Children Should Not Be Exposed to Anthrax Vaccine for Research Purposes

The National Biodefense Science Board's advice to the Obama administration and U.S. Department of Health and Human Services (HHS) on Friday to test the anthrax vaccine on children should be rejected because such studies would be unethical and irresponsible, Public Citizen said in a letter sent today to the agencies. Public Citizen strongly opposes the proposed research.

Anthrax vaccine shots have never been tested on children, and there is no ethical justification for doing so now, the letter said. In particular, such experiments would provide no direct benefit to the children and would expose them to the known significant risks of harm related to the vaccine, such as severe allergic reactions and neurologic disorders.

Millions of taxpayer dollars currently are being spent to maintain a national stockpile of anthrax vaccine. Exaggerating the risk of an anthrax bioterrorism event for both adults and children may help justify such expenditures, but should not be used to justify unethical research in children, the letter said.

"Anthrax in the U.S. currently is not a serious health problem affecting the health or welfare of children, and the extremely remote chance of children being exposed to anthrax is not sufficient justification for testing the anthrax vaccine in children," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. "Particularly since there are antibiotics approved by the Food and Drug Administration (FDA) for use in children to treat post-exposure cutaneous or inhalation anthrax, including penicillin and doxycycline, the experimental testing of the anthrax vaccine on children is irresponsible and unnecessary."

Additionally, parents who are appropriately informed are unlikely to give permission for their children to be enrolled in experiments testing the anthrax vaccine, the letter said.

"It is highly unlikely that parents who are truly informed about the nature of the anthrax vaccine, the absence of benefits to the subjects and the highly unlikely possibility of anthrax exposure to children would give permission for their children to be in such research," Carome said."