FDA approval of avian flu vaccine moves preparedness forward

A statement from Assistant Secretary for Preparedness and Response Nicole Lurie, M.D.

The nation marks a historic step in pandemic preparedness today with the U.S. Food and Drug Administration’s approval of our first adjuvanted pandemic influenza vaccine, Q-pan, manufactured by GlaxoSmithKline (GSK) to protect against H5N1 influenza.

Using adjuvants in vaccine can reduce the amount of vaccine antigen needed to stimulate an immune response in people. Antigen is the component of the vaccine that stimulates the person’s immune system to protect against a virus. Needing less antigen in each dose of vaccine means more doses of vaccine will be available in a pandemic, and the approval by FDA means this adjuvanted vaccine is safe and effective.

GSK developed the vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA), in the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services.

Every few decades, new strains of influenza emerge for which the public has little immunity. If a strain spreads from person to person widely across the globe, the virus could become a pandemic. All types of influenza can be deadly including H5N1, better known as avian influenza or bird flu. People have become ill from avian flu after close contact with infected birds. Of the 600 people who have become ill in the past decade, close to 60 percent died from this flu.  

We now have a flu vaccine to protect the health of a greater number of people, should this deadly virus change from one that spreads from birds to people to one that can spread person to person like the seasonal influenza virus.

The public health challenge in a pandemic is to get as many people vaccinated as possible as quickly as possible, and an approved, adjuvanted vaccine can help health officials across the country do just that.  

In an H5N1 pandemic, the U.S. government could have more than 35 million doses of this adjuvanted vaccine available within weeks to protect people, and GSK could produce additional doses to meet the nation's needs for this vaccine.

Approval of this vaccine shows what can be accomplished through private-public partnership.  Since 2007 BARDA has worked with GSK to move the vaccine forward in the development process, and both partners funded the safety and efficacy studies needed to reach approval. In 2010, after responding to the first flu pandemic the world had experienced in decades, the Obama administration recognized the need to produce additional medical countermeasures more rapidly in the face of public health threats. Today’s announcement from the FDA brings our nation one step closer to this goal.

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Last revised: November 22, 2013