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LONDON — The first 10,000 mpox vaccines are finally due to arrive next week in Africa, where a dangerous new strain of the virus — which has afflicted people there for decades — has caused global alarm.
The slow arrival of the shots – which have already been made available in more than 70 countries outside Africa — showed that lessons learned from the COVID-19 pandemic about global health care inequities have been slow to bring change, half a dozen public health officials and scientists said.
Among the hurdles: It took the World Health Organization until this month to start officially the process needed to give poor countries easy access to large quantities of vaccine via international agencies.
That could have begun years ago, several of the officials and scientists told Reuters.
Mpox is a potentially deadly infection that causes flu-like symptoms and pus-filled lesions and spreads through close physical contact. It was declared a global health emergency by the WHO on Aug. 14 after the new strain, known as clade Ib, began to proliferate from the Democratic Republic of Congo to neighboring African countries.
In response to Reuters questions about the delays in vaccine deployment, the U.N. health agency said on Friday it would relax some of its procedures on this occasion in an effort to now accelerate poor countries' access to the mpox shots.
Buying expensive vaccines directly is out of reach for many low-income countries. Denmark's Bavarian Nordic and Japan's KM Biologics make the two key mpox shots. Bavarian Nordic's costs $100 a dose; the price of KM Biologics 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 — to instead request donations of shots from rich countries. That cumbersome process can collapse, as it has before, if donors feel they should keep the vaccine to protect their own people.
The first 10,000 vaccines on their way to Africa — made by Bavarian Nordic – were donated by the United States, not provided by the U.N. 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 "really outrageous" that, after Africa struggled to access vaccines during the COVID pandemic, the region had once again been left behind.
In 2022, after a different mpox strain spread outside Africa, smallpox shots were repurposed by governments within weeks, approved by regulators and used in roughly 70 high and middle-income countries to protect those most at risk.
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.
But no shots have been available in Africa outside clinical trials. A key reason: Vaccines needed to be greenlit by the WHO before they could be bought by public health care groups including Gavi, the Vaccine Alliance.
Gavi helps poorer countries buy shots, supplying childhood vaccines in this way routinely. It administered a global scheme for all vaccines during COVID-19 and has up to $500 million to spend on mpox vaccines and logistics.
The Africa CDC has said 10 million doses may be needed across the continent.
But the WHO only this month asked vaccine manufacturers to submit the information needed for the mpox shots to receive an emergency license — the WHO's accelerated approval for medical products. It urged countries to donate shots until the process was finalized in September.
The WHO said it is working with the authorities in Congo to put together a vaccination plan, and on Friday said Gavi could start talks while it finalized its emergency approval.
Sania Nishtar, chief executive of Gavi, said the WHO's aim to now act quickly on approvals and improvements in funding showed "the somewhat brighter side of where we are compared to COVID." Asked to comment on the approval delays, she said, "Hopefully this is another learning moment for us."
WHO criticized
The WHO's role in approving medical products has revolutionized supply in low-income countries, which often lack the facilities to check new products themselves, but it has also faced criticism for its slow speed and complexity.
The Geneva-based U.N. health agency said on Friday it did not have sufficient data during the last mpox emergency in 2022 to start an approval process for the vaccine, and it has been working with manufacturers since then to see if the available data warranted an approval.
Mpox, which includes several different strains, has caused 99,000 confirmed cases and 208 deaths worldwide since 2022, according to the WHO. The tally is likely an underestimate as many cases go unreported.
Infections have been brought under control in rich regions by a combination of vaccines and behavior change among the highest-risk groups.
With the main earlier mpox strain, men who have sex with men were most at risk, but the new clade Ib variant seems to spread more easily through other close contact, including among children, as well as through sexual contact among heterosexual people.
The country currently hardest hit by mpox is Congo. Since January 2023, there have been more than 27,000 suspected cases and 1,100 deaths there, according to government figures, mainly among children.
But the first 10,000 vaccines donated by the United States are not destined for Congo but for Nigeria, as a result of several years of talks between both governments, according to a source involved in the process who was not authorized to speak to the media. Nigeria has had 786 suspected cases this year, and no deaths.
The Nigerian health ministry did not respond to a request for comment; the U.S. Agency for International Development said it has also donated 50,000 doses to Congo but the arrival date is not yet finalized.
