Request Booster Doses of ERVEBO®
Initial doses of ERVEBO® are approved by FDA for prevention of EVD. However, duration of protection given by an initial ERVEBO dose is unknown. Since booster dose is not an FDA-approved indication for ERVEBO, the CDC is sponsoring an expanded access IND protocol to allow for booster dose administration.
Expanded access Investigational New Drug (IND) program for ERVEBO as booster dose vaccination
ERVEBO is available under the IND program for pre-exposure prophylaxis (PrEP) in individuals who were previously vaccinated with ERVEBO (e.g., ≥ 6 months since prior vaccination) and are at potential occupational risk for exposure to Zaire ebolavirus. Final eligibility decisions for booster doses, including dose interval, will be assessed on an individual case-by-case basis.
See the Expanded Access Investigational New Drug (IND) Protocol #7298, ERVEBO (Ebola Zaire Vaccine, Live) Booster Dose Vaccination for Domestic Pre-exposure Prophylaxis (PrEP) Vaccination of Adults (≥ 18 years of age) at Potential Occupational Risk for Exposure to Zaire ebolavirus [PDF – 610 KB] for further details including healthcare provider responsibilities under this IND program.
How to request booster doses under the IND program
Licensed healthcare providers interested in ERVEBO as a booster for a previously vaccinated patient should review the IND protocol to ensure the patient meets the eligibility criteria, then send an email to firstname.lastname@example.org with subject line: Request for ERVEBO vaccine booster. The CDC Ebola Vaccine Program will respond to provide the required instructions and forms for eligible requests. See Sections 5 and 7 of the IND protocol [PDF – 600 KB] and the listed appendices for further details.