Improving the Nation's pandemic influenza response capabilities through expanding manufacturing capability

NOTICE OF INTENT This serves as notice of the Biomedical Advanced Research & Development Authority's (BARDA) intent to proceed with the programs as outlined below. This notice in no way commits the Government to proceeding with any solicitation. Title: Improving the Nation's pandemic influenza response capabilities through expanding manufacturing capability. Synopsis: Over the last 20+ years, remarkable strides have been made in improving the Nation's influenza pandemic preparedness and response capabilities. As part of this effort, BARDA has partnered with numerous domestic influenza vaccine developers to support licensure and/or capacity expansion for three different influenza vaccine manufacturing platforms, namely egg-, cell-, and recombinant protein-based vaccines as well as oil-in-water adjuvant technologies. As part of an ongoing program, BARDA works with these US FDA licensed influenza vaccine manufacturers to produce virus - seeds, manufacture clinical investigational lots, perform clinical safety and immunogenicity trials, and manufacture at commercial scale pandemic influenza vaccines for stockpiling or response. As influenza virus is constantly evolving, these ongoing activities are critical to maintaining a ready response posture. BARDA also recognizes that having multiple influenza vaccine manufacturing platforms is crucial, as no one platform will necessarily work best in all situations. Therefore, BARDA continues to support development of additional influenza vaccine production platforms. BARDA has previously identified that the mRNA vaccine production platform has characteristics that could complement currently licensed influenza vaccine manufacturing approaches. In particular, mRNA vaccines can be rapidly switched to a new viral strain, as witnessed with the COVID-19 response. This is an important attribute when responding to a new viral strain that emerges and spreads rapidly with little warning. Over the last several years, BARDA has supported advancement of mRNA-based infectious disease vaccines, including seasonal and pandemic influenza. As the next steps in this effort, BARDA is providing this Notice of Intent for two potential funding announcements that are projected to be released within the next 120 days: Accelerating Near-term Availability of mRNA-based Pandemic Influenza Vaccine: This solicitation will identify partner(s) with existing domestic large-scale commercial mRNA vaccine production, including fill/finish, and labeling/packaging activities that could be readily repurposed for a pandemic influenza response. The goal of this effort is to rapidly enable a mRNA-based national pandemic influenza response capability by generating manufacturing and clinical data with various influenza strains of pandemic potential. As existing facilities and manufacturing capabilities will be utilized, the primary focus is currently projected to be manufacturing of investigational product and clinical trial(s) to test the safety and immunogenicity of vaccines targeted to various influenza virus subtypes/strains as mutually agreed upon by BARDA and the Offeror. Rapid Pandemic Influenza and Emerging Infectious Disease Vaccine Development and Response Capability: An enduring pandemic preparedness effort requires a long-term partnership centered around not just a particular vaccine, but also all the other components that make up a preparedness and response capability. BARDA anticipates releasing a solicitation centered on forming such a partnership. A mRNA-based seasonal/pandemic influenza vaccine platform is envisioned to complement currently existing pandemic influenza response capabilities. Importantly, as part of this partnership, BARDA envisions a capability that will continually - exercise preparedness and response efforts at small scale, ensuring the ability to rapidly pivot to address pandemic influenza or any other emerging infectious disease that poses a threat. While this partnership will focus on enabling domestic CGMP manufacturing capability and subsequent annual costs to support the response capability, it does not envision dedicated new-build construction. This notice does not constitute a call for submissions or a promise to issue a call for submissions in the future. This notice does not commit the USG to contract for any supply or service whatsoever. Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA is not at this time seeking proposals, and will not accept unsolicited proposals. It is anticipated that BARDA may release a solicitation for the above requirements within 120 days of posting. Once released, we encourage all responsible sources that meet the minimum eligibility criteria detailed above, to submit a proposal, which will be considered by BARDA. Interested parties should monitor this site (www.sam.gov) and other BARDA communication channels (e.g., https://www.medicalcountermeasures.gov/) for updates on the potential release of a solicitation. Industry Discussions: Potential Offerors are encouraged to meet with BARDA representatives by requesting a TechWatch meeting online at: https://medicalcountermeasures.gov/request-barda-techwatch-meeting/. Please indicate in your request for which potential funding announcement you are requesting a meeting. Such discussions would only be intended to get a better understanding of the possible capability to meet the potential USG need. Department of Health and Human Services (HHS) Administration for Strategic Preparedness & Response (ASPR) Biomedical Advanced Research & Development Authority (BARDA) 400 7th St. SW Washington, DC 20024