Inactive

BARDA is issuing this RFI to assist in understanding the landscape of EBOV vaccines. For the purpose of this RFI, EBOV vaccines include those that are currently licensed by the US Food and Drug Admini... BARDA is issuing this RFI to assist in understanding the landscape of EBOV vaccines. For the purpose of this RFI, EBOV vaccines include those that are currently licensed by the US Food and Drug Administration (FDA) for prevention against Ebola Virus Disease (EVD) and have demonstrated clinical efficacy. Respondents are asked to provide the following information: Overview of existing FDA-licensed vaccine for protection against disease caused by EBOV, including: Viral antigen targeted Adjuvant (if applicable) Vaccine vector (if applicable) Number of doses required for protection 2. Regulatory and licensure information: FDA licensure date FDA approved indications FDA package insert as attachment 3. Manufacturing Any plans for improving manufacturing capacity, sustainability, and reduced cost per dose (high level summary only in an abstract format) Status of contract manufacturing organization (CMOs) (API) and (FF), and whether or not any existing or proposed capacity is US based Status of adjuvant supply (if applicable) Responses should be limited to five pages (or less) and shall be sent electronically to Yifan.Yang@hhs.gov and jonathan.gonzalez@hhs.gov. Responses are due no later than November 15, 2023, by 3PM US EST.