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Anthrax Vaccine Shipments Await Government Blessing

FDA needs to do final inspection of renovated plant, but supply still goes only to military

FRIDAY, Oct. 26, 2001 (HealthDayNews) -- The federal government is working frantically to give the nation's only anthrax vaccine maker the go-ahead to send fresh batches of the vaccine to American soldiers by next month.

But even if Michigan-based Bioport Corp. is shipping the vaccine by Thanksgiving, as company and government officials hope, don't look for it in your local pharmacy.

The company has an exclusive, $29 million contract to supply the U.S. military -- and only the U.S. military. Over the next 10 years, the Department of Defense plans to spend $322 million to develop additional biological warfare vaccines.

That's not to say that some civilians who are exposed to anthrax might not soon be able to use the vaccine. The Centers for Disease Control and Prevention (CDC) has applied to the U.S. Food and Drug Administration (FDA) to use the vaccine in special cases where people have been exposed to anthrax and are allergic to antibiotics. The FDA has 30 days to respond to the request.

"We anticipate they'll approve it pretty soon," says CDC spokeswoman Kathryn Warren. She explains that the CDC does not plan to use the vaccine in the general population, but wants it on hand for special scenarios.

"It's just so we'll have the paperwork done and be ready if we need it," she adds.

The anthrax vaccine is considered even more vital now that the CDC has confirmed that more than a dozen people have been diagnosed with anthrax and more than 30 others have been exposed to the spores, following the mailing of tainted letters to media companies in Florida and New York City and to federal government offices in Washington, D.C.

Since 1998, Bioport's lab has not met FDA safety standards and no new shipments of the vaccine have gone to the military. However, the company says it has filed the last of the necessary paperwork with the FDA for a final inspection of its renovated lab.

Since new owners bought Bioport in September 1998, a major renovation of the lab has been completed and test lots of the vaccine have been made and stored, says Bioport spokeswoman Kelly Rossman-McKinney. For security reasons, she would not say exactly how much vaccine has been stored.

"All we're waiting for is the FDA to give us the green light, and we're ready to go," she says. "An on-site inspection is all that's needed now."

The FDA concurs.

"We're committed to reviewing their submission and doing the necessary inspection. At the same time, we'll be insuring the safety and effectiveness of the vaccine," says FDA spokeswoman Lenore Gelb.

FDA officials add the agency will review the plant as quickly as possible, although they would not give an exact timetable on any inspections. When the plant was last inspected in October 2000, the entire inspection process lasted about two weeks.

Rossman-McKinney says Bioport hopes to be shipping new batches of anthrax vaccine by Thanksgiving.

"Right now, everything is moving so quickly, it might change tomorrow. In our world, sooner is better, as long as no corners are cut in the process," she adds.

And for the time being, all of the vaccines will go to soldiers, she stresses.

Anthrax, a rare disease, is usually contracted after contact with infected animals or contaminated animal hides or hairs. But in recent years, certain countries and terrorist groups have been trying to turn the dangerous bacteria into a deadly biological weapon.

The vaccine for anthrax has existed since 1970, but has been used almost entirely by military personnel. Since September 1998, the military has mandated that all soldiers be vaccinated against anthrax.

Fortunately, Bioport's vaccine is not the only weapon against anthrax that's on the horizon.

Researchers at Ohio State University have tested a genetic vaccine that used pieces of the bacteria's DNA on mice with success. Although a DNA-based vaccine would be more effective, produce fewer side effects and be less costly to produce than the traditional vaccine, human tests are at least 18 months away.

In the meantime, there are three types of antibiotics that are approved for use with anthrax: ciprofloxacin (Cipro), tetracyclines and penicillins. If taken within a day or two of exposure, these drugs greatly increase chances for survival.

Anthrax is caused by the bacteria Bacillus anthracis. Once it enters your bloodstream, it produces toxins that kill human cells. Untreated, the disease can be fatal. Symptoms typically appear within seven days of exposure, according to the CDC. There are three types of anthrax: inhalation, cutaneous (skin) and intestinal. Of the three, inhalation anthrax is the most deadly, with an 80 percent to 90 percent mortality rate.

What To Do

For more information on anthrax and the current vaccine, read this information from the CDC. And check out Bioport.

For more on the various bioterrorist weapons, try the American Medical Association. And learn more about bioterrorism defense from the Center for Civilian Biodefense Studies.

For more on anthrax and the mail, try the U.S. Postal Service.

SOURCES: Interviews with Kelly Rossman-McKinney, spokeswoman, Bioport Corp., Lansing, Mich.; Lenore Gelb, spokeswoman, U.S. Food and Drug Administration, Rockville, Md.; Kathryn Warren, spokeswoman, Centers for Disease Control and Prevention, Atlanta
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