Pressure to approve BioPort Corp.'s factory has grown since last fall's anthrax outbreak killed five people on the East Coast.
Thursday, the Food and Drug Administration said BioPort's factory had met all federal requirements to resume production and shipments of anthrax vaccine to the Defense Department, which owns all of the shots the Lansing, Mich., company makes.
Also, three batches of previously produced vaccine have passed quality checks and can be shipped immediately, the FDA said.
"Yes, there was an important public health need to move forward on this," said FDA vaccine chief Dr. Kathryn Zoon. But, "I can assure you the agency did no shortcuts."
The anthrax vaccine itself has been approved by the FDA since the 1970s, and used regularly to protect veterinarians and scientists working with anthrax.
The Pentagon has pledged to inoculate millions of troops against an anthrax attack, and already has vaccinated 500,000. Soldiers are supposed to get six shots over 18 months, plus an annual booster dose.
But that program has been on hold since 1998, when BioPort bought the vaccine-producing lab from the state but found it couldn't ship a single dose.
The problem: BioPort's renovated laboratory repeatedly failed to pass FDA inspections, which found contamination, inadequate record-keeping and unapproved procedures. Several vaccine batches failed sterility tests. Ultimately, BioPort even had to hire another factory, Hollister-Stier Laboratories in Spokane, Wash., to fill the vaccine vials when its own procedures kept failing.
FDA said Thursday that BioPort's own lab and Hollister-Stier had fulfilled all remaining federal requirements to routinely produce the vaccine, and that three previously produced batches could be shipped immediately.
Now BioPort will be treated like all other vaccine manufacturers, with each batch undergoing specific testing for purity, potency and sterility and FDA certification required before each batch can be shipped.
The anthrax vaccine has been controversial over the years. Hundreds of soldiers have refused to take the shots, worried they could be connected to complaints of chronic fatigue, memory loss and other problems.
Having enough on hand caused a stir with the fall anthrax attacks-by-mail, too. The Pentagon shared some of its remaining doses with federal health officials, who offered to give the vaccine to people exposed to anthrax as part of an experiment to see if it might provide additional protection on top of antibiotic treatment. Only about 130 people accepted that offer.
The government says the vaccine overall is very safe, with rare severe side effects such as dangerous allergic reactions.
But in clearing BioPort's production, the FDdid change the vaccine's labeling to upgrade one warning and make some side-effect information more clear.
First, the vaccine now states that there are some unconfirmed reports of birth defects among women vaccinated while pregnant, so pregnant women must weigh the need for vaccination against that possible risk, Zoon explained.
Second, the label spells out that local side effects are quite common, including pain, swelling, redness and nodules at the site of the injection, she said. Systemic side effects, such as joint pain or fever, are relatively low. The label also states that other rare problems, such as neurologic conditions, have been reported among vaccine users but there's no evidence that the shots caused the problem.
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