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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