The National Strategy for Pandemic Influenza [PDF] (November 2005) designated the Department of Health and Human Services (HHS) as the lead agency for public health preparedness and medical response to a probable or actual influenza pandemic. Within HHS, the BARDA Influenza Division is charged with the advanced development and procurement of medical and non-pharmaceutical countermeasures for pandemic influenza preparedness and response.
The Influenza Division uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures for pandemic influenza, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, and to build and sustain their domestic manufacturing infrastructure. Using this approach, Influenza Division has achieved a number of milestones in pandemic influenza preparedness, including:
- Licensure of the first pandemic influenza vaccine (2007)
- Achieving stockpile targets for pre-pandemic vaccine (2009)
- Achieving stockpile targets for antiviral drugs (2009)
- Emergency Use Authorization (EUA) of an unlicensed IV antiviral drug (2009)
- Biologics License Application (BLA) filing for cell-based influenza vaccines (2011)
- BLA filing for adjuvanted pandemic vaccines (2012)
Supporting Advanced Development of Vaccines, Antiviral and Therapeutic Agents
Influenza Division supports the advanced development of seasonal and pandemic influenza vaccines toward U.S. licensure. The Influenza Division targets the following vaccines: (1) cell-based vaccines, (2) antigen-sparing adjuvanted vaccines, which are designed to conserve antigens by mixing in vaccine-boosting compounds known as adjuvants, and (3) next-generation recombinant vaccines.
Influenza Division also supports the advanced development of new antiviral and therapeutic agents to treat and protect against influenza infection and procures antiviral drugs to fulfill the Federal stockpile goal and support the fulfillment of State stockpiling goals.
Supporting Vaccine Development, Manufacturing and Stockpiling
To establish domestic pre-pandemic influenza vaccine stockpiles, Influenza Division supports the development and manufacture of vaccines against different H5N1 virus clades, or families of closely related strain variants. This includes a program to secure supplies of raw materials, including eggs for domestic manufacturing of seasonal and novel influenza vaccines, and the manufacturing of novel influenza vaccine candidates for clinical evaluation. In addition, Influenza Division is charged with procurement of pandemic vaccine, such as the 2009 H1N1 monovalent vaccine.
Developing Diagnostic Capabilities and Non-Pharmaceutical Countermeasures
Influenza Division collaborates closely with CDC on the development of point of care and rapid high-throughput clinical laboratory diagnostics. The Influenza Division also supports non-pharmaceutical countermeasure development, such as a next-generation, low cost and easy to use ventilators, research to better understand the effectiveness of respirators in protection from the influenza virus, and procurement of masks and respirators.