Oct 28, 2011 (CIDRAP News) – An expert advisory panel today approved a recommendation that the US Department of Health and Human Services (HHS) develop a plan to study the use of anthrax vaccine in children before an attack with Bacillus anthracis.
A National Biodefense Science Board (NBSB) working group presented a draft of its final report to the full board today during a public teleconference. It weighed the pros and cons of gathering safety and immunogenicity data about the anthrax vaccine either before or after an attack.
The NBSB working group advises the federal government on biodefense countermeasure issues.
Before the vote, board members had the opportunity to voice their support or concerns. Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta, said she agreed that data are needed before a bioterror event, but noted that the science arguments collide with ethical issues.
Though she said the working group was sensitive to ethical issues, she proposed that the group’s recommendation be forwarded to an appropriate group for additional ethical consideration. The board tweaked its recommendation to include Berkelman’s suggestion.
John Grabenstein, RPh, PhD, senior medical director for adult vaccines at Merck, said he has served on ethics review boards for about 20 years. “Kids are recognized as a vulnerable population, and there are special requirements to protect them,” he said. “I’d rather know what the response is before the vaccine is offered to many, may kids.”
The report’s recommendations support the writing of a good protocol that would give parents a lot of information and plenty of time to consider all the aspects of a pre-event study, he added.
In April Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response (ASPR) at HHS, asked the NBSB’s anthrax working group to explore complex scientific, ethical, legal, and regulatory issues related to pediatric anthrax vaccination. The group held a public engagement meeting in July, and in September presented the report’s executive summary to the full board and fielded comments from the public.
Anthrax vaccine adsorbed (AVA) has been used in about 2.5 million military members, so researchers are more familiar with the vaccine’s safety and immunogenicity profiles in adults. Though US bioterror response plans say both adults and children should receive three doses of the vaccine with antibiotic prophylaxis after an anthrax attack, no studies have been conducted in children, which make up about a quarter of the US population.
During the public comment part of the meeting, members of the public strongly opposed the NBSB’s recommendation, while others spoke in favor of it. Vera Sharav, with the Alliance for Human Research Protection, told the group that there is no evidence that anthrax is a threat that affects US children, and she accused the board of making the decision to protect vaccine company profit margins.
Meryl Nass, MD, an internist who has studied anthrax vaccine injuries and bioterror issues, said she believes the US public is almost unanimously against pursuing anthrax vaccine studies in children in advance of a bioterror attack. “But the people inside the beltway see things differently,” she added.
However, Steve Krug, MD, a pediatrician and emergency physician in Chicago, said he took part in the NBSB’s public engagement session in July. “The ethical issues are very pertinent, but I support the recommendations of this working group,” he said.
The report and recommendation passed by a 12 to 1 vote. Patricia Quinlisk, MD, MPH, the board’s chair, opposed sending the recommendation to HHS. “My background has influenced how I feel. I don’t know if a pre-event option is the appropriate response,” she said during the comment period before the vote. Quinlisk, a microbiologist and epidemiologist, is medical director for the Iowa Department of Public Health and has served on a host of vaccine safety and bioterror advisory groups.
After the vote, Lurie said she wanted to make sure the public knows that the NBSB is an advisory body and that its recommendations are not binding. She said the issue of studying the anthrax vaccine in children is very complex, and she predicted that dose-sparing studies being conducted in adults will have affect AVA issues related to children.
“We’re not ready to make a decision at this time but will continue the dialogue,” Lurie said.