Bavarian Nordic has secured the first mpox vaccine pre-qualification from the World Health Organization since the disease outbreak was declared an emergency a month ago.
The vaccine, dubbed MVA-BN, is a two-dose injection for adults over 18. WHO said it can be used to vaccinate children, pregnant women and immunocompromised people if the risks of not being vaccinated outweigh the risk of off-label use. The pre-qualification is based on data presented to the European Medicines Agency.
Further, in cases of supply constraints, single shots of the mpox vaccine can be given instead, which could spread out supply, WHO said in a press release on Friday. Data show one dose is 76% effective at protecting against mpox, whereas two doses are 86% effective, the public health organization said.
Since the beginning of the year, around 723 people have died from different mpox outbreaks across 14 African countries. Now, “urgent scale up in procurement, donations and rollout” of mpox vaccines are needed, WHO’s Director-General Tedros Adhanom Ghebreyesus said.
UNICEF and Africa CDC have said there is a need for potentially 10 million to 12 million doses of mpox vaccines in 2025. Already, Bavarian has shipped over 250,000 doses of its mpox vaccine. The company said on Thursday it could supply up to two million more doses by the end of the year and up to 13 million doses by the end of 2025.
To address long-term supply constraints, Bavarian is looking to transfer MVA-BN manufacturing to other companies based in Africa and elsewhere, which could result in an extra 50 million doses produced over the next 12 to 18 months.
WHO declared the need for an mpox vaccine as an emergency on Aug. 7 and since then has been assessing the suitability of Bavarian’s MVA-BN vaccine. A week later, the mpox outbreak was declared a public health emergency.