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Anthrax Vaccine Called Effective Force Protection
 
 By Douglas J. Gillert
 
American Forces Press Service

 WASHINGTON -- 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."