WHO Approves First Mpox Vaccine as Outbreaks Surge in Over 120 Countries

• Sep 13, 2024

The World Health Organization (WHO) has made a significant move in the global fight against mpox, approving the MVA-BN vaccine as the first of its kind to be included on its prequalification list. This approval is expected to play a critical role in curbing the spread of the disease, particularly as mpox cases continue to rise across the globe.

WHO made the announcement on Friday, emphasizing that this approval is a major step towards controlling the outbreak, which has affected over 120 countries with more than 103,000 reported cases since 2022. In Africa alone, 14 countries have reported a combined 25,237 suspected and confirmed cases and 723 deaths in 2024. The vaccine, developed by Bavarian Nordic A/S, was reviewed and recommended by the European Medicines Agency, which is the regulatory authority responsible for its evaluation.

According to WHO Director-General Tedros Ghebreyesus, the approval of this vaccine is a crucial development in combating mpox, both in the current outbreaks in Africa and in preventing future outbreaks. He stressed the need for swift action in scaling up vaccine procurement and distribution to ensure it reaches areas with the greatest need. Alongside the vaccine rollout, other response measures will be vital in containing the spread of the disease.

The MVA-BN vaccine is approved for adults over 18 years old and is administered in two doses, spaced four weeks apart. Data from WHO indicates the vaccine's effectiveness, showing 76% protection after the first dose and increasing to 82% following the second dose. WHO also recommends its use in infants, children, adolescents, pregnant women, and immunocompromised individuals during outbreak situations where the benefits outweigh potential risks.

Despite the vaccine not being licensed for individuals under 18, WHO suggests its "off-label" use in these populations during mpox outbreaks. This recommendation was backed by the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation, which reviewed the available data and highlighted its potential to protect those at high risk of exposure.

Recently, both Nigeria and the Democratic Republic of Congo (DRC) have received vaccine donations to help combat the ongoing outbreaks. Nigeria received 10,000 doses of Jynneos, a vaccine approved by the U.S. Food and Drug Administration (FDA) for the prevention of smallpox and mpox. Similarly, the DRC received 99,100 doses of Jynneos in early September, marking a significant boost in Africa’s mpox response efforts.

The Africa Centres for Disease Control and Prevention (Africa CDC) reported that the DRC is the epicenter of mpox in Africa, recording nearly 22,000 cases and 716 deaths in 2024 alone. Nigeria, another country heavily affected, confirmed 67 cases out of over 1,000 suspected cases in the first half of the year.

With ongoing outbreaks in several African countries, including Kenya, Rwanda, and Ghana, WHO's approval of the MVA-BN vaccine comes at a critical time. It offers a glimmer of hope in the global effort to control the spread of mpox and prevent future outbreaks.