Vaccine meets safety requirements.(Brief Article)

2002 JUN 26 - (NewsRx.com & NewsRx.net) -- Findings from the Anthrax Vaccine Expert Committee (AVEC) do not suggest a high frequency of medically important adverse events associated with anthrax vaccination

Between March 1998 and March 2002 525,000 U.S. military personnel were vaccinated against anthrax. In the case of an outbreak, this vaccine could be extended to civilians, as occurred in December 2001. The Anthrax Vaccine Expert Committee (AVEC), a civilian panel of physicians and scientists set up to monitor the safety of vaccination, published its first paper in the May 2002 issue of Pharmacoepidemiology and Drug Safety, showing that reports sublmitted to the Vaccine Adverse Reporting System (VAERS) over a 2-year period did not indicate a high frequency or unusual pattern of serious vaccine-related reactions.

Anthrax is a serious disease caused by the bacterium Bacillus anthracis. It is of special concern because spores can easily be weaponised. Recent illnesses and deaths in the U.S. associated with anthrax spores in the mail further underscore the grave potential this bacterium has as an instrument of bioterrorism.

The anthrax vaccine is made from a sterile filtrate of a microaeorophilic culture of an attenuated, nonencapsulated, nonproteolytic strain of B. anthracis. The culture filtrate is adsorbed to aluminium hydroxide to create the final vaccine, which is known as Anthrax Vaccine Adsorbed (AVA). AVA is administered as a primary series of six subcutaneous injections followed by annual booster injections. Since military vaccination programs were initiated in 1999 there have been many circumstantial rumors about the safety of the vaccine. In an accompanying editorial Neal Halsey, director of the Institute for Vaccine Safety commented, "The public must be confident that vaccines are made as safe as possible in order to maintain the high levels of acceptance that are necessary to control the disease. "This report should help address and reduce many of these concerns."

The AVEC reviewed and medically evaluated 602 of reports adverse events submitted to the Vaccine Adverse Event Reporting System (VAERS). This was correlated with information from the immunization records maintained by the Defense Medical Surveillance System allowing the committee to profile adverse events with respect to person, location, receipt of other drugs and vaccine lot.

"A question of paramount interest was whether a review of this initial set of 602 VAERS reports would find an excessive number of medically important adverse events attributable to AVA," said committee chair and lead author John Sever. "That was not the case. There were no deaths among those reports and only 7 of 34 reported serious adverse events were judged by the committee to fit the WHO causality categories of probable or very likely/certain to be caused by the vaccine.

Six were local injection site reactions, all of which involved a period of hospitalization but resolved completely. They ...