The chairman of the National Biodefense Science Board said today while his panel voted in favor of testing children with an anthrax vaccine prior to any anthrax threat, it also wanted a second opinion: an ethical review of doing the test.
“We wrestled with giving a vaccine to children (that was) untested,” said John S. Parker, M.D., Major General (Retired), and chair of the board. “We wanted to reduce the unknown risk to children in a pre-event, scientifically controlled situation.”
Parker told the Presidential Commission for the Study of Bioethical Issues that “respectable members of the public do not believe in the threat (and) do not believe that vaccines are effective … but it’s clear to me that the facts speak louder. If there is an anthrax release, … we must strive to have the same degree of surety of the vaccine’s safety in children as it is in adults.”
The anthrax vaccine is known to be safe in adults. More than 10 million doses have been given to 1.2 million people – most of them in the U.S. military – with no major side effects. But there have been no studies on whether the vaccine is safe with children.
Parker said tests are needed to answer that question. “If we are as a nation exposed to a weapon of mass destruction, (that) will include children,” he said, adding that in one doomsday modeling of an attack, “7.2 million people were exposed to anthrax spores and 25 percent of those were children.”
Bioethics Commission Chair Amy Gutmann, President of the University of Pennsylvania, asked Parker: “Your board strongly supported having safety trials for a children’s vaccine, correct?”
Parker said one member dissented, resulting in a 12-1 vote. “This wasn’t easy,” he said. “Up until this particular task, we always had unanimous votes.”
Gutmann also asked Parker whether the trial with children for an anthrax vaccine would seek volunteers of parents who wanted their children to participate.
“We have talked with first responders, with families in the Special Forces, there are groups out there that would want their families protected as much as they are protected,” Parker said. “ … That doesn’t say that these people have any obligations that they would be first-comers to be volunteers. But there are numbers in our population that would like their family involved.”
Parker said that he also favored testing children prior to any attack with the anthrax vaccine because many adults had significant soreness after receiving the shots.
“With anthrax, the injection goes from local redness and tenderness to severe redness and tenderness, malaise, and a few people have had fever. A lot more people have complained about anthrax injection than the flu shot.”
He continued: “I was immunized and although I didn’t return to a doctor to say it hurt, but it hurt. I had reaction. And I knew why. I don’t know how a child at age two will react to that.”