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July 25, 2005
AF Times
Troops divided on getting voluntary vaccine shots

By Deborah Funk
Times staff writer

 About half of the service members and civilian workers offered anthrax vaccinations under the Pentagon’s temporary, voluntary program are accepting the shots — and the other half are saying, “No, thanks.”

“We wish it was higher, because that’s about 50 percent [who are] vulnerable,” said Army Col. John Grabenstein, director of the Military Vaccine Agency.

Roughly 20,000 military members have been offered the vaccine since the government launched its voluntary program May 19. Of those, about half accepted vaccination.

Some people already have been vaccinated more than once under the voluntary program, Grabenstein said. The anthrax vaccine license requires six shots over 18 months, with the first three administered two weeks apart. Annual booster shots also are given.

To avoid identifying areas of vulnerability, defense officials would not provide data by service, occupation or other breakdowns on who is accepting or declining vaccination.

Grabenstein said troops who received shots under the mandatory program are more likely to volunteer under this program so they can continue the vaccination series. Conversely, people who never were vaccinated against anthrax are more likely to decline the shots.

The participation level may reflect the rare opportunity service members have to make choices while in the military, and some may decline the shot “just for the taste of liberty,” Grabenstein said.

(Randi Note: Page 14 of the report, September 2002: http://www.gao.gov/new.items/d02445.pdf

(Overall, a large majority of the respondents—77 percent—indicated that they would not or probably would not have taken the anthrax vaccine shots if AVIP were a voluntary program).

Some may decline it because they dislike the idea of getting the shots or have no experience with the anthrax vaccine, he said.

The government launched its voluntary program after six service members and civilian employees successfully sued the government to stop the mandatory program that began in 1998. A federal judge ruled that the vaccine was not properly licensed to protect against the inhalation anthrax and, therefore, the government could not force service members to take the shots for that purpose.

Justice Department lawyers who represent the government have appealed the judge’s ruling. The plaintiffs have until the end of July to file a response to the appeal.

Meanwhile, the voluntary program is permitted under an “emergency use authority” that allows wide-scale use of drugs that are not licensed or are licensed for a purpose other than their intended use.

In this case, anthrax vaccine is licensed to protect against the form of the disease that infects the skin, not the inhalation form. The emergency use authority granted by the Food and Drug Administration requires the Pentagon to allow service members to decline the shots without fear of career, administrative or legal risk.

Grabenstein said there have been “zero” punishments for service members who have not volunteered for the new program.

Mark Zaid, a Washington attorney who represents the six plaintiffs in the lawsuit, said he believes even more people would decline the shots if military members did not have a strong mentality to follow orders.

“When it was mandatory, it was a loyalty program by the senior leadership for no one to challenge the implementation,” Zaid said. “As a voluntary program, it still remains a loyalty program for those who may be recipients. I have little doubt that many people are taking it on faith that ‘if the leadership said it is good, that’s what I’m going with.’”

Zaid said he suspects defense officials have downplayed information that contradicts their position that the vaccine is safe and effective.

Troops who will be in South Korea or in the Central Command area of operations — mainly Southwest and Central Asia — for at least 15 consecutive days are offered the shots. Under the old program, if they refused, they had no choice without risking legal or administrative action.

Meanwhile, the FDA is reviewing public comment it has solicited on the vaccine’s license. The agency’s previous failure to do that was the omission upon which the federal judge based his decision to shut down the mandatory program.

The FDA has said the vaccine is safe and protects against inhalation anthrax, and wants to license it as such.

Defense officials will “revisit the question” of whether to resume the mandatory program after the FDA issues its final ruling on the vaccine’s license, Grabenstein said.