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CDC Rushed Paperwork For Anthrax Vaccinations
Contaminated vaccine from a contaminated lab - yeah, good idea

Source for this article:

CDC Rushed Paperwork For Anthrax Vaccinations
48 Congressional Aides Received Inoculations

By Shankar Vedantam and Mary Pat Flaherty
Washington Post Staff Writers
Saturday, December 22, 2001; Page A10

Just hours before 48 congressional staffers received the anthrax vaccine Thursday, officials at the Centers for Disease Control and Prevention had yet to finish the paperwork that would lay out the risks and benefits of the shots.

The late-night session Wednesday to finalize consent forms for the inoculations exemplifies the pressure federal officials faced as they tried to implement their unprecedented vaccination plan this week.

With Hill staffers about to leave for the holidays, CDC officials raced to get needed approvals that would enable them to offer the vaccine to anyone who requested it. A CDC board responsible for reviewing patient protections in research wrapped up its work on the vaccine proposal between 9 and 10 p.m. Wednesday, by CDC accounts. By the start of Thursday's workday at 10 a.m., four dozen Hill staffers who had been exposed to anthrax were receiving the first of three shots they will get over the next month in the vaccination program.

The groundwork for the anthrax inoculation program had been laid in October, when the CDC submitted an application to the Food and Drug Administration. It proposed providing vaccine and extra doses of antibiotics to people known to have been exposed to anthrax spores.

The CDC needed FDA clearance because its proposed use of the vaccine and extended use of antibiotics were new and had not received a formal government review. In addition, the vaccine's maker, BioPort Corp., has yet to receive FDA approval for its manufacturing facility.

Between Oct. 5 and this week, the CDC amended its plan four times, including significant changes to the consent forms. In its Oct. 5 filing, the CDC endorsed the vaccine in its consent form, saying it "can prevent anthrax disease" and, used with antibiotics, "could save your life."

The final versions of the forms released Thursday are much more constrained. They state that the Department of Health and Humans Services is not "making a recommendation whether you should or should not take this vaccine" and that "you should not consider the vaccine as treatment for anthrax."

The original request seeking FDA approval was made when federal health officials were worried about an influx of new cases, CDC Director Jeffrey P. Koplan said, adding that having the application pending positioned the agency to move more quickly as events evolved.

Offering the vaccine to those already exposed "wasn't an option that sprang to mind then," Koplan said.

FDA regulations require the agency to review applications for investigational uses of new drugs within 30 days, which helps explain the seeming haste in the plan, Mary Pendergast, a former deputy at the FDA, said. And it is not uncommon for the FDA and the sponsor of a proposed drug test to have back-and-forth discussions about how to bring a proposal into compliance with FDA rules.

But she also noted that federal agencies "appear to have given themselves a deadline of making the vaccine available before Congress went out for the session so that put them up against the clock."

As part of its FDA application, the CDC was required to estimate how many people would be eligible for the vaccine and how it would be administered. The application also had to present a proposed informed consent sheet that subjects in the vaccine program would receive.

The first version of the plan estimated between 100 and 5,000 people could be eligible, while acknowledging an unforeseen scenario could drive the number higher. The final version estimates between 100 and 10,000 people could be eligible, barring an unforeseen event.

CDC officials say that the speed with which the proposal was developed and approved reflected the fluidity of the crisis.

"Some of these individuals may have been more highly exposed than what we once thought -- that's where the urgency comes from," CDC spokesman Tom Skinner said. Scientists, he said, are also theorizing that small numbers of spores might persist in some individuals who have been heavily exposed and could burst into a lethal infection once a 60-day course of antibiotics -- as exposed workers already have been offered -- was completed.

Skinner said that CDC's most recent amendment to the application followed the release of results from a Canadian experiment, in which a test subject sat in a room about the size of a single-car garage and slit open an envelope filled with nontoxic bacteria and lay the open envelope down on a table. Sensors and tests evaluated how many of the spores from the bacteria were released into the air and how many got in the volunteer's body.

Greg Martin, an infectious diseases expert at the National Naval Medical Center who has been helping treat Senate staffers who had been exposed to anthrax, said that the Canadian results caused researchers to recommend the vaccinations.

© 2001 The Washington Post Company

Sheri Nakken, R.N., MA 
Vaccination Information & Choice Network, Nevada City CA & Wales UK
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