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.
Contact: Jeff Minerd
NIH/National Institute of Allergy and Infectious Diseases