The Democratic Republic of the Congo (DRC) is grappling with a severe mpox outbreak, which has been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO). In response, the WHO has prequalified the MVA-BN vaccine, the first vaccine against mpox to achieve this status, offering hope for controlling the spread in the DRC and beyond.
This prequalification, based on information from the vaccine’s manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency (EMA), allows for faster procurement and distribution of the vaccine. It is a critical step for African countries like the DRC, where outbreaks have been particularly devastating.
According to WHO Director-General Dr. Tedros Adhanom Ghebreyesus, the move is crucial not only for the DRC but also for other African nations facing similar crises. “We now need urgent scale-up in procurement, donations, and rollout to ensure equitable access to vaccines where they are needed most,” said Dr. Tedros.
The MVA-BN vaccine is a two-dose injection administered four weeks apart and can be stored at 2–8°C for up to eight weeks, making it feasible for distribution even in remote regions. While it is approved for individuals over 18 years old, the vaccine can be used “off-label” for children, pregnant women, and immunocompromised individuals during outbreaks, according to WHO guidance.
The WHO Strategic Advisory Group of Experts (SAGE) has recommended the vaccine for high-risk groups, such as healthcare workers and people living in areas with active transmission, like the DRC. In supply-limited situations, WHO advises that a single dose can be given, offering up to 76% effectiveness in preventing infection before exposure. Two doses increase effectiveness to 82%.
The DRC has been at the forefront of the current mpox outbreak in Africa, with 25,237 suspected and confirmed cases and 723 deaths reported across 14 African countries as of September 2024. The rapid approval of the MVA-BN vaccine offers hope for reducing transmission and saving lives in communities hit hardest by the outbreak.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the importance of fast-tracking vaccine approvals by national regulatory bodies in affected countries like the DRC. “This decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccines,” she said.
With more than 103,000 mpox cases reported globally since 2022, the outbreak in the DRC remains one of the most pressing concerns. WHO is also evaluating two other vaccines, LC-16 and ACAM2000, to expand options for fighting the disease.
