Anthrax vaccine tests in children not expected soon

WASHINGTONDon't look for testing of the anthrax vaccine to begin in children any time soon.

Controversy arose last year as experts debated whether such studies should be done to learn how to treat children in case of a bioterror attack.

But a presidential commission says the government would have to take multiple steps -- including more safety research in young adults -- before it would be ethical to consider tests in children.

"The safety of our children is paramount, and we have to get this precisely right," said Dr. Amy Gutmann, who chairs the Presidential Commission for the Study of Bioethical Issues, which released its report Tuesday.

More than a decade after the anthrax attacks, the government has a multibillion-dollar stockpile of drugs and vaccines to fight an array of threats. There's no information on whether those so-called countermeasures would work in children like they're expected to help their parents, or even what dose to use. Yet if a large attack were to occur, children undoubtedly would receive those untested products.

Worried about how to handle an emergency, a government advisory group recommended studying the anthrax vaccine in children if independent ethics experts agreed it could be done appropriately. The Obama administration put that question to the panel.

Tuesday's answer: Children don't gain any benefit from pre-attack research with the anthrax vaccine or other countermeasures. So the panel said such studies would be ethical only if they presented no more than minimal risk to participants -- like the risk from a routine medical check-up. Determining that would require, among other things, more testing in adults, the panel added. Something that proved safe in 18-year-olds, for example, might be a candidate to study next in 16- and 17-year-olds.

However, the government should plan now for how it would study children who receive those treatments in the event of an attack, the panel said.

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The Health and Human Services Department, which requested the advice, said it would review the findings.

John Parker, chair of the National Biodefense Science Board which first recommended a vaccine study in children, told Nature News that some studies might ease the minds of worried parents in the event of an emergency.

"In the chaos of an anthrax exposure, I just think a little knowledge up front may contribute to a decreased amount of parental concern and being put on the spot to consent to have a vaccine where there's no data," said Parker, who was speaking on behalf of himself and not for the science board.