HHS Funds Advanced Development Of H5N1 Influenza Vaccines

HHS Secretary Mike
Leavitt announced today that the department has awarded contracts totaling
$132.5 million to three vaccine makers for the advanced development of H5N1
influenza vaccines using an immune system booster called an adjuvant. An
adjuvant is a substance that may be added to a vaccine to increase the
body's immune response to the vaccine's active ingredient, called antigen.




"In the event of an influenza pandemic, a vaccine that uses adjuvant
could provide a way to extend a limited vaccine supply to more people,"
Secretary Leavitt said. "These contracts are a continuation of our
aggressive multi- pronged approach to a potentially critical public health
challenge."


The Department has awarded five-year contracts to GlaxoSmithKline for
$63.3 million and to Novartis Vaccines and Diagnostics, Inc. for $54.8
million. In addition, HHS is funding IOMAI Corporation for $14.4 million
for 15 months to complete Phase 1 clinical trials of their candidate
vaccine. IOMAI may receive an additional $114 million in funding upon
successful completion of the Phase 1 trials. Phase 1 trials are the first
stage of testing in people and normally include a small (usually less than
100) group of healthy volunteers. Overall the three contracts support
advanced development work through Phase 3 clinical trials in the U.S. that
are aimed at obtaining U.S. licensure for the product. In addition, the
contracts support the establishment of U.S.-based manufacturing
capabilities.



Under the contracts each company will build up its capacity to produce
within six months after the onset of an influenza pandemic either 150
million doses of an adjuvant-based pandemic influenza vaccine or enough
adjuvant for 150 million doses of a pandemic influenza vaccine. In addition
to supporting the development of each company's antigen-sparing vaccine
candidate, the contracts also require each company to provide its
proprietary adjuvant for U.S. Government-sponsored, independent evaluation
with influenza vaccines from other manufacturers.



Initial clinical studies of H5N1 vaccine in humans have shown that two
90- microgram doses of the vaccine are required to stimulate a level of
immune response that researchers anticipate would provide protection for an
individual against the H5N1 strains that have been spreading among birds in
Asia. However, the addition of adjuvant to these candidate vaccines may
reduce the amount of antigen (active ingredient) per dose needed to achieve
effective individual protection.



HHS' effort to pursue adjuvant-based vaccine is part of a broader
effort by the department to accelerate the development and production of
new technologies for influenza vaccines within the U.S. For example, in May
2006 HHS announced a $1 billion investment to support the advanced
development of cell-based production technologies for influenza vaccines
and will help to modernize and strengthen the nation's influenza vaccine
production by creating an alternative to producing influenza vaccines in
eggs.



The H5N1 strain of avian flu has spread to more than 40 countries and
has led to the deaths of hundreds of millions of additional birds, which
has heightened concern about the possibility of a human flu pandemic.
Furthermore, the number of avian flu cases in humans has reached more than
260 cases in 10 countries. More than half of those persons infected have
died. 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.



More information on pandemic preparedness including information on
vaccines can be found online at
pandemicflu/vaccine/index.html.


U.S. Department of Health and Human Services

hhs