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NIAID Announces Contracts to Develop Vaccine Against H5N1 Avian Influenza
The National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health, has awarded two contracts
to support the production and clinical testing of an investigational
vaccine based on a strain of avian influenza, H5N1, which might
have the potential to cause pandemic influenza. If a pandemic of
H5N1 avian influenza were to occur in humans, production of such
a vaccine on a commercial scale could be used to protect laboratory
workers, public health personnel at risk and, if needed, the general
public.
The new contracts were awarded to Aventis Pasteur Inc. of Swiftwater,
PA, and to Chiron Corporation of Emeryville, CA. Both companies
already manufacture inactivated influenza virus vaccines that are
licensed for use during annual influenza seasons.
"The outbreak of H5N1 avian influenza again in Asia earlier
this year, which resulted in 34 documented cases of human illness
and 23 deaths, underscores the national and international imperative
to develop new and improved medical tools to prepare for the threat
of pandemic influenza," says Anthony S. Fauci, M.D., director
of NIAID. "Vaccines are key to preparing for the public health
emergency that pandemic influenza would entail."
Influenza is an important disease that causes significant death
and disability in the United States every year. According to the
U.S. Centers for Disease Control and Prevention, more than 100,000
cases of flu require hospitalization and as many as 36,000 people
die from influenza or its complications annually. Pandemic influenza
is much rarer, but much more deadly. Pandemics are global epidemics
that emerge infrequently but unpredictably and involve strains of
the flu virus to which humans have little or no immunity. The last
pandemic swept the globe in 1968; most public health experts believe
the world is overdue for another one.
To develop their inactivated vaccines, the two companies will use
a strain of H5N1 avian influenza taken from a Vietnamese patient
in February 2004. With approval from the U.S. Food and Drug Administration,
the investigational vaccines will then be tested for safety and
immunogenicity in Phase I and Phase II clinical trials. These trials,
to be conducted by NIAID's Vaccine and Treatment Evaluation Units
(VTEUs), will study the vaccine in healthy adults first with subsequent
studies planned in children and the elderly.
Until 1997, avian influenza had never been known to directly infect
humans, but in that year an outbreak of avian influenza type H5N1
infected 18 people in Hong Kong, six of whom died. The virus did
not spread easily between humans and did not result in a pandemic.
Likewise, the outbreak of H5N1 avian influenza in humans in late
2003 and early 2004 did not result in a pandemic in part because
it also did not spread easily from person to person.
Aventis Pasteur and Chiron will each produce between 8,000 and
10,000 doses of the investigational vaccine made through established
techniques in which the virus is grown in eggs and then inactivated
and further purified before being formulated into vaccines. The
use of established techniques to develop the investigational vaccines
will help to promote rapid licensing of commercial pandemic vaccines
in the event of a pandemic outbreak.
NIAID is a component of the National Institutes of Health, an agency
of the U.S. Department of Health and Human Services. NIAID supports
basic and applied research to prevent, diagnose and treat infectious
diseases such as HIV/AIDS and other sexually transmitted infections,
influenza, tuberculosis, malaria and illness from potential agents
of bioterrorism. NIAID also supports research on transplantation
and immune-related illnesses, including autoimmune disorders, asthma
and allergies.
Press releases, fact sheets and other NIAID-related materials are
available on the NIAID Web site at http://www.niaid.nih.gov
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