BARDA’s Pandemic Influenza Medical Countermeasure Stockpile Building Programs

Topics on this Page:

• Vaccines
• Antiviral Drugs
• Non-Pharmaceutical Countermeasures

BARDA uses a comprehensive portfolio approach to stockpile a broad array of medical countermeasures for pandemic flu, including vaccines, therapeutics, and non-pharmaceutical countermeasures.

Vaccines

Vaccines are a key tool to an effective response to an influenza pandemic.  Vaccines offer pre-exposure protection to individuals who are at risk for contracting influenza.  Because it is not known which strain of influenza will cause the next pandemic, we cannot make and stockpile a matched pandemic vaccine ahead of time.  However, using a process similar to the one deciding the formulation of the seasonal influenza vaccine, we can anticipate influenza strains with pandemic potential and stockpile a limited amount of that vaccine for critical workers, which may provide partial protection if it is genetically close to the emerging pandemic strain.  Under the HHS Pandemic Influenza Plan (November 2005), the Department’s key goals for vaccine preparedness are:

• Stockpile enough pre-pandemic influenza vaccines to cover 20 million persons in the critical workforce;
• Develop sufficient domestic manufacturing capacity to produce pandemic vaccine for the entire U.S. population of 300 million persons within six months of pandemic onset. 

To establish domestic pre-pandemic influenza vaccine stockpiles, BARDA supports the development and manufacture of vaccines against different H5N1 virus clades (families of closely related strain variants). BARDA also supports the secure supply of raw materials including eggs for domestic manufacturing of seasonal and pandemic influenza vaccines, and the development and manufacturing of small lots of influenza vaccine using strains with pandemic potential 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. 

To fulfill our pre-pandemic vaccine stockpiling goals:

• HHS has invested $1 billion to date for the establishment of pre-pandemic influenza vaccine stockpiles, resulting in the development and manufacture of egg-based inactivated split monovalent bulk vaccines (bulk batches of ready-to-use single-strain vaccines) against circulating H5N1 avian influenza virus strains. Such emergency stockpiles are essential for immunizing critical personnel upon a pandemic influenza outbreak, pending the production of a vaccine against the actual pandemic strain.
• Supported the development and manufacturing of the first licensed H5N1 vaccine
• By the end of 2008, the H5N1 pre-pandemic vaccine stockpile held enough vaccine for over 11 million people.
• In late 2008 5.2M doses of an antigen-sparing adjuvant were purchased. With delivery of these materials the H5N1 pre-pandemic stockpile will have enough material to immunize over 13.5 million people.

Antiviral Drugs

Antiviral medications lessen the impact of a virus after an individual has been infected, and are used for treatment for influenza infections. Under certain circumstances, these drugs can also reduce transmission of the virus or even prevent infection.

Currently, the pandemic influenza stockpile is comprised of two products from a class of drugs known as neuraminidase inhibitors, which work by blocking the ability of the virus to multiply beyond the infected host cell.  Tamiflu® (oseltamivir) is manufactured by Roche as oral capsules or liquid suspension. Relenza® (zanamivir) is manufactured by GlaxoSmithKline as a powder and administered via a respiratory inhaler. As stated in the HHS Pandemic Influenza Plan the Department’s key goals are to:

• Establish national influenza antiviral drug stockpiles to treat 25% of the U.S. population during a pandemic, plus an immediate readiness cache of 6 million treatment courses for containment at pandemic onset;
• Support the advanced development of new and promising influenza antiviral drugs toward U.S. licensure; and
•  Boost U.S.-based production of antiviral drugs.

To fulfill antiviral drug stockpile goals, BARDA has:

• Awarded contracts in 2004-2007 totaling more than $924 million to establish and coordinate the Federal and State pandemic stockpiles of antiviral drugs.
• Procured 50 million treatment courses for storage in the Strategic National Stockpile (SNS) by the end of 2007 – completing the federal contribution to the antiviral goal.
• Supported States to purchase 23 M treatment courses of antiviral drugs by the end of 2008 towards the 31 million treatment course goal for State stockpiles under a federal subsidy.
• Together, the Federal and State stockpiles will comprise the 81 million treatment courses needed to cover 25% of the U.S. population as well as a small cache of antiviral drugs to be used to slow or contain a pandemic virus domestically or internationally.

Non-Pharmaceutical Countermeasures

BARDA released an RFP in January for the advanced development of a next-generation portable ventilator to meet the needs of during an influenza pandemic or other CBRN event in which there was an overwhelming number of patients requiring respiratory support.