HQ Team
September 5, 2024: The World Health Organization expects the first delivery of mpox vaccines, made by Bavarian Nordic and donated by the European Union, today in Congo — the outbreak’s epicentre.
“We expect the first delivery of vaccines to arrive in the Democratic Republic of Congo tomorrow, donated by the European Commission’s Health Emergency Preparedness and Response Authority, or HERA,” said Tedros Adhanom Ghebreyesus, the WHO’s director-general, on September 4.
“The DRC’s Ministry of Health plans to begin deploying the vaccines this weekend,” he told journalists, according to a WHO statement. The WHO didn’t specify the quantity of vaccines set to arrive in Congo.
“I thank the European Union and the European Commission for their donation, and we call on countries with stockpiles of vaccines to work with us and our partners to get those vaccines to where they are needed now.”
The WHO declared a global emergency on August 14 following an outbreak of the disease in the continent, with Congo and Burundi being the worst-hit nations.
Three vaccines on radar
The global agency recommended vaccines including Bavarian Nordic’s MVA-BN, KM Biologics’ LC16 vaccines, or the Emergent BioSolutions’ ACAM2000 vaccine when the others are unavailable.
The LC16 vaccine and ACAM2000 are available in the US and Europe while African nations have no access to both, which were widely used in the 2022 outbreak.
In August, the European Commission announced that it was working with Bavarian Nordic to secure and donate more than 215,000 doses of Jynneos to Africa Centres for Disease Control and Prevention (African CDC).
Tedros said WHO was working with its partners to “coordinate vaccine demands, share information on doses available, and ensure those doses are directed to areas where they can contribute to controlling the outbreak.
“We have also been supporting DRC and other countries to ensure the necessary cold chain systems are in place, to support communications campaigns to provide information about vaccination and to counter mis- and disinformation.”
Severe vaccine shortage
The mpox vaccine situation in Africa is marked by a severe shortage and inequitable access.
As the world abandoned smallpox vaccination in 1979 on WHO recommendation due to the nonexistence of the disease, the added protection against mpox has also abated.
There is no ongoing global plan to supply vaccine doses to low and middle-income nations as the major bulk of doses is either held or preordered by high-income nations.
The US holds most doses, with the remaining supply secured by Europe, the UK, Canada, and Australia. Due to scarcity and other nations’ preventative vaccination procurement, the African CDC claims that vaccinations are not readily available on the continent and that no supply has been established.
The United Nations Children’s Fund, the world’s largest single vaccine buyer, issued an emergency tender last month to buy mpox vaccines to fight the rapid spread of the disease in the African continent.
The collaboration to increase access and timely allocation also includes working together to facilitate donations of vaccines from existing stockpiles in high-income countries to contain the ongoing transmission of mpox.
10 million doses needed
More than 18,000 suspected cases of mpox, including 629 deaths, have been reported this year in the Democratic Republic of the Congo which is at the epicentre of the crisis. Four out of five deaths have been in children.
“Vaccination is one part of the continental response plan that WHO has been developing with the Africa CDC, and which we expect to publish on Friday (September 6). But vaccines alone won’t stop these outbreaks,” Tedros said.
“We’re also working to strengthen surveillance, risk communication, community engagement, clinical and home care, and coordination between partners at every level.”
African officials have estimated that 10 million vaccine doses are needed for current mpox outbreaks in the region.
Rogerio Gaspar, PhD, the WHO’s director for regulation and prequalification, said three mpox vaccines were under review for emergency use listing (EUL) evaluation and were at different stages of review.
Bavarian Nordic’s Jynneos vaccine fits the requirements for prequalification and is being evaluated for full prequalification, he said.
Process of review
Officials have reviewed an application from KM Biologics, which makes the LC16 vaccine stockpiled in Japan and is putting together its first round of questions about the vaccine. An EUL decision could come before the end of the month, Gaspar said. LC16 was used in Japan in 1974 to vaccinate young children.
Gaspar said officials met with Emergent BioSolutions on September 4 about its ACAM2000 vaccine, and the company could file its first data by Friday and meet with WHO officials next week, with a full EUL application that could come sometime over the next two weeks.
He noted that health officials have concerns, raised earlier by WHO vaccine advisors, about the use of ACAM2000 in people with underlying health conditions.
The WHO has also taken steps to speed the availability of mpox diagnostics to African countries and recently invited companies to express interest in EUL submission. Gaspar said four companies have expressed interest, and two submissions are at an advanced stage.
