Last Updated

26 Jun 2003

Source: The Lancet 359 (9310), March 16, 2002.

SCIENCE AND MEDICINE

Anthrax vaccine is safe and effective--but needs improvement, says IOM

by Marilynn Larkin

The current US anthrax vaccine is effective and "acceptably safe"-- but "heightened efforts" are needed to improve the way it is used and to develop a better vaccine, concludes an expert advisory committee of the Institute of Medicine (IOM). The report, The Anthrax Vaccine: Is it safe? Does it work?, was funded by the Pentagon, but committee chair Brian Strom (University of Pennsylvania School of Medicine, Philadelphia, PA, USA) asserts that "if we had a bias to begin with, it probably was against the military. I felt we just had to turn over the right stone and we'd find a smoking gun out there. But we didn't find it, and we looked hard."

Some two million military personnel have had the vaccine, which requires six subcutaneous injections over 18 months and yearly boosters. Some 400 refused to comply with Pentagon orders for mass vaccination because of injection site reactions and fears that the vaccine could cause symptoms similar to those seen in gulf war syndrome. Nevertheless, says Strom, studies showed that safety "is comparable to that of other vaccines".

Mass vaccination of the military was halted while the vaccine's manufacturer, BioPort (East Lansing, MI, USA), corrected certain manufacturing deficiencies. The Pentagon is expected to resume vaccinations in light of the IOM report.

According to a New York Times article on March 7, critics say the studies reviewed by the committee were "flawed, because soldiers were typically reluctant to complain about adverse reactions". But former military man Tom Johnson, director of respiratory therapy at Long Island University (Brooklyn, NY, USA), says, "yes, the culture is such that you don't want to report -- but the military undoubtedly made a strong effort to make sure side effects were reported. They don't want to find out 10 years down the road that they have a 'BioPort disease' phenomenon, like gulf war syndrome, to deal with. They may be heavy handed in the way they operate, but they don't want to repeat their errors."

Meanwhile, a multicentre study aimed at improving the current vaccine will be launched next month, says principal investigator Gregory Poland (Mayo Clinic, Rochester, MN, USA). "We'll look at differences in reactions between men and women, evaluate different ways of giving the vaccine --eg, intramuscularly instead of subcutaneously--and see whether we can reduce the doses to four and still get a satisfactory response", says Poland.