The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) has issued a sources sought notice for the development of universal influenza vaccine candidates towards FDA licensure.
These improved vaccines will offer greater effectiveness over a wider array of strains within an influenza virus subtype and greater duration of protection over the currently licensed influenza vaccines. Improved vaccines will also have greater effectiveness in populations like the young, elderly, and immunocompromised which do not respond well to the currently licensed influenza vaccines.
The minimum mandatory eligibility criteria are as follows:
Demonstration of Advanced Development of the Proposed Universal Vaccine Candidate – Completion of Phase I clinical trials for safety and immunogenicity for an improved influenza virus vaccine by the time of contract proposal submission.
Plans for U.S. Vaccine Product Licensure – Demonstrate this commitment by documenting the submission of a US IND for the proposed universal influenza vaccine candidate.
U.S. Vaccine Manufacturing Capability – Written commitment to do the technology transfers and/or to establish a domestic capability necessary to domestically manufacture, test, and release final container product containing a universal influenza vaccine candidate within 12 weeks of a pandemic declaration with a manufacturing surge capacity of 50 million doses within six months.
Further details are available under Solicitation Number: SS-BARDA-2014-UNIVERSALINFLUENZA-0001. Responses are being accepted until September 1, 2014.
