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Pediatricians ponder anthrax vaccine tests

Knight Ridder Newspapers

WASHINGTON - The government’s effort to develop a new vaccine against anthrax has raised red flags among critics over plans to eventually test an experimental version on children.


Robert Bock, a spokesman for the National Institute of Child Health and Human Development, said the new anthrax vaccine would not be tested on 100 first- and second-graders until it is first tested safely on adults. That is under way now, he said.

"If that study is successful, there will probably be a protocol to test the anthrax vaccine in children," Bock said.

While federal rules govern how children can be used in medical research, Barbara Loe Fisher, president of the National Vaccine Information Center, said the threat of anthrax exposure was too remote to subject children to a possibly dangerous substance.

"There is almost no risk to these children of being exposed to a form of ... anthrax that has been weaponized" so it can be inhaled, said Fisher, whose not-for-profit group has been pushing for vaccine safety since the 1980s.

"The benefits are zero, and risk is quite high," she said.

Several pediatricians involved in bioterrorism issues, however, said that given the potential threat, it would be irresponsible not to include children in the test.

"Considering that in a worst-case scenario, this vaccine would have to be used in an emergency over a very short period of time, we would be in a bad position medically and ethically if it were not tested beforehand," said Stanley Plotkin, emeritus professor of pediatrics at the University of Pennsylvania.

Plotkin was a consultant on a 2002 study that declared the current anthrax vaccine to be "effective" and "acceptably safe."

But government researchers at the National Institutes of Health now are trying to find a better vaccine.

There are concerns the current vaccine, which has been in use for several decades, causes too many side effects. They range from simple headaches and muscle pains to more serious and complex ailments such as heart problems, arthritis, multiple sclerosis, hypertension, diabetes and blood clots.

The current vaccine is given in a series of six doses over 18 months, with annual boosters. More than 1.3 million military and civilian personnel have taken it.

Made by the BioPort Corp. of Lansing, Mich., the vaccine has been approved only for anthrax exposure through the skin, not through inhalation, the way it would be disseminated on a battlefield or in a public place.

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