"There is an urgent need to devise more effective measures to protect U.S. citizens from the harmful effects of anthrax spores used as instruments of terror," said Secretary Thompson. "These awards represent the first step toward our goal of securing an initial 25 million doses of an improved anthrax vaccine for our emergency stockpile."
"Vaccines are the best method of protecting the public against infectious diseases," said NIAID Director Anthony S. Fauci, M.D. "At NIAID, one of our top priorities is to work with industry to create new and improved vaccines against possible agents of bioterrorism. These vaccines must be suitable for civilian populations of varying ages and health status. In addition, the vaccines must be safe, easy to administer, and capable of inducing an immediate protective immune response."
The currently licensed anthrax vaccine, administered almost exclusively to military personnel, must be given in six doses over 18 months. The new vaccine will be required to provide immunity to inhalation anthrax in three or fewer doses, which is expected to reduce the administration time. It is hoped that a quicker administration time and other technological improvements would allow the vaccine to protect individuals from anthrax spores even if the vaccine was given shortly after exposure.
The companies awarded contracts today are Avecia, of Manchester, United Kingdom, and VaxGen Inc., of Brisbane, California.
Under the terms of the contracts, the companies will base their vaccine candidates on a promising vaccine concept. The vaccine will contain the protective antigen of the anthrax bacterium, which will be produced with recombinant DNA technology. This type of vaccine is called a recombinant protective antigen (rPA) anthrax vaccine.
The companies' challenge will be to take this experimental vaccine strategy through several stages of development, including manufacturing pilot lots of the vaccine, testing for safety in laboratory and clinical trials, testing for efficacy in animals, and preparing and submitting all necessary Food and Drug Administration (FDA) applications. Each company will also submit a feasibility plan to manufacture, test, secure FDA approval for, and deliver to the government up to 25 million doses of its vaccine.
Because of the urgent national concern this effort is meant to address, the contracts emphasize timely completion of milestone-based performance criteria.
In Spring 2003, NIAID plans to announce a new competition for one company to be chosen to manufacture and maintain the 25-million dose emergency stockpile. Consideration for this subsequent manufacturing contract will be competitive and not limited to the two companies awarded contracts today.
These awards are part of the Department of Health and Human Service's efforts to build and sustain a robust and long-term program for biodefense research. In February 2002, NIAID convened a Blue Ribbon Panel to review the NIAID Biodefense Research Agenda for CDC Category A Agents, those potential agents of bioterrorism that would have the largest impact on public health. One of the highest priorities identified by this panel was to quickly produce candidate anthrax vaccines.
NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, 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.
The National Institute of Allergy and Infectious Diseases is a component of the National Institutes of Health, U.S. Department of Health and Human Services