Bird Flu :: Leavitt on approval of Avian Influenza Virus H5N1 Vaccine

Statement given by Mike Leavitt, Secretary of Health and Human Services, on the Approval of the First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1:

Mike Leavitt:

The approval by the Food and Drug Administration (FDA) of the first U.S. H5N1 influenza vaccine for use in humans is a sign of progress in our ongoing efforts to protect the American people from a pandemic.

We have the opportunity to be the first generation that prepares for a pandemic, and we are working to that meet that challenge.

To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health. Pandemics happen, and we must minimize the impact of the next pandemic when it comes.

HHS has been making significant investments in vaccines, antivirals, and research. In 2006 we awarded $1 billion in contracts to develop cell-based vaccines against both seasonal and pandemic influenza with the goal of having sufficient domestic vaccine production capacity to vaccinate all Americans within six months of the declaration of a pandemic. Also, we are working on dose-sparing measures to enable us to produce more treatment courses for more people and are developing a library of live virus vaccine candidates against all known influenza strains with pandemic potential. In addition, we have developed rapid diagnostic testing for H5 strains that shorten testing time. We have also developed community mitigation strategies should a pandemic break out and continue to encourage vigorous state and local planning.

Today’s announcement is the result of a collaborative effort between FDA and the National Institutes of Health, which funded the vaccine research through its National Institute of Allergy and Infectious Diseases. To date, HHS has purchased 13 million doses of this vaccine, enough to cover 6.5 million people.

It is our collective resources and cooperation that will help make our pandemic preparedness efforts succeed and position us to better prepared tomorrow than we are today.

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