BARDA’s Pandemic Influenza Advanced Development Programs:

Topics on this Page:

• Vaccines
• Antiviral Drugs
• Diagnostics

As part of its commitment to supporting a robust development pipeline, BARDA supports multiple advanced development programs for vaccines and antivirals.

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. 

BARDA is sponsoring the advanced development of seasonal and pandemic influenza vaccines toward U.S. licensure in support of these goals. These advanced development programs are targeted vaccines such as (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

BARDA Pandemic Influenza Vaccine Advanced Development Milestones

• Contracts:  BARDA has awarded contracts totaling over $1.5 billion in 2005-2007 to accelerate development and production of new cell-based and antigen-sparing technologies for influenza vaccines towards U.S.-licensure. There is a manufacturing surge capacity target in each contract for domestic production of at least 150 M doses of pandemic vaccine per manufacturer within 6 months of pandemic onset.
• Grants:  BARDA has provided grants totaling $25.4 million, as well as technical project management, to support international H5N1 vaccine development with global partners.
• Solicitation:  BARDA has issued an RFP in 2007 for advanced development of recombinant influenza vaccines based on hemagglutinin genes or proteins that may be manufactured in 12 weeks or less post-pandemic onset. The goal of this program is to foster FDA licensure of recombinant vaccines from domestic facilities that can produce 50M doses of pandemic vaccine within 6 months of pandemic onset.
• Interagency Leadership:  BARDA is leading an HHS interagency – industry partnership to study whether H5N1 antigens from one manufacturer may be used effectively with adjuvants from other manufacturers to enable extension of the pandemic vaccine supply (Mix-N-Match study).

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.  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.

BARDA Pandemic Influenza Vaccine Advanced Development Milestones:

• Contract Award:  Awarded a contract in 2007 for $102.6 million for advanced development and domestic industrialization of a new influenza neuraminidase inhibitor antiviral drug; and
• Solicitation:  Posted an advanced development RFP in December 2008 and will award additional contract(s) for new influenza antiviral drugs and perhaps combination drug studies.

Diagnostics

Quick and accurate diagnosis of pandemic influenza viruses in humans is essential to early treatment.  Currently available tests require specially equipped laboratories, and take as long as one to two weeks to obtain results. 

To facilitate the development of “point of care” (POC) rapid diagnostics capable of detecting pandemic flu viruses within 30 minutes in a clinical setting, BARDA and the Centers of Disease Control and Prevention (CDC) awarded four contracts totaling $17.7 million in December 2006 for early prototype device development with the goal of U.S. licensure.

A RFP was issued by CDC with BARDA in 2007 for proposals to develop rapid high-throughput clinical laboratory diagnostics. Contract awards totaling $13 million were made in 2008 to two companies to develop the high throughput diagnostic platforms. Plans for support of development of simple or perhaps home-based rapid influenza diagnostics are on-going.