WHO Approves Bavarian Nordic’s Vaccine as First Mpox Shot

20 September 2024
Manufacturer Bavarian Nordic has secured a significant milestone by achieving the first mpox vaccine prequalification from the World Health Organization (WHO) since the recent outbreak was declared an emergency last month.

The vaccine, named MVA-BN, is administered as a two-dose injection for adults over the age of 18. However, the WHO has indicated that it can also be used to vaccinate children, pregnant women, and immunocompromised individuals if the benefits of vaccination outweigh the risks associated with off-label use. This prequalification is based on data submitted to the European Medicines Agency.

In situations where vaccine supply is limited, the WHO has suggested that single-dose administration could be an alternative, which would help to extend the available vaccine supply. According to WHO data, a single dose has been found to be 76% effective in protecting against mpox, while the efficacy increases to 86% with two doses.

Since the beginning of the year, approximately 723 deaths have been reported across 14 African countries due to various mpox outbreaks. WHO Director-General Tedros Adhanom Ghebreyesus emphasized the urgent need for scaling up the procurement, donation, and distribution of mpox vaccines.

UNICEF and the Africa Centers for Disease Control and Prevention (Africa CDC) have projected a potential requirement of 10 to 12 million doses of mpox vaccines by 2025. Bavarian Nordic has already dispatched over 250,000 doses of its vaccine. The company announced on Thursday that it could provide up to two million more doses by the end of this year and potentially up to 13 million doses by the end of 2025.

To address long-term supply issues, Bavarian Nordic is exploring the possibility of transferring the production of the MVA-BN vaccine to other manufacturers based in Africa and other regions. This strategic move could potentially result in an additional 50 million doses being produced over the next 12 to 18 months.

The WHO declared the necessity for an mpox vaccine as an emergency on August 7, and since then, it has been evaluating the suitability of Bavarian Nordic's MVA-BN vaccine. Additionally, the mpox outbreak was declared a public health emergency a week later.

This move marks a pivotal step in addressing the global mpox outbreak, ensuring that vaccines are more readily available to vulnerable populations around the world.

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