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Oct. 18, 2006—“Hundreds of thousands of troops” will receive the newly resumed mandatory anthrax vaccination, William Winkenwerder, assistant secretary of defense for health affairs, told reporters Monday. At least 200,000 will receive the shot over the next 12 months, beginning within the next 30 to 60 days.

The military’s anthrax vaccination immunization program (AVIP) has been running in a voluntary status since an order by US District Court Judge Emmett Sullivan called a halt in 2004 to mandatory vaccinations. Sullivan maintained that the FDA had not ruled that the vaccine was effective against an airborne threat. In the view of the FDA, the court’s interpretation of the FDA ruling amounted to little more than a technical glitch. A year later, on Dec. 19, 2005, FDA issued a “final” final rule, declaring the vaccine effective against all manner of potential exposures.

Despite the enhanced FDA ruling, the Pentagon decided to continue AVIP on a voluntary basis. Winkenwerder said the delay in resuming mandatory shots was due to “follow-up legal issues,” namely meetings between litigants and the judge this past spring. He explained, too, that DOD then undertook a “full review of all our vaccination programs” and rolled in a look at “potential vaccination” for pandemic flu scenarios. After all that, he said the Pentagon leadership agreed it was time to “move forward” with the mandatory program once again.

Perhaps the chief reason for returning to the mandatory program is that only 50 percent of the military members in high threat areas have voluntarily taken the vaccine. “This rate of vaccination not only put the service members at risk but also jeopardized unit effectiveness and degraded our medical readiness,” said Winkenwerder.

He went on to say that he actually expected only a 50 percent return, because “nobody likes getting shots.” In his view, military members, unlike the general public, expect something to be mandatory if it is “truly important to the mission and if there truly is a threat.”

Since there is no widespread, heightened threat at this time, the Pentagon plans to resume vaccinated only those personnel in high-risk jobs or high-risk regions, specifically those deploying to Southwest Asia and the Korean peninsula.    

“There have been very public comments by terrorists about obtaining chemical and biological threats” and DOD believes those threats mostly exist in the areas they have designated for shots, Winkenwerder said. There are currently no plans to expand the mandatory program to all military personnel.

Other military personnel who already have received part of the six-shot vaccine regimen, he said, may continue with AVIP at their own discretion.
  
Is It Safe?
Questioned about the vaccine’s safety, Winkenwerder replied that AVIP had been reviewed by eight different independent groups and received FDA’s “exhaustive review.” As a result, the issue of safety is absolutely settled, he asserted, saying, “The vaccine is safe and effective.”

When pressed further for details about safety, he said “none” of the long-term anthrax vaccination studies, including those of some 700,000 discharged military members, has shown “any long-term medical consequence or deleterious effect of the vaccine.” The only risks associated with the medication are the mild side effects common to most vaccines. They include local swelling, pain, redness, inflammation, and, for a short period of time, flu-like symptoms.

However, Winkenwerder added, “There is no vaccine, there's no medical treatment, there is no drug for which there has never been a single significant side effect or event noted in not one person.”

What about the untold numbers of service members who refused to take the vaccine? Winkenwerder said that there might have been “significant numbers” of personnel who refused AVIP in 1998 and 1999, however in 2004, the last year it was mandatory, there were only 10 people out of 700,000 who separated from the military rather than be vaccinated.

When a person declines the shot, “our first approach is not to discipline people, but it is to remind them of the importance of the threat, of all the facts about the vaccine, and why it is being used,” Winkenwerder continued. He asserted that educating the service member almost always quells hesitations about the treatment.

Still Pentagon and FDA assurances haven’t stopped critics so far. In fact, Mark Zaid, lawyer for the six plaintiffs in the lawsuit that blocked DOD’s program in 2004, reportedly is ready to file a new lawsuit, one that would not rest on technicalities. He said Monday in response to the Pentagon plan to re-start vaccinations, “It is an unnecessary, unproven, and potentially unsafe vaccine.”


[For more background on the controversial Pentagon anthrax vaccination program, read Air Force Magazine’s December 2000 article “The Anthrax Issue.”]