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

WASHINGTON, April 17 /PRNewswire-USNewswire/ -- 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.
Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.