In a significant move to combat the ongoing mpox outbreaks, the World Health Organization (WHO) has announced the addition of the MVA-BN vaccine to its prequalification list. This marks the first vaccine against mpox to receive WHO’s prequalification.
Since the global mpox outbreak began in 2022, over 120 countries have confirmed more than 103,000 cases. In 2024 alone, 25,237 suspected and confirmed cases and 723 deaths have been reported across 14 African nations.
The WHO’s prequalification process ensures that medical products meet international standards for quality, safety, and efficacy, with a particular focus on low- and middle-income countries. WHO Director-General Dr. Tedros Adhanom Ghebreyesus underscored the importance of this approval, noting that it represents a major advance in tackling the virus, particularly in regions like Africa, where mpox outbreaks have been ongoing.
WHO has prequalified the MVA-BN vaccine, the first vaccine against #mpox to be approved!
This approval is a major step towards expanding access and reducing transmission in high-risk communities.https://t.co/Tk700dct6J pic.twitter.com/v42K66u0rP
— World Health Organization (WHO) (@WHO) September 13, 2024
The MVA-BN vaccine, developed by Bavarian Nordic A/S, underwent a rigorous review process in collaboration with the European Medicines Agency, which served as the regulatory authority for the vaccine.
The MVA-BN vaccine, administered in two doses four weeks apart, is recommended for people over 18 years of age. WHO noted that, after being stored under cold conditions, the vaccine can be kept at a temperature of 2-8°C for up to eight weeks, making it easier to manage in various settings.
The WHO Strategic Advisory Group of Experts (SAGE) on immunization has recommended the vaccine for individuals at high risk of exposure during an outbreak.
While not currently licensed for individuals under 18, WHO has approved the “off-label” use of the vaccine in younger populations, including infants, children, adolescents, and those who are pregnant or immunocompromised. However, WHO emphasized the need for additional data on the vaccine’s safety and effectiveness in these groups.
Available data suggests that a single dose of the MVA-BN vaccine administered before exposure offers approximately 76% protection against mpox, while the full two-dose regimen raises the effectiveness to about 82%. Post-exposure vaccination, however, is less effective, as per WHO.
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