Anthrax Vaccine Called Effective Force Protection
By Douglas J. Gillert
American Forces Press Service
WASHINGTON, Nov. 5, 1998 Despite a few well-publicized attacks against DoD's mandatory anthrax vaccination program, a senior defense health official said the vaccines are safe, effective and necessary.
"We're pleased with the progress of the vaccination program. We're following it very closely to make sure we do it right," said Rear Adm. Michael Cowan, medical readiness director on the Joint Staff.
Cowan said the anthrax program received the full backing and approval of the federal Food and Drug Administration, and that both DoD and the FDA test and approve all batches of the vaccine at the manufacturing facility in Michigan. He said adverse reactions by people receiving the vaccine have been extremely low.
"The side effect percentage is something like .0002 percent, which makes it many times safer, for example, than the diphtheria shots we give our children," Cowan said. There's been just one reported reaction by a service member who experienced Guillain-Barre Syndrome, a type of temporary paralysis associated with other vaccines, surgery and insect stings. The affected service member fully recovered, Cowan said, and the Pentagon is on the lookout for any additional cases of side effects.
Critics of the vaccine program question the safety and quality of the manufacturer, Bioport Corp. of Lansing, Mich. They cite a February FDA inspection that found deviations from FDA standards in record-keeping and testing procedures. The report suggested that some service members have received inoculations from a 1993 batch that didn't get a required FDA revalidation before it was put to use.
"That batch was properly revalidated," Cowan said. "There has never been a batch that's gone out that has not been current and fully FDA-approved." The FDA and DoD work closely with Bioport anytime inspections find fault with production or record-keeping processes at the plant, the admiral said. The FDA and a DoD contractor test all vaccine produced by Bioport for sterility, stability, purity and potency.
Cowan compared the tests to the way NASA checks and rechecks the space shuttle and launch vehicles.
"NASA is famous for having redundant procedures to make sure that, if anything goes wrong, there's another procedure in place to catch it, and another procedure in place to catch that," he said. "You can't have a flat tire in space and pull over to fix it.
"The FDA is the same way. They have very tight controls and many checks to make sure nothing slips through the cracks. We're very comfortable with them and we think they've done their job to make sure no problems occur [with the anthrax vaccine]. Bioport also has shown a very strong intent to do their job right."
Cowan attributes some of the fear and paranoia over the anthrax program to irresponsible distribution of information, mostly over the Internet.
"There's a lot of misinformation out there, and it's the responsibility of each individual to not only get information about things that affect him, but test the quality of that information," he said. He recommended service members and their families visit the DoD anthrax Web site, currently located on the DoD home page at www.defenselink.mil.
"We're updating the anthrax Web site, trying to target our audience and speak to them in terms that are easy to understand," he said. "Folks who visit the [revamped] Web site are going to find more information in a format they're comfortable with."
Anthrax inoculations fall under the much broader category of force medical protection, which includes surveillance of areas where biological weapons may be a threat; early detection of chemical attacks; the use of antibiotics and other medicines to treat symptoms of biological contamination; and a host of other measures. Anthrax gets attention, Cowan said, because it is deadly and easily obtained, transported and added to explosives.
The vaccine targets the essence, or heart, of anthrax, making it highly effective, Cowan said. However, Russian scientists recently reported they had genetically altered anthrax, making it resistant to their vaccine. Such a strain would provide a potent and fatal weapon if it falls into the hands of a rogue nation or transnational terrorists. Cowan said DoD is attempting to obtain the altered strain for testing against the Bioport vaccine.
"We are just as serious as we can be about protecting our forces from all ends," Cowan said. And because anthrax is easily turned into a biological weapon, he said, the vaccine will continue to be mandatory for service members.
"It takes very little skill to obtain the wild anthrax culture and use it in some sort of weapon," he said. "Anthrax is the poor man's atomic bomb. By immunizing our force, we are immunizing ourselves against an 'atomic' bomb."