Testing of Anthrax Vaccine in Kids a No Go, Experts Say

MIAMI - NOVEMBER 03: Marina Spelzini, a registered nurse, measures out an H1N1 vaccine shot at the Miami Dade County Health Department downtown clinic on November 3, 2009 in Miami, Florida. Unlike other parts of the country which are experiencing long lines and shortages of the vaccine, South Florida is not having this problem. The Miami-Dade County Health Department received 195,000 doses of the vaccine but has only given out about 10,100. Broward County has 52,000 doses on hand and has administered about 10,000 doses. (Photo by Joe Raedle/Getty Images) (2009 Getty Images)

The anthrax vaccine won’t be tested on children any time soon.

After controversy arose last year when experts debated whether studies should be done to learn how to treat children in case of a bioterror attack, 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.

It has been more than a decade since the fear of anthrax attacks caused the government to begin to build up a multibillion-dollar stockpile of drugs and vaccines to fight an array of threats.

There's no information yet 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.

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Worry over how to handle such an emergency caused a government advisory group to recommend studying the anthrax vaccine in children but only if independent ethics experts agreed it could be done appropriately. The Obama administration put that question to the panel.

Their answer came Tuesday saying that children do not gain any benefit from pre-attack research with the anthrax vaccine or other countermeasures. 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.

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

Based on reporting by the Associated Press.

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