Military (Again) Orders GIs to take Controversial Anthrax Vaccine

by Tod Ensign

In July, 2002, the Pentagon announced that it was reviving its mandatory anthrax vaccine program. An earlier program, launched in 1998 to inoculate all 2.4 million active duty GIs and reservists, ground to a halt in 2001 amid shortages caused by the manufacturer's closure due to its violation of FDA safety rules. At least 1,000 servicemembers, citing health concerns, refused to be vaccinated. Many of them were court-martialled and/or punitively discharged with less than honorable separations.

Following a scientific review and the infusion of millions of federal dollars, Bioport, of Lansing, MI was finally able to win FDA approval to resume vaccine production in January 2002.

One of the two principal objections to the vaccine is that it was originally designed in the 1950s only to protect stockyard and tannery workers from cutaneous (skin) exposure from anthrax- ridden cattle. Biological weapons using the anthrax virus rely upon airborne spores being inhaled by humans. This raises the question of whether the vaccine would protect GIs if bio weapons were deployed.

The other is that the vaccine's design and perhaps shoddy manufacture has caused many more adverse health effects to recipients than the manufacturer has acknowledged. A GAO report published in October, 2001 found that 76% of National Guard members it surveyed reported adverse reactions, with 24% reporting systemic reactions. The manufacturer has claimed that only 34% report any adverse reaction with less than 1% being systemic.

In March 2002, the independent Institute of Medicine, which is affiliated with the National Academy of Sciences, published a Pentagon-funded study which concluded that the vaccine is safe and, when combined with antibiotics after exposure, "may keep inhilational anthrax from developing"

The same report however noted, that given the vaccine's known side effects, the lengthy six shot regimen and the antiquated technology used to produce it, there is a strong need to develop a better vaccine.

Who Must Participate in the Program

Any GI who will be on the ground in a "high threat" area, currently in or around the Arabian peninsula, for more than fifteen (15) days must participate in the shot program. Military commanders hope to begin inoculations at least 45 days before GIs are deployed to "threat areas." In addition, any GI or reservist who received one or more shots under the earlier program must now complete the six shot sequence.

Anthrax vaccine is given in six shots spread over eighteen (18) months. The first three shots are given two weeks apart. It is believed that this will provide a "significant level of protection" from anthrax weapons. The fourth shot is given six months after the first followed by the final two given at six month intervals. An annual booster is given after all six shots have been administered.

Female GIs who're deployed to "threat areas" must also take the shots, unless they're pregnant. According to the Army Times, one unpublished Navy study suggested that some pregnant sailors who received the shots may have suffered birth defects linked to the vaccine. Another unanswered question concerns females who may receive the vaccine while not realizing that they're pregnant.

On the legal front, at least three lawsuits have been filed opposing the military's mandatory vaccine program. The first one was filed against Bioport, the manufacturer, in October 2001 on behalf of two female GIs who were inoculuated. Army Sp/4 Sandra Larson died of aplastic anemia after completing the 18 month shot regimen. The second plaintiff, Chief Warrent Officer Ronda Wilson suffered such acute health problems after being inoculated that she was discharged as medically unfit two years later.

The second suit was filed by two leading Air Force "refuseniks" Majors Tom "Buzz" Rempfer and Russ Dingle who quit the Connecticut Air National Guard rather than take the vaccine. Their suit alleges that the FDA violated its own regulations when it licensed the vaccine for protection against inhaled anthrax.

Two other Air Force refusers, Major "Sonny" Bates and Captain John Buck, MD, have also filed a federal lawsuit in April 2002. Their complaint alleges that since the vaccine is an "experimental drug" the military must obtain "informed consent" from each GI before it can administer it.

So far, none of the lawsuits have succeeded in stopping the military's program nor in recovering any damages for injury or wrongful death.