WHO Grants ‘Pre-Qualification’ Approval for Mpox Vaccine

On September 13, the World Health Organization (WHO) announced the approval of MVA-BN as the first mpox vaccine to be included on its pre-qualification list. This significant step aims to bolster the global fight against mpox amidst ongoing outbreaks, primarily in Africa.

The WHO’s Strategic Advisory Group of Experts on Immunization recommended the use of the MVA-BN vaccine, which is manufactured by Bavarian Nordic A/S. This vaccine is designed for adults over the age of 18, administered in a two-dose regimen spaced four weeks apart.

Dr. Tedros Adhanom Ghebreyesus, the WHO Director-General, stated, “The first pre-qualification of a vaccine against mpox represents a crucial advancement in addressing the disease. It is vital not only for the ongoing outbreaks in Africa but also for future prevention efforts.” He emphasized the necessity for urgent actions to scale up vaccine procurement and distribution to ensure fair access for communities significantly impacted by the disease.

Evidence suggests that a single dose of the MVA-BN vaccine offers an estimated effectiveness of 76% in preventing mpox, while receiving both doses increases this effectiveness to 82%.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, noted that the pre-qualification will expedite the procurement processes for mpox vaccines by national governments and international organizations like Gavi and UNICEF. This is particularly important for aiding communities facing ongoing emergencies related to mpox outbreaks.

Furthermore, the pre-qualification action by WHO is expected to help national regulatory authorities fast-track the necessary approvals for the vaccine, thereby improving accessibility for all in need worldwide.

In August, the organization declared mpox a global health emergency, following the recommendations from an emergency committee focused on the disease.

While the vaccine is not authorized for individuals under 18, WHO guidelines indicate that it may be administered “off-label” to infants, children, adolescents, pregnant women, and those with compromised immune systems. This guidance implies that during outbreaks, the potential benefits of vaccination are deemed to outweigh the risks associated with the vaccine.

Dr. Rogerio Gaspar, WHO Director for Regulation and Pre-qualification, highlighted ongoing efforts to advance the pre-qualification and emergency use listings for two other mpox vaccines: LC-16 and ACAM2000. He confirmed that six expressions of interest for mpox diagnostic products for emergency use have already been submitted.

According to WHO data, over 120 countries have reported more than 103,000 mpox cases since the global outbreak began in 2022. In light of the rising cases and the potential for future outbreaks, the approval of the MVA-BN vaccine is seen as a crucial step towards controlling the spread of mpox, assisting health authorities in their response efforts while also equipping communities with the necessary tools to manage this public health crisis.