The World Health Organization (WHO) has officially announced the addition of the MVA-BN vaccine to its prequalification list, marking it as the first vaccine approved for mpox (formerly known as monkeypox). This critical milestone is expected to significantly improve access to the vaccine in regions with a pressing need to control the spread of the virus.
According to WHO’s statement on its website, the inclusion of the MVA-BN vaccine in the prequalification list aims to help reduce transmission and aid in containing the ongoing outbreak of mpox, particularly in vulnerable communities.
WHO’s “prequalification” and “emergency use listing” mechanisms are essential tools used to evaluate the quality, safety, and efficacy of medical products, such as vaccines, diagnostics, and medicines.
These mechanisms ensure that the products are suitable for use, particularly in low- and middle-income countries, where public health systems may be strained, and access to life-saving treatments can be limited.
The prequalification process for the MVA-BN mpox vaccine was based on data provided by its manufacturer, Bavarian Nordic A/S. This data was carefully reviewed by the European Medicines Agency (EMA), which serves as the primary regulatory authority for this vaccine.
WHO has prequalified the MVA-BN vaccine, the first vaccine against #mpox to be approved!
— World Health Organization (WHO) (@WHO) September 13, 2024
This approval is a major step towards expanding access and reducing transmission in high-risk communities.https://t.co/Tk700dct6J pic.twitter.com/v42K66u0rP
WHO’s endorsement signifies that the vaccine meets global standards for safety and effectiveness, making it a valuable tool in combating mpox outbreaks worldwide.
By prequalifying the MVA-BN vaccine, WHO hopes to streamline the process for countries to access this crucial medical resource, particularly in regions experiencing active outbreaks or those at high risk.
This step underscores WHO’s commitment to ensuring equitable access to vaccines and other essential medical products, particularly in areas where healthcare systems may struggle to cope with the demand during health crises. WHO Director-General Dr Tedros Adhanom Ghebreyesus said:
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“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future. We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.”
The MVA-BN vaccine’s approval not only represents a scientific achievement but also highlights the importance of global cooperation in addressing emerging health threats like mpox.
With this new vaccine readily accessible, public health efforts to control mpox transmission and protect at-risk populations are expected to make significant strides.
The WHO has approved the MVA-BN vaccine for use in adults over 18, administered in two doses, four weeks apart. It can be stored at 2-8°C for up to eight weeks after cold storage.
While not licensed for those under 18, it may be used “off-label” for infants, children, adolescents, pregnant, and immunocompromised individuals in outbreak settings where the benefits outweigh risks.
A single dose provides 76% effectiveness, while two doses increase protection to 82%. Amid a global mpox outbreak, with over 103,000 cases since 2022, WHO continues to monitor its spread, particularly in Africa.