The Biomedical Advanced Research and Development Authority (BARDA) has released a Request for Project Proposals (RPP) aimed at vaccine development and response for emerging infectious diseases and rapid pandemic influenza. The RPP, numbered RRPV-24-08-mRNALongTerm, focuses on creating a lasting partnership that builds and maintains a robust mRNA preparedness and response system for pandemic influenza and emerging infectious diseases.
Key Information and Deadlines
The RPP was officially issued on August 30, 2024, with a firm proposal submission deadline set for 1 PM Eastern on December 16, 2024. Applicants seeking to clarify technical details, or any aspect of the proposal requirements must submit their initial questions by September 17, 2024, to ensure a timely response from the government. Supplemental questions will be due November 1, 2024.
Project Scope and Objectives
The primary aim of this RPP will start with a focus on developing influenza mRNA vaccines to enhance current pandemic influenza response capabilities. As the program advances past the licensing of these vaccines, it will place greater emphasis on regularly testing and refining preparedness and response efforts on a smaller scale. This approach ensures the ability to quickly adapt to any pandemic influenza or emerging infectious disease that may pose a threat.
The successful Performer(s) must be able to conduct clinical and regulatory work to ensure vaccines can be tested, licensed, and distributed where needed. The program will lead efforts to improve the mRNA platform, including collaborating with new technology developers to enhance vaccine effectiveness and accessibility.
The partnership will focus on leveraging existing domestic CGMP manufacturing facilities to manage costs and support production, avoiding the need for new construction. Success will depend on utilizing mRNA’s modular design to meet and sustain product goals. The facility will also need to support the production of both pandemic and seasonal vaccines, as well as other RNA-based products.
The Performer is expected to deliver high-quality data packages, including randomized controlled trials, to expedite local approvals or WHO Emergency Use Listing (EUL) and ensure equitable global access to USG-funded countermeasures during outbreaks.
After licensing the influenza vaccine (expected within the first 5 years of the award), the program will focus on maintaining manufacturing capabilities and continuously testing small-scale preparedness. The ultimate goal is to be a key part of the nation’s pandemic response for influenza and other emerging diseases, working with BARDA to develop multiple products using a single, adaptable platform.
Eligibility and Proposal Requirements
Respondents to this RPP must be members of the Rapid Response Partnership Vehicle Consortium (RRPV-Consortium) at the time of their proposal submission.
Additionally, to respond to this RPP, Offerors must show evidence they satisfy the following minimum eligibility criteria:
- Demonstrated experience in mRNA vaccine manufacture under CGMP (Performer must provide documentation that clinical material was produced under CGMP).
- Evidence that a Phase 1 clinical trial with an mRNA viral vaccine candidate has been initiated.
- Demonstrated experience in vaccine development as demonstrated by an active Investigational New Drug (IND) with the U.S. FDA for a vaccine product.
- Meet SPRS security requirement. (Full requirements can be provided)
This solicitation presents an essential opportunity for consortium members to establish a long-term partnership for developing and maintaining a robust mRNA system for pandemic influenza and emerging infectious diseases. The initiative will focus on influenza mRNA vaccines to enhance response capabilities and, as the program evolves, will emphasize ongoing small-scale preparedness and adaptability. All interested parties are urged to review the detailed requirements and guidelines provided on the RRPV website and to prepare their submissions thoughtfully and thoroughly.
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