FDA OKs anthrax vaccine shipments

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Posted 8:04AM on Friday, February 1, 2002

OKEMOS, MICHIGAN - Millions of anthrax vaccine doses could be available to the military by the end of the year following the federal government's decision to let the nation's sole manufacturer resume distribution. Thursday's approval by the Food and Drug Administration was a relief for BioPort Corp., the beleaguered Lansing, Mich., lab that had been unable to pass the necessary FDA inspections for nearly four years. ``I think it's safe to say this is the biggest day in the company's history,'' BioPort President Bob Kramer said. Pressure to approve the firm's factory has grown since anthrax killed five people this fall. BioPort will produce and ship 2 million vaccine doses for the military this year, and between 3 million and 8 million next year, Health and Human Services Secretary Tommy Thompson said. The vaccine is given in six shots over 18 months, plus an annual booster dose. While the government does not recommend vaccinating the general public, having BioPort producing again is important if civilians need to share the military's supply in future bioterrorist attacks, Thompson said. The government and the firm both said the Sept. 11 attacks and the subsequent fears over anthrax exposure had no impact on the decision to approve BioPort. ``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.'' Whether the Defense Department will use the doses for mass vaccinations is uncertain. A Pentagon statement Thursday said inoculations will continue for certain special-mission units but that it ``is undertaking a thorough review of all factors to decide its future use of the vaccine.'' Kramer said BioPort must meet the Pentagon's needs before making the vaccine available for civilians. But he added that BioPort will soon be discussing civilian use with federal health officials. The anthrax vaccine itself has been FDA-approved since the 1970s, and used regularly to protect veterinarians and scientists working with anthrax. But vaccinating soldiers has been on hold since 1998, when BioPort bought the vaccine-producing lab from the state - but found it could not ship a single dose. BioPort's renovated laboratory repeatedly failed to pass FDA inspections, which found contamination, inadequate record-keeping and unapproved procedures. Ultimately, BioPort hired another factory, Hollister-Stier Laboratories in Spokane, Wash., to fill the vaccine vials when its own procedures kept failing. BioPort finally got its lab approved a month ago and was waiting for Hollister-Stier to pass. Now that BioPort has fulfilled FDA's requirements, it will be treated like all other vaccine manufacturers: The FDA must agree that each new batch meets potency and sterility standards before it can be shipped. Kramer said three batches of vaccine produced in 2001 can be shipped immediately. Neither he nor the FDA would say how many doses are in each batch, citing national security. But Kramer said it was ``a significant number.'' This fall, about 130 people were inoculated with vaccine from the Pentagon's supply after being exposed to anthrax in the mail attacks. The government wanted to see if it provides additional protection on top of antibiotic treatment. Even with FDA approval, the controversy surrounding the vaccine isn't likely to go away. Hundreds of soldiers have refused the shots, worried they could be connected to complaints of chronic fatigue, memory loss and other problems. The government says the vaccine is safe, with rare severe side effects such as dangerous allergic reactions. But in clearing BioPort, the FDA did change the vaccine's labeling to upgrade one warning and clarify some side-effect information. 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 said. Second, the label spells out that pain, swelling and redness are common at the injection site, Zoon said. The label also states that other rare problems, such as neurological conditions, have been reported among vaccine users but there is no evidence that the shots caused those problems.