Anthrax vaccine manufacturer seeks to gain approval of FDA

BY THE MICHIGAN DAILY

Published October 15, 2001

LANSING (AP) Amid reports of new anthrax exposures at the U.S. Capital yesterday, the nation"s only maker of an anthrax vaccine filed paperwork asking federal officials for approval to ship the vaccine.

Lansing-based BioPort Corp. has continued to manufacture the vaccine since buying a state-owned laboratory in 1998. But it has been unable to ship any because it has failed to meet U.S. Food and Drug Administration standards after renovating the plant two years ago.

The vaccine has gained attention in recent days as 12 people around the country have either tested positive for anthrax or have been exposed to the bacteria. A piece of mail sent to U.S. Senate Majority Leader Tom Daschle"s office in Washington, D.C., tested positive for anthrax yesterday.

BioPort spokeswoman Kim Brennen Root said yesterday that the company finished submitting several hundred pages of studies and reports to the FDA on Friday. She said the documents prove BioPort can make repeated batches of the anthrax vaccine in a safe, controlled environment.

"We feel that we have fully met our obligations to the agency," she said. "Very clearly, we have the right people doing the right jobs in a timely manner."

An FDA spokeswoman confirmed yesterday that the agency received the documents. She wouldn"t say how long it will take the FDA to complete its review. The FDA has four to six months to review the information.

BioPort spent $16.8 million most of it federal dollars to expand and upgrade the facility. Root said last week that it"s not unusual for approval of a renovated vaccine plant to take two to three years.

During that time, however, the FDA has found repeated problems at the lab. The company failed FDA inspections in 1999 and 2000. An FDA report issued in October 2000 said BioPort failed to ensure that its facilities were sterile and well-ventilated.

The FDA also said BioPort did not submit complete annual reports in 1998 and 1999 and was failing to keep proper records on people who suffered adverse effects to the anthrax vaccine.

Root said the company is confident it could begin shipping the vaccine early next year if it wins FDA approval. She wouldn"t say what the company will do if the FDA refuses to license BioPort.

"Failure is not an option for this company," she said.

BioPort is the Pentagon"s sole source of the anthrax vaccine. About 500,000 of the 2.4 million troops and reservists the military wanted to vaccinate have received the vaccine, but the program has basically been put on hold as supplies to vaccinate additional troops have run low.

Anthrax is a bacteria that can cause severe damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics often is successful if the infection is caught in time.

At the Pentagon"s request, the Michigan National Guard has been guarding the facility since the beginning of October. No specific threats have been made against the company, which keeps a shoebox-sized container of live anthrax at the site under heavy security.

Last year, the U.S. House Committee on Government Reform issued a report that accused the Pentagon and BioPort of having a relationship that blocked the creation of newer anthrax vaccines and left the vaccine program vulnerable to supply shortages and price increases.

Root insisted yesterday that the company is up to the job. She said the Sept. 11 terrorist attacks and subsequent anthrax scare have strengthened BioPort"s resolve.

"We wake up every day and we think we are part of the solution," she said.

The vaccine hasn"t been available for civilian use, although Root said yesterday that BioPort employees in direct contact with the anthrax vaccine have been vaccinated.

Once the FDA approves the distribution of the vaccine, she said, the Pentagon and other federal agencies will have to decide whether to expand vaccinations to those not in the military. Most health officials so far have seen little need for a nationwide anthrax immunization program. Anthrax is not contagious.