FDA Licensed Smallpox Vaccines
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Biomedical Advanced Research and Development Authority (BARDA), under the U.S. Department of Health and Human Services (HHS), has issued a Sources Sought Notice (SSN) to gather feedback from current and potential biopharmaceutical partners regarding FDA-licensed smallpox vaccines. This market research will inform possible future acquisitions and programs. Responses are due February 16, 2026.
Scope of Work
BARDA is seeking to understand the landscape of US FDA-licensed smallpox vaccines for individuals at high risk of infection, excluding those with boxed warnings. Respondents are asked to provide detailed information on:
- Vaccine Overview: Viral antigen, adjuvant, vaccine vector, and required number of doses.
- Regulatory Information: FDA licensure date, approved indications, contraindications, warnings, precautions, and the FDA package insert.
- Manufacturing: Plans for improving capacity, sustainability, and cost reduction; status of Contract Manufacturing Organizations (CMOs) and adjuvant supply; and whether capacity is US-based.
- Clinical: Plans for expanding the target population or engaging the FDA on expanding indications.
Contract & Timeline
- Type: Sources Sought / Market Research
- Set-Aside: None specified
- Response Due: February 16, 2026, by 3 PM US EST
- Published: January 26, 2026
- Department/Agency: Health And Human Services / OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE
- Product Service Code: 6505 (Drugs And Biologicals)
Evaluation
Information collected from this SSN will serve as continued market research. This notice is for information gathering purposes only and does not obligate the US Government to award a contract.
Additional Notes
Responses must be submitted electronically via the BDR Portal after registration. Proprietary information should not be included in responses. Primary contact is Yifan Yang (yifan.yang@hhs.gov); secondary contact is Jonathan Gonzalez (Jonathan.Gonzalez@hhs.gov).