HHS Awards First Contract Under Project BioShield to California Company To Produce Anthrax Vaccine
HHS on Thursday announced that it has awarded the first contract under Project Bioshield to California-based VaxGen, giving the company $877 million to manufacture 75 million doses of a newly developed anthrax vaccine, the Washington Post reports (Kaufman, Washington Post, 11/5).
Project Bioshield, established in July, authorizes $5.6 billion over the next 10 years to encourage pharmaceutical and biotechnology companies to work with NIH to develop antidotes, vaccines and other products to treat and protect against a host of potential biological weapons (California Healthline, 7/22).
The VaxGen contract, with NIH's National Institute of Allergy and Infectious Diseases, will provide enough anthrax vaccine doses for 25 million people (AP/Wall Street Journal, 11/4). The vaccine could be used for advanced protection from anthrax or in combination with antibiotics to treat the disease (Jacobs, San Jose Mercury News, 11/5). FDA officials will not review the vaccine for safety or effectiveness until 2007, but it could be distributed and used before regulatory approval if CDC declares a health emergency.
The contract stipulates that VaxGen will begin delivering the vaccine to the national stockpile within two years at a fixed price negotiated with HHS. After the first 75 million does of the vaccine are stored, and after receiving regulatory approval, VaxGen could sell the vaccine, which requires three separate injections, to the general public and the military (Washington Post, 11/5).
VaxGen will not receive any money until doses of the vaccine are placed in the national stockpile (Maugh, Los Angeles Times, 11/5). VaxGen CEO Lance Gordon said the company is expected to deliver the first vaccine to the stockpile in 2006 (San Jose Mercury News, 11/5).
VaxGen was one of two biotechnology companies competing for the contract, and the company already has received $20.9 million from the government for early stage clinical trials of the anthrax vaccine, which has been in development for more than 10 years (AP/Wall Street Journal, 11/4). In after-hours trading, VaxGen shares rose 16% and in "over-the-counter" trading the stock closed up $1.90 at $14.35 (Los Angeles Times, 11/5).
"Acquiring a stockpile of this new anthrax vaccine is a key step toward protecting the American public against another anthrax attack," HHS Secretary Tommy Thompson said (Washington Post, 11/5).
Anthony Fauci, director of NIAID, said VaxGen is "taking a lot of risk to be involved in this" (Los Angeles Times, 11/5).
Gordon said, "It's really a sea change for the company. We took a fair amount of risk to get here and the government recognized that in determining pricing" (San Jose Mercury News, 11/5).