A WHO official providing nutrition support to internally displaced children in Gedaref state, Sudan.

Over half of Sudan’s citizens face acute hunger and three-quarters of a million are in danger of starving to death – the official definition of famine – yet international assistance has been slow and inadequate.

Conflict has killed approximately 30,000 people and forced over a fifth of the population of 50 million to leave their homes, most in the past 15 months since fighting began between the Sudanese Armed Forces (SAF) and the paramilitary Rapid Support Forces (RSF).

The warring factions, previously allies in a successful coup in 2021, have used heavy artillery on each other, destroying  infrastructure, including health facilities and homes.

The RSF, which evolved from the Arab Janjaweed militia, has also been accused of “ethnic cleansing” of non-Arab groups, particularly the Massalit in West Darfur.

“Targeting the Massalit people and other non-Arab communities by committing serious violations against them with the apparent objective of at least having them permanently leave the region constitutes ethnic cleansing,” Human Rights Watch noted back in May, reporting widespread killing and raping of civilians.

Others including the United Nations Special Adviser on the Prevention of Genocide, Alice Wairimu Nderitu, have warned that RSF may be involved in genocide.

“The global inaction in the face of atrocities of this magnitude is inexcusable,” said HRW executive director Tirana Hassan.

Famine in Darfur 

A malnourished child in one of the few remaining functional health facilities in Sudan.

The UN Office for the Coordination of Humanitarian Affairs (OCHA) reported last week that nutrition surveys carried out in all 18 states indicate “an alarming deterioration of the nutrition situation”.

The surveys recorded global acute malnutrition (GAM) of 30% and over – the famine threshold – in Al Lait, At Tawisha and Um Kadadah in North Darfur.

Over 80% of the surveys recorded a GAM prevalence of 15% and above, which is higher than the World Health Organization (WHO) emergency threshold. 

However, Sudanese military leaders have denied that there is a famine, which could trigger a UN Security Council resolution empowering agencies to deliver relief across borders, according to the BBC.

Meanwhile, Medecins sans Frontieres (MSF) warned that thousands of children could die of malnutrition in ZamZam camp for displaced people in North Darfur last month, and the independent Famine Review Committee confirmed that famine was “plausible” in the camp back in July.

Most supply roads to the camp are controlled by the RSF who have made it “all but impossible to bring therapeutic food, medicines, and essential supplies” into the El Fasher area since May, according to MSF.

“The malnutrition rates found during the screening are massive and likely some of the worst in the world currently,” says MSF’s Claudine Mayer. “It’s even more terrifying as we know from experience the results are often underestimated in the area when we use only the mid-upper arm circumference criteria, like we did here, instead of combining it with measuring [children’s] weight and height.”

Residents of the camp, which shelters about 500,000 people, held a protest on 30 September demanding that the RSF allow aid to reach the camp, reporting dire shortages of food, water and medicine, according to the Sudan Tribune.

OCHA warned that the nutrition situation is “expected to deteriorate further in 2025 due to ongoing conflict, food insecurity, compromised health, water, sanitation and hygiene (WASH) services, displacement, access constraints and disease outbreaks”.

Floods, cholera and malaria

In September, calamitous floods damaged more infrastructure and homes, exacerbating cholera, malaria and dengue fever and displacing even more people.

“Since the current [cholera] outbreak began in July 2024, over 18,000 cases of cholera and approximately 550 deaths have been reported in 10 states across the country,” according to UNICEF, which delivered 1.4 million doses of oral cholera vaccines to Sudan last week.

Vaccinations will be offered to people living in the hardest-hit states of Gedaref, Kassala and River Nile.

A UN humanitarian relief worker walks through the remains of a house destroyed by recent floods.

Save the Children’s interim country director, Mohamed Abdiladif, said that most of the child cholera deaths “are from other complications due to weakened immune systems due to malnutrition”.

“For children, the collapsing healthcare system is not only depriving them of emergency medical care, but also disrupting their access to essential routine services, including lifesaving vaccinations for children under five and maternity care for pregnant mothers. Cases of cholera, measles and dengue fever have risen exponentially in recent months, and now hundreds of people are losing their lives to entirely preventable causes,” he added.

Earlier in the week, UNICEF also delivered some 190,000 doses of malaria vaccines to help protect children from malaria.

“Ongoing disease outbreaks are pushing Sudan’s already fragile healthcare system to a breaking point and exacerbating weaknesses in the sanitation and hygiene infrastructure,” according to UNICEF.

“Limited access to safe water and adequate sanitation, especially in overcrowded displacement sites and camps increases the risk of transmission. Children who have never been vaccinated and those suffering from malnutrition are particularly at risk.”

WHO estimates that 70-80% of health facilities are either closed or barely operational in areas worst affected by conflict, such as Al Jazirah, Kordofan, Darfur and Khartoum, while about 45% of health facilities in other parts of the country are similarly affected.

Muted international support

US-backed peace talks held in Geneva in August were boycotted by SAF leader Abdel Fattah al-Burhan.

However, a group of mediators calling itself the “Aligned for Advancing Lifesaving and Peace in Sudan (ALPS) Group”, representing Saudi Arabia, Egypt and the United Arab Emirates (UAE), is negotiating for humanitarian aid.

But a Ministerial meeting convened by Germany, France and the US last month on the sidelines of the United Nations General Assembly in New York, failed to come up with any tangible aid plan for Sudan. 

“Participants expressed deep concern about the catastrophic and still rapidly deteriorating situation in Sudan,” according to a joint statement of participants issued after the meeting 

The meeting was attended by representatives of the UN, Germany, France, US, EU, African Union, the Intergovernmental Authority on Development (IGAD) in Eastern Africa, the League of Arab States, UK, Ethiopia, Uganda, Egypt, Saudi Arabia, UAE, Norway, Switzerland and Türkiye. 

Participants called on the warring parties to “immediately re-engage in negotiations, cease hostilities and finally end the war”. 

They also called on them to commit, as a first step, to “localised humanitarian pauses and ensure immediate humanitarian access to El Fasher, Sennar and Khartoum so that civilians are protected and humanitarian operations can reach those in most dire need of lifesaving assistance”.

They also appealed to “all foreign actors” to refrain from “providing military support to the warring parties and to focus their efforts towards building the conditions for a negotiated resolution of the conflict”. SAF has accused the UAE of arming the RSF (denied by UAE), while it may be getting arms from Iran.

While the statement also noted that the international community “should be prepared to explore options to support the implementation and durability of any future local or nationwide cessation of hostilities”, it did not propose any concrete actions.

Meanwhile, UN agencies report being woefully under-resourced to support the Sudanese people. Humanitarian organisations have requested $2.7 billion in aid, yet received less than half this, according to WHO Director General Dr Tedros Adhanom Ghebreyesus.

Tedros visited Sudan in mid-September ande descried seeing children “wasted to skin and bone” while their mothers pleaded for food.

Image Credits: @UNHCR, WHO, BBC, UN Office for the Coordination of Humanitarian Affairs (OCHA).

From left: Corine Karema and Francine Ntoumi
From left: Corine Karema and Francine Ntoumi

Three African countries—Algeria, Cabo Verde, and Mauritius—have successfully eliminated malaria, but dozens more still face this deadly disease. Globally, only 44 countries have eradicated malaria.

The question of whether the rest of Africa catch up was explored in the latest Global Health Matters podcast, hosted by Dr. Garry Aslanyan.

To delve into this issue, Aslanyan spoke with two pioneers in the field: Francine Ntoumi, founder and executive director of the Congolese Foundation for Medical Research in the Republic of the Congo, and Corine Karema, director of Malaria, NTDs, and Global Health at Quality and Equity Health Care in Rwanda.

“I believe that with the few African countries that have eliminated malaria and the tools we currently have, it is possible for Africa to eliminate malaria,” said Karema. “But we need to be serious. We need to boost and accelerate our efforts in malaria elimination.”

So, what’s preventing its eradication? The experts identified four key challenges:

  • Research
  • Community engagement
  • Finances
  • Biological challenges, like drug resistance

“The major gap, we say, is the financial gap,” said Ntoumi. “To have our government putting more funds in for fighting malaria.”

Explained Karema: “With the anti-malarial drugs we are currently using, we’re already seeing partial resistance in four countries—Rwanda, Uganda, Tanzania, and Ethiopia—to the only effective treatments we have.”

Another significant challenge is climate change, as environmental factors will affect the mosquito, the vector of malaria, and subsequently impact both humans and animals.

Both experts advocated for a One Health approach to eradicating malaria, which involves bringing together experts from various disciplines.

“The environmental component has not been fully considered in our investigations,” said Ntoumi. “So, that is an opportunity to do better.”

The discussion also addressed the malaria vaccine, which has made headlines in public health circles for its potential to save lives, particularly children’s lives. However, the results so far have been limited, returning to one of the core challenges: research.

“We hear many promises to reduce the malaria burden, but so far, the results with these two vaccines—R21 and RTS, which are pre-qualified by the WHO and recommended for use in seasonal and high-transmission areas—are still limited,” Ntoumi explained. “The data is promising, but there’s more to be done. Additionally, the limited availability of vaccine doses remains a problem. Perhaps this will change, but cost is also a concern. We need financial support to gather local data to improve vaccine implementation. If we don’t have enough doses, who gets them? We need more research to guide our advice to stakeholders.”

Karema emphasised that it took over 50 years to develop the vaccine and 20 years to create anti-malaria combination therapies. She added, “Just imagine if research prioritised malaria.”

For now, she concluded, there is no “silver bullet” except for “data, data, data” to guide policies and interventions toward eradication.

Listen to the Global Health Matters podcast on Health Policy Watch.

Visit the podcast website.

Image Credits: Screenshot.

Pan American Health Organization
The 61st Pan American Health Organization Directing Council adopted health policies for the region ranging from tobacco cessastion to climate and health.

WASHINGTON DC – The Pan American Health Organization (PAHO) wrapped up its 61st Directing Council on Friday, after member states adopted policies ranging from health system strengthening to climate and health adaptation and mitigation. The council also reflected on lessons learned from the COVID-19 pandemic and presented a roadmap for a new strategic plan for the next six years. 

These discussions, held between 30 September and 4 October, come a few months following Hurricane Beryl’s devastation of the Caribbean and a historically high dengue transmission.

Reflecting on the past year’s achievements, PAHO leadership noted how these challenges and the COVID-19 pandemic, revealed the region’s structural dependence on imported vaccines, the geographic concentration of innovation and production capacities, and vulnerable global supply chains.

Despite these challenges, PAHO continues to implement innovative policies, leveraging lessons learned from the COVID-19 pandemic to tackle more than 30 communicable diseases through its Elimination Initiative.

“This is an achievable goal,” said PAHO Director General Dr Jarbos Barbosa da Silva in his presentation of the region’s annual report.

“The lessons learned from the pandemic are challenges that we must recognize, learn from and be prepared to face again. Despite this, I am pleased to say that we have made progress,” Barbosa said.

Detailing PAHO’s work in the past year, Barbosa praised a new noncommunicable disease (NCD) initiative in light of the Region’s growing drivers of morbidity and mortality such as hypertension, diabetes, asthma, and heart disease. 

“This program is grounded in our conviction that primary health care is the backbone of resilient health systems and the best entry point for timely care,” continued Barbosa. PAHO’s HEART initiative, its model of care for cardiovascular risk management, with special emphasis on the control of hypertension and secondary prevention in primary health care, has already 4.4 million people under treatment. 

“If the Americas improved population-based hypertension control from the current level of 36% to a target of 50%, over 400 000 cardiovascular disease (CVD) deaths could be avoided. Furthermore, if secondary CVD prevention efforts were expanded, many more deaths could be averted.”

Barbosa also reflected on the progress of its other flagship programs: the Zero Maternal Deaths Initiative, the digital transformation of the health sector, and the strengthening of regional production and Regional Revolving Funds.

With these programs tackling a wide range of health challenges, Barbosa noted that the “work over the past year has been guided by two fundamental principles: an appetite for innovation and a commitment to equity. Equity is our moral compass in the pursuit of health for all people. And innovation reflects the drive to always improve the way we work, adopting the best tools and evidence that can generate the greatest impact.”

‘A source of pride’: routine vaccinations bounce back

PAHO Dr Jarbos Barbosa
PAHO director general Dr Jarbas Barbosa da Silva (second from left) announced an “ambitious” roadmap for a new regional strategy at the 61st Directing Council.

The meeting provided a space for member states and PAHO leadership to reflect on regional achievements, including the recovery of routine vaccination rates. The Region of the Americas made the most progress in the recovery of routine vaccination coverage following the COVID-19 pandemic disruptions. 

“In the last two years, the countries of the region managed to halt the decline in routine vaccination coverage and, in fact, achieved an increase for most antigens, achieving, as I mentioned this morning, 88% coverage for the third dose of the DTP vaccine,” said Barbosa. “I believe this is a source of pride for each of the countries present here.”

Strengthening action on climate and health

Fishing vessels at the Bridgetown Fisheries Complex in Barbados damaged by Hurricane Beryl on July 1, 2024.

Member states approved a new policy on health and climate change. This aims to strengthen health sector action on health and climate change with a particular focus on equity given the vulnerability of the region, its economic dependence on  “climate-sensitive sectors such as agriculture and tourism, and high levels of social inequality,” said the document. 

“Progress toward addressing climate change and its health impacts has been uneven across the Region of the Americas. Only a few countries are implementing essential health adaptation and mitigation measures, and most such efforts have given insufficient consideration to health equity,” notes the document. 

With five lines of action, the climate change and health policy aims to strengthen adaptation and mitigation to climate change and health, ensure active community participation, especially involving those in vulnerable situations, and improve surveillance systems as well as increase climate and health financing. 

“Climate change threatens to worsen existing health inequities, disproportionately affecting populations and territories in vulnerable situations,” said Gerry Eijkemans, PAHO director of Social and Environmental Determinants for Health Equity, in a press release.

This is why “the health sector must take immediate and decisive action on climate change and health, with specific efforts to integrate equity in adaptation and mitigation measures,” she added.

The council also approved measures to address Indigenous health, tobacco control, and epidemic surveillance.

Image Credits: PAHO/Karina Zambrana, PAHO/Karina Zambrana, UNDP.

Abbott’s Alinity m MPXV assay

The first mpox test that enables health facilities to test people and get results onsite has been given Emergency Use List (EUL) approval by the World Health Organization (WHO).

Abbott’s Alinity m MPXV assay is a polymerase chain reaction (PCR) test that can give an mpox diagnosis within around two hours from a swab of a patient’s lesion.

Until now, African countries affected by mpox have had to send samples away to laboratories, often waiting days for the results.

Although a suspected 34,297 mpox cases have been identified in 16 African countries since the beginning of the year, a mere 6,806 have been confirmed by a laboratory test.

In addition, the positivity rate of tests has been under 50% (47% average) – particularly in the Democratic Republic of Congo (DRC) where the majority of cases have been identified. Only 37% of suspected cases in the DRC have been tested this year.

Dr Jean Kaseya, Director-General of the Africa Centres for Disease Control and Prevention, has pointed to numerous problems with testing including that specimens have not been collected properly, been compromised during transportation or have been processed by people without the necessary experience.

The WHO described its EUL as “pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply”. 

“Early diagnosis of mpox enables timely treatment and care, and control of the virus,” it stressed.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, described the listing of the first mpox diagnostic test as a “significant milestone in expanding testing availability in affected countries”.

“Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”

The WHO is considering the EUL of three other mpox tests from Cepheid, Roche and CerTest Biotec after calling on mpox IVDs manufacturers to submit an expression of interest for EUL on 28 August.

The Alinity test can detect both clade I and clade II of the mpox virus. However, it needs to be administered by “trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures”, according to WHO.

The EUL process accelerates the availability of life-saving medical products in a Public Health Emergency of International Concern (PHEIC). 

“The EUL for Alinity m MPXV assay, allowing for its use, will remain valid as long as the PHEIC, justifying the emergency use of mpox in vitro diagnostics, is in effect,” said the WHO.

Rwandan Health Minister Dr Sabin Nsanzimana

The first two people with Marburg also had malaria, which slowed down their diagnosis, Rwandan Health Minister Dr Sabin Nsanzimana told a media briefing on Thursday hosted by the Africa Centres for Disease Control and Prevention (Africa CDC).

This follows the revelation that the suspected index case died on 8 September, according to Dr Brian Chirombo, the World Health Organization’s (WHO) Rwanda representative, speaking at a global WHO briefing held at the same time. 

However, Nsanzimana stressed that Marburg was only confirmed on 26 September.

“The hospital that was attending to the first suspected cases raised the alarm, saying we’re seeing patients, two cases, that are not responding to usual [malaria] treatment. The symptoms for Marburg are very similar to those of  malaria,” said Nsanzimana.

“Its high fever, a severe headache, muscle pain and joint pain and fatigue, and later on, gastrointestinal [pain], nausea, vomiting.  For malaria-endemic countries, these are well known symptoms for malaria.”

As the first case was becoming very sick, Rwanda’s Biomedical Centre, the National Public Health Institute and National Reference Laboratory were called in to investigate and take samples. After running a multitude of tests, they eventually diagnosed Marburg last Thursday.

The outbreak, now comprising 36 confirmed cases, stems from a single cluster in Kigali. This is centred on the two hospitals that treated the earliest suspected cases – the University Teaching Hospital of Kigali (known as CHUK) and the King Faisal Hospital. 

All cases reported in other districts first had contact either with the index case or the health workers who treated him in the capital city before travelling elsewhere. However, the minister added that an Africa CDC map (below) of affected districts was slightly misleading as included districts with case contacts as well as cases.

Marburg outbreak, mapping both cases and location of contacts.

Nsanzimana confirmed that one case has been confirmed in the district alongside the Democratic Republic of Congo (DRC), but as the incubation period for Marburg is up to 21 days, more cases could emerge in the coming days.

Some 80% of Marburg cases are health workers, while new cases steam from their “very close contacts”, said Nsanzimana. Eleven people have died so far.

‘No travel ban’

Meanwhile, in the absence of a Marburg diagnosis, widow of the earliest known case travelled to Belgium. However, she did not have symptoms, had since tested negative and completed 21 days’ quarantine under the guidance of Belgian authorities.

A young German medical student who had been an intern in own of the hospitals had also returned to Germany, but had also tested negative for the virus.

However, the health minister said said his country would be tightening controls at airports. None of the contacts of cases would be allowed to leave the country until they had completed the 21-day quarantine. Thermal cameras were already in use at the siport to screen for people with high temperatures.

Earlier, the Rwandan government suspended visits to hospital patients and boarding school students.

However, Africa CDC Director General Dr Jean Kaseya was emphatic that “there is no travel ban policy”. He reported being inundated by people asking whether they should continue to travel to Rwanda.

“We are flying to Rwanda. I will be in Rwanda, attending meetings. It’s an outbreak that is managed and, as we have outbreaks in all other countries, there is no travel ban. And I repeat it: travellers should not cancel their trips to Rwanda,” said Kaseya.

Pipeline for Marburg vaccines and therapeutics

Dr Ana Maria Restrepo, WHO Co-Lead of R&D Blueprint for epidemics, said that while there were candidate vaccines and therapeutics for Marburg, “they don’t yet have the clinical efficacy data that will allow our colleagues in the regulatory team to proceed with emergency use listing”.

“WHO has been working with a consortium of over 180 researchers and developers from all around the world, and we hope that we all continue to work collectively and together to support the government Rwanda, to seek the opportunity to evaluate these candidates and therapeutics using a state of the art randomized trials,” Restrepo told the WHO press briefing.

In the absence of any approved treatment, Gilead has donated around 5000 doses of its anti-viral medication, remdesivir, which is being given to patients, said Kaseya.

Mpox continues to surge

Mpox cases, 2 October 2024

While mpox has been upstaged by the more deadly Marburg, there continues to be a steady uptick in cases – around 2,500 every week – said Kaseya.

Currently, there are 34,297 suspected cases but the confirmed cases remain a very low due 6,806 due to a myriad of logistical problems. Ghana this week became the 16th African country to confirm an mpox case.

Kaseya also reported that cases in DRC capital of Kinshasa had surged in late September, coinciding with the reopening of schools. Some 46% of all mpox cases are in children.

Trials would soon begin to test the efficacy of a new therapeutic drug, Brincidofovir, while another trial testing the efficacy of “fractional doses” of the current Bavarian Nordic MVA-BN vaccine is also imminent. If successful, this could massively reduce the need for vaccines, which are in short supply.

Meanwhile, the WHO’s director of regulation and pre-qualification, Dr Rogerio Gaspar, reported that the global body was on the brink of authorising Bavarian Nordic’s MVA-BN vaccine for children aged 12 to 17, and was still engaged with the Japanese producer of the vaccine LC16, which has emergency use listing.

Lenacapavir, packaged as Sunlenca in the US, where is sells for $42,250 for two injections.

HIV activists have hailed the announcement by Gilead on Wednesday that it has authorised six generic manufacturers to sell its breakthrough HIV treatment, lenacapavir, in 120 low- and middle-income countries. 

However, they have urged Gilead to expand the deal to include countries such as Brazil, Colombia and Mexico.

Lenacapavir is a long-acting injectable drug that has proven 100% successful in preventing HIV in women who received it twice a year, and almost 100% protective for men and gender minorities who have sex with men in clinical trials.

Results of the PURPOSE1 trial involving women were presented at the International AIDS conference in Munich in July, receiving a standing ovation.

In late September, results from the PURPOSE2 trial reported 99% success rate for the drug as pre-exposure prophylaxis (PrEP).

While lenacapavir is not yet authorised in many countries, it is licensed in the US as Sunlenca for people with drug-resistant HIV, and costs $42,250 a year for two injections.

A wide range of organisations, including UNAIDS, called on Gilead to lower costs and license generic companies to produce the injection. The company undertook to do so at a media briefing at the AIDS conference in July, 

On Wednesday, Gilead CEO Daniel O’Day announced it had signed voluntary licencing deals with the six generic companies to produce lenacapavir. Four of the companies are from India: Reddy’s Laboratories, Hetero Pharma, Emcure and Mylan (a subsidiary of Viatris). Egypt’s Eva Pharma and Pakistan’s Ferozsons Laboratories are also part of the deal.

“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said O’Day.

“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary licence partners after lenacapavir for PrEP is approved.”

Most of South America excluded

Activists at the International AIDS conference protesting against the high price of lenacapavir.

Public Citizen’s access to medicines director Peter Maybarduk said Gilead had “heard the call in part” from people living with HIV and allies worldwide to make lenacapavir “available for global, timely affordable supply, by licensing developing country manufacturers”.

“Its licence will help ensure access to needed treatment for many people and countries. But it leaves out others, including most of South America, where communities continue to fight against real challenges for access,” Maybarduk added.

“Gilead will continue to control who sells lenacapavir and where, through restrictive licensing terms, which will limit availability of affordable lenacapavir even where Gilead claims no patents.”

Public Citizen would have preferred Gilead to license the Medicines Patent Pool, which “would have helped Gilead reach as many people as possible through equitable access terms and brought added credibility”. 

UNAIDS applauded Gilead for licensing the generic companies – including one on the African continent – without waiting for registraion.

“Lenacapavir, which requires only two injections per year, could be game changing – if all who would benefit can access it,” noted UNAIDS.

However, it said that 41% of new HIV infections are in upper-middle income countries, so the “exclusion of many middle-income countries from the licenses is deeply worrying and undermines the potential of this scientific breakthrough”.

UNAIDS also welcomed Gilead’s statement of commitment to “non-profit pricing”, and urged the company to name a specific price.

“Respected researchers have shown it is possible to produce and sell lenacapavir for $100 per patient per year, falling to as little as $40,” it noted.

HIV advocacy organisation AVAC welcomed the speedy issuing of the licenses and the fact that the generic companies come from three different countries, but noted that “key countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir” had been left out.

“This challenges the field’s ability to use this new option at the scale needed to drive down HIV incidence as quickly as possible to meet global targets,” said AVAC, noting that the price of lenacapavir is “still unknown”.

Untaid ‘prepared to invest immediately’ in generics

Meanwhile, Unitaid welcomed the announcement, adding that it is “prepared to invest immediately and collaborate to fast-track access to lenacapavir”.

Unitaid, an initiative hosted by the World Health Organization (WHO) that promotes equitable access to treatment for key global diseases, said it was ready to assist the six generic companies that have been licensed.

“This is a potentially game-changing medication that could dramatically turn the tide against HIV infections, and we must ensure, without delay, global access to lenacapavir for all those who need it,” said Dr Philippe Duneton, Unitaid’s executive director. 

Duneton urged Gilead to “expand its licensing framework to include all populations in need, clarify its plans for registration in all trial countries, and provide a clear timeline for when lenacapavir will be accessible in the countries it promises to serve”.

Brazil was one of the countries that hosted the PURPOSE trials and “cannot be excluded from licensing agreements, and registration plans,” noted Unitaid.

Unitaid, working with the Wits RHI (South Africa) and Clinton Health Access Initiative (CHAI), will soon launch an Expression of Interest for generic lenacapavir licensees to for support for “the accelerated development, regulatory filing, commercialisation, and cost-effective launch pricing for generic lenacapavir”. 

It also urged Gilead to ensure an access strategy that is “transparent, global, and equitable, prioritising those in greatest need wherever they live”. 

“There is an urgent need to understand what pricing policies would be put forward by Gilead, and whether the same populations excluded today from the possibility of acquiring lower-cost generic products in the future, will also be left with unaffordable for-profit prices.”

Story updated to include UNAIDS comment.

Image Credits: Gilead.

Health workers being briefed about Marburg in Rwanda.

Twenty-nine people in Rwanda have been diagnosed with Marburg, the deadly haemorrhagic virus, and 10 have already died, according to the country’s health ministry on Tuesday.

This is three more cases and four more deaths since the outbreak was announced last Friday.

The Rwandan Ministry of Education suspended visits to students in boarding schools on Wednesday to prevent the spread of the virus in schools. 

This follows Sunday’s decision by the health ministry to suspend hospital visits and restrict the funerals of people suspected to have died of Marburg, confining their size to 50 people and outlawing home vigils and open caskets.

Some 70% of those infected are health workers at two facilities in the Rwandan capital, Kigali, and the 19 surviving patients are currently in isolation in hospital, according to the health ministry.

Cases have also been detected in three districts bordering Rwanda’s neighbours, the Democratic Republic of Congo (DRC), Uganda and Tanzania.These countries have weaker health systems and surveillance than Rwanda, and there are fears of that the disease might already be in those countries.

Marburg in Rwanda, October 2024

However, an alarmist report suggesting that Marburg may have spread to Belgium is untrue.

“Contact tracing is underway, with about 300 contacts under follow-up as of 29 September 2024,” according to the World Health Organization (WHO).

“One contact travelled to Belgium from Rwanda. WHO was made aware of this by the public health authorities in Belgium. They shared detailed information on the contact’s situation, that they remained healthy, completed the 21-day monitoring period, did not present with any symptoms, and are not a risk to public health.”

Marburg update, 1 October 2024

Transmission via fruit?

There is no vaccine or proven treatment for Marburg, a zoonotic disease from the same filovirus family as Ebola. Between 20-90% of people with the disease will die, according to the US CDC.

However, there are “several promising candidate medical countermeasures that are progressing through clinical development”, according to the WHO Africa region, which is “coordinating a consortium of experts to promote preclinical and clinical development of vaccines and therapeutics against Marburg virus disease”.

The Sabin Vaccine Institute’s vaccine candidate began Phase II trials in humans a year ago,.

The first known cases were identified in 1967 in Marburg, Germany, in people suspected of coming into contact with infected monkeys from Uganda.

Since then, Egyptian fruit bats have been identified as reservoirs for the Marburg virus.  Human contact between infected bats, including exposure to their urine and faeces, as well as contact with primates infected by bats are the main suspected routes of transmission.

However it is also possible that people could be infected via fruit, according to a 2021 study by Brian Amman of the Viral Special Pathogens Branch at the US CDC and colleagues.

They showed that Marburg-infected bats “can shed virus onto discarded fruit” that can remain stable for around six hours on mangoes and bananas, fruits that are enjoyed by bats and primates, including humans. 

“Consuming or handling of fruit bitten or spat-out by bats is a risk factor” for Marburg spillover to humans and other sensitive wildlife, according to the study.

But person-to-person transmission “requires extremely close contact with a patient,” according to the Africa Centres for Disease Control and Prevention (Africa CDC).

“Infection results from contact with blood or other body fluids (faeces, vomit, urine, saliva, and respiratory secretions) with high virus concentration, especially when these fluids contain blood. Transmission via infected semen can occur up to seven weeks after clinical recovery.”

The incubation period varies from two to 21 days. Thereafter, illness “begins abruptly, with high fever, severe headache and severe malaise”. 

On the third days, patients may experience “severe watery diarrhoea, abdominal pain and cramping, nausea and vomiting”.

“Although not all cases present with haemorrhagic signs, severe haemorrhagic manifestations may appear between five and seven days from symptoms onset, and fatal cases usually have some form of bleeding, often from multiple areas,” Africa CDC notes.

Keep calm, urges health ministry

Rwandan Health Minister Dr Sabin Nsanzimana appealing for calm on national television on Sunday.

Rwanda’s Ministry of Health has urged Rwandans to “remain vigilant and strengthen preventive measures by ensuring hygiene, washing hands with soap, sanitizing hands, and taking necessary precautionary measures when in contact with other individuals”.

Health Minister Sabin Nsanzimana has also appealed for calm, saying that people can continue with their daily lives as the government “has begun to identify hot spots”. However, he appealed to those with symptoms to seek immediate health from their nearest health facility or via an emergency number.


The same infection prevention and control protocols used for other viral haemorrhagic fevers, such as Ebola, should be followed to prevent transmission, according to the WHO Africa Region.

In a joint effort with USAID, WHO has delivered over 500 clinical care, infection prevention and control supplies to Rwanda.

Image Credits: Ministry of Health, Rwanda.

Dr Joachim Hombach (left), WHO senior health advisor to SAGE and Dr Kate O’Brien, WHO Director of Immunization lay out new recommendations on RSV, rubella and polio vaccination.

For the first time ever, the World Health Organization (WHO) has recommended that pregnant women be vaccinated against respiratory syncytial virus (RSV), or that their newborns receive a dose of monoclonal antibodies to protect them against severe RSV disease, which has seen a global resurgence as the COVID-19 pandemic waned. 

In 2022-2023, RSV was the second most detected virus (10.9%) after SARS-CoV-2 (22%), after two seasons of low circulation, presumably due to pandemic-era restrictions. 

The new guidance on RSV, another new recommendation aimed at accelerating the pace of rubella vaccination in under-5s, as guidance on polio jabs and others, were all issued by WHO’s Strategic Advisory Group on Immunization (SAGE) at a press conference on Wednesday. 

The guidance came against data showing that routine vaccinations in 2023 still had not caught up with pre-pandemic levels. 

“In 2023, there were 14.5 million children who didn’t get even a single dose of vaccine.” noted  Dr Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines and Biologicals, at the briefing.  

“Before we hit the pandemic, that number was 12.8 million children, so the world has not recovered back to the performance that was already achieved before we hit the pandemic.

World lags in vaccinating ‘zero dose’ children 

Africa was one of only two WHO regions that in 2023 reduced the number of ‘zero-dose’ never reached by any vaccinations.

That leaves Gavi, The Vaccine Alliance, also behind on its target of reducing the number of ‘zero-dose’ children by 25% by 2025, the Alliance said yesterday in its annual progress report, also issued on Wednesday. 

However, there was good news for the Africa region, which was one of only two regions in the world that saw a decrease in the number of ‘zero dose’ children who have not been reached by any routine immunization programs. 

“The Africa region actually had a decrease in the number of zero dose children in 2023 compared with 2022 which is really good news,” O’Brien said. 

“And in addition to that, the Africa region was one of, again, a limited number of regions that also had a decrease in the number of children who did not receive a measles vaccine. That has fallen to 11.5 million children, compared with 12.2 million children in 2022,” O’Brien said. 

Progress globally in HPV vaccination 

Girls wait after receiving HPV vaccinations at a primary school in Masaka, Rwanda; in 2023, Africa’s HPV vaccine rates were among the highest in the world.

Both SAGE and Gavi report also noted progress on the drive to eliminate cervical cancer by immunizing 14 million girls with the HPV vaccine. There too, the African region stood out with the greatest gains in immunization rates of almost any other region in the world, O’Brien said.  

“With 14 million girls vaccinated against HPV with Gavi support… this number is greater than the previous 10 years combined.” said Gavi in a press statement. “Gavi has now helped prevent over 600,000 future deaths from cervical cancer alone and is on track to reach 86 million girls by the end of 2025.”

RSV recommendation includes two options  

RSV
In May, 2023, GSK’s Arexvy vaccine became the first to be approved for use against the respiratory syncytial virus (RSV), which WHO has now recommended for pregnant women.

The RSV recommendation to countries comes in two parts: either introduce the new RSV for pregnant women in their third trimester to protect their fetus against congenital RSV, preventing the disease in newborns. Alternatively, countries might opt to administer a single dose of monoclonal antibodies to the newborn babies themselves, the SAGE panel recommended.

There are pros and minuses of each approach. The RSV monoclonal antibody remains very expensive to procure. But clinical vaccine trials also have indicated a safety “signal” of slightly more pre-term births among women who get the vaccine – although the increase was very small and  outweighed by the survival gains of newborns whose mothers were vaccinated.

“Close to 97% of the [RSV] related mortality is estimated to occur in low and middle income countries,” said SAGE chair Dr Hanna Nohynek. “We now have, after 60 years of waiting, … two interventions to prevent RSV in children, that is maternal immunization and then monoclonal antibodies to small children.

“SAGE recommended that all countries should introduce passive immunization to prevent severe RSV disease in children, and that could take place either by maternal vaccination or by this monoclonal antibody.  

“In the vaccine efficacy studies, there was a documented safety observation of imbalanced preterm delivery in two trial sites with maternal vaccination, mainly in South Africa and Argentina, and SAGE looked into this signal. But considering the risks and the benefits, and clearly there is a major benefit to be expected,” she said, adding that researchers would continue to collect more data on the pre-term birth issue. 

Rubella vaccine recommended universally

Infant in Rwanda receives a combined measles and rubella vaccine. WHO has now recommended that rubella should be included in routine vaccination, even In countries falling short on measles vaccination.

In another piece of significant, but technically nuanced advice, SAGE also recommended that rubella vaccine be administered “universally” in countries, even if they haven’t yet reached an  80% rate of measles vaccination. 

About 32,000 infants a year are born with congenital rubella syndrome, an insidious form of the disease that causes severe heart defects and intellectual disability. Those cases mostly occur in just 19 countries with historically low overall vaccination rates. 

Previous WHO recommendations held that countries should achieve 80% coverage with at least an initial dose of measles vaccine – with measles being used as a proxy for a country’s immunization outreach capacity.  

That was due to concerns that in countries with low-vaccination rates overall, introduction of the rubella vaccine could actually increase environmental exposures of girls and pregnant women to the rubella virus overall, and thus cause even more CRS cases in newborns. 

But new modeling work and analysis shows that the 80% threshold rate is “overly conservative and no longer warranted,” the SAGE experts said in a press statement.  

Six of the 19 remaining countries with no rubella containing vaccine (RCV) are now planning to introduce it, and SAGE recommends that the vaccine thus be introduce in the 13 remaining countries.

“The universal introduction of RCV, accompanied by wide age-range campaigns at introduction, should be initiated in the remaining 13 countries. Regular follow-up campaigns are recommended in countries where routine MCV coverage is below 90%,” SAGE said.

Reinforcement of polio vaccines 

The September campaign to vaccinate children with oral polio dose in conflict-wracked Gaza reached its 90% coverage goal. WHO now recommends a jab of inactivated virus, as well, in situations where that’s feasible.

SAGE also recommended that during polio outbreaks, and subsequent vaccine campaigns, a jab of inactivated poliovirus (IPV) be administered along with the oral polio vaccine (OPV), so as to better reinforce the immunity of children at risk.

Adding the injection would help better protect against environmental exposures to vaccine-derived poliovirus, in outbreaks such as the one seen recently in Gaza, as well from exposures to wild poliovirus, still circulating in countries such as Afghanistan and Pakistan, WHO said, adding “unless it would impact the timeliness of the response.” 

Currently, WHO and country partners are in the process of phasing out the bivalent OPV and replacing it with a novel OPV vaccine that does not mutate as easily in the environment to cause new infections in other young children. 

However, two doses of OPV are needed to build the required immunity, with a weaker response in undernourished children, while recent studies have shown that the IPV has a reinforcing response in the gut to the OPV vaccine, whatever type was administered, as well as protecting from polio’s most severe outcome, paralysis, and that is a boost to at-risk children generally.  

“The whole intention here is to shift over to a world where we no longer give oral polio vaccine, but we are relying in that end stage of polio eradication on injectable form of of the vaccine,” pointed out O’Brien, noting that in most developed countries that shift has already happened, and IPV is the only vaccine that infants and young children already receive.

“So including the injectable polio vaccine along with the oral polio vaccines whenever there’s an outbreak,… and including the injectable form of the polio vaccine for the preventive campaigns, wherever that is possible, provides a sort of dual protection in order to enhance the immunity and to protect against the possibility of circulating [vaccine-derived] strains that could transform into ones that that cause paralysis.”

Weighing vaccine costs, benefits and scientific evidence 

Cutting across all of the WHO’s recommendations are issues of vaccine costs, as well as nuanced considerations of benefits that can be obtained – and the gaps in knowledge that countries must weigh up in decision-making. 

“Fifty years ago, there were seven diseases against which we have vaccines today. Today there are over 30 diseases that are vaccine preventable. And there has been a huge success rate in developing vaccines in the past 15 to 20 years,” O’Brien said, leading to “more vaccines available than any country can take up.”

More and more vaccines are constantly being developed, particularly with the recent introduction of new technologies, such as mRNA. That leaves countries forced to weigh up an increasing array of factors, including the scientific evidence and data around relative costs and benefits of various choices. 

“So we’re really in a new era of vaccine development and vaccine deployment,” she said. “But it really depends also on the characteristics of the disease and the characteristics of the vaccine relative to that disease, in order to achieve that ultimate end point of disease prevention, which is the most equitable kind of disease prevention we could ever have, which is complete eradication of the disease

But the increase in vaccine options also means that more and more countries are struggling with questions around the evidence of a vaccine’s benefits against costs, and many of the newest vaccines and solutions may also remain out of reach until prices come down.

Price drops usually only happen when a vaccine becomes available in generic form or agencies such as Gavi procure the jabs in bulk on behalf of low- and middle-income countries.  

“Vaccine is not a prevention tool unless it’s actually used,” O’Brien remarked.  “And so this is at the heart of vaccination programs: that they get to the countries that need them.”

Image Credits: Flickr – UNICEF Ethiopia, University of Oxford/Tom Wilkinson, UNICEF, NIAID, WHO, WHO.

Thousands protest anti-LGBTQ laws in Budapest, Hungary in 2021.

UNAIDS expressed “deep concern” Wednesday over Georgia’s newly adopted anti-LGBTQ+ law, saying that it could threaten progress made over the past decade to end AIDS in the former Soviet republic of 3.7 million people at the crossroads between Europe and Asia. 

The new legislation exacerbates stigma and hinders “LGBTQ+ people’s access to essential health services” which “undermines Georgia’s efforts to end AIDS and combat other infectious diseases,” said the UN agency in a press statement. 

UNAIDS has long called out the risk such legislation poses to public health efforts to control HIV and other infectious diseases – leaving at-risk groups even more reluctant to seek out health services for fear of stigmatization and even prosecution.

The UNAIDS comments echoed a statement issued by the UN Office for the High Commissioner of Human Rights’ saying the new law will “impose discriminatory restrictions on education, public discussion, and gatherings related to sexual orientation and gender identity.”

Georgia’s new law on “family values and protection of minors”  bans Pride events and public displays, as well as censoring related films and books. 

It follows moves by several other European countries – including Hungary and Poland – to curb LGBTQ+ rights. Nearly a dozen African countries have criminalized LGBTQ+ relationships, with some instituting stiff penalties, including the death penalty or life in prison. 

Georgia’s move comes after a recent study from the European Union’s Fundamental Rights Agency, which found that 14% of people who identified as a sexual minority experienced some form of violence. 

While UNAIDS and other international organizations have decried such laws, they remain popular in socially conservative countries. A 2018 poll from the Washington DC-based National Democratic Institute suggested that only 23% of Georgians believe that protecting the rights of sexual minorities is important. Similarly, a 2022 poll suggested that only 0.99% of Georgians agree that homosexuality is “justifiable” compared to 62% of Canadians and 45% of Americans. 

Anti-LGBTQ+ legislation could “undermine” fight against infectious diseases

Georgia historically has reported low rates of HIV infections, with new infections concentrated in persons who inject drugs (PWIDs) and men who have sex with men (MSM). 

Yet its Georgia country report states that the prevalence of HIV – the number of people living with the disease – remains “alarmingly stable” at 21.5% for the MSM population, suggesting that the most at-risk groups still are not being reached. Worryingly, 36% of people living with HIV were not aware of their positive HIV status. 

Furthermore, the UNAIDS country report found that over 40% of Georgians believe that HIV positive children should attend schools with HIV negative children, noting:  “Stigma kills, but solidarity saves lives. Upholding the rights of LGBTQ+ people is crucial to advancing public health, social cohesion, and equality for all.”

Image Credits: Lydia Gall/ Human Rights Watch.

WHO Director General Dr Tedros Adhanom Ghebreyesus greets Afrigen’s Prof Petro Terblanche at the mRNA facility in South Africa

The establishment of an “mRNA hub” in South Africa to build the capacity of low- and middle-income countries (LMICs) to develop vaccines during the COVID-19 pandemic was widely hailed as a solution to Africa’s lack of manufacturing ability.

But three years after its launch in June 2021, the hub faces uncertainties, risks and shortfalls –  including that it may simply become a “technological solution” that maintains the status quo rather than a genuine transfer of knowledge and capacity to LMICs, according to a recent report

Authors Professor Matthew Herder, chair in Applied Public Health at Dalhousie University in Canada and Ximena Benavides from Yale University in the US, base their observations on interviews with 35 key players and numerous documents, some of which were obtained via an access to information request to the Canadian government.

The hub is the initiative of the World Health Organization (WHO) and the Medicines Patent Pool (MPP). Spurred by the failure of high-income countries to share their COVID-19 vaccines at a time of extreme need, the WHO and MPP selected a South African consortium comprising biopharmaceutical company Afrigen Biologics, vaccine producer Biovac and the SA Medicines and Research Council, as its partner to kickstart a facility capable of developing and producing mRNA vaccines in a LMIC. 

Once this was done, they were to teach other facilities in LMICs across the world how to do the same.

The mRNA programme currently includes the South African consortium and 14 other LMIC-based partners.

The current mRNA programme partners

Championing voluntary IP transfer

But the way in which the hub is governed and operates does not sufficiently transfer power and capacity to LMICs, the authors contend.

“The architects of the programme are working within the existing system of biopharmaceutical production and, at the same time, preserving their own control over the programme’s design and preferred measures meant to remedy shortfalls in equitable access to mRNA-based interventions,” they argue.

“In particular, MPP continues to champion voluntary [intellectual property] licensing as the optimal means to improve local production capacity in LMICs even though that mechanism did not attract collaboration from more established mRNA manufacturers in the context of COVID-19 and slowed adoption of a more transformative end-to-end approach to R&D and manufacturing.”

They also argue that the “technological outcomes” of the programme are uncertain unless there is “significant reform and concerted effort to redistribute not just IP, but agency to LMIC actors”.

Without these “there is a significant risk that the programme, which is claimed by WHO and MPP as a collective effort to improve manufacturing capacity in LMICs for LMICs, will not solve the problem of equitable access to biopharmaceutical innovation”.

‘In line with status quo’

While the mRNA programme may improve the sharing of knowledge, the authors observe, it has been developed “in line with the status quo” of global biopharmaceutical production.

This includes “weak conditionalities around product affordability, participants’ freedom to contract with third parties, and acceptance of market-based competition”, they argue.

The WHO and MPP also exert “tight control over the programme” and this “evokes the dynamics that are often in play in global health, to the detriment of empowering LMIC-based manufacturers to generate mRNA products in response to local health needs”, they argue.

For example, the MPP has created its own technology transfer unit to manage technology transfer within the mRNA programme. But typically, technology is transferred from one party with direct experience in using it, to another, through sharing hands-on know-how. 

“I’ve worked for more than 30 years in the industry. You do not have a remote group that does tech transfer. If a group is going to do tech transfer, it needs to be in the facility that’s sending the technology out,” one participant told the authors.

The hub’s donors – France, the European Commission, Germany, Norway, Belgium, Canada, South Africa and the African Union – have committed $117 million to the programme (with $89 million received so far).

But some of the high-income countries (HICs) that have invested in the mRNA programme have also made demands that have shaped the programme. Canada, for example, stipulated that its funding be allocated to the hub in Cape Town and four other countries only: Senegal, Nigeria, Kenya and Bangladesh.

“According to one interview participant, while HICs are supportive of transferring technology to LMICs, they would prefer that such transfers do not extend to the more upstream inputs into mRNA vaccine production, including novel LNPs and antigens,” the authors note.

Charles Gore (MPP), Petro Terreblanche (Afrigen), WHO’s Dr Tedros Ghebreysus,South Africa’s Health Minister Dr Joe Paahla, and Anne Tvinnereim, Norwegian Minister of International Development, at the ribbon-cutting to formally open Afrigen  on 20 April, 2023.

Contradictory legal agreements – and pricing silence

The report notes that the MPP has crafted a set of legal agreements including a technology transfer template in which LMICs are granted a “non-exclusive, royalty-free, non-sublicensable, non-transferable, irrevocable, fully paid-up, royalty-free licence” to the technology.

They also get access to any rights held by Afrigen and Biovac “to make, or have made, use, offer for sale, sell, have sold, export or import” products in their respective territories and other LMICs.

In exchange, LMICs must grant MPP a worldwide, non-exclusive, royalty-free licence to data and the inventions to “facilitate the development and equitable access of health technologies”.

Brazil’s Bio-Manguinhos has baulked at the idea that technology it has developed with  funding from the Brazilian government “would flow to manufacturers from participating LMICs, which in some cases, are for-profit commercial entities, without anything in return”, with official Patricia Neves describing this as an “injustice”.

South Africa also contested the absence of royalties, and its agreement with MPP states that any licence may include a “royalty sacrifice”.

Meanwhile, Indonesia’s BioFarma negotiated the right to sell products to HIC. 

“MPP also stopped short of requiring that resulting mRNA products be priced affordably for populations in need outside of a Public Health Emergency of International Concern (PHEIC),” the authors note.

If an mRNA product developed by an LMIC partners targets a PHEIC, they cannot charge more than the cost of production plus a 20% mark-up.

“Traditionally, MPP has not interfered in pricing. Our model is based on competition, and clearly we are potentially giving this to 15 companies around the world,” MPP executive director Charles Gore told the authors.

In response, the authors remark that the MPP “appears to be comfortable relying on free-market competition among LMIC-based manufacturers instead of imposing affordability clauses when it comes to products generated by virtue of participating in the mRNA programme”.

Moving beyond COVID

A researcher in the WHO mRNA hub at Afrigen in South Africa.

It took Prof Petro Terblanche’s Afrigen only two months to develop an mRNA vaccine for COVID-19 based largely on a Moderna “recipe” published online. It has since transferred this knowledge to facilities in countries including Bangladesh, Serbia and Brazil.

But the urgency related to COVID-19 has passed. Expanding the programme’s focus upstream is now seen as crucial to its overall sustainability given that demand for COVID-19 vaccines is limited. 

At a meeting in Bangkok in late 2023, WHO and MPP officials outlined “potential sub-consortia – engaging partners both inside and outside of the programme – focused on R&D around pathogens of shared, regional interest,” according to the authors.

Afrigen is increasingly focusing on the development of second-generation technologies important in mRNA production, such as novel lipid nanoparticles (LNPs), and new disease targets like TB, malaria and HIV.

“The critical question is whether the funding that has been secured for the programme and supporting the development of these second-generation mRNA technologies has been leveraged into a shared set of commitments geared towards improving equitable access,” the authors note.

While Afrigen targeted 11 potential diseases for mRNA product development, its proposals focusing on Lassa fever, RSV, and other disease targets have been turned down by a variety of funders.

Terblanche has conceded that her “hand will now be forced to prioritise” in favour of market rewards – particularly as the MPP expects the programme to be “self-sustaining” by 2026.

But an increasing number of “use patents” that claim IP on the use of mRNA technology are being filed in South Africa and other LMICs, and these threaten to block Afrigen and partners’ R&D plans.

Recalling that some of the companies that took part in the the influenza vaccine hub later shut down production, WHO’s Martin Friede estimates that if a handful of LMIC manufacturers manage to make mRNA vaccines, the programme will be an overall success.

Meanwhile, MPP’s Gore noted that “we are funding [Afrigen] to develop and then shift [the technology] out,” but “they don’t [yet] have a business model.”

MPP’s Marie-Paule Kieny speculates that Afrigen will, in the end, probably yield to market forces: “The hub is really there to establish a first platform and improvement, and to help with an early pipeline. After that we are fully aware that Afrigen is a private company, at one point they will try to find somebody to buy them out and to get the benefit,” she told the authors.

‘Failure of imagination’

But the authors describe the “near inevitability of Afrigen’s exit in the eyes of those who designed the programme” as an indication of the “underlying failure of imagination concerning how the mRNA programme is governed”. 

A more “inclusive and decentralised” governance structures could “shield initiatives such as the mRNA programme from the risks and constraints posed by dominant market actors”. 

This decentralized structure could involve “representatives from participating LMICs capable of steering the programme’s R&D towards local population” in the overall governance and day-to-day decision-making., they argue.

“Second, multiple actors would need to serve as regional mRNA hubs – as originally planned – in order to mitigate the risk that one organization’s failure (or acquisition by an outside actor) might compromise the programme as a whole,” they argue.

“Instead, WHO and MPP internalised programme decision-making within two hand-picked committees [the “Scientific and Technical Review Committee and the mRNA Scientific Advisory Committee], leaned on private actors like Afrigen to play crucial roles, preserved their discretion about what projects and partnerships to pursue, and limited input from LMIC governments and civil society during the programme’s first two-plus years of operation,” they note.

“It remains to be seen whether MPP, which has ascended in the sphere of global health during the pandemic as a result of its role as the central power broker for the entire mRNA programme, will over time cede some of its control and take the steps necessary to truly empower LMIC manufacturers,” they observe.

Health Policy Watch will publish an interview with the Medicines Patent Pool responding to these findings shortly.

Image Credits: WHO, WHO, Kerry Cullinan.