A shot-in-the-dark vaccine
Anthrax shots are offered without all risks revealed
Staffers of Senate Majority Leader Tom Daschle rolled up their sleeves last week to receive a dose of anthrax vaccine. The vaccine, which is approved for use prior to anthrax exposure, is being offered on an experimental basis to Capitol Hill workers and postal employees who were already exposed to extremely high levels and may still harbor the deadly germ. But Anthony Fauci, head of infectious disease research at the National Institutes of Health, says this approach is largely based on theory, and there is "zero data" showing the vaccine will help.
And there are risks. Side effects noted in the informed consent form include joint pain, fever, and nausea. Worse, documents obtained by U.S. News show the form does not tell participants the course of shots they're getting--three doses instead of the usual six--is also untested. "[Food and Drug Administration] approval of the anthrax vaccine is based on the six-dose regime," wrote Kathryn Zoon, head of FDA's Center for Biologics Evaluation and Research in a September 1999 letter to Defense Department officials. "Because we are unaware of any data demonstrating that any deviation from the approved intervals of doses . . . will provide protection from anthrax infection," she strongly recommended the military stick to FDA's dosing schedule in its vaccine program. An FDA spokesperson now says the shortened schedule is actually part of what they are studying.
The FDA has not tested or approved the specific vaccine lot being used and has yet to inspect the plant where the vaccine vials were filled. So why the rush? Rep. Christopher Shays of Connecticut, a critic of the vaccine, charges that the FDA is under pressure to approve it because "the feeling now is we need the vaccine so much."
This story appears in the December 31, 2001 print edition of U.S. News & World Report.
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