The World Health Organization (WHO) announced on Friday the MVA-BN vaccine as the first prequalified vaccine against Mpox, improving access in urgent areas to reduce transmission and contain the outbreak, according to a press release.
The WHO’s prequalification is based on data submitted by the manufacturer Bavarian Nordic A/S and reviewed by the European Medicines Agency.
The MVA-BN vaccine, approved for individuals over the age of 18, requires two doses, with a four-week interval between each, and can be stored at temperatures between 2 – 8 degrees Celsius for up to eight weeks.
“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 the future,” WHO Director-General Dr Tedros Adhanom Ghebreyesus stated.
“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,” he added.
The vaccine is 76% effective with a single dose administered before exposure and 82% effective with a two-dose schedule, however, WHO noted that the efficacy of post-exposure vaccination is reduced.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, noted that the prequalification process will streamline vaccine procurement and facilitate the approval process for national regulatory authorities.
The MVA-BN vaccine’s prequalification offers governments and international agencies, such as the Global Alliance for Vaccines and Immunization (Gavi) and the United Nations Children’s Fund (UNICEF), valuable support for managing the ongoing emergency, according to Nakatani.
The WHO Strategic Advisory Group of Experts (SAGE) reviewed the available scientific evidence and concluded that the MVA-BN vaccine should be used for high-risk individuals during Mpox outbreaks. While the vaccine is not currently licensed for individuals under 18’s. , However, a case-by-case approach may be considered for infants, children, adolescents, pregnant women, and individuals facing immunocompromising conditions, if the potential benefits outweigh the risks involved.
In situations where supply is constrained, the WHO recommends a single dose but emphasizes that further data on safety and efficacy is required.
WHO also initiated the prequalification and emergency use licensing processes for two additional MPX vaccines, LC-16 and ACAM2000, and received six expressions of interest for diagnostic products.
Since designating the Mpox virus as a public health emergency of international concern on August 14, the latest figures from the WHO report over 103,000 cases and 723 deaths from outbreaks in Africa.