Last Updated

19 Jan 2003

Source: Wall Street Journal, January 31, 2002.

POLITICS AND POLICY

FDA Clears BioPort to Resume Shipments of Anthrax Vaccine

By CHRIS ADAMS, Staff Reporter

WASHINGTON -- Federal regulators gave permission to the nation's sole maker of the anthrax vaccine to resume shipments to government stockpiles, resolving years of federal concerns about the vaccine's production.

BioPort Corp. won clearance from the Food and Drug Administration to provide vaccine to the Pentagon, which has a contract with the small, closely held Lansing, Mich., concern. During the height of the anthrax scare last fall, the company was bombarded with inquiries from civilians looking to get vaccinations for themselves. The Pentagon inoculates troops to protect them from biological attack using anthrax, but the Centers for Disease Control and Prevention doesn't recommend vaccination against anthrax for the general public.

In announcing the move, Health and Human Services Secretary Tommy Thompson, who oversees the FDA, described the vaccine as a "critical component in our arsenal against bioterrorism" and said the vaccine "meets FDA high standards for safety and efficacy."

Despite the strong desire on the part of military and health officials to see the product produced, the vaccine and BioPort have been through a difficult history. BioPort was founded in 1998 expressly to acquire an outdated anthrax-vaccine-production facility from the state of Michigan. The company signed a contract with the Department of Defense to produce anthrax vaccine, and then worked to renovate the facility and gain FDA approval for permission to make the product. Regular production of the vaccine had stopped in 1998 before BioPort bought the facility. In various follow-up visits by FDA inspectors, BioPort was cited for deficiencies in record-keeping, sterility precautions and manufacturing deviations.

While the decision to allow BioPort to resume shipments was expected at some point, it has taken far longer than officials once thought. In October, during the height of the anthrax scare, federal officials were regularly talking to or meeting with company officials and thought approval might come in mid-November.

FDA approval followed clearance of a plant in Spokane, Wash., that will serve as a "filling facility" for BioPort's vaccine. The Spokane facility was inspected in early January; the BioPort manufacturing plant in Michigan had cleared inspection in late December.

The company will now release three "lots" of the vaccine to the Defense Department. The FDA wouldn't detail information on the size of the lots, citing national-security considerations.

The company is already producing new lots of the vaccine. Under FDA procedures for vaccines, no lots of the anthrax vaccine will be distributed from the facility until federal officials review records and, in some cases, rerun quality tests.