FDA Licensed Smallpox Vaccines

The Biomedical Advanced Research and Development Authority (BARDA) is issuing a Sources Sought Notice (SSN) to collect feedback from current and potential biopharmaceutical partners on FDA-licensed smallpox vaccines. The SSN aims to understand the landscape of vaccines that are currently licensed by the FDA for prevention against disease caused by Variola virus (smallpox). Respondents are asked to provide information on their existing FDA-licensed vaccine, including the viral antigen targeted, adjuvant, vaccine vector, and number of doses required for protection. • The SSN is for information gathering purposes only and does not obligate the US Government to award a contract. • Respondents should provide regulatory and licensure information, including FDA licensure date, approved indications, and any contraindications or warnings. • Manufacturing information, such as plans for improving manufacturing capacity and reducing cost per dose, should also be provided. • Clinical information, including plans for expansion of the target population and engagement with the US FDA, is also requested.