RFI - Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage
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 Department of Health and Human Services (HHS), specifically the Biomedical Advanced Research and Development Authority (BARDA), has issued a Request for Information (RFI) titled "Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage." This RFI seeks to identify and understand the development maturity of "Day One" influenza vaccine candidates that offer both routine seasonal protection and partial protection against emerging pandemic influenza viruses. Responses are due July 15, 2026, at 1:00 PM EDT.
Scope of Work
BARDA aims to address the critical protection gap during the earliest phase of a pandemic, where current vaccine technologies require significant time for strain-matched deployment. "Day One vaccines" are defined as those that:
- Deliver seasonal influenza protection.
- Provide partial protection against emerging pandemic influenza viruses at the onset of a Public Health Emergency.
This RFI seeks information on candidate Day One vaccines, including their development maturity, technical feasibility, manufacturing readiness, and regulatory considerations. Key areas of interest include broadly protective vaccine designs, T-cell based approaches, adjuvants, mucosal delivery, combination strategies, and novel correlates of protection.
Requested Information
Respondents are asked to provide detailed information across several categories:
- Organizational Overview: Expertise, experience, and partner CDMOs.
- Vaccine Candidate Overview: Construct details, seasonal strategy, mechanism of protection, and alignment with Day One attributes.
- Projected Pandemic Response Utility: How the candidate provides Day One protection, modeling data, and priming potential.
- Development Status: Current stage, regulatory status, projected timeline, and next steps.
- Nonclinical Data: Product characterization, immunogenicity, breadth, durability, heterologous challenge, and safety/toxicology.
- Manufacturing and CMC Readiness: Process, scale, yield, timeline, release testing, and commercial feasibility.
- Clinical Data and Planned Development Strategy: Available clinical data, planned trial designs, seasonal non-inferiority strategy, and co-administration plans.
- Regulatory Considerations: Proposed pathway for inferring pandemic benefit, correlates of protection, and special program eligibility.
Contract & Timeline
- Type: Request for Information (RFI) / Sources Sought
- Set-Aside: None specified
- Response Due: July 15, 2026, 1:00 PM EDT
- Published: June 3, 2026
- Place of Performance: Washington, DC 20024, United States
Submission Details
Responses must be submitted via email to rrpv@ati.org in PDF format, with a maximum of 10 pages (including a 1-page executive summary), using no smaller than 10-point font.
Important Notes
This RFI is for information gathering only and does not guarantee a future solicitation or award. Submission is voluntary, and responses will be treated as sensitive information. Selected companies may be invited for one-on-one meetings. Membership in the RRPV consortium is required for future Requests for Project Proposals (RPPs) but not for this RFI response.
Contact Information
Primary Contact: Wendy Rehman (wendy.rehman@ati.org)