Experts call for study of anthrax vaccine's pediatric safety

A federal working group recently recommended that the U.S. government study the immunogenicity and safety of the anthrax vaccine for pediatric use.

The group, made up of members of the National Biodefense Safety Board, was tasked to explore the complex scientific, ethical, legal and regulatory issues associated with pediatric vaccination and presented their findings to the full NBSB committee for discussion, according to CIDRAP News.

Researchers have more experience with the effects of the anthrax vaccine in adults because it has been given to approximately 2.5 million members of the military. No studies have been conducted on children, who make up about 25 percent of the U.S. population. Federal biodefense plans call for children to receive the vaccine after an anthrax attack.

Currently, the anthrax vaccination is intended to protect against dormant spores that are capable of germinating after antibiotic prophylaxis is over, CIDRAP News reports. The vaccine has yet to be licensed for either children or adults for post-exposure prophylaxis.

If an anthrax attack were to occur, exposed adults could be given the vaccine under an emergency use authorization. Children could be given it only under an investigational new drug protocol, and with parent or guardian consent.

The working group recommended that the government make arrangements to test the vaccine in children before the advent of a bioterror attack, beginning with small groups of older children, according to CIDRAP News. They further suggested that if the protocol does not clear review boards, the government should test the vaccine on children during the response phase of an anthrax attack.