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Author Topic: Three New Contracts Will Focus On Antigen-Sparing Vaccines  (Read 2061 times)

ama

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Three New Contracts Will Focus On Antigen-Sparing Vaccines
« on: January 17, 2007, 02:03:38 PM »

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Date: Wed, 17 Jan 2007 13:40:56 -0500
Sender: "US Dept of HHS: Press Releases, Other Info" <HHSPRESS@LIST.NIH.GOV>
Subject: HHS RELEASE--HHS FUNDS ADVANCED DEVELOPMENT OF H5N1 INFLUENZA VACCINES

Date:  January 17, 2007
For Release:  Immediately
Contact: HHS Press Office
(202) 690-6343
 
Headline:  HHS FUNDS ADVANCED DEVELOPMENT OF H5N1 INFLUENZA VACCINES
Three New Contracts Will Focus On Antigen-Sparing 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 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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Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.
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