Vaccine Maker Not Fully Investigating Anthrax Complaints

By Deborah Funk

Army Times

November 20, 2000

The sole maker of the anthrax vaccine, BioPort Corp., has not fully investigated whether reported physical complaints are related to its vaccine, according to federal regulators.

Food and Drug Administration officials, who visited the Lansing, Mich., facility from Oct. 10 to Oct. 26, reported that:

** BioPort has not looked for trends in possible adverse reactions to the vaccine, as required. Under FDA guidelines, the company is supposed to look for any pattern of "adverse events" that may be "associated with the use of a biological product ... whether or not considered product related."

** The company also "has not investigated adverse events for anthrax vaccine that are different from those stated in the package insert," inspectors wrote. Among the possible symptoms of adverse reactions not investigated are nausea, diarrhea, vomiting, double vision, dizziness, memory loss, shortness of breath and blackouts.

The symptoms of adverse reactions mentioned in the package insert include only swelling, soreness and small lumps at the injection site or in the arm, and systemic reactions such as malaise, lethargy, chills and fever.

** The company has not probed the reported death of a military member who received the anthrax vaccine, nor did it report the incident to the FDA within 15 days of receiving the information, as required.

Army Sgt. Sandra L. Larson, 32, died June 14, three months after receiving her sixth anthrax shot at Fort Riley, Kan. The cause of death is reported as aplastic anemia, which is a bone-marrow disease, and invasive aspergillosis, an infection of tissues or mucous membranes marked by inflammatory lesions.

Her sister, Nancy Rugo, testified before Congress Oct. 3 that she believes anthrax vaccine was the cause.

BioPort spokeswoman Kim Brennen Root said the company had not reported the death because the company was notified about it through a federal Vaccine Adverse Event Reporting System report while FDA inspectors were on site. "It's not as if we sat around with that VAERS report in our hands," she said.

The Anthrax Vaccine Expert Committee, which the Department of Health and Human Services convened at the request of the Defense Department, has been reviewing VAERS reports to look for trends related to military use of the anthrax vaccine. It may become the role of the company's medical affairs staff when that department is developed, Root said.

The observations are among 18 noted by FDA inspectors in last month's review of BioPort's operations. Many of the problems were noted in the "filling suite," where vials are filled with the vaccine.

The inspectors noted that its "design and construction ... environmental monitoring, cleaning and employee practices do not assure sterility of products filled in the suite."

BioPort officials say they are planning to hire another company to fill the vials with the vaccine. Another area of concern is BioPort's documentation. Reports, records and testing documents are not always complete or accurate, inspectors noted.

In one case, for example, BioPort's records showed that two lots of anthrax vaccine were destroyed, but the lots were actually in the inventory that had been quarantined.

BioPort acknowledges documentation "is a weakness" and is working to improve it, Root said.