The World Health Organisation (WHO) made a significant announcement: the MVA-BN vaccine is now officially prequalified as the first vaccine against mpox.
This means that the vaccine has met WHO’s standards for quality, safety, and effectiveness, and can now be widely used to help control mpox outbreaks.
Mpox, a virus that causes flu-like symptoms and a distinctive rash, has been a concern globally, especially with recent outbreaks in Africa.
The MVA-BN vaccine, produced by Bavarian Nordic A/S, has been reviewed by the European Medicines Agency and found to be effective in protecting against this disease.
This prequalification is a crucial step in increasing access to the vaccine in communities that need it most, aiming to reduce transmission and manage the ongoing outbreaks.
The MVA-BN vaccine is administered in two doses, given four weeks apart, and is suitable for adults over 18 years old. It can be stored in regular refrigerators for up to eight weeks, making it easier to distribute and use in various settings.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus stressed the importance of this approval in the fight against mpox.
He called for increased efforts to scale up vaccine procurement and distribution, ensuring that those most at risk have access to this essential tool.
Dr. Yukiko Nakatani from WHO highlighted that this approval will help speed up vaccine availability through international agencies like Gavi and UNICEF, crucial for responding to emergencies in Africa and other regions.
It will also assist national authorities in expediting vaccine approvals and increasing access.
The vaccine’s effectiveness has been promising: a single dose can protect about 76% of people from mpox if given before exposure, while the full two-dose series offers around 82% protection.
Though currently not licensed for people under 18, the vaccine may still be used in special cases where the benefits outweigh the risks, such as in severe outbreaks.
Data so far indicates that the vaccine is safe and effective based on clinical studies and real-world use during the current global outbreak.
WHO is also working with manufacturers of other mpox vaccines and diagnostic products to address the ongoing public health emergency.
Since August 2024, WHO has been addressing the mpox outbreak as a public health emergency of international concern (PHEIC).
The outbreak, which began in 2022, has affected over 120 countries, with more than 103,000 confirmed cases globally.
In 2024 alone, there have been over 25,000 cases and 723 deaths across 14 countries in Africa.
The introduction of the MVA-BN vaccine is a hopeful step towards controlling this challenging outbreak and saving lives.
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