The World Health Organisation (WHO) has granted prequalification to the MVA-BN vaccine, marking it as the first vaccine approved for mpox.
This milestone is expected to improve access to the vaccine, particularly in communities where the need is most urgent.
WHO’s prequalification service rigorously assesses the quality, safety, and efficacy of medicinal products. Once a product meets the necessary standards, it is added to the WHO’s prequalification list, ensuring global acceptance and building confidence among healthcare providers.
In a statement issued on Friday, September 13, WHO revealed that the prequalification of the MVA-BN vaccine, produced by Bavarian Nordic A/S, followed a review by the European Medicines Agency. The vaccine is recommended for individuals over 18 years old and is administered as a two-dose injection, with a four-week interval between doses.
The WHO emphasized that this prequalification will help facilitate timely access to the vaccine in regions experiencing mpox outbreaks, helping to reduce transmission and contain the virus. The WHO Strategic Advisory Group of Experts (SAGE) on Immunization endorsed the vaccine for people at high risk of exposure.
While the vaccine is not currently approved for individuals under 18, the WHO noted that it may be used “off-label” for younger populations and vulnerable groups, including pregnant and immunocompromised individuals, when necessary.
The WHO also recommended a single-dose administration in areas with limited supply. Data indicates that a single-dose vaccine given before exposure provides 76% effectiveness against mpox, while the two-dose schedule raises effectiveness to 82%.
The vaccine has shown a good safety profile in clinical trials and during its use amid the ongoing global outbreak, which began in 2022. WHO stressed the need for continued data collection on the vaccine’s effectiveness, especially against new virus strains.
Tedros Ghebreyesus, WHO Director-General, hailed the prequalification as a significant step forward in combating mpox, especially in Africa, where the virus has caused widespread outbreaks. He called for urgent efforts to scale up vaccine procurement, donations, and rollout to ensure equitable access.
Mpox was declared a public health emergency of international concern by the WHO in August 2024, with 25,237 suspected and confirmed cases and 723 deaths reported across 14 African countries this year alone.
