The Department of Health and Human Services’ National Biodefense Science Board (NBSB) has given the US government its okay to initiate a trial of an anthrax vaccine in children.
NBSB approved the recommendation by a 12-1 vote on 28 October, after several months’ deliberation.
The board’s chairwoman, Patricia Quinlisk, who is the Iowa public health department’s medical director, opposed the recommendation.
The Department of Health and Human Services should develop a plan and conduct a pre-event paediatric study of Anthrax Vaccine Adsorbed (AVA)—the only human anthrax vaccine in the US licensed by the Food and Drug Administration—to include a research Investigational New Drug (IND) application, according to an October draft report by NBSB.
The board recommended that HHS submit such a study protocol to at least one national ethics review board before moving forward, and that it revisit the issue if new anthrax vaccines or other therapeutic countermeasures became available.
Meryl Nass, an internal medicine specialist who has studied anthrax vaccine injuries and bioterror issues, is concerned about safety issues. She says studies of military members who received the anthrax vaccine show that 1-2 per cent experience serious adverse events.
She also says that results from a Centers for Disease Control and Prevention trial of the anthrax vaccine from 2002 to 2007 have yet to be published, but presentations from investigators involved indicate that 7 per cent of the more than 1,000 subjects experienced a serious adverse event.
Nass, who is not an NBSB member but participated in the board’s 28 October telephone meeting, says Nicole Lurie, HHS’ Assistant Secretary for Preparedness and Response, appeared to back away from the issue, telling board members that it might be hard to find funding for such a study.
University of Minnesota’s Center for Infectious Disease Research and Policy quoted Lurie as saying at the 31 October meeting: “We’re not ready to make a decision at this time but will continue the dialogue.”