News Release -- FOR IMMEDIATE RELEASE

Monday, July 13, 2009

HHS Purchases Additional H1N1 Vaccine Ingredients

HHS Secretary Kathleen Sebelius announced today that the department will commit $884 million to purchase additional supplies of two key ingredients for potential H1N1 vaccine to further prepare the nation for a potential resurgence of the 2009 H1N1 virus.  

“We recognize that preparedness is shared responsibility between federal, tribal, state, local governments, private organizations and individuals. We are doing our part to be as prepared as possible for the impact that this infectious disease could have on our country,” Secretary Sebelius said. “Vaccines may serve an important role in that preparedness. The action we are taking today will provide flexibility in a future immunization program, if a program is recommended.”

The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts with Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. The vaccine ingredients will become a part of the pandemic stockpile, for use if a vaccination campaign is necessary.

Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvant could be added to a vaccine to boost the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

In May, Secretary Sebelius directed approximately $1 billion to be used for the development of a vaccine and for clinical studies to determine dose level and assess the safety and effectiveness of potential vaccines. 

The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response established the existing contracts with these companies in 2004 as part of the National Strategy for Pandemic Influenza.

More information about today’s contract action is available at https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx.  For the latest on the 2009 Influenza A H1N1 virus, see www.flu.gov. To learn more about the National Strategy for Pandemic Influenza visit http://www.flu.gov/plan/federal/pandemic-influenza.pdf.  More about BARDA is available at http://www.hhs.gov/aspr/barda/index.html.

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The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines.

A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed 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. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

HHS Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009

HHS orders an additional 56 million doses of vaccine: September 21, 2009

The U.S. Department of Health and Human Services ordered an additional 56 million doses of vaccine for the 2009 H1N1 flu from MedImmune and Sanofi Pasteur. HHS used approximately $438 million in existing funds for the purchase.  The additional vaccine purchase will help to ensure that anyone who wants a vaccine will be able to obtain one when the vaccine becomes available.  The Advisory Committee on Immunization Practices recommended that five groups of people receive the vaccine as soon as it is available (http://www.flu.gov/individualfamily/vaccination/index.html). The 2009 H1N1 flu vaccine will be available beginning in October and throughout the flu season.