Amid an escalating and complex mpox outbreak in the Democratic Republic of the Congo (DRC), which has spread beyond its borders, the first vaccine doses are expected to arrive in the country tomorrow, the head of the World Health Organization (WHO) said today at a briefing.
Tedros Adhanom Ghebreyesus, PhD, the WHO’s director-general, said the DRC’s health ministry plans on deploying the vaccines this weekend. The delivery was donated by the European Commission Health Emergency Preparedness and Response Authority.
“I thank the European Union and the European Commission for its 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,” he said.
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 (Africa CDC) to donate based on established vaccine planning and regional needs.
WHO evaluating 3 vaccines for emergency use
Health officials in Africa have estimated that 10 million vaccine doses are needed for current mpox outbreaks in Africa, but so far only Nigeria and the DRC have taken regulatory steps that would allow the vaccines to be used. Since then, the WHO has fast forwarded plans for emergency use listing (EUL) of mpox vaccine and has allowed groups to go ahead and start precuring doses.
Rogerio Gaspar, PhD, the WHO's director for regulation and prequalification, said three mpox vaccine are under review for EUL evaluation and are at different stages of review. Bavarian Nordic’s Jynneos vaccine fits the requirements for prequalification and is being evaluated for full prequalification.
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 today 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 2 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.
Interest from 4 diagnostic test makers
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.
“We hope to move as soon as possible to have a number of diagnostics emergency use listed,” he said. “As we know this is absolutely essential on the response and the follow-up of the epidemiology of mpox, to have relevant diagnostics,” he said.
