HHS Awards $232 Million in Biodefense Contracts For Vaccine Development

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

society."

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

encountered again.

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