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WASHINGTON, D.C. -- HHS Secretary Tommy G. Thompson has
announced four new contracts totaling more than $232 million to fund development of new vaccines against three potential agents of bioterrorism: smallpox, plague and tularemia. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will administer the contracts.
"We are moving as quickly as possible to develop new vaccines to ensure
that our nation is protected against an array of potential bioterror agents,"
Thompson said. "These new contracts are the next steps in our plans
to build a robust stockpile of critical medical countermeasures and supplies,
so we are even more prepared to respond to a biological attack or outbreak."
These awards respond to a key objective of the NIAID biodefense research
agenda, which emphasizes the development of new and improved medical products
against "Category A" agents -- those considered by the Centers for Disease
Control and Prevention to pose the greatest threat to national security.
The smallpox awards continue advanced development work that began in
February 2003 on two modified vaccinia Ankara (MVA) vaccine candidates. These
contracts will support larger scale manufacturing of the vaccines as well as
further safety and effectiveness studies in animals and humans. The tularemia
and plague awards will fund early-stage product development of the respective
vaccines, which will include dosage formulation, pilot batch production and
initial clinical assessment. All four contracts are for purchases of vaccine
lots intended for research use. Any future purchases of additional vaccines
for stockpiling in the event of an emergency will depend on the results of the
research currently underway.
"In a short period of time, we have greatly expanded our partnerships with
industry to spur the development of vaccines against the most deadly agents of
bioterrorism," said Anthony S. Fauci, MD, director of the NIAID. "These
important new contracts reflect our commitment to develop medical tools to
protect citizens against pathogens that could be deliberately introduced into
NIAID awarded two contracts totaling up to $177 million for advanced
development of MVA vaccines against smallpox. The three-year contracts were
awarded to Bavarian Nordic A/S of Copenhagen, Denmark, and Acambis, Inc., of
Cambridge, Mass., and Cambridge, England. MVA is a highly weakened form of
the vaccinia virus that cannot replicate in human cells.
Previous NIAID research has demonstrated that MVA is nearly as effective
as the standard smallpox vaccine, making it a promising candidate for use in
children and pregnant women as well as people with weakened immune systems or
skin conditions such as eczema. The new contracts will allow the companies to
continue the work they began under contracts awarded in February 2003.
For the plague vaccine, NIAID awarded a contract to Avecia Biotechnology,
Ltd., of Manchester, England. The three-year, $50.7 million contract covers
the manufacture of a new plague vaccine as well as animal testing and initial
human trials. There is currently no licensed plague vaccine, and the pneumonic
form of the disease, which infects the lungs and can spread from person to
person through the air, is nearly always fatal unless antibiotic treatment is
started within 24 hours of infection.
NIAID also modified an existing contract with DynPort Vaccine Company LLC
of Frederick, Md., to include the manufacture of a pilot batch of live,
attenuated tularemia vaccine. The three-year, $4.5 million contract
modification also covers stability testing of the vaccine. Tularemia is a
highly infectious bacterial disease most often transmitted by ticks and
insects. In humans, illness is characterized by intermittent fever, headache
and swelling of the lymph nodes. This live, attenuated vaccine contains a
weakened form of the tularemia bacterium, enabling the immune system to
recognize and produce neutralizing antibodies against the bacterium if it is
NIAID is a component of NIH, 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.
Source: National Institute of Allergy and Infectious Diseases