NAIROBI, Kenya- The World Health Organization (WHO) has officially added the MVA-BN vaccine to its prequalification list, marking a significant milestone in the global fight against mpox.
This approval promises to speed up access to the vaccine in areas that need it most, reducing transmission rates and helping contain the ongoing outbreak.
The decision, based on information from the vaccine manufacturer Bavarian Nordic A/S and a review by the European Medicines Agency, brings hope to communities grappling with this public health emergency.
By adding the MVA-BN vaccine to its prequalification list, WHO aims to facilitate faster procurement and rollout of this critical vaccine.
The endorsement is a green light for governments and international agencies such as Gavi and UNICEF to push forward with large-scale procurement, ensuring that front-line communities receive the support they need.
Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, stressed the urgency of this move, emphasizing the need for immediate scale-up in procurement, donations, and distribution to ensure equitable access to vaccines.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, noted that this prequalification could also help national regulatory authorities accelerate approvals, ultimately increasing access to quality-assured vaccines.
The MVA-BN vaccine, suitable for individuals over 18, is administered as a two-dose injection given four weeks apart.
Its flexibility in storage—kept at 2-8°C for up to eight weeks—also makes it a practical option in outbreak scenarios.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has recommended the MVA-BN vaccine for those at high risk of mpox exposure during an outbreak.
Notably, while the vaccine is not licensed for those under 18, it can be used “off-label” in infants, children, adolescents, and even pregnant or immunocompromised individuals, provided the benefits outweigh potential risks.
Given current supply constraints, WHO also advocates for single-dose use in outbreak situations to maximize vaccine reach.
Data shows that a single-dose MVA-BN vaccine before exposure provides approximately 76pc effectiveness, while the full two-dose schedule boosts effectiveness to about 82pc.
However, the vaccine is notably less effective when administered post-exposure, underscoring the importance of proactive vaccination efforts.
This prequalification comes in the wake of the escalating mpox outbreaks in Africa and other regions.
The Democratic Republic of the Congo is currently experiencing a significant surge, leading to WHO’s declaration of a Public Health Emergency of International Concern (PHEIC) on August 14, 2024.
Since the global outbreak began in 2022, over 120 countries have reported more than 103,000 mpox cases.
Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, announced that prequalification and emergency use listing procedures are ongoing for two additional mpox vaccines, LC-16 and ACAM2000.
So far, WHO has received six expressions of interest for mpox diagnostic products as part of its emergency use listing process.
These efforts highlight WHO’s proactive approach to managing the mpox crisis and expanding global access to effective vaccines and diagnostic tools.
