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The first 10,000 Mpox vaccines will finally arrive in Africa next week, where A dangerous new type of virus – from which people there have suffered for decades – has sparked global concern.
The slow rollout of vaccines — which have already been made available in more than 70 countries outside Africa — has shown that lessons learned from the COVID-19 pandemic about global health care inequities have been slow to materialize, a half-dozen public health officials and scientists said.
One of the hurdles: It took until this month for the World Health Organization (WHO) to officially begin the process that requires making large quantities of vaccine readily available to poor countries through international agencies. That process could have begun years ago, several officials and scientists told Reuters.
Ampox is a potentially fatal infection that causes flu-like symptoms and pus-filled sores and is spread through close physical contact. Declared a global health emergency by the World Health Organisation On August 14, a new strain known as Clade IB began spreading from the Democratic Republic of the Congo to neighbouring African countries.
In response to Reuters questions about delays in vaccine deployment, the UN health agency said on Friday, August 23, that it would take the opportunity to relax some of its procedures to speed up access to Mpox shots in poorer countries.
Buying expensive vaccines outright is out of reach for many low-income countries. The two leading Ampox shots are made by Denmark’s Bavarian Nordic and Japan’s KM Biologics. Bavarian Nordic costs US$100 per dose; KM Biologics’ price is unknown.
The long wait for WHO approval for international agencies to buy and distribute the vaccine has forced individual African governments and the continent’s public health agency – the Africa Centres for Disease Control and Prevention (CDC) – to request donations of vaccines from rich countries. This cumbersome process could collapse if donors feel they must keep the vaccine to protect their own people.
The first 10,000 vaccines to be sent to Africa – manufactured by Bavarian Nordic – were donated by the United States, not provided by the United Nations system.
Helen Rees, a member of the Africa CDC’s Mpox emergency committee and executive director of the Wits RHI Research Institute in Johannesburg, South Africa, said it was “truly outrageous” that after struggling to access vaccines during the Covid pandemic, the region has once again been left behind.
In 2022, after a different ampox strain spread outside Africa, smallpox vaccines were retooled by governments in a matter of weeks, approved by regulators and used to protect the most at-risk people in nearly 70 high- and middle-income countries. Those vaccines have now reached 1.2 million people in the United States alone, according to the U.S. Centers for Disease Control and Prevention (CDC).
But no vaccine is available in Africa, outside of clinical trials. One of the main reasons for this is that vaccines need to be approved by the WHO before they can be purchased by public health groups such as Gavi, the Vaccine Alliance.
Gavi helps poor countries buy vaccines, thus ensuring that vaccines are regularly available to children. It operated a global plan for all vaccines during COVID-19 and has up to US$500 million to spend on Ampox vaccines and logistics.
The Africa CDC has said as many as 10 million doses may be needed across the continent.
But the WHO only this month asked vaccine makers to submit the information needed for Ampox shots to receive emergency licensure — the WHO’s accelerated approval for medical products. It urged countries to hold off on donating shots until the process is finalized in September.
The World Health Organization said it was working with authorities in Congo to develop a vaccination plan, and said on August 23 that Gavi could begin negotiations until emergency authorization was finalized.
Gavi chief executive Sania Nishtar said the WHO now aims to work faster on approvals and improve funding, which “shows a somewhat brighter side of our situation compared to Covid.” When asked to comment on the approval delay, she said, “Hopefully this is another learning moment for us.”
WHO criticized
The WHO’s role in approving medical products has revolutionised supply in low-income countries, which often lack the facilities to test new products on their own, but it has also been criticised for its slow pace and complexity.
The Geneva-based UN health agency said it did not have enough data to begin the approval process for the vaccine during the last Mpox emergency in 2022, and that it has since been working with manufacturers to see if the available data justifies approval.
According to the WHO, ampox, which includes several different strains, has caused 99,000 confirmed cases and 208 deaths worldwide since 2022. This number is likely an underestimate as many cases go unreported.
Infections have been brought under control in affluent areas by a combination of vaccines and behavioural changes among the highest-risk groups.
As with the main initial ampox strain, men who have sex with men were most at risk, but the new Clade IB variant appears to spread more easily through other close contacts, including children, as well as through sexual contact between heterosexual people.
The country most affected by ampox is currently Congo. According to government data, since January 2023, there have been more than 27,000 suspected cases and 1,100 deaths, most of them children.
But according to a source involved in the process who was not authorized to speak to the media, the first 10,000 vaccines donated by the US are not for Congo but for Nigeria, the result of years of negotiations between the two governments. There have been 786 suspected cases in Nigeria this year, and no deaths.
The Nigerian health ministry did not respond to a request for comment; the US Agency for International Development (USAID) said it had also donated 50,000 doses to Congo, but the arrival date had not yet been finalised.
Children at Risk
In Congo, the country’s governance is another part of the problem. Battling conflict and multiple competing disease outbreaks, its government has not yet officially asked Gavi for vaccine supplies and took months to talk to donor governments. Its drug regulator only approved two main vaccines in June.
Neither Congo’s health ministry nor Japan’s health ministry, which is working to receive a large quantity of KM Biologics vaccine donation, responded to requests for comment for this story.
Bavarian Nordic said this week that it needs orders now to produce the vaccine on a large scale this year.
Congo’s government has told reporters it expects to receive vaccine donations next week, but three donor sources told Reuters it was unclear whether that would happen. Europe’s pandemic preparedness agency said in an email its 215,000 doses would not arrive before September.
The USAID spokesperson said Bavarian Nordic and Congo are still discussing pre-shipment requirements needed to ensure proper storage and handling. For example, the vaccines will need to be kept at -20 degrees Celsius.
In eastern Congo, some 750,000 people fleeing conflict are living in camps, including seven-year-old Sagesse Hakizimana and her mother Elizabeth Furaha. She is one of more than 100 children infected with ampox in an area near the city of Goma in North Kivu, according to doctors.
“Imagine fleeing a war and then losing your child to this disease,” said Furaha, 30, as she applied ointment to her son’s rash. His symptoms were subsiding. Last week he was transferred to a new Ebola treatment centre for treatment.
“We need a vaccine for this disease. It’s a bad disease that weakens our children.”
Even when vaccines arrive, questions remain about how to use them: Bavarian Nordic’s vaccine – the most widely used worldwide – is only available for adults. KM Biologics’ vaccine can be given to children, but is more complicated to administer.
Beyond these questions, scientists have not yet reached a consensus on which groups should be vaccinated first, although a possible strategy is ring vaccination, where contacts of known cases are given priority.
“We saw in the case of COVID-19 that the vaccine was available, but the population didn’t want it,” says Jean-Jacques Muyembe, co-discoverer of the Ebola virus and director of the Institut National de Research Biomédicale (INRB) in Kinshasa. He and other scientists said other public health measures in Africa, such as raising awareness and better diagnostics, were also key to stopping the spread of ampox; vaccines are not the only solution.
Some global health experts say the World Health Organization and others should have already focused on improving access to ampox vaccines, as well as testing for the disease and treatment.
“Processes (at the World Health Organization) for vaccines and funding for vaping should have started years ago,” said Ayoade Alakija, who co-chairs a global health partnership aimed at making the vaping response more egalitarian.
He said his comments were not a criticism of the WHO, which can only prioritize what its member countries wish. “It’s a matter of what the world considers a priority, and (that) is not diseases that primarily affect black and brown people.”
In a statement, the WHO said it is “urging all partners, including countries, manufacturers and communities, to scale up efforts, increase vaccine donations, reduce prices and provide other necessary support to protect people at risk during this outbreak”.
Africa CDC chief Jean Kaseya said he was working to engage African vaccine manufacturers to increase supplies and reduce prices, but that it would take time.
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