(This story was resubmitted from August 24 to correct the name in the credit report to Jaafar Al-Qatantani.)
By Jennifer Rigby
LONDON (Reuters) – The first 10,000 doses of the MBOX vaccine are finally due to arrive next week in Africa, where a dangerous new strain of the virus that has infected people there for decades is causing global concern.
The slow arrival of vaccines — already available in more than 70 countries outside Africa — showed that lessons from the COVID-19 pandemic about global health inequality were slow to change, six public health officials and scientists said.
Among the hurdles: The World Health Organization only formally began this month the process needed to give poor countries easy access to large quantities of vaccines through international agencies.
Several officials and scientists told Reuters that it may have started years ago.
Chickenpox is a potentially deadly infection that causes flu-like symptoms and pus-filled lesions and is spread through close physical contact. The World Health Organization declared a global health emergency on August 14 after the new strain, known as clade Ib, began spreading from the Democratic Republic of the Congo to neighboring African countries.
The World Health Organization said on Friday, in response to Reuters’ questions about the delay in vaccine distribution, that it would relax some of its procedures on this occasion in a bid to speed up access to MBOX vaccines for poor countries.
Buying expensive vaccines outright is out of reach for many low-income countries. There are two main doses of the MPOX vaccine, made by Danish company Bavarian Nordic and Japanese company KM Biologics. The Bavarian Nordic vaccine costs $100 per dose; the price of the KM Biologics vaccine 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 Centers for Disease Control and Prevention, to seek vaccine donations from rich countries instead. That cumbersome process could collapse, as it has before, if donors feel they must hold on to 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, and were not provided by the UN system.
“It’s really outrageous” that after Africa struggled to access vaccines during the Covid pandemic, the region is once again falling behind, said Helen Rees, a member of the Africa CDC emergency committee and executive director of the RHI Research Institute at Wits University in Johannesburg, South Africa.
In 2022, after a different strain of smallpox spread outside Africa, governments reintroduced smallpox vaccines within weeks, received regulatory approval, and were used in about 70 high- and middle-income countries to protect people most at risk.
These vaccines have now reached 1.2 million people in the United States alone, according to the US Centers for Disease Control and Prevention (CDC).
But no vaccines have been available in Africa outside of clinical trials, largely because the vaccines needed approval from the World Health Organization before public health groups, including the Gavi vaccine alliance, could buy them.
Gavi helps the poorest countries buy vaccines, and routinely delivers childhood vaccines this way. It has run a global vaccine rollout during the COVID-19 pandemic and has up to $500 million to spend on MPOX vaccines and logistics.
The Africa Centers for Disease Control and Prevention said 10 million doses are needed across the continent.
But the WHO only this month asked vaccine manufacturers to submit the information needed to receive MBOX vaccines for emergency authorization — the WHO’s rapid approval of medical products — and urged countries to donate vaccines until the process is completed in September.
The World Health Organization said it was working with authorities in Congo to develop a vaccination plan, and said on Friday that the Global Alliance for Vaccines and Immunization could begin talks while its emergency authorization is being finalized.
Sania Nishtar, CEO of Gavi, said the WHO’s goal now was to move quickly on approvals and improve funding, which showed “a bit of a bright side to our situation compared to Covid.” Asked to comment on the approval delays, she said: “Hopefully this will be 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 vet new products themselves, but has also faced criticism for its slow speed and complexity.
The Geneva-based UN health agency said on Friday it did not have enough data during the last emergency for the Mbox vaccine in 2022 to start the vaccine approval process, and has been working with manufacturers since then to see if the available data merits approval.
Chickenpox, which includes several different strains, has caused 99,000 confirmed cases and 208 deaths worldwide since 2022, according to the World Health Organization. That number is likely an underestimate as many cases go unreported.
In affluent areas, the infection has been brought under control thanks to a combination of vaccines and behaviour change among the most at-risk groups.
For the previous main strain of mpox virus, men who have sex with men were most at risk, but the new Ib variant appears to spread more easily through other close contact, including among children, as well as through sexual contact between heterosexual people.
Congo is currently the country most affected by dengue fever. Since January 2023, there have been more than 27,000 suspected cases and 1,100 deaths there, according to government figures, most of them children.
But the first 10,000 vaccines donated by the United States will not be for Congo but for Nigeria, the result of several years of talks between the two governments, according to a source involved in the process who was not authorized to speak to the media. Nigeria has recorded 786 suspected cases this year, and no deaths.
Nigeria’s health ministry did not respond to a request for comment. The U.S. Agency for International Development said it had also donated 50,000 doses to Congo, but an arrival date had not yet been determined.
Children at risk
In Congo, governance is another part of the problem. Amid conflict and multiple competing disease outbreaks, its government never formally requested vaccine supplies from Gavi, and it took months to talk to donor governments. Congo’s drug regulator only approved the two main vaccines in June.
Neither the Congolese Ministry of Health nor Japan’s Ministry of Health, which is working to donate large quantities of KM Biologics vaccines, responded to requests for comment for this story.
Bavarian Nordic said this week it needs orders now to produce vaccines in large quantities this year.
Congo’s government told reporters it hoped to receive vaccine donations next week, but three donor sources told Reuters it was not clear whether that would happen. The European Union’s pandemic preparedness agency said by email that its 215,000 doses would not arrive until September at the earliest.
A USAID spokesperson said Bavaria Nordic and Congo are still discussing pre-shipment requirements to ensure proper storage and handling. For example, the vaccines must be stored at -20 degrees Celsius.
In eastern Congo, some 750,000 people are living in camps after fleeing the conflict, including seven-year-old Sagisi Hakizimana and his mother, Elizabeth Furaha. He is one of more than 100 children infected with mbox in a single area near the city of Goma, in North Kivu, according to doctors.
“Imagine you are fleeing war and then losing your child to this disease,” said Furaha, 30, as she rubbed ointment on her son’s rash, adding that his symptoms were beginning to ease. He was receiving treatment last week at a rebuilt Ebola treatment center.
“We need a vaccine for this disease. It is a serious 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.
In addition to these questions, scientists have not yet agreed on which groups should be vaccinated first, although a possible strategy is ring vaccination, where contacts of known cases are prioritized.
“We saw with Covid-19 that the vaccine was available but the population did not want it,” says Jean-Jacques Muyembe, one of the discoverers of the Ebola virus and director of the National Institute of Biomedical Research in Kinshasa.
Other public health measures, such as raising awareness in Africa and improving diagnosis, were also key to stopping the spread of dengue; vaccines are not the only solution, he and other scientists said.
Priorities
Some global health experts say the WHO and other organizations should have focused earlier on improving access to mpox vaccines as well as disease tests and treatments.
“The processes (at WHO for vaccines) and diagnostics funding for Mepox should have started a few years ago,” said Ayoade Alakija, who co-chairs a global health partnership that aims to make vaccine responses more equitable.
She said her comment was not a criticism of the WHO, which can only prioritize what member states want. “It’s about what the world prioritizes, not diseases that primarily affect black and brown people,” she said.
In a statement, the World Health Organization said it “urges all partners, including countries, manufacturers and communities, to mobilize efforts, increase vaccine donations, reduce prices and provide other essential support to protect vulnerable people during this outbreak.”
Jean Cassia, head of the Africa Centers for Disease Control and Prevention, said he was working to engage African vaccine manufacturers to boost supply and lower prices, but that would take time.
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