monkeypox vaccine stuck in who regulatory process: "zero supply" in africa, expected to be approved in september
2024-09-04
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half a month after the world health organization announced on august 14 that the monkeypox epidemic once again constituted a global health emergency (pheic), african countries hardest hit by the epidemic have still not received a single dose of vaccine.
the africa centers for disease control and prevention said monkeypox cases are increasing rapidly in central africa, with nearly 4,000 cases reported in the past week, a 200% increase. the virus has infected tens of thousands of people and killed more than 600 people, mostly children, since the beginning of the year.
the paper reporter asked questions at the who headquarters
"what we need most now is a vaccine," said dr. samuel roger kamba, the minister of health of the democratic republic of congo. the democratic republic of congo is the epicenter of this round of monkeypox outbreak. since january, a new variant of the virus has appeared in the country. vaccines play a key role in controlling the outbreak. although the country has requested vaccines two years ago and manufacturers say they still have stocks, the country, like most african countries, still has no vaccine available.
on august 31, unicef issued an emergency tender to purchase monkeypox vaccines. under the emergency tender, unicef will sign a conditional supply agreement with the vaccine manufacturer: to purchase and deliver the vaccine immediately after funding, demand and regulatory requirements for the vaccine are in place.
“it is critical to address the current monkeypox vaccine shortage and get the vaccine to the communities that need it now,” said leila pakkala, director of unicef’s supply division.
yukiko nakatani, assistant director-general of the world health organization for access to medicines and health products, said in an interview with the paper (www.thepaper.cn) and other media that who is currently reviewing the information submitted by vaccine manufacturers and expects to approve it soon in the next few weeks.
where is the vaccine?
monkeypox is a viral zoonosis that belongs to the same family of viruses as smallpox. it is primarily transmitted through skin-to-skin contact, including sexual contact, but can also be spread through droplets during prolonged face-to-face contact, and causes fever, muscle pain, and skin lesions. monkeypox usually causes milder symptoms than smallpox, but can be fatal.
monkeypox has been circulating mainly in africa for decades, but a new strain called clade 1b was discovered in central africa this year, and preliminary studies show it is more contagious and pathogenic, prompting the world health organization to issue its highest alert on august 14.
the traditional smallpox vaccine protects against monkeypox, but as smallpox was eradicated worldwide, that vaccine was stopped in africa in the 1980s, meaning people born since then are more susceptible to monkeypox.
the africa centers for disease control and prevention estimates that 10 million doses of vaccine are needed across the continent to fight the current epidemic, and the country that needs it most is the democratic republic of the congo.
so where are the vaccines? an analysis by the new york times suggests they are stuck in the convoluted drug regulatory process at the world health organization.
after the global monkeypox outbreak in 2022, newer vaccines based on the original smallpox vaccine with fewer side effects have been approved by health regulators and widely used in some developed countries. these vaccines include the mva-bn vaccine developed by danish manufacturer bavarian nordic (also known as jynneos in the united states and imvanex in europe), and the japanese lc16 vaccine. the latter is currently the only vaccine approved for use in children.
andtraditionally, most low- and middle-income countries have relied on who approval for which vaccines and treatments are safe and effective, a process called prequalification (pq).
since the global monkeypox outbreak in 2022, the who has not officially approved the above-mentioned vaccine, nor issued an emergency use license to speed up access to the vaccine. this has left international organizations such as unicef and the global vaccine and immunization alliance (gavi), which rely on who certification to purchase and distribute vaccines and help developing countries carry out vaccination campaigns, "stuck" there.
some health experts said the monkeypox case showed the who was "extremely risk-averse" and "unprepared to act quickly in an emergency."earlier, the who said that it did not approve vaccines that had already been approved for use in europe and the united states because it lacked the data required for a comprehensive review. and the "emergency use license" procedure can only be carried out after a public health emergency of international concern (pheic) is declared.
however, the above report pointed out that the danish manufacturer first met with the who to discuss the monkeypox vaccine in august 2022 and submitted an information dossier about the vaccine in may 2023. the dossier contains research approved by the european medicines agency many years ago, as well as research data conducted after the vaccine was deployed during the monkeypox epidemic in 2022. however, the who did not begin formally reviewing the research until last week.
in this regard, yukiko nakatani said in an interview with the paper and other media that this monkeypox epidemic is different from the last one and is mainly caused by a new strain, so the safety and effectiveness of the vaccine needs to be re-evaluated.
secondly, the who's approval process also includes an assessment of the suitability of the vaccine to ensure the smooth promotion of the vaccine in africa. for example, the storage temperature can reach 2 to 8 degrees celsius instead of minus 20 degrees celsius; the storage time can also be longer, reaching 4 to 6 months, while previous monkeypox vaccines did not meet these conditions.
"a major difference between the work of the who and the drug regulatory authorities in developed countries is that european and american countries are only responsible for safety issues for their own populations, while low- and middle-income countries need to rely on the who to make judgments. therefore, they must be highly cautious about vaccine safety issues and must make scientific judgments based on data," added yukiko nakatani.
she also pointed out that before the who declared a monkeypox emergency, her team had been in close communication with vaccine manufacturers to obtain the clinical data needed for a comprehensive review. the who expert group will meet in the week of september 16 to review the submitted data, and if they are satisfied with the results, they may issue an emergency license as early as that week.
in an interview with the paper and other media, who chief scientist jeremy farrar also stated, "safety is our first and most important consideration. especially in vulnerable communities, we must ensure that the evidence and guidance used are as strong as possible. think about the opposite. if you put something into public use and it turns out to be unsafe for some reason, then the entire vaccine program will be strongly opposed." he said.
prices are high and rich countries are hoarding
since the who has not yet approved the emergency use authorization for monkeypox vaccine, many countries can only "save themselves in a roundabout way."
congo's drug regulator approved the jynneos and lc16 vaccines on june 27, allowing the country to accept donations of the vaccines.
africa has had monkeypox outbreaks for years, but only recently has efforts begun to vaccinate at-risk populations. jean kaseya, director-general of the africa centers for disease control, said africa needs 10 million doses of vaccine to stop the spread of monkeypox.
when the pandemic struck in 2022, wealthy countries quickly used their new vaccine stocks to protect their populations, while only a small number of vaccines arrived in africa despite pleas from african governments.
spain's ministry of health announced last week that it would donate 20% of its monkeypox vaccine stockpile, or about 500,000 doses, to african countries battling monkeypox.
"we believe it makes no sense to stockpile vaccines where they are not needed," the spanish health ministry said in a statement, adding that it would urge the european commission to propose that all eu member states also donate 20% of their vaccine stocks.
the spanish donation alone exceeds pledges so far from the european union and the u.s. other pledges include 215,000 doses from vaccine maker bavarian nordic and about 100,000 doses each from france and germany.
the good news is that who spokesman tarik jasarevic told reporters at a press conference in geneva last week that bavarian nordic, the manufacturer of mva-bn, "has the capacity to produce 10 million doses by the end of 2025 and can already supply up to 2 million doses this year." he also said that stocks of the lc16 vaccine made in japan are "quite substantial."
but the danish vaccine costs about $110 per dose, and two doses are required for full vaccination. for most african countries, the prices of both vaccines are currently too expensive.
africa has so far received less than 10% of the estimated $245 million it needs to fight the growing monkeypox outbreak, the head of africa disease control says.
vaccines alone are not enough
on august 26, who launched a global strategic preparedness and response plan for monkeypox outbreaks, and recommended that monkeypox patients, their close contacts, and health workers involved in treatment use masks to curb the spread of the monkeypox virus on a larger scale.
several who officials pointed out in interviews that vaccines alone cannot solve the epidemic, and it is unlikely that vaccines will be available to everyone in a short period of time. therefore, various measures need to be strengthened to curb the further spread of monkeypox.
these measures include strengthening surveillance to identify factors contributing to the spread of the virus so that vaccination campaigns can be targeted to those most at risk.
the africa cdc is developing a unified response plan to promote health measures to slow the spread of the monkeypox virus, which will be presented to african leaders for consideration at a meeting in september.
however, african countries face huge challenges in implementing these measures. in addition to monkeypox, the democratic republic of the congo is currently facing a number of public health crises, with cholera and severe malaria also threatening children's lives. hundreds of thousands of people displaced by ongoing armed conflicts live in refugee camps with extremely poor sanitation.
at a who regional meeting in africa last week, dr. dimi ogoina, a professor of infectious diseases at niger delta university in nigeria, said that in the absence of vaccines and drugs, african health workers should focus on providing supportive care, such as ensuring patients have enough food and get mental health support, as many patients infected with monkeypox often have a sense of shame.
"it's very, very unfortunate that africa has had monkeypox for 54 years and we still don't have a vaccine and are only now starting to think about treatments," he said.
(interns chen yutong and su hang also contributed to this article)
liu dong, chief reporter of the paper
(this article is from the paper. for more original information, please download the "the paper" app)
