[NVIC] Pentagon Won't Stop Forcing Anthrax Vaccine

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National Vaccine Information Center Newsletter

e-NEWS

October 17, 2006

:: Mandatory Anthrax Shots to Return

:: Pentagon to resume forced anthrax vaccine program

" But as recently as this spring, the Government Accountability Office, the

investigative arm of Congress, said questions remain about the vaccine.

" The long term safety of the licensed vaccine has not been studied, " the

agency said in a May 9 report. " . . . Also, there is some evidence that the

current anthrax vaccine may have diminished efficacy against certain

virulent strains of anthrax. " Barbara Loe Fisher, president of the National

Vaccine Information Center, said her nonprofit advocacy group is adding

more information to its Web site about the research and development of

biological defense vaccines. " The DOD has a moral duty to fully disclose

anthrax vaccine risks, as well as benefits, to soldiers and allow them to

make an informed, voluntary decision, " she said in a statement " -

Lee, Washington Post

" The forthcoming mandatory program is just as senseless as before and the

FDA's new determination remains legally and scientifically flawed, " said

Mark Zaid, one of the attorneys. Winkenwerder, who has not taken the

anthrax vaccine, said the FDA's final order settles legal questions and the

Pentagon is prepared for a court challenge......Under the voluntary

program, only 50 percent of troops offered the shot accepted

it.Winkenwerder said those numbers were too low and left U.S. forces

unprepared for bioterrorist attacks. He said service members expect a shot

to be mandatory if it is important. " - , Reuters

Barbara Loe Fisher Commentary:

The attorneys, who have represented U.S. soldiers forced to take the

experimental anthrax vaccine without their voluntary informed consent, are

going to continue to battle the Pentagon's immoral policy in federal court.

And the National Vaccine Information Center, which yesterday launched the

Military and Biodefense Vaccine Project (www.military-

biodefensevaccines.org) to better inform the public about military and

biodefense vaccines which can be forced on both military and civilian

populations, will continue our 25-year effort to defend the human right to

voluntary, informed consent to vaccination or any other medical intervention.

Mandatory Anthrax Shots to Return

The Washington Post

Tuesday, October 17, 2006; A03

By Lee

Washington Post Staff Writer

Click here for the URL: (registration required)

The Defense Department will resume mandatory anthrax vaccinations for more

than 200,000 troops and defense contractors within 60 days, a Pentagon

official said yesterday, rejecting the concerns of some veterans and

service members who say that the vaccine has not been proved safe or

effective.

The vaccinations will be required for most military units and civilian

contractors assigned to homeland bioterrorism defense or deployed in Iraq,

Afghanistan or South Korea, said Winkenwerder Jr., a physician and

the assistant secretary of defense for health affairs. As troops rotate in

and out of those regions, the number receiving vaccinations will grow

considerably, he said.

A lawsuit filed by six former or current service members had blocked the

mandatory vaccinations since October 2004, when U.S. District Judge Emmet

G. Sullivan ruled that the Food and Drug Administration had erred in

approving the vaccine in 2003 without seeking public comment and conducting

a full review.

But the FDA then held a 90-day comment period to overcome that hurdle and

granted the vaccine final approval last December, clearing a legal path for

the Pentagon to resume the controversial program.

" The FDA went out again . . . and came to the very unambiguous and clear

conclusion that the vaccine was safe and it was effective against all forms

of exposure, " Winkenwerder said. " In our view, that has definitively

settled the question. "

But Mark Zaid, an attorney for the six plaintiffs, said yesterday that

Sullivan's ruling and the Pentagon's remedy both turned on procedural

technicalities. The plaintiffs plan to file a new lawsuit challenging the

government's contention that human studies from the 1950s and more recent

studies in animals demonstrated the safety and efficacy of the vaccine.

" It is an unnecessary, unproven and potentially unsafe vaccine, " Zaid said.

" Everyone is concerned as to their health, and the fact is that there is no

scientific evidence that the vaccine works in humans. . . . I think this

program is nothing more than a glorified public relations campaign to

demonstrate that they are doing something. "

Anthrax is a deadly infectious disease caused by the spore-forming

bacterium Bacillus anthracis . A month after the Sept. 11, 2001, attacks,

letters tainted with anthrax infected people in Connecticut, Florida, New

Jersey, New York and the District. The unsolved attacks killed five people,

sickened 17 and caused about 10,000 to be put on antibiotics.

Although the previous anthrax attacks occurred on U.S. soil, Winkenwerder

said troops overseas are believed to be a higher risk, and military

personnel in the United States do not have to receive the six shots.

" I have not been vaccinated because I'm not in any of the targeted groups, "

Winkenwerder said. " If I was, I would receive the vaccine without hesitation. "

The Clinton administration began the mandatory vaccinations in 1997. Over

the next few years, hundreds of active-duty service members refused to take

the vaccine, and more than 100 were court- martialed as a result.

Winkenwerder said that 27 people refused the vaccine and left the military

in 2003, and that 10 did so in 2004. A voluntary vaccination program that

Sullivan allowed last year saw participation rates of 50 percent,

Winkenwerder said. In all, more than 1.2 million military and civilian

personnel have received the vaccine.

Some who received vaccinations for anthrax and smallpox around the time of

the 2003 invasion of Iraq have complained of fatigue, migraines, pain and

diseases such as multiple sclerosis.

Winkenwerder said that, as with any vaccine, some who receive the shots

develop adverse reactions, but that there is no evidence to indicate a

particular problem with the anthrax vaccine.

But as recently as this spring, the Government Accountability Office, the

investigative arm of Congress, said questions remain about the vaccine.

" The long term safety of the licensed vaccine has not been studied, " the

agency said in a May 9 report. " . . . Also, there is some evidence that the

current anthrax vaccine may have diminished efficacy against certain

virulent strains of anthrax. "

Barbara Loe Fisher, president of the National Vaccine Information Center,

said her nonprofit advocacy group is adding more information to its Web

site about the research and development of biological defense vaccines.

" The DOD has a moral duty to fully disclose anthrax vaccine risks, as well

as benefits, to soldiers and allow them to make an informed, voluntary

decision, " she said in a statement.

Pentagon to resume forced anthrax vaccine program

Reuters

Mon Oct 16, 2006 4:43pm ET

By

Click here for the URL:

WASHINGTON (Reuters) - The Pentagon on Monday said it will force troops in

Iraq, Afghanistan and South Korea to be vaccinated against anthrax,

restarting a court-halted program after U.S. regulators declared the shots

safe and effective.

But Winkenwerder, assistant secretary of defense for health

affairs, said the Pentagon has no plans to vaccinate troops serving

elsewhere, including those in the United States -- site of the only major

anthrax attack against Americans, which killed five people in 2001.

" There are terrorists operating in and around Iraq and in that part of the

world, " Winkenwerder said. " That's a higher threat area. "

The move to reopen the mandatory vaccination program follows a final order

from the U.S. Food and Drug Administration in 2005 that found the anthrax

vaccine safe and effective in preventing anthrax disease.

But attorneys whose lawsuit previously shut down the mandatory anthrax

vaccination program said they plan to file a new suit to challenge its

resumption.

" The forthcoming mandatory program is just as senseless as before and the

FDA's new determination remains legally and scientifically flawed, " said

Mark Zaid, one of the attorneys.

Winkenwerder, who has not taken the anthrax vaccine, said the FDA's final

order settles legal questions and the Pentagon is prepared for a court

challenge.

Anthrax spores can be used in germ warfare to give victims the deadly

bacterial disease. The Pentagon argues the shots are needed to protect

troops against bioterrorism.

A federal district court in 2005 allowed the Pentagon to give some troops

the vaccinations on a voluntary basis after ordering a halt to the

mandatory shots the year before.

The court's action came after a lawsuit filed by six unnamed military

personnel and civilian workers who objected to the vaccinations. Some

troops had refused to get the mandatory shots due to worries about side

effects, and some had been thrown out of the military.

Under the voluntary program, only 50 percent of troops offered the shot

accepted it.

Winkenwerder said those numbers were too low and left U.S. forces

unprepared for bioterrorist attacks. He said service members expect a shot

to be mandatory if it is important.

More than 1.4 million service members have been vaccinated since 1998,

according to the Defense Department.

Winkenwerder could not say how many troops would be vaccinated under the

mandatory program, which should start in 30 to 60 days. Troop levels total

143,000 in Iraq, 21,000 in Afghanistan and 28,000 in South Korea.

NVIC E-News is a free service of the National Vaccine Information Center

and is supported through membership donations.

NVIC is funded through the financial support of its members and does not

receive any government subsidies. Barbara Loe Fisher, President and Co-

founder.

Learn more about vaccines, diseases and how to protect your informed

consent rights at www.nvic.org

NVIC

NVIC

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