BioPort, Sole U.S. Anthrax-Vaccine Maker, Struggles to Solve Its Regulatory Problems

By LAURA JOHANNES, CHRIS ADAMS and GEETA ANAND

StaffReporters of THE WALL STREET JOURNAL

October 9, 2001

The discovery that at least two people have been exposed to anthrax inFlorida brings greater urgency to solving the regulatory and manufacturing problems at BioPort Corp., the only company in the U.S. licensed to make an anthrax vaccine. Unfortunately, any solution seems to be at least a month away.

BioPort, a closely held company in Lansing, Mich., stopped making the vaccine in 1998, after the Food and Drug Administration found numerous deficiencies at BioPort's aging plant. Even after renovations were completed, an FDA inspection in November 1999 found numerous deficiencies in record-keeping, sterility precautions and methods for assuring consistency of the vaccine. In an inspection report dated Oct. 26, 2000, the agency found numerous violations in a part of the plant where vials are filled with various products, including the anthrax vaccine.

The October report also noted that the company failed to file a timely report to the agency on a military employee who died in June 2000, three months after receiving the vaccine. It is unclear if the vaccine caused the death, but the company still is required by law to report the fatality within 15 days. Company spokeswoman Kim Brennen Root says BioPort was notified of the death the day the inspectors arrived, and it did meet the 15-day requirement. The FDA inspectors noted in their report that BioPort hadn't recorded the date of notification.

Anthrax vaccine made prior to the suspension is available only to U.S.military personnel. Since the Sept. 11 terrorist attacks, BioPort has been flooded with inquiries from civilians interested in acquiring the vaccine. The company has set up a special hotline that informs callers that "every dose is being used or reserved for the American armed forces."

The vaccine has sparked protests from some military personnel who feel it is dangerous. A group representing military personnel says it believes the vaccine may have caused several deaths and asserts that it has documented 1,000 cases where people have become seriously ill. BioPort says the vaccine is safe and serious side effects are rare; it believes the deaths in military personnel who received the shots likely were the result of other causes.

The FDA referred phone calls to the Department of Health and Human Services,which said the FDA is "working pretty closely" with BioPort to helpit resolve its problems.

"I don't know if it's daily contact, but it's a high number of contacts," said Kevin Keane, a department spokesman. Before Sept. 11, the FDA expected that BioPort might come into compliance within three or four months, he said. Now the goal is to have that happen within six weeks. "They are working together closely to try to get the facility open as quick as possible," he said.

Ms. Root said BioPort already has corrected many of the deficiencies noted in the inspection reports and is in the process of correcting the others in time for the next inspection, expected soon. The company has made a test batch of vaccine and expects by Oct. 15 to complete its application to the FDA to begin making vaccine at its renovated plant, she said.

Sen. Tim Hutchinson, an Arkansas Republican who is a member of the Senate Armed Services Committee, said the different branches of government haven't been "coordinating or cooperating" with one another in response to the threat of bioterrorism. He urged that such coordination be a priority for President Bush's new cabinet position, the Office of Homeland Security.

Sen. Hutchinson said he believes the government needs to take over the manufacture of vaccines against diseases used in bioterrorism. He pushed a $3 million appropriation in a defense bill approved in the Senate two weeks ago for the design of a manufacturing plant for the U.S. government to make the anthrax vaccine.

Though BioPort is the only company with the license to make the vaccine, Merck& Co. executives said they have been talking with Defense Department officials in recent months about how to aid the fight against bioterrorism, including whether the Whitehouse Station, N.J., company could become a supplier for an anthrax vaccine. No decisions have been reached yet, the company said. AmericanHome Products Corp., of Madison, N.J., which like Merck also has a large vaccine business, said it isn't working on anthrax vaccines.

Still, the involvement of a large pharmaceutical concern would be no immediate solution. A Merck spokesman said that even if producing an anthrax vaccine was given top priority, it would take months.