BioPort to track reactions to vaccine

FDA concerned that certain batches may have adverse effects

by A.J. Evenson and Tim Martin

Lansing State Journal

Friday, November 10, 2000

Lansing's BioPort Corp. will begin tracking adverse reactions to its anthrax vaccine, a response to a U.S. Food and Drug Administration report made public this week.

The FDA wants BioPort to determine whether certain batches of the vaccine - used primarily by the military - are causing unusual reactions in those who take it. The government has a similar trend-tracking system already in place.

The FDA report, which followed a two-week inspection of the Lansing labs in October, was made public this week. The report also questions the company's handling of a reported June death of a U.S. servicewoman. The woman told family members and the military she believed she was sickened by the vaccine.

BioPort officials say the vaccine they make is safe, and that efforts to expand how reactions are monitored already are under way. The company has hired a Rochester Hills doctor to oversee a formal tracking system.

"It is important, certainly, for those reports to be reviewed and investigated," BioPort spokeswoman Kim Brennen Root said. "Trending is a relatively new notion in terms of the number of people who are now being vaccinated."

The FDA's findings offer yet another hurdle for the Lansing company, plagued with financial problems and concerns over the safety of its premier product - used to combat a deadly biological weapon possessed by Iraq and up to nine other nations.

The Pentagon wants to vaccinate all 2.4 million of its troops against anthrax. Those efforts have been temporarily suspended until BioPort receives FDA approval for its newly renovated labs where the vaccine is made.

BioPort has been working toward that approval since August 1999, and company officials say they expect to have it by mid-2001.

The FDA's latest report is not directly related to those efforts. It stems from a routine inspection - conducted every two years - of general operations at the Lansing lab.

The FDA made the report public this week. It cited 18 areas of concern, most of which involved packaging and filling. BioPort officials have already said they will hire another company to take over those tasks.

But the report also questions BioPort's handling of reaction reports.

The government tracks reactions to the anthrax vaccine through the Vaccine Adverse Event Reporting System - a joint FDA and Centers for Disease Control and Prevention program.

The military requires personnel to report adverse reactions. Other individuals, health-care providers and vaccine manufacturers can also report to the system.

The FDA gathers the reports, and forwards them to the Anthrax Vaccine Expert Committee - a panel of civilian medical experts sponsored by the U.S. Department of Health and Human Services. The panel reviews adverse reaction forms every four to six weeks. BioPort is notified following the review.

Reports of reactions are rare.

The military has inoculated 491,911 people with the anthrax vaccine since the mid-1990s. Fewer than a half percent of those have reported adverse reactions.

Root said BioPort had received at least 600 reports of reactions, but didn't know an exact number. The company, she said, will track the reactions through a special software program that would uncover possible trends in specific batches of the vaccine.

The FDA report already indicates some evidence of trends in various batches of the vaccine.

The report shows "numerous complaints for nausea, diarrhea and vomiting" by those who received doses from anthrax vaccine Lot FAV030. The same lot also reports "double vision, dizziness, memory loss and shortness of breath."

Reactions to Lot FAV020 include "reports of memory loss, dizziness and blackouts."

The FDA report was critical of BioPort's handling of the claim made by Sgt. Sandra Larson, who died June 14 at age 32. Larson's sister - Nancy Rugo of Spokane, Wash. - says her sister suspected anthrax vaccine contributed to her sickness.

"She was adamant about it," Rugo said this week. "She did a lot of research on it while she was hospitalized."

BioPort is investigating the death, Root said.

An autopsy report made no mention of the vaccine, Rugo said. The death was attributed to aplastic anemia, which attacked Larson's bone marrow.

Larson's death was the second reported through the government's adverse-reaction reporting system.

BioPort employee Richard Dunn died in July following an 11th dose of the vaccine. An autopsy suggested the vaccine may have been a factor in the 61-year-old man's death, though further study is under way.

Contact A.J. Evenson at 377-1015 or aevenson@lsj.com or Tim Martin at 377-1061 or tmartin@lsj.com.