FDA to act on future of anthrax vaccine production at Michigan facility
By Sandra Jontz, Washington
bureau
WASHINGTON — The decision to restart production of an anthrax vaccine rests now
with the Food and Drug Administration, which is reviewing the application made by the sole
U.S. facility authorized to produce it.
As part of the application process, Michigan-based BioPort, the only company holding a
production license, had to manufacture the vaccine to prove it could make one. That means,
if approved by the FDA, the country has a new stockpile of the vaccine, a Pentagon
spokesman said.
But how much of a stockpile?
Pentagon and FDA officials say they’re not allowed to talk about it.
In November, the Pentagon announced a halting of anthrax immunizations DOD-wide to
preserve the existing approved stockpile to inoculate servicemembers and civilians
reporting for duty in Southwest Asia and parts of Korea.
Much has changed since then.
For weeks, the country has been plagued by fear of anthrax contamination. To date,
three people have died, several have contracted the bacteria and dozens have been exposed.
And investigators have no idea who is behind the plot to spread the potentially fatal
bacteria through the United States Postal Service.
Production of the anthrax vaccine halted in January 1998, when the Michigan Department
of Public Health, which held the license before BioPort bought the facility nine months
later, started producing it under a changed process unapproved by the FDA.
It changed the manufacturing process when the Pentagon decided it wanted to vaccinate
all servicemembers instead of just those deployed to high-risk areas, Pentagon spokesman
James Turner said.
"They had to speed things up when they went from producing for a few thousand to
millions of people," Turner said.
Defense Secretary Donald H. Rumsfeld said last week he hopes the Pentagon might salvage
the contract with BioPort and boost production of the vaccine.
"We’re going to try and save it," Rumsfeld said of the program.
"There have been other efforts that have failed over a period of years. And it may or
may not be savable."
Pentagon officials are set to meet with representatives of the Department of Health and
Human Services to "fashion some sort of an arrangement whereby we give one more crack
at getting the job done with that outfit," Rumsfeld said. "It’s the only
outfit that, in this country, has anything under way, and it’s not very well under
way."
Last week, HHS Secretary Tommy Thompson testified before the House Committee on
Government Reform, Subcommittee on National Security, Veterans Affairs and International
Relations that President Bush asked Congress for an additional $1.5 billion so HHS can
better respond to a bioterrorism attack.
Of the funds requested, $1.2 billion is earmarked for the production of vaccines and
antibiotics, Thompson said.
"The president and my department are also committed to the development and
approval of new vaccines and therapies," he said.
Even before the Sept. 11 attacks, the FDA was working with the Pentagon on a vaccine
development program, he said.
"FDA provides assistance to DOD regarding the research required to develop new
vaccines, as well as assistance during all phases of development," Thompson said.
"FDA also works with DOD’s office that screens new and unusual ideas for
development of products to treat diseases and develop diagnostic tools."
The snag in production came when Michigan facility officials changed filters and
fermenters to reduce processing time and boost production volume, said Nancy Kingsbury,
managing director of Applied Research and Methods for the GAO, an investigative oversight
arm of the U.S. Congress.
Kingsbury testified Tuesday before the House Subcommittee on National Security,
Veterans’ Affairs, and International Relations of the Committee on Government Reform
that the manufacturing process was changed without properly notification to the FDA,
tasked with determining if the vaccine is safe and effective.
Last October, Congress asked the committee to review changes the Michigan government
and BioPort made.
For information on the DOD anthrax vaccination program, go to www.anthrax.osd.mil.
Back to October stories
Page Two news roundup
Stories from September, 2001
Stories from August, 2001
Stories from July, 2001
Stories from June, 2001
Stories from May, 2001
Stories from April, 2001
Stories from March, 2001
Stories from February,2001
Stories from January, 2001
Stories from December, 2000
Stories from November, 2000
Stories from October, 2000
Stories from August and September, 2000
Stories from June and July, 2000
Home |
