Mark A. DeSorbo
LANSING, MI—Being the sole maker of an anthrax vaccine during a war on terrorism has not been the only challenge BioPort Corp. has dealt with recently.
“The first challenge was purchasing a facility that was undergoing significant renovation, and the second challenge was meeting U.S. Food and Drug Administration (FDA) process validation requirements,” says BioPort spokesperson Kim Brennan Root.
On January 31, after settling pre-existing violations of current good manufacturing practices (cGMPs) that date back nearly four years, BioPort received the FDA's final approval to begin distributing its licensed anthrax vaccine from its updated facility.
“Our 220 employees have kept their sense of dedication and focus for three years to get to this day,” says Robert Kramer, BioPort's president. “They've worked around the clock, and they've made countless personal sacrifices to gain this approval because they realize how vital the vaccine is.”
Bernard A. Schwetz, FDA's acting principal deputy commissioner, says the agency worked as quickly as possible to review licensed supplements and resolve such outstanding issues as sterility, safety and efficacy with BioPort for the supplement to be approved.
“Our goal had always been to assure that the anthrax vaccine meets high standards for safety and efficacy,” he adds.
A BioPort spokesperson told CleanRooms in December that approval could take as long as six months, but the FDA managed to complete the approval process in less than two months.
“In this matter, no short cuts were taken,” says FDA spokesman Jason Brodsky. “This was a priority for the agency and many staff members and scientists worked long hours, weekends and even cancelled scheduled leave to continue the work in reviewing BioPort's application for approval.”
BioPort was given tentative approval from the FDA last December, and final approval was contingent upon the FDA inspection of Hollister-Stier Laboratories LLC (Spokane, WA), the company contracted by BioPort to fill finished vials with anthrax vaccine adsorbed (AVA) after BioPort decommissioned its only filling operation.
“This is now a very high-profile product at a time when anthrax issues are more on the front burner. Now, very clearly, prevention of bio-terrorism is still on the forefront,” Brennan Root says. “We are very pleased with the timely manner the FDA conducted its inspections, and we are glad to have a very sound working relationship with the FDA.”
The sterility, safety and efficacy of anthrax vaccines manufactured at the facility have been an issue with the FDA long before BioPort's mid-1998 acquisition of the Michigan Biologics Products Institute (MBPI), which was then owned by the Michigan Department of Public Health, according to Congressional testimony.
In October 2000, Mark A. Elengold, deputy director of operations for the FDA's Center for Biologics Evaluation and Research (CBER), told the Congressional Committee on Government Reform that the agency had inspected the facility on numerous occasions during the last 10 years, “identifying a number of deficiencies requiring correction.”
“In particular, the FDA conducted a surveillance inspection of MBPI in November 1996,” Elegold says. “During that inspection, FDA investigators documented numerous significant deviations from the Food, Drug and Cosmetic (FD&C) Act, FDA's regulations and current good manufacturing practices.”
In 1997, the FDA issued a “notice of intent to revoke” letter, which meant MBPI had to comply with FDA standards or risk having remaining vaccine seized and the facility shut down.
Although MBPI responded with a strategic plan to comply, many issues still had not been resolved when the agency returned to the facility in February 1998. MBPI was then forced to quarantine 11 lots of the anthrax vaccine that were believed to have been contaminated with particle matter and could pose problems with the vaccine safety and efficacy.
By mid-1998, however, BioPort had purchased the facility, agreeing to complete the strategic plan that MBPI started.
“Since BioPort is the only licensed manufacturer of the anthrax vaccine, today's approval is especially important,” Health and Human Service Secretary Tommy G. Thompson said in a January 31 statement. “Although the Centers for Disease Control (CDC) does not recommend vaccination for the general public, this product is a critical component in our arsenal against bio-terrorism.”
According to The Associated Press, Americans will probably have to depend on the current anthrax vaccines if there's another biological attack because second-generation injections are being formulated, but are not ready.
Daniel Lucey, director of the Infectious Disease Service at the Washington, D.C Hospital Center, told reporters at a recent anthrax vaccine forum that there is only one batch that is ready to go and that is the one the FDA approved in the 1970s.
“This is the only vaccine that we will have if there is another anthrax attack,” Lucey says. “Yes, it's a licensed vaccine, but it was licensed to be given before exposure to anthrax. It wasn't approved for post-anthrax exposure and that's why it needs to be done under very close monitoring.