• Influenza Vaccine Development Programs

  BARDA supports a number of core services to assist the production of required products, in a manner that is timely, reliable and cost effective.

• Pandemic Influenza Vaccine Stockpile Program

  BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures for pandemic flu, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures and to build and sustain their domestic manufacturing infrastructure.

• Influenza Diagnostics Program

  Congress seeks to improve our Nation's emergency preparedness with Project BioShield, which provides the government with the ability to develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against a public health threat.

• Influenza Therapeutics Program

  A primary goal of the program is to establish national stockpiles of FDA-approved antivirals to ensure treatment of influenza-infected persons during an influenza pandemic.

  Influenza Vaccine Manufacturing Infrastructure

  BARDA's Strategic Science and Technology Division helps bring innovation to our programs. The innovation programs identify and support the advancement of platform technologies that enhance capabilities for the development and manufacturing of medical countermeasures that focus on biodefense, pandemic influenza and other emerging infectious diseases.

• International Influenza Vaccine Manufacturing Capacity Building Program

  Congress seeks to improve our Nation's emergency preparedness with Project BioShield, which provides the government with the ability to develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against a public health threat.

BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures for pandemic flu. This includes developing vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures for influenza preparedness and building and sustaining facilities for their domestic manufacturing infrastructure.

• Advanced Development Milestones and Stockpiling for Influenza
• Influenza Antivirals, Diagnostics and Devices
• Pandemic Influenza Spending Reports

Influenza Vaccines

Vaccines offer pre-exposure protection to individuals who are at risk for contracting influenza. The effective use of vaccines is a key tool for preventing a pandemic or limiting its spread.

Under the HHS Pandemic Influenza Plan (November 2005), the Department's key goals for vaccine preparedness are:

• Develop sufficient domestic manufacturing capacity to produce pandemic vaccine for the entire U.S. population within six months of pandemic onset.
• Stockpile vaccines against influenza viruses with pandemic potential to cover 20 million persons.

BARDA's planning efforts support the advanced development of seasonal and pandemic influenza vaccines toward U.S. licensure. Targeted vaccines include (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.

To establish domestic pre-pandemic influenza vaccine stockpiles, BARDA has supported the development and manufacture of vaccines against different H5N1 virus clades (families of closely related strain variants). BARDA supports the secure year-round supply of raw materials including eggs for domestic manufacturing of seasonal and novel influenza vaccines and the development and manufacturing of novel influenza vaccine candidates for clinical evaluation. BARDA also provides cost-sharing support to expand the domestic influenza vaccine manufacturing infrastructure by retrofitting existing vaccine manufacturing facilities and building new cell-based influenza vaccine manufacturing facilities.

Following the 2009 H1N1 influenza pandemic, Secretary Sebelius released the Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs (2010), which was made available concurrent to the Presidential Council of Advisors on Science and Technology's Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of the Pandemic Influenza. Both emphasize the need for technologies to make more vaccine available, faster, to improve our pandemic response capabilities. To address these recommendations, HHS has a number of initiatives underway in the form of collaborations among BARDA, CDC, NIH, FDA and industry partners.

H1N1 2009 PANDEMIC RESPONSE

In the spring of 2009, a H1N1 influenza virus emerged as a novel virus with pandemic potential. The virus's genes were a combination of genes most closely related to North American swine-lineage H1N1 and Eurasian lineage swine-origin H1N1 influenza viruses. This strain had genetically acquired the ability to cross hosts from swine to humans and had the capability of human-to-human transmission. Studies undertaken by health agencies determined that seasonal influenza vaccine provided no protection against this strain of 2009-H1N1 influenza A. Amid outbreaks of disease in Mexico and the U.S., the Acting HHS Secretary declared a public heath emergency on April 26, 2009.

BARDA Response Activities:

In May 2009, BARDA issued new orders to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine.

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain and the development of a vaccine candidate virus for distribution to manufacturers domestically and internationally. Standard practice when new influenza strains are discovered include the mixing of clinical sample of the virus with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs to produce the vaccine. Conventional methods of production have depended on this egg-based technology that has been in use since the 1950s for the production of influenza vaccines. Although generally reliable, this particular viral strain did not grow well in egg-based systems at first, resulting in a delay for first available vaccine.

The 2009 H1N1 influenza pandemic tested our nation's preparedness against an emerging virus and our ability to respond and adapt to a large-scale, public health emergency with the potential for enormous health consequences. On the whole, the response to the 2009 H1N1 influenza pandemic was successful. Notable successes include:

• the rapid identification and characterization of the 2009 H1N1 pandemic virus;
• the development and production of a 2009 H1N1 vaccine in record time;
• the efficient distribution of antiviral medications from the SNS to the states;
• the use of Emergency Use Authorizations (EUAs) to increase the availability of antiviral medications and speed the availability of diagnostics, including the first EUA for an investigational medical countermeasure;
• the development and rapid updating of clinical guidance on the treatment of 2009 H1N1;
• the effective communication with the public regarding methods to prevent transmission of the influenza virus.

Although all of these activities demonstrated that our preparedness for an influenza pandemic had key processes and protocols in place, opportunities for improvement were identified in a number of areas to ensure preparedness from a future pandemic or other public health emergency. Key examples are modernizing vaccine development technologies, developing advanced diagnostics for detection and surveillance, improving modeling efforts, and developing mechanisms for accelerated regulatory review and approval of safe and effective vaccines.

Industry partners are encouraged to visit the BARDA Broad Agency Announcement and sign up for a BARDA TechWatch meeting.