VaxGen Wins Extension on Anthrax Vaccine
By Renae Merle
Washington Post Staff Writer
Friday, November 17, 2006; Page D07
http://www.washingtonpost.com/wp-dyn/content/article/2006/11/16/AR2006111601522.html
VaxGen Inc., a California biotechnology firm, said yesterday that the government
had given it more time to conduct human testing of its anthrax vaccine,
postponing a decision on whether the program should be canceled.
The Food and Drug Administration threw the effort into doubt earlier this month
after calling a halt to testing in response to questions about the drug's
reliability. The decision put the company in potential violation of its contract
with the Department of Health and Human Services, which required testing to
begin Nov. 13.
VaxGen said HHS has decided to extend the company's deadline for resolving the
issue until Dec. 18. At stake is a contract potentially worth $1 billion.
Meeting that deadline will be difficult. The company has yet to hold a formal
telephone or in-person meeting with the FDA.
Those meetings should occur no later than the middle of December, said Lance
Ignon, VaxGen's vice president of corporate affairs. "HHS, it appears, has
provided the necessary time for us to meet with FDA to try to discuss our data
and try to find a pathway forward," he said.
VaxGen's anthrax vaccine effort, already years behind schedule, is the largest
component of the Bush administration's Project BioShield, a $5.6 billion effort
to counter bioterrorism threats. The firm has run into several technical
problems, including a previous failed human test, and has struggled to fund its
research. The contract calls for the company to be paid after it delivers the
vaccine -- which is supposed to be enough for 25 million people, roughly the
population in the New York and Washington metropolitan areas combined.
The latest problem centers on the vaccine's stability or the rate at which it
would deteriorate while stockpiled. VaxGen has said it was encouraged by the
improvements it made to the vaccine's stability, but that FDA still had
concerns.