The World Health Organization (WHO) has approved the MVA-BN vaccine against mpox, marking the first time a vaccine for the virus has received such clearance.
This move aims to ensure “timely and increased access” for millions at risk in Africa, where over 20,000 cases have been reported this year.
The MVA-BN vaccine, developed by Danish pharmaceutical company Bavarian Nordic, was prequalified by the WHO on Friday. It was previously approved for adult use in Europe and the United States.
The WHO’s endorsement is expected to expedite access to the vaccine, reduce transmission rates, and help control the outbreak. WHO Director-General Tedros Adhanom Ghebreyesus emphasized the importance of this development, calling for an urgent increase in vaccine procurement, donations, and distribution.
“We now need to urgently scale up procurement, donations, and rollout to ensure equitable access where it is needed most, alongside other public health tools, to prevent infections, stop transmission, and save lives,” Ghebreyesus said.
The vaccine is administered in two doses, four weeks apart, and has an estimated effectiveness of 82% for individuals aged 18 and older.
For infants, young children, pregnant women, and those with compromised immune systems, the vaccine may be used when its benefits outweigh the risks.
In situations of limited supply, the WHO recommends giving the vaccine as a single dose, which is 76% effective.
The prequalification is expected to accelerate procurement by governments and international agencies such as the Gavi vaccine alliance and UNICEF, and to facilitate faster regulatory approvals globally.
