Vaccine Manufacturer Faulted

By THOMAS D. WILLIAMS
The Hartford Courant
November 11, 2000

The manufacturer of the anthrax vaccine has failed to properly track or investigate serious adverse reactions by people being inoculated, a recent federal inspection reveals.

BioPort Corp. of Lansing, Mich., is required under a federal regulation to monitor adverse reactions not on the vaccine's label, the U.S. Food and Drug Administration said in the inspection report.

The FDA said that many complaints of adverse reactions to the vaccine from members of the armed services were not being tracked or investigated by BioPort. One of those complaints involved a servicewoman who died in June of aplastic anemia and invasive aspergillosis.

It is not clear what triggered the death of the woman, who had received all six anthrax inoculations and whose family had noted her complaints of adverse reactions to the shots. BioPort has submitted an adverse-reaction report on the servicewoman since the FDA inspection; the results of that report have not been made public.

The FDA report said inoculations that appear to have come from three particular lots of the vaccine - FAV030, FAV041 and FAV020 - resulted in complaints. The symptoms included blackouts, nausea, diarrhea, vomiting, double vision, dizziness, memory lossand shortness of breath. The company investigated none of these patient reports, the FDA said.

A spokeswoman for BioPort, Kim Brennen Root, said the company has been working on a new system to review and investigate adverse-vaccine reactions since well before the FDA inspection last month.

One frequent critic of the military's inoculation program, U.S. Rep. Christopher Shays, R-4th District, said the results of the inspection are not surprising.

"The firm's entrenched incuriosity about adverse [vaccine] events shared by the Pentagonmeans the health effects of the vaccine program on U.S. military readiness are still not being acknowledged,'' said Shays, who is among a group of congressmen urging the program be halted. "As a result, good men and women willing to serve and die for their country are being made needlessly ill.''

Lenore Gelb, an FDA spokeswoman, declined to comment on Shays' criticism. She referred to FDA officials' previous testimony about how anthrax vaccine safety is assured through regular FDA, defense department and joint committee oversight of adverse-vaccine reactions.

James Turner, a Pentagon spokesman, confirmed that monitoring.

"The FDA and Centers for Disease Control have not found any indication of unexpected side effects related to the anthrax vaccine and, in fact, has found such reactions to occur at a decreased rate to that of most other vaccines,'' Turner said.

The vaccine has come under controversy since the military began a mandatory inoculation program for all 2.4 million enlistees in early 1998. More than 1,200 soldiers have complained of adverse reactions of varying length and severity, while scores more have been disciplined for refusing to take the inoculation or have resigned rather than take it. The vaccine is intended to protect troops from possible biological warfare by enemies.

The two successive manufacturers of the anthrax vaccine - BioPort and the state of Michigan's health department - have been cited for many violations at the plant in Lansing. The FDA has allowed BioPort to use only older batches of the vaccine created by its predecessor, Michigan's health department.