Overview of the RFI
The Biomedical Advanced Research and Development Authority (BARDA), through the Rapid Response Partnership Vehicle (RRPV), has released a Request for Information (RFI) titled “Advanced Clinical Development and Licensure of an Adjuvanted Egg-based Influenza Vaccine.” Through this market research effort, BARDA is seeking feedback from industry, academia, and other stakeholders to better understand the development maturity of commercially sustainable adjuvanted egg-based influenza vaccine capabilities based on licensed seasonal influenza vaccines and licensed adjuvants.
Influenza viruses are constantly evolving in wild and domestic animal populations, posing an ongoing threat to national and global health security. A critical vulnerability in current pandemic preparedness is the ability to scale rapidly from the identification of a novel pandemic strain to deployment of a strain-matched vaccine. Vaccine adjuvants are essential to that preparedness strategy. In BARDA’s framing, adjuvants can boost the magnitude and durability of the immune response, broaden the protection spectrum, and enable dose-sparing, all of which are critical during a fast-moving pandemic response.
Technical Areas of Interest
BARDA is seeking input on adjuvanted egg-based influenza vaccine candidates that meet all four of the following in-scope attributes:
- Use a vaccine adjuvant that is a component in a U.S. licensed vaccine product and commercially distributed
- Use an inactivated vaccine antigen based on a U.S. licensed egg-based seasonal influenza vaccine
- Intend to have a nonclinical IND-enabling study data package completed by Q4-CY2026
- Demonstrate development maturity to start clinical trials by Q3-CY2027
Respondents are invited to address the following technical areas:
- Organizational Overview: Core expertise, influenza vaccine development experience, CDMO partnerships, and end-to-end development plans
- Vaccine Candidate Overview: Description of the vaccine construct, including the antigen target and adjuvant
- Nonclinical Data: Preliminary efficacy data from relevant animal models, GLP toxicology studies, and CMC information demonstrating Phase 1 GMP adherence
- Clinical Data Strategy: Definition of biomarkers being measured, intended use in the clinical trial, and analytical validation strategy compliant with FDA guidance
- Manufacturing and CMC Readiness: Readiness of both the licensed adjuvant and licensed seasonal antigen components
- Regulatory Considerations: Regulatory strategy for the combined adjuvanted vaccine candidate
- Development and Manufacturing Strategy Through Licensure: Planned clinical trial design and manufacturing plans through Process Performance Qualification
BARDA also notes that nucleic acid-based vaccines, licensed cell culture-based influenza vaccines, licensed recombinant influenza vaccines, and licensed live attenuated influenza vaccines are outside the scope of this RFI.
Important Information for Respondents
BARDA is seeking information on the type of product development work for which respondents would seek funding, including preclinical, CMC, and Phase 1 categories. Respondents may propose work across one or multiple categories and should clearly specify all applicable categories.
Responses should consist of a cover page and a technical response in PDF format, with the technical response no longer than 10 pages, including a one-page executive summary. Responses to the General Questions section are not included in this page limit.
Respondents do not need to be members of the RRPV consortium to submit a response to this RFI; however, membership would be required to participate in any future Request for Project Proposals (RPP) associated with this requirement.
Key Dates
- RFI Issued: June 24, 2026
- Response Deadline: July 10, 2026 at 1:00 p.m. EDT
- One-on-One Meetings: Selected companies may be invited to attend a meeting during the RRPV Annual General Membership Meeting on August 26-27, 2026 in Arlington, VA
Submissions should be sent via email to [email protected].
Why This Matters
This RFI provides valuable insight into BARDA’s current pandemic influenza priorities. The agency appears to be focused on de-risking and sustaining egg-based influenza response capacity by pairing existing licensed seasonal vaccine platforms with licensed adjuvants that could support scalable use. For vaccine developers with relevant antigen, adjuvant, manufacturing, regulatory, or clinical capabilities, this is an opportunity to help shape future federal investment in one of the most critical areas of national health security.
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