mRNA Rapid Pandemic Influenza and Emerging Infectious Disease Vaccine Development and Response Capability

To: Prospective Partners & Interested Parties Subject: RFI Overview & Response Instructions The Influenza and Emerging Infectious Diseases Division (IEIDD) of the Biomedical Advanced Research and Development Authority (BARDA), the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) is issuing this Request for Information (“RFI”) in order to collect feedback on the attached draft solicitation document (see “Attachment 1: BARDA Rapid Pandemic Influenza and Emerging Infectious Disease Vaccine Development and Response Capability RFI: Draft Solicitation For Comment”) in anticipation of the final solicitation, which could be published as soon as January 2024. It is expected the solicitation will be open for 30 calendar days. Information collected from this RFI will serve as continued market research for the refinement of the requirement using BARDA’s Other Transaction Authority to enter a long-term (i.e., 25-year) partnership with an mRNA vaccine developer(s) to provide a sustained mRNA vaccine-based preparedness and response capability for influenza and emerging infectious diseases. BARDA envisions that this effort will support BARDA’s mission by addressing the following objectives/tasks: Develop large-scale domestic mRNA vaccine manufacturing capability with licensed seasonal and pandemic influenza mRNA vaccines. Regularly ‘exercise’ preparedness and response efforts at small scale to ensure readiness to rapidly pivot to address pandemic influenza or any other emerging infectious disease that poses a threat. Develop and lead platform innovation efforts, allowing for continued improvement of the mRNA platform to create more effective and accessible vaccines. Establish a critical component of the Nation’s pandemic response for influenza and any other emerging infectious disease that works collaboratively with BARDA to develop multiple products using a single, flexible platform. Further background information is described in the attached draft solicitation. BARDA is seeking the following: Information and feedback on all components of the attached draft solicitation with comments and feedback sought on the pertinence and feasibility of each component of the draft document. Additionally, BARDA seeks questions/comments on the following: Any restrictions impacting the effort and/or authorities; Proposal instructions; Evaluation criteria; Comments about pricing information/ceilings, and The overall solicitation structure. If possible, please provide feedback utilizing the attached Excel spreadsheet (“Attachment 2 – RFI Draft Solicitation Feedback Form”) referencing the page and line numbers, including edits/comments. Please provide a courtesy email advising the following: When the official solicitation is released, is this vendor interested in proposing? If so, what would the proposed teaming structure likely look like? NOTE: BARDA has a pressing internal timeline for this requirement. If there are no significant changes in the scope of this effort from draft Solicitation to final Solicitation, would this vendor be able to provide a proposal response within 30 calendar days of solicitation opening? Important Note: Interested parties should not prepare or submit a proposal response to Attachment 1 - Draft Solicitation The purpose of this RFI is only to collect information by receiving feedback/comments to Attachment 1-Draft Solicitation. BARDA will not issue any awards from responses to this RFI. Responses will not be evaluated in any way. BARDA will not return or provide feedback on any submissions, but BARDA does reserve the right to further engage with respondents to clarify their understanding of submitted comments. Additionally, while we will not provide feedback to this RFI, commonly asked questions and accompanying BARDA responses may be made public and would be anonymized to contain no identifying information. Responses to this RFI are considered source selection sensitive information and will be protected with confidentiality accordingly. By submitting a response to this RFI, the responder understands and acknowledges that review of those responses may include non-federal BARDA personnel serving in scientific, engineering, and technical assistance (“SETA”) or similar support service roles. Please submit documents and questions to [email protected] . Your reply is appreciated by December 22, 2023, 09 : 00 AM ET. Thank you in advance for any submission as we anticipate responses received to this RFI will be highly beneficial to BARDA. We appreciate your continued interest in this requirement.