FDA Licensed Smallpox Vaccines

The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the Department of Health and Human Services, has issued a Sources Sought Notice (SSN BARDA-CBRN-01262026) to gather market research on FDA-licensed smallpox vaccines for high-risk populations that do not contain boxed warnings. Respondents must provide detailed information across four critical categories: vaccine overview (viral antigen, adjuvant, vector, and dose requirements); regulatory and licensure details (FDA licensure date, approved indications, contraindications, boxed warnings, precautions, and FDA package insert); manufacturing plans (capacity improvements, cost reduction strategies, contract manufacturing organization capabilities for both active pharmaceutical ingredients and finished formulations with emphasis on U.S.-based capacity, and adjuvant supply status); and clinical plans (target population expansion and FDA engagement strategies for indication expansion). Responses are limited to five pages and must be submitted electronically to the BDR Portal by February 16, 2026 at 3:00 PM Eastern Standard Time. Potential respondents must establish a BDR Portal account prior to submission and should direct inquiries to Yifan Yang (yifan.yang@hhs.gov) or Jonathan Gonzalez (jonathan.gonzalez@hhs.gov).

This Sources Sought Notice carries no set-aside designations and does not obligate the U.S. Government to award a contract or reimburse any costs incurred by respondents. No specific award value, budget range, or quantity requirements are identified in this market research solicitation, as the SSN is designed to inform potential future acquisitions and programs rather than to issue a binding procurement. The notice does not identify incumbent contractors or current awardees. Submissions will be treated as confidential and will be accessible only to BARDA staff and existing BARDA collaborators, ensuring that proprietary information remains protected from public disclosure. This notice represents an opportunity for biopharmaceutical partners to position themselves for potential future government contracting in the smallpox vaccine space.