WHO Prequalifies Bavarian Nordic’s MVA-BN Vaccine as First Mpox Vaccine

Prequalification:
The World Health Organization (WHO) has prequalified the MVA-BN vaccine developed by Bavarian Nordic as the first vaccine against mpox, facilitating timely and increased access to this vital product in communities with urgent need.

Vaccine Details:
The MVA-BN vaccine is administered in two doses, four weeks apart, to individuals 18 years and older, with an estimated 82% effectiveness. It may also be used "off-label" in infants, children, pregnant women, and immunocompromised individuals in outbreak settings where the benefits outweigh the risks.

Global Impact:
The prequalification is expected to accelerate procurement by governments and international agencies such as Gavi and UNICEF, and help fast-track regulatory approvals in countries worldwide.

Emergency Use:
In supply-constrained outbreak situations, WHO recommends single-dose use, which has an estimated 76% effectiveness.

Public Health Emergency:
The mpox outbreak in Africa has been declared a Public Health Emergency of International Concern (PHEIC) by WHO, emphasizing the need for urgent scale-up in vaccine procurement, donations, and rollout.