Request IND-Labeled Vaccine
Expanded access Investigational New Drug (IND) program
The manufacturing of licensed vaccine by Merck is actively underway. Ervebo® is not planned for commercial marketing and vaccine access within the U.S. will be facilitated through the U.S. government. During the period of time when the licensed vaccine is not available, the Centers for Disease Control and Prevention (CDC) is sponsoring an expanded access IND program to provide domestic access to IND-labeled vaccines that were manufactured prior to licensing (referred to as IND-labeled vaccine). CDC will make IND-labeled vaccine available for recommended use when licensed vaccine doses are unavailable or in limited supply.
CDC will provide IND-labeled vaccine when requested by licensed healthcare providers from institutions or sites with individuals who meet the eligibility criteria included in the 2020 ACIP recommendations pdf icon[PDF – 2.3 MB]. Under this expanded access IND program, the requesting healthcare providers will serve as site investigators and will assume the oversight responsibility for vaccine receipt, handling, and use at their institutions or sites. They will also monitor and report any serious adverse events resulting from IND-labeled vaccine administration. See the IND protocol #7298, Domestic Use of Ebola Zaire Vaccine (rVSV-ZEBOV; V920) for Pre-exposure Prophylaxis (PrEP) Vaccination of Adults (≥ 18 years of age) at Potential Occupational Risk for Exposure to Zaire ebolavirus, for further details. pdf icon[PDF – 354 KB]
Requesting IND-labeled vaccine
After reviewing the IND protocol to ensure the patient meets the eligibility criteria, licensed healthcare providers interested in getting the IND-labeled vaccine for their patient should send an email to firstname.lastname@example.org with subject line: Request for Ebola vaccine. The CDC Ebola Vaccine IND Program will respond to provide the required instructions and forms for eligible requests. See Sections 5 and 7 of the IND protocol and the listed appendices for further details.