Thursday, January 13, 2005

Feds move 3 ways to restart anthrax vaccine program

AF Times
January 17, 2005

Feds move 3 ways to restart anthrax vaccine program
One strategy has FDA meeting judge’s ruling

By Deborah Funk
Times staff writer

The government is using a three-pronged approach to try to reinstate the military’s anthrax vaccination program, which the Pentagon says is needed to protect service members who face a “heightened” risk of attack from the potential biological weapon.
In the latest move, the Food and Drug Administration is now seeking public comment on the information it relied upon to declare that anthrax vaccine was effective against all forms of the disease — something a federal judge in October said the FDA previously had failed to do.

The Dec. 29 notice published in the Federal Register gives the public 90 days to comment on the FDA’s proposed rule on the safety and efficacy of the vaccine as protection against anthrax.

The FDA proposes that the vaccine be indicated to protect against all forms of anthrax, to include both the skin form of the disease and also inhalation anthrax, the type defense officials say could be used as a weapon.

The FDA acknowledged in its notice that the current vaccine is not the same one used in human tests done more than 40 years ago. That vaccine was obtained from a researcher at Fort Detrick, Md., and its manufacturing process has changed several times since then, as has the manufacturer.

Even so, the FDA said it has reviewed the vaccine’s historical development and found that the Pentagon has had “continuous involvement with, and intimate knowledge of,” the formulation and manufacturing processes of the various versions of the vaccine over the years.

That, the FDA said, is enough to make a determination that the current vaccine is comparable to the original vaccine, a conclusion backed up by animal tests.

Chicago attorney John J. Michels Jr., who represents six anonymous service members and civilian defense employees who sued the government and shut down the Pentagon’s mandatory vaccination program, took issue with the FDA’s position.

Among other things, he questioned how the FDA could apply the human study results of the original vaccine to one that is now in its fourth version.

He also said the vaccine was not properly licensed in 1970 because the licensing agency at the time failed to account for the fact that the manufacturing process had changed since the human study was done. Also, the test results combined cases of skin and inhalation anthrax, even when there were too few inhalation cases to statistically prove whether the vaccine was effective against that form of the disease, Michels said.

The Defense Department also is forming two other lines of attack to try to reinstate its mandatory anthrax vaccine program.

On behalf of the Pentagon and the Department of Health and Human Services, the Justice Department is appealing the federal judge’s October decision that the anthrax vaccine was not licensed for inhalation anthrax, and therefore could not be forced on troops without their consent.

Outside the court system, Deputy Defense Secretary Paul Wolfowitz has asked the Health and Human Services secretary to allow the Pentagon to administer the vaccine under the “emergency use authority” of a law passed last year called Project BioShield.

The law says that, to the extent practicable, vaccines should be used under Project BioShield with the consent of those who are to be inoculated.

Defense officials have not said whether they plan to seek authority to make the anthrax vaccine mandatory for service members under their Project BioShield request.

In a written response to questions, defense officials said only that “specific details on program resumption are being discussed” with the Department of Health and Human Services.

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