Filed at 7:58 p.m. ET
LANSING, Mich. (AP) -- The nation's sole maker of the anthrax vaccine said
Monday that it has met federal production requirements at its laboratory and
is on the verge of resuming shipments to the Pentagon.
BioPort Corp. said a Dec. 27 letter from the Food and Drug Administration
clears it to begin shipping the vaccine, provided a separate laboratory in
Washington state that puts the vaccine into vials also gets FDA approval.
The vaccine itself also must be tested by BioPort for purity, potency and
sterility and be released by the FDA. Shipments could begin later this month.
Pressure to get the labs approved has grown since U.S. troops began
heading overseas in the war on terrorism and since last fall's anthrax
outbreak killed five people on the East Coast.
The vaccine has been licensed by the FDA since the 1970s. BioPort bought
its lab from the state in 1998 but has been unable to sell the vaccine
because the building failed two FDA inspections after a renovation. The
company has spent nearly four years trying to meet FDA requirements.
In its letter, the FDA said the company has made or is in the process of
making the seven production-related changes requested by inspectors during a
visit last month.
At Hollister-Stier Laboratories in Spokane, Wash., where the vaccine
manufactured by BioPort is put into vials, FDA inspectors cited six
production-related changes needed for approval. Three of the changes involve
record-keeping data and all appear to be resolvable, according to FDA and
BioPort officials.
The Pentagon had planned to inoculate about 2.4 million troops against
anthrax. But only 500,000 personnel received at least one shot before the
program was put on hold three years ago when military supplies began to run
low.
``That is a signal that the military could consider its course in terms of
scaling up vaccinations,'' company spokeswoman Kim Brennen Root said.
The Pentagon owns all the vaccine BioPort has produced and pays the
company around $36 million each year, Root said.
Hundreds of military personnel have refused to take the shots. Opponents
of the military's vaccine program say the shots could be connected to
complaints of chronic fatigue, bone and joint pain, memory loss and other
problems.
BioPort officials contend the vaccine, which is given in a series of six
shots over 18 months, is safe.
The federal Centers for Disease Control and Prevention has obtained some
of the vaccine and offered to vaccinate anyone exposed to anthrax. Only about
50 people have taken them up on the offer so far.
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On the Net:
BioPort Corp.: http://www.bioport.com
FDA: http://www.fda.gov
CDC: http://www.cdc.gov