Test of anthrax vaccine in children gets tentative OK

A presidential ethics panel has opened the door to testing an anthrax vaccine on children as young as infants, bringing an angry response from critics who say the children would be guinea pigs in a study that would never help them and might harm them.

The report, however, released on Tuesday by the Presidential Commission for the Study of Bioethical Issues, said researchers would have to overcome numerous hurdles before launching an anthrax-vaccine trial in children. It now goes to Secretary of Health and Human Services Kathleen Sebelius, who will decide whether to take the steps the commission recommended.

The one anthrax vaccine approved in the United States, called BioThrax, is made by Emergent BioSolutions Inc of Rockville, Maryland. The company reported $215.9 million in sales of BioThrax, its only licensed product, in 2012.

The ethics commission took up the issue after a biodefense panel recommended in 2011 that the anthrax vaccine be tested in children. That endorsement, by the National Biodefense Science Board, came with the caveat that such a study also get the go-ahead from a bioethics panel.

It did, albeit conditionally.

"We have to get this precisely right," panel Chair Amy Gutmann, president of the University of Pennsylvania, said at a news conference. "Many significant steps would have to be taken" before a pediatric anthrax vaccine trial could be considered, she said. But she added that it is important "to develop the knowledge needed to save children's lives" in the event of an anthrax attack.

Balancing the need to protect children against the need to know, for instance, the safe dose of the vaccine, made this "one of the most difficult ethical reviews a bioethics board has ever conducted," Gutmann said.

Activists said the board was wrong not to oppose unequivocally testing the anthrax vaccine in children.

Vera Sharav, founder of the Alliance for Human Research Protection, predicted that such a study would cause "moral harm for us as a nation and suffering for the children. They should have said, 'thou shalt not.'"

'DARK ZEPHYR'

The idea of testing an anthrax vaccine in children arose when a 2011 war game, called Dark Zephyr, presented to policy makers a scenario in which terrorists released anthrax on a city modeled on San Francisco. Doctors did not know what dose of the vaccine to give children. That presented a dilemma: should children be vaccinated anyway, or should the government test the vaccine on them first to establish a safe dose?

Information about safety has come from giving the vaccine to some 2.9 million adults, mostly members of the armed forces who were thought to be at risk of exposure to biological weapons in Iraq. Information about efficacy has come from animal studies, as it is unethical to expose someone to anthrax intentionally to see if the vaccine works, and from measurements of the anthrax-fighting antibodies a vaccinated person produces.