WHO Approves Bavarian Nordic's MVA-BN As First Vaccine Against Mpox

The World Health Organisation has approved Bavarian Nordic's MVA-BN as the first vaccine against mpox. The vaccine is now in the WHO's prequalification list for timely and increased access in communities with urgent need and to reduce transmission and help contain the outbreak.

In a press release, the global organisation said that its assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency, the regulatory agency of record for this vaccine.

Data available with WHO shows that a single-dose MVA-BN vaccine given before exposure has an estimated 76% effectiveness in protecting people against Mpox, with the two-dose schedule achieving an estimated 82% effectiveness.

"Vaccination after exposure is less effective than pre-exposure vaccination," it said.

The organisation recommends single-dose use in supply-constrained outbreak situations and has emphasized the need to collect further data on vaccine safety and effectiveness in these circumstances.

Bavarian Nordic's news release said that MVA-BN is indicated for active immunisation against smallpox, mpox, and related orthopoxvirus infections and disease in all adults.

"According to recommendations from the WHO, MVA-BN may however be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised people in outbreak settings where the benefits of vaccination outweigh the potential risks," it added.

“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,” the release quoted WHO Director-General Dr Tedros Adhanom Ghebreyesus as saying. “We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.”

The escalating mpox outbreak in the Democratic Republic of the Congo and other countries was declared a public health emergency of international concern by the WHO Director-General a month ago. 

A total of 103,000 cases have been reported in over 120 countries since the onset of the global outbreak in 2022, according to WHO.

Based on data available as on Sep. 8, in 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries of the African Region.