Aligning Licensure and Recommended Use to Expedite Vaccine Access in Response to the Ongoing Bundibugyo Ebolavirus Epidemic in Central Africa

The ongoing Orthoebolavirus bundibugyoense—Bundibugyo virus (BDBV)—epidemic is the worst Ebolavirus outbreak in a decade and is rapidly expanding, with >4600 suspected cases in the Democratic Republic of Congo (DRC) alone. It has caused 2186 deaths and spread to neighboring countries. As BDBV has no approved vaccine, timely response will require adapted use of existing vaccines approved for other ebolaviruses and expedited development of novel vaccines targeted toward BDBV. Access to vaccines is fundamental to public health emergency response and generally depends on two expert bodies in each country: a national regulatory authority (e.g., the US Food and Drug Administration (FDA)) and a national immunization advisor. Receding traditional global health assistance compounds already-limited licensure and recommended use in the DRC and other low-income countries confronting recent outbreaks of Ebola, Marburg, and mpox, exacerbating access gaps for high-risk populations. This commentary thus clarifies the critical importance of a robust national immunization advisor, coordinated closely with expanded licensure, in expediting access to vaccines and other essential epidemic response tools. Using the regulatory responses of the Republic of Rwanda and DRC, it demonstrates that clearer delineation of roles between these bodies is critical for effective response, can help prioritize self-sufficiency and greater regional public health cooperation, and will thus enable swifter control of Bundibugyo.