arrangement incorporates Nestlé’s science and technology seminars, which reached around 7,000 students across over 300 academic institutions in more than 90 countries last year, and will be extended through a joint symposium later in 2026. 

The World Food Academy targets students, early-career researchers, and young professionals “particularly from priority regions in the Global South.”

Within days, an open letter coordinated by the International Baby Food Action Network (IBFAN) and authored by Phillip Baker of the University of Sydney began circulating. It carries nearly 500 signatures from public health researchers, nutritionists, lawyers, and civil society organisations around the world. It calls on UNU-INWEH to terminate the partnership immediately. Its reasoning is grounded in the UN’s own published standards for engagement with the private sector.

Nestlé is the largest transnational food corporation in the world. It is a documented and persistent violator of the International Code of Marketing of Breast-milk Substitutes – the 1981 World Health Assembly instrument created, in substantial part, in response to the company’s marketing practices. 

It is among the largest global manufacturers of ultra-processed foods, identified by the 2025 Lancet series on ultra-processed food as a principal commercial determinant of diet-related chronic disease. 

Distorting nutrition science

It is also documented as a major actor in the broader pattern by which large food and beverage corporations distort nutrition science – funding research designed to produce favourable findings, sponsoring professional societies, and undermining the independence of the evidence base that public health policy depends on. 

It participates in industry associations that lobby against public health regulation of food marketing and against the breastmilk code. 

Nestlé’s UN-system footprint expanded sharply between December 2025 and March 2026. A UNFPA coalition membership on women’s health, the UNU-INWEH academy, and a new ILO partnership on labour rights in coffee supply chains were announced within five days of the academy. 

None of these partnerships, nor their concentration in a single four-month window, has been the subject of any published UN-system review.

Criminal investigation

The contradiction is sharpest at the level of UNU-INWEH itself. Nestlé’s water-related conduct is the subject of an ongoing criminal investigation in France, regulatory action in the United States, and decades of Indigenous-led litigation across the Americas over aquifer depletion, over-extraction, and unauthorised treatments. 

A water institute lending its name to a company whose water practices are themselves the subject of regulatory and judicial proceedings is the textbook case of reputation washing.

The UN system has spent two decades building rules of engagement for this kind of oppositional arrangement. The 2015 UN Guidelines on Cooperation between the UN and the Business Sector require that partnerships advance UN aims and that partners demonstrate commitment to human rights and Global Compact principles. 

The 2017 UN Sustainable Development Group Common Approach to Due Diligence requires documented scrutiny where there is public brand association, exchange of assets, or promotion of a business-led initiative – all three of which this partnership involves. 

UNDP has translated these principles into a detailed operational policy with exclusionary criteria, risk-tiered due diligence pathways, and decision-making separated from initiating staff. 

Breach of due diligence policy

UNU has its own due diligence policy, promulgated by the rector in September 2024, with comparable exclusionary criteria and a requirement that high-risk business-sector partnerships be escalated to institute directors in consultation with the office of the rector.

A more specific layer applies to the food and nutrition sector. UNICEF’s 2023 guidance states categorically that it will avoid all partnerships with Code violators and with ultra-processed food manufacturers. 

WHO’s Framework of Engagement with Non-State Actors (FENSA) identifies the conferral of UN legitimacy on corporate actors as a foundational risk. World Health Assembly Resolution 69.9 of 2016 calls on academic institutions not to allow companies marketing foods for infants and young children to sponsor meetings or enter promotional partnerships. 

In 2024, WHO and UNICEF jointly reaffirmed the principle of avoiding all partnerships with Code violators. Beyond these frameworks, an open-ended intergovernmental working group is negotiating, under Human Rights Council Resolution 26/9, a legally binding instrument to give the voluntary 2011 UN Guiding Principles on Business and Human Rights binding force.

The Nestlé partnership is a breach of these provisions. The accountability failure is not procedural. It is categorical: the partnership is of a kind the UN system’s own frameworks identify as one to avoid, and UNU’s own Due Diligence Policy provides the mechanism that would have caught it. That mechanism does not appear to have been applied.

Levels of harm

Mothers and babies are harmed by the marketing of infant formula in place of breastfeeding.

The harm operates on two levels. The first and most fundamental is to children, mothers, and parents whose feeding choices, nutrition, and health are shaped by the marketing practices and product environments the Code exists to regulate. 

The second is to the UN system itself, and to the institutions whose work the partnership undermines – among them WHO, UNICEF, and UNU’s own International Institute for Global Health (UNU-IIGH).

UNU-IIGH, in Kuala Lumpur, hosts a ‘power and accountability’ research programme covering, among other things: accountability deficits of the world’s largest food and beverage, pharmaceutical, and financial corporations; the political economy of commercial milk formula marketing; aggressive tax avoidance by transnational corporations that drains public fiscal capacity in the Global South; and governance capture of inter-governmental institutions. 

Among the programme’s recent outputs is a Lancet article on the inadequacy of current efforts to hold corporations accountable. The Nestlé partnership undermines this work.

Publicly funded research products are lost, inter-agency collaborations disrupted, and the institutional voice of researchers working on commercial determinants of health is structurally weakened. Three years of work is now shadowed by an arrangement the work itself would have recommended against.

The case is not isolated. In late 2025, the Pan American Health Organization (PAHO), the WHO Regional Office for the Americas, signed a three-year Framework Agreement with Ferrero International to support initiatives for “children, adolescents, and families in vulnerable conditions.” 

Researchers, civil society, and the BMJ raised the same concerns that the IBFAN letter raises now: a UN agency lending its name to a major ultra-processed food manufacturer in the very policy domain where the company’s interests run against the public health evidence. On 15 April 2026, PAHO terminated the agreement.

Private funding filling gaps

Two cases, two UN agencies. The pattern is not accidental. The UN’s financial architecture – assessed contributions are now a small proportion of operating budgets, with voluntary earmarked private funding filling the gap – rewards arrangements with well-resourced private partners and penalises institutes that decline them. 

Reinforcing this is the multi-stakeholder model that the World Economic Forum and the World Health Summit have promoted for two decades as the standard architecture of global governance – framing corporations, philanthropies, and states as equivalent partners, weakening public responsibility and intergovernmental accountability. Without active central enforcement of the UN’s own frameworks, the pressure runs one way.

The UN is a global public institution. Its founding Charter establishes it as an institution designed to serve the peoples of the world. It derives its mandate and legitimacy from member states acting through intergovernmental bodies: the World Health Assembly, the General Assembly, and the governing councils of the specialised agencies. 

Its authority rests on the premise that it represents collective public interest, not the interests of particular donors or sectors. Each partnership of this kind erodes public trust in the multilateral system itself, at a moment of declining public confidence in international institutions. 

Within this system, UNU institutes occupy a particular role: an academic and rigorous think tank governed by an independent academic council, providing space for constructive critique while operating in accordance with UN principles. 

Enforcing existing guidelines

When UNU lends its name to a company whose practices the UN has spent decades regulating against, the exchange is clear: the corporation gains legitimacy and access to the next generation of food and nutrition professionals. The UN loses its legitimacy as the arbiter of the standards it exists to uphold.

What is required is not new guidelines. They exist. What is required is enforcement –  transparently, with documented risk-benefit analyses, with decision-makers separated from the staff initiating partnerships, with published exclusionary criteria actually applied. 

UNDP has done this; UNU has the equivalent on paper but appears not to have applied it here. Direct correspondence with the UNU rector and the directors of UNU-INWEH and UNU-IIGH, raising these concerns, has to date received no response. 

Under UNU’s own due diligence policy, a business-sector partnership of this scale would require enhanced due diligence with the direct involvement of the institute director and consultation with the office of the rector. Whether that consultation occurred, and what it concluded, is now the central question.

Three steps must follow. First, UNU-INWEH should terminate the partnership and publish the due-diligence record that preceded its announcement. 

Second, UNU should apply its existing due diligence policy to the Nestlé case and expand its exclusionary criteria to align with the food and nutrition sector frameworks the broader UN system has already adopted – including ultra-processed food manufacturers and Code violators alongside the tobacco and weapons categories the policy already names. 

Third, the United Nations must take enforcement of its own engagement frameworks more seriously, including review by the UN Sustainable Development Group of concentrated patterns of corporate engagement, such as Nestlé’s recent clustering of partnerships across UN agencies, and active management of conflicts of interest, including the instrumentalisation of UN legitimacy by private actors.

The credibility of the UN system depends on the clear separation of its public mandate from the commercial interests its work often contests. Once that line is blurred, it becomes very difficult to draw again.

Dr Unni Karunakara is a Senior Fellow at the Global Health Justice Partnership at Yale Law School in the US; the Richard von Weizsäcker Fellow at the Robert Bosch Academy in Berlin, and a visiting professor at Manipal University, India. He was the interim director of the United Nations University International Institute for Global Health (UNU-IIGH)  in 2024-2025.  and international president of Médecins Sans Frontières (MSF) from 2010-2013. He has held various academic and research fellowships at universities in South Africa, Zimbabwe, Uganda, Germany and the United Kingdom, focusing on forced migration, and healthcare delivery to neglected populations affected by conflict, disasters and epidemics. 

Image Credits: FDA, WHO.

White and blue labelled COVID-19 vaccine
This week’s BioNTech factory closures raise critical concerns over European vaccine supply chains.

This week’s announcement of BioNTech factory closures in Germany marks an end to the country’s pandemic-era COVID-19 vaccine production boom. The Mainz-based pioneer announced that it will manufacture its final batches of the vaccine domestically later this year, transferring all future production to its American partner, Pfizer.

This strategic retreat from Germany – which includes the shuttering of facilities in Marburg, Idar-Oberstein, and the recently acquired CureVac site in Tübingen – is scheduled for completion by the end of 2027, according to German media reports. In total, the company plans to cut up to 1,860 jobs across production sites in Germany, as well as in Singapore.

The company’s leadership attributed the restructuring to plummeting global demand for pandemic products and a necessary pivot toward funding a high-stakes oncology pipeline. BioNTech reported a net loss of €531.9 million in the first quarter of 2026, a sharp decline from previous years.

Closures prompt calls for industrial policy

Modern glass building with European Union flags
The EU Commission recently authorized mCombriax, the first combined mRNA flu-COVID vaccine.

Economic experts warn that relying on volatile corporate and geopolitical developments to maintain vaccine supplies threatens European health security.

“We have seen in the COVID pandemic that a purely business-driven choice of production sites for vaccines can lead to supply bottlenecks in a crisis,” Professor Sebastian Dullien, scientific director at the Macroeconomic Policy Institute, warned in an interview with Reuters.

To prevent future shortages, he urged the government to take stock of vaccine production capacities and implement industrial policies, such as state subsidies or “Buy European” regulations for health insurance companies, to maintain vital production capacities across the continent.

The German federal government dismissed warnings of supply bottlenecks, maintaining that the country’s vaccine supply remains secure and other manufacturers will compensate for the shortfall.

Indeed, foreign manufacturers are stepping in to fill the void, with US pharma company Pfizer likely to utilise its established manufacturing facilities in Europe to absorb BioNTech’s production in the EU. Further underscoring this transatlantic market shift, European regulators recently authorised mCombriax, a new messenger RNA vaccine produced by US rival Moderna that protects adults aged 50 and older against both COVID-19 and seasonal influenza.

US trade policies and EU legislation to reshape global markets

While the approval of foreign products like mCombriax addresses immediate health needs, this deepens EU reliance on American imports, underscoring the fragility of Europe’s supply lines, currently exacerbated by a trade conflict with the US.

The BioNTech factory closures unfold against the backdrop of a recent US Presidential Proclamation imposing up to 100% tariffs on pharmaceutical imports. Although a preferential 15% rate exists for products from the European Union (EU) and Japan, alongside a 10% rate for the United Kingdom, the overarching threat of a trade war leaves European governments scrambling.

To counter its dependency on US imports and to secure local manufacturers, the EU is currently advancing the Critical Medicines Act and the European Biotech Act. These measures aim to incentivise domestic production through public procurement, streamlined regulatory pathways, state subsidies, and “Buy European” rules to shield European health security from global trade ruptures.

Image Credits: Spencer Davis via unsplash, Paws and Prints via unsplash.

Dr Abdi Mahamud, WHO’s director for Health Emergency Alert and Response Operations.

The first person suspected of contracting hantavirus outside of passengers on the Hondius cruise ship is currently in a Dutch hospital.

She is a flight attendant who came into contact with a former passenger who briefly boarded a KLM flight in Johannesburg, South Africa, but was prevented by airline staff from flying to Amsterdam as she was too sick. 

The woman died shortly afterwards in a Johannesburg hospital. Her husband had died on board the ship on 11 April, the first casualty in the ship’s hantavirus outbreak. She had left the ship at St Helena Island on 24 April to accompany his body home.

Cabo Verde permitted the medical evacuation of three patients, but denied permission for passengers to disembark. The ship has since sailed for Tenerife in the Canary Islands. It is expected to arrive by 11 May, where it is hoped that Spanish authorities will assist passengers to return home. 

However, the President of the Canary Islands, an autonomous community of Spain, has said he will not allow the ship to dock – although the Spanish President has assured the World Health Organization (WHO) that passengers will be able to leave the ship.

Cruise operator Oceanwide Expeditions said that two Dutch infectious disease doctors had joined the cruise to “ensure that optimal medical care can be provided if necessary, during the next stage of this evolving situation”.

The WHO has advised that “all passengers stay in their cabins. The cabins are being disinfected, and anyone who shows symptoms will be isolated immediately”, WHO Director General Dr Tedros Adhanom Ghebreyesus told a media briefing on Thursday.

A WHO expert and an expert from the European Centre for Disease Prevention and Control (ECDC) have also joined the ship.

Together with the two Dutch doctors, they are “conducting a medical assessment of everyone on board and gathering information to assess their risk of infection”, said Tedros.

“WHO is developing a step-by-step, operational guidance for the safe and respectful disembarkation and onward travel journey for all passengers when they arrive in the Canary Islands,” he added.

Tedros thanked Spanish President Pedro Sanchez for his “generosity and solidarity” for agreeing to accept the ship in the Canary Islands, describing the risk to the islands as low.

Dr Tedros thanked Spanish President Pedro Sanchez for agreeing to accept the cruise ship in the Canary Islands.

Eighth patient in Switzerland

Oceanwide Expeditions confirmed that all 30 passengers who disembarked at St Helena on 24 April have been contacted. One, a Swiss national with mild symptoms, is currently in a Zurich hospital.

“The Swiss Federal Office of Public Health (FOPH) has confirmed that a passenger who travelled on the first leg of the voyage has tested positive for hantavirus and is currently being treated at the University Hospital Zurich. His wife, who accompanied him, has not shown symptoms but is self-isolating as a precaution,” the company said in a statement

So far, eight passengers are suspected of hantavirus infection. Three have died, one is in hospital in Johannesburg, three were evacuated from Cabo Verde to undisclosed European hospitals – and the eighth is the Swiss man.

“Five of the eight cases have been confirmed as hantavirus, and the other three are suspected,” said Tedros.

“Hantaviruses are a group of viruses carried by rodents that can cause severe disease in humans. People are usually infected through contact with infected rodents or their urine, droppings or saliva. The species of antivirus involved in this case is the Andes Virus, which is found in Latin America and is the only species known to be capable of limited transmission between humans,” he added.

Collaboration with US

Dr Abdi Mahamud, WHO’s director for Health Emergency Alert and Response Operations, said that each country is responsible for repatriating citizens from the ship and tracing any citizens who may have had contact with those exposed to the virus.

Although the US decided to leave the WHO, it has citizens on board the ship and Mahamud said that collaboration with the US CDC is “going very well on a technical level”.

US CDC officials have joined meetings of the Global Outbreak Alert and Response Network (GOARN) “so the information flow is there, transparent and frank, and information sharing”, he added.

The US remains party to the International Health Regulations (IHR), which stipulates the conduct of countries in the event of disease outbreaks, and was receiving formal communication on the outbreak through that.

“This outbreak shows why the world needs a global entity that coordinates,” added Mahamud, also commending Argentina – which also quit the WHO – for coming forward with information, as the cruise started in that country.

Dr Anais Legand, WHO technical lead on viral haemorrhagic fevers, described “excellent collaboration” with her counterpart at US CDC, including sharing of technical assessments almost every day.

Dr Anais Legand, WHO technical lead on viral haemorrhagic fevers.

Long incubation

Mahamud confirmed that the incubation period for the virus is up to six weeks, but that only confirmed cases needed to isolate. 

Contacts of cases need “active monitoring”, which was up to host countries to define, he added.

At this stage, PCR testing by South African and Senegalese scientists had confirmed the Andes virus, a species of hantavirus found mostly in Argentina – which is where the cruise started.

Scientists are currently engaged in genome sequencing of the virus to see whether it was the same as that from an Argentinian outbreak in 2018, which affected 34 people, said Mahamud.

This is the only other known instance of human-to-human transmission. That outbreak evolved from an infected person who attended a concert.

Dr Maria Van Kerkhove, WHO’s Director of Epidemic and Pandemic Management. stressed the importance of “global solidarity”, adding that the WHO has “pulled together all of the global experts related to hantaviruses, in particular the Andes Virus”, to assist in managing the outbreak.

Image Credits: 2011, Sokomoto Photography for International AIDS Vaccine Initiative (IAVI).

Vials of Pfizer´s COVID-19 vaccine. Recent studies showing vaccine’s safety and effectiveness blocked by US FDA.

Officials at the Food and Drug Administration have blocked publication of two studies supporting the safety of widely used vaccines against Covid-19 and other safety studies on shingles in recent months, a spokesperson at the US Department of Health and Human Services confirmed.

In October, 2025 FDA scientists were directed to withdraw two Covid-19 vaccine studies that had been accepted for publication in medical journals, the New York Times reported on Tuesday. Then in February, top F.D.A. officials refused to sign off on the submission of abstracts of studies of Shingrix, a shingles vaccine, to a major drug safety conference,

The withdrawn FDA studies on COVID vaccines involved the use of massive 2023 and 2024 vaccine data sets by agency scientists, compiled and analyzed with outside data firms. Pre-prints and abstracts of the studies that have been made public have largely confirmed the vaccines’ safety.

One study, which examined the Covid vaccine in people older than 65, was posted on the prestigious preprint server Medrxiv.org. The study reviewed the records of about 7.5 million Medicare beneficiaries who got the vaccine, in the first six weeks after their jab. Among 14 health outcomes potentially caused by the vaccine, including heart attacks, strokes and Guillain-Barré syndrome (an auto-immune disorder), researchers found only outcome of concern, anaphylaxis, a severe allergic reaction affecting about 1 in a million people to get the Pfizer COVID vaccine.

“No other statistically significant elevations in risk were observed,” the researchers reported. The study was withdrawn under pressure from FDA officials after it had been accepted by the peer reviewed journal Drug Safety, according to the New York Times report.

An abstract of a second COVID safety study was published at the August 2025 conference of the International Society of Pharmacoepidemiology (ISPE), where it remains online. The study monitored the safety of three leading COVID-19 vaccines, produced by Pfizer-BioNTech, Moderna, and Novavax, among individuals aged 6 months–64 years who received the shots in 2023-24. The researchers found evidence of rare, adverse events, previously reported, primarily fever-related seizures and myocarditis (inflammation of the heart muscle). But no new elevated risks were identified among the 4.2 million vaccine recipients analyzed.

“Given the available evidence, F.D.A. continues to conclude the benefits of vaccination outweigh the risks,” the study’s abstract concludes. Withdrawal of that FDA study from submission to the peer-reviewed journal, Vaccine, was first reported by STAT News.

Shingrix vaccine study also blocked by FDA – outside of agency’s purview

In the case of the Shingrix vaccine against shingles, FDA officials in February failed to sign off for scientific staff to submit abstracts on two studies to a drug safety conference. One study found the vaccine’s efficacy to be in line with findings from the clinical trials done before agency approval. A second safety study also aligned with what was known, finding an elevated but low risk for Guillain-Barré syndrome, an autoimmune disease already noted in the vaccine’s label, the New York Times reported.

Asked about the withdrawal of the Covid vaccine safety studies, Andrew Nixon, a spokesman for the Department of Health and Human Services, was quoted saying: “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data. The F.D.A. acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”

Regarding the blocked shingles vaccine research, he said, “The design of that study fell outside the agency’s purview.”

A senior administration official told the New York Times that the decisions about the research had not reached Dr. Marty Makary, the F.D.A. commissioner, or Health Secretary Robert F. Kennedy Jr. Dr. Vinay Prasad, head of the FDA. vaccine office at the time, did not respond to requests for comment.

In recent weeks, Dr. Jay Bhattacharya, who was serving as interim leader of the US Centers for Disease Control and Prevention (CDC) also canceled the publication of a report concluding that the COVID vaccine sharply cut the odds of hospitalizations and emergency room visits last winter, claiming that the study had limitations.

The current US Administration, under the leadership of HHS Secretary Robert F Kennedy Jr, has dramatically cut research funding for vaccine development and cast doubt on multiple aspects of vaccine effectiveness and safety. It has also frozen vaccine funding to Gavi, the Vaccine Alliance, over alleged safety issues related to the use of thimerosal, as a preservative in some vaccines most often used in low- and middle-income countries where cold chain remains a problem. Those are concerns that WHO, backed by leading vaccine experts, has said are long resolved. See related story:

https://healthpolicy-watch.news/us-freezes-all-funds-to-gavi-over-vaccine-preservative-thimerosal/

Image Credits: Mat Napo/Unsplash.

Wonder, a healthy 8-month-old with his mother, Naomi. He was one of the first infants to receive Coartem® Baby when he was hospitalised at 3-months in The Methodist Hospital, Muwasi, Ghana.

The World Health Organization has ‘pre-qualified’ Coartem® Baby, the first-ever malaria treatment for young infants of 4.5 kilograms or less.

The combination treatment, now being rolled out in Ghana, aims to fill a longstanding gap in treatments available for children under the age of 5, who constitute three quarters of the estimated 610,000 malaria deaths worldwide. 

Until now, infants with malaria have been treated with formulations intended for older children, which increase the risk of dosing errors, side effects and toxicity.” said WHO Director General Dr Tedros Adhanom Ghebreyesus speaking to reporters last week.  

“This new formulation of artemether-lumefantrine helps to close a long-standing treatment gap for some 30 million babies born each year in malaria-endemic areas of Africa.”

The artemisinin-based combination treatment, developed by Novartis together with Medicines for Malaria Venture (MMV), can be used on newborns and infants as small as 2kg.  

It was approved by the Swiss drug regulatory agency, Swissmedic in July 2025.  Since being introduced in Ghana through a combination of pubic and private sector procurement, thousands of infants have been treated with the formula in a response exceeding expectations. 

WHO Pre-qualification paves way for mass procurement

But WHO’s ‘prequalification’, announced last week, is a critical step in paving the way for bulk procurement of the treatment by international agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria for distribution in low-income countries at concessionary prices, said Pierre Hugo, MMV Vice President of Access and Product Management. 

Prequalification is WHO’s ‘stamp of approval’ assuring the quality, safety and efficacy of vaccines and medicines for major diseases like malaria, HIV/AIDS and tuberculosis. WHO’s list of prequalified products is used by UNICEF, the Global Fund, and other agencies procuring products in bulk, to inform their choices about drug and vaccine purchases. 

 “WHO prequalification is a critical milestone because it enables procurement by major global health funders… While specific procurement volumes have not yet been announced, this step paves the way for large-scale access in malaria-endemic countries,” said Hugo.

“This [prequalification] decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them,” said Novartis’ Lutz Hegemann, President of Global Health.

Eight other African countries joined in the Swissmedic “Marketing Authorisation for Global Health Products” (MAGHP)  process for approving the new malaria formulation, including Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Uganda and Tanzania.  

The process aims to support the national regulatory agencies of low-income countries in the Swissmedic assessment, building trust and confidence that can help fast-track national marketing authorisations following Swissmedic’s approval.

Incorporating into WHO treatment guidelines next step for mass rollout 

The next important milestone will be for the medicine to be added to the WHO treatment guidelines, Hugo said, expected in mid-2026. This is another requirement for Global Fund bulk procurement of new medicines and vaccines, along with registration of the treatment in national regulatory systems.  

“Coartem® Baby represents a breakthrough not just in science, but in equity, closing a long-standing treatment gap for the smallest and most vulnerable malaria patients. With WHO prequalification now secured, the focus shifts from innovation to access, ensuring that this life-saving treatment can reach newborns across malaria-endemic regions.”

Earlier this month, WHO also prequalified three new rapid diagnostic tests that can detect strains of malaria that older tests miss.

Said Tedros, “Together with vaccines, new diagnostics and next-generation mosquito nets, it’s another step towards a malaria-free world”. 

Image Credits: Novartis.

The cruise ship Hondius, affected by a hantavirus outbreak after setting sail from Argentina on 1 April, to Antartica and across the South Atlantic. The ship is now moored off the West African Archipelego of Cabo Verde.

Two more people linked to the cruise ship Hondius were reported to have fallen ill in Switzerland and France, according to Swiss and European media reports Wednesday. In the Swiss case, the infection and its links to the cruise ship were confirmed by the Swiss Federal Office of Public Health. On the reported French case, a WHO spokesperson said that the agency had “reached out to French authorities to verify”.

Meanwhile, one passenger and two crew members with suspected hantavirus cases were evacuated from the ship Hondius and flown to the Netherlands to receive medical care,  the World Health Organization also confirmed.

The ship at the centre of the hantavirus outbreak is currently moored off the coast of the West African Archipelago of Cabo Verde. It was supposed to sail to the Canary Islands and dock there on Saturday, where Spanish authorities will assess the remaining passengers, disinfect the ship and conduct a full epidemiological investigation, according to Maria van Kerkhove, director of the World Health Organization’s (WHO) Department of Epidemic and Pandemic Preparedness and Prevention, who spoke at a media briefing in Geneva on Tuesday.

Canary Island authorities, however, have balked at receiving the vessel, while Spanish government officials have said that the plan is in line with a WHO request and “international humanitarian principles.”

Wednesday’s evacuated crew members both were suffering from “acute respiratory symptoms, one mild and one severe”. The other evacuee was German passenger who had been in close company with a passenger who died on the ship on 2 May, according to cruise operator Oceanwide Expeditions. All of those remaining on board the ship, which was carrying almost 150 passengers when it first set sail from Argentina on 1 April, have been asked to remain in the cabins as a precaution until the ship reaches a port of call.

With the report of the Swiss case, eight cruise passengers or former passengers are suspected of having contracted the virus. But laboratory tests have only confirmed it in two of the cases, and one case appears asymptomatic, said Van Kerkhove at Tuesday’s briefing. Three passengers have died, two while on board, including a 69-year-old Dutch man on 11 April and a German citizen on 2 May. The Dutch man’s wife, also died shortly after being medically evacuated to South Africa. Another passenger who was medically evacuated to South Africa remains in intensive care. 

“Illness onset occurred between 6 and 28 April 2026 and was characterised by fever, gastrointestinal symptoms, rapid progression to pneumonia, acute respiratory distress syndrome and shock.,” according to the WHO.

There is no specific treatment, and a high case fatality rate of up to 50% for the hantavirus found in the Americas, but “early supportive medical care is key to improving survival”, according to WHO.

A Swiss and French national each become ill in two more cases linked to the cruise

WHO’s Maria Van Kerkhove at a Geneva press briefing Tuesday on the hantavirus emergency.

The WHO has deemed the global threat posed by the outbreak to be “low”, based on the historically low incidence of human-to-human infection from the virus.

However, on Wednesday a French national was reportedly hospitalized in Europe with a suspected case of the virus after taking a flight with the Dutch woman evacuated from the ship to South Africa, and who later died.  The French woman had not been aboard the Hondius cruise ship at all.

In Switzerland, another former Hondius cruise passenger was being treated for the hantavirus at Zurich University Hospital after having spent some time on the cruise ship in April, according to the Swiss Federal Office of Public Health, which stated on Wednesday, “one person with a hantavirus infection is currently being treated at the University Hospital Zurich (USZ). The patient is male and returned to Switzerland after travelling on the cruise ship on which there were a number of hantavirus cases.”

The man’s wife has not shown symptoms, but is self-isolating, while Swiss authorities are tracing the couple’s contacts, the FOPH stated.

People usually contract hantaviruses from exposure to the urine, droppings or saliva of infected rats. Human-to-human transmission is “uncommon”.

Such transmission has, however, been documented in Argentina and Chile involving the Andes virus, a species of the hantavirus. The “working assumption” is that the Andes virus was responsible for the outbreak aboard the ship, Van Kerhkove said.  But health authorities will only know for sure after the virus is sequenced from the British patient being treated in South Africa. T

Even the Andes virus variant, however, will typically only spread between humans in “very close physical contact”, Van Kerhkove said.  “When you have an enclosed settings, you have people that are spending a lot of time together. These types of things can happen.” 

Andes virus, with some human-to-human transmission endemic to Argentina

Route of the infected cruise ship Hondius from Ushuaia, Argentina to Antartica and across the Atlantic.

The Andes virus is endemic to Argentina, where the cruise ship began its voyage across the South Atlantic on 1 April. It is thus possible that the index passenger was infected before he embarked in Ushuaia, Argentina, rather than on the ship, officials say.  The ship traveled to Antartica and then onto a number of islands and archipelegos off the coast of Africa, along a well-trod Southern Atlantic cruise route featuring spectacular landscapes of both glacial mountains and tropics. 

The first person to die was the Dutch 69-year-old male passenger “who suddenly became ill in the ship en route from Ushuaia to St Helena Island, and presented with fever, headache, abdominal pain, and diarrhoea”, according to the South African Department of Health. He died on arrival at St Helena. His wife then flew to South Africa from St Helena Island, but collapsed at Johannesburg airport and later died at a nearby health facility.

“The initial case and his wife joined the boat in Argentina, and with the timing of the incubation period of hantavirus, which can be anywhere from one to six weeks, our assumption is that they were infected off the ship,” said Van Kerkhove.

A third patient, a British national, became acutely ill while the ship was travelling from St Helena to Ascension Island, and was flown to a private health facility in South Africa. He has been confirmed with hantavirus and is in a “critical condition in isolation”.

Hantavirus infection was confirmed in two of the patients by South Africa’s National Institute for Communicable Diseases (NiCD). Further tests, including sequencing of the virus, is being conducted by NiCD, as well as well as testing the two symptomatic patients on board with the support from Institut Pasteur of Dakar in Senegal. 

President of Canary Islands opposes Spanish Government order to dock the ship

President of the Canary Islands Fernando Clavijo is speaking after opposing the Spanish government’s plan to let the ship dock there.

The president of the Canary Islands, Fernando Clavijo, told reporters in Tenerife that he opposed the Spanish government’s plan to let the ship dock there, Sky News reported.

Clavijo, who belongs to the main opposition party in Spain, said the cruise ship has requested to dock at Tenerife on Saturday.

“The World Health Organisation has explained that Cape Verde is unable to carry out this operation,” the Spanish Health Ministry said in response. “The Canary Islands are the ​closest location with the necessary capabilities. Spain has a moral and legal obligation to assist these people, among whom are also several Spanish citizens.”

Van Kerkhove described the collaboration with member states on the emergency as “excellent”.

The WHO was informed of “a cluster of severe acute respiratory illness” aboard the ship by the UK on 2 May, in terms of the International Health Regulations, she added.

The timeline issued by Oceanwide Expeditions is as follows:

  • On 11 April, the 69-year old Dutch passenger died on board. The cause of death could not be determined at the time.
  • On 24 April, his body was disembarked on St Helena, with his wife accompanying the repatriation.
  • On 27 April, Oceanwide Expeditions was informed that the wife, also a Dutch national, had become unwell during the flight to Johannesburg, South Africa, and had died shortly afterwards in a South African hospital. On 4 May,  a variant of hantavirus was confirmed in the woman.
  • On 27 April, another British passenger became seriously ill and was medically evacuated to South Africa. This person is currently being treated in the intensive care unit in Johannesburg and is in a critical but stable condition. A variant of hantavirus has also been identified in this patient.
  • On 2 May, another passenger, of German nationality, also died on board the ship. The cause has not yet been definitively established.

–Updated on 6 May with new developments, reported by Elaine Ruth Fletcher.

Image Credits: Franklin Braeckman/Oceanwide Expeditions , El Pais/OpenStreetMap, Sky News .

A midwife examines a pregnant woman.

The International Day of the Midwife (May 5) reminds us that safe birth is not a stand-alone event, but part of the broader continuum of sexual and reproductive health and rights

Most maternal deaths occur during labour, birth, or shortly after birth. Nearly 290,000 women died during and following pregnancy and childbirth in 2020, with 95% of these deaths occurring in low- and lower-middle-income countries. 

The major causes included severe bleeding, hypertensive disorders, infections, complications from unsafe abortion, and obstructed labour. Yet these events are largely preventable or treatable when skilled care, referral, medicines, blood, and emergency obstetric services are available. 

Midwives are often the first – and sometimes only – skilled provider able to detect and respond to such complications in a timely manner.  

But the world currently faces a shortage of up to a million midwives – part of a larger global health workforce crisis – that is concentrated in the countries and communities where maternal and newborn mortality is highest.

Although skilled birth attendance globally is around 80%, this figure hides severe inequities within and between countries. Women in rural areas, poor households, conflict settings, humanitarian crises, and marginalized communities are least likely to have access to a skilled midwife or other qualified birth attendant. 

Access is not only about whether a health care facility exists, but also depends on distance, transport, user fees, staffing, respectful care, medicines, referral systems, and whether women trust the system enough to use it.

Safe birth and post-natal care are not standalone events. They are part of the broader continuum of sexual and reproductive health and rights that includes health education, contraception, antenatal care, screening of sexually transmitted infections, safe birth, emergency response, postnatal and newborn care, breastfeeding support, and referral, as well as safe abortion and post-abortion care. 

High maternal mortality ratio

The current global maternal mortality ratio of 223 deaths per 100,000 live births is well above the Sustainable Development Goal target of achieving less than 70 deaths per 100,000 live births by 2030. 

Midwives can provide around 90% of essential SRHR care when they are educated, licensed, regulated, and supported to international standards. 

But in many low-resource settings, midwives are too few, poorly distributed, underpaid, ill-equipped, or not fully authorized to practice to their competencies.  

Scale-up to achieve universal coverage of midwife-delivered interventions is one of the clearest and most practical routes to faster progress and to averting a larger share of maternal and neonatal deaths and stillbirths. 

Investment in the workforce must include education, fair pay, regulation, safe working conditions and career pathways, supplies, data systems, and integration into primary health care. 

Policy settings need to remove financial barriers to care and treat SRHR as a complete package, rather than as a range of isolated services.

Countries are demonstrating increasing innovation in the midwifery field. In Sierra Leone, for example, structured preceptorship (mentorship) programmes are strengthening hands-on clinical skills and confidence among midwives, helping translate training into safer care at the bedside. 

In Ethiopia, a center of excellence in midwifery trains disadvantaged rural girls to become ethical and compassionate midwives in their own communities.  Efforts such as these are key to empowering midwives and the women and children they serve before, during and beyond childbirth.

Midwives already save lives every day. The task now is to ensure that they can do so for women everywhere.

 

Dr Teguest Guerma is the founder and CEO of LeDeG Midwifery College, established in 2015 to address critical gaps in maternal health across Ethiopia and beyond.

 

Image Credits: Elizabeth Poll/MMV, Twitter: @WHOAFRO.

South Africa, speaking for the Africa Group and Group for Equity.

Colombia has appealed for a new “method” to settle the outstanding annex of the Pandemic Agreement, after World Health Organization (WHO) member states failed to reach agreement last week after almost a year of talks.

Talks on a Pathogen Access and Benefit Sharing (PABS) system were due to wrap up last Friday night, but have since been extended to July, with a resolution in that regard being prepared for the World Health Assembly, which starts on 18 May.

“There is one fundamental point that we request be included in the resolution: extending the negotiating period makes no sense unless the negotiating method is changed,” Colombian  Ambassador Germán Velásquez told the Intergovernmental Working Group (IGWG) shortly before the meeting closed last Friday evening.

“It is not possible to continue seeking consensus in the same way. Why not introduce the concept of ‘progressive consensus’? Once a majority has been reached on specific points, a vote should be held if necessary, and negotiations should continue.”

Colombia is part of the Group for Equity, a large cross-regional alliance of countries that has been pushing for a PABS annex that ensures the inequity of the COVID-19 pandemic, where wealthy countries commandeered all the scarce vaccines, is not repeated.

The proposal for voting also has the support of some civil society groups, notably Pedro Villardi, from Public Services International, a trade union federation with over 30 million members.  

“If we need [to reach an agreement], why don’t we vote? We have a majority of countries pushing for equitable provisions… and we have a few countries that are opposing these measures and defending the position of the pharmaceutical industry and other big corporations,” Villardi told a recent briefing on the negotiations.

Increasingly frustrated

The Group for Equity and the Africa Group – which represent the vast majority of member states – have become increasingly frustrated by what they see as developed countries protecting the interests of their pharmaceutical companies instead of levelling the playing field ahead of future pandemics.

The PABS system is due to govern how dangerous pathogens are shared during public health emergencies and how any medical products (benefits) that accrue from this information are shared. 

The dispute, mainly between developed and developing countries, hinges on how countries that share pathogen information can benefit from any vaccines, therapeutics or diagnostics (VTD) developed as a result.

The Group for Equity and Africa want mandatory benefit-sharing, with the terms set out in standard contracts between the WHO and pharmaceutical companies.

Several European countries – notably those with powerful pharmaceutical industries – argue that compulsory benefit-sharing will stifle research and development. 

According to the current draft, the WHO will receive a donation of 10% of vaccines or medicines produced by pharmaceutical companies that sign up to PABS – but only during a pandemic, not a public health emergency of international concern (PHEIC).

‘Deep regret’

At the close of last week’s talks, South Africa – unusually speaking both for Africa and the Group for Equity – expressed “deep regret” that IGWG is “still far from reaching consensus on the text of the Pandemic Agreement annex”.

“We have engaged constructively and in good faith, including by putting forward concrete proposals. We also considered other approaches, but found, ultimately, that these fall short of the IGWG mandate to deliver a PABS annex that preserves the principle of an equal footing between access and benefit sharing,” said South Africa.

“Approaches that risk decoupling these elements, or introducing fragmentation from the outset, are not sustainable foundations for the system we are tasked to build, and may only legitimise the unfair status quo regarding access to essential health products,” added South Africa, referring to a “hybrid” proposal put forward by some European countries during informal negotiations.

The two groups are “strongly united” on a PABS system that is “fair, equitable and capable of correcting long-standing imbalances, including inequitable access to VTDs and unjust extraction of our genetic resources”, said South Africa.

“A credible landing zone requires legal certainty at a point of access on how benefit-sharing obligations will be operationalised and enforced. This is neither excessive nor unreasonable. It is fundamental to trust in the system.”

Convergence

Nepal, speaking for Southeast Asia, warns against weakening the link between access and benefit-sharing.

Nepal, speaking for WHO’s South East Asia region, stressed “the importance of ensuring that the PABS system preserves the intrinsic linkage between access and benefit-sharing. 

“Approaches that risk weakening this relationship or introducing fragmentation from the outset would not provide a sustainable or equitable foundation for the system we are mandated to establish,” Nepal cautioned, apparently also in reference to the “hybrid” option.

Meanwhile, another diverse group represented by the Dominican Republic, but including Australia, the Bahamas, Barbados, Malaysia, Mexico, Norway and Singapore, offered to be a bridge to find “convergence” for a “sufficiently clear, credible and operationally effective” PABS system.

Meanwhile, the EU also expressed regret at the failure to reach agreement, expressing its full commitment to “finalise and agree on a PABS system that will make a real difference and truly change things on the ground”.

The European Union regrets that IGWG was unable to reach agreement on PABS.

‘Disservice to humanity’

The next IGWG will be from 6 to 17 July, and the new aim is for a PABS annex to be ready for next year’s World Health Assembly. 

Closing Friday evening’s session WHO Director General Dr Tedros Adhanom Ghebreyesus acknowledged that the talks have been “a roller coaster”.

“Real progress was made on the PABS annex, but important differences remain. Please stay engaged. We need everyone. My one piece of advice is this: please approach the outstanding issues with a sense of urgency, because the next pandemic is a matter of when, not if,” said Tedros.

Echoing this warning, Helen Clark and Ellen Johnson Sirleaf, co-chairs of The Independent Panel for Pandemic Preparedness and Response, said that “a lack of action to prevent and prepare for the next pandemic threat is a disservice to humanity”. 

They called on governments to do more on pandemic prevention, preparedness, and response (PPPR): “All countries must be able to detect and rapidly report outbreaks which may pose an international threat.”

However, they also acknowledged that many low- and middle-income countries are impacted by high debt levels, and a sharp decline in development assistance. 

“Leaders have an opportunity to demonstrate their commitment to protect humanity at the upcoming UN High-Level Meeting on PPPR in New York in September. 

“There, they must make progress to fill enduring gaps in PPPR including on co-ordination, financing, equity, and accountability. They should also make it clear that the PABS Annex must be finalised to enable the WHO Pandemic Agreement to proceed.”