Federal regulators gave final approval Thursday to resume shipments of anthrax vaccines, four years after the nation's sole manufacturer halted production because of factory problems.
The action by the Food and Drug Administration marks an important step in the government's efforts to prepare for anthrax attacks. Five people died from the inhaled form of the disease last fall after contaminated letters were sent through the mail.
The government already has purchased millions of doses of Cipro and doxycycline, antibiotics that have been shown to prevent and treat infections caused by the deadly bacteria.
The FDA's action allows BioPort Corp., based in Lansing, Mich., to immediately ship three lots of the vaccine, each of which contains hundreds of thousands of doses. At the same time, the company must put additional warnings on its product, including one about possible birth defects among women who are vaccinated while pregnant.
FDA officials said they moved quicker than usual because of the threat to public health, but they said they did not compromise their standards for BioPort.
"It's the same work, the same standards," said Mark Elengold, a deputy director in the FDA's Center for Biologics Evaluation and Research. "We hold all manufacturers of licensed biologics products to a high standard. They will be held to the same standard as everyone else."
At the same time, Elengold acknowledged the public interest in the issue. "Did we have people working on it longer and harder? Yes," he said. "People put in a lot of overtime."
Previous violations cited by the FDA included contamination and poor record-keeping. Some old batches failed sterility tests.
While the FDA's action settles regulatory concerns about BioPort, there's still a heated debate about the safety of the vaccine, which some critics say can have deadly side effects. A lawsuit filed in October on behalf of one dead and one injured soldier claims that BioPort failed to sufficiently test the efficacy and safety of the vaccine used to immunize U.S. military personnel.
BioPort officials said they are pleased with the FDA approval and hope that it reaffirms the vaccine's safety and efficacy. The company has been working to meet federal requirements since purchasing the facility from the state of Michigan in September 1998.
"I don't think it will bring a complete end to the naysayers, but nothing speaks to the naysayers like success," said Bob Kramer, president and chief operating officer of BioPort. "All of the hard work that we've endured over the last three years has paid off."
Most scientists say the anthrax vaccine is safe for adults, causing only minor side effects such as a lump, soreness and redness at the injection site that can last for days. Some people also experience fever and joint pain, although those symptoms occur less commonly.
The FDA has required that BioPort more clearly explain those side effects on warning labels.
Because of BioPort's problems, the Pentagon was forced to scale back plans to vaccinate all 2.4 million active and reserve troops. While it reviews Thursday's approval, the Pentagon said it will continue to vaccinate only special mission units. A decision about future vaccination plans will be made soon.
To achieve full immunity, a person must get six doses over 18 months, plus annual booster shots.
In December, the Department of Health and Human Services struck a deal to buy about 10,000 doses of the vaccine from the Defense Department for people exposed to the deadly anthrax spores along the East Coast. Some experts were concerned that some people may still have bacteria lingering in their lungs that could make them sick even after completing antibiotic regimens.
The federal Centers for Disease Control and Prevention in Atlanta did not recommend that people take the vaccine, but rather, called it an experimental treatment and allowed high-risk people to decide for themselves.
Of the 10,000 people characterized as high risk, only 190 had received the first dose of the vaccine as of last week, CDC spokeswoman Cynthia Glocker said. Those people also were offered an additional 40 days of antibiotics, on top of the 60-day supply they initially received.
BioPort's Kramer said the company hopes to produce enough vaccine to inoculate police officers, firefighters, investigators and lab technicians--the people who are among the first to respond to emergencies.
The company also hopes to stockpile enough vaccine for civilians in the event of a large-scale anthrax attack. Currently, the vaccine is not recommended for and is not available to the general public.