NEWS
BYTES
April 2007
HHS
Funds Advanced Development of H5N1 Influenza Vaccines
Three New Contracts Will Focus On Antigen-Sparing Vaccines
U.S. Department
of Health and Human Services
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 I 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 http://www.pandemicflu.gov/vaccine/index.html.
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