WASHINGTON– A key panel of government advisers Friday recommended that the federal government sponsor a controversial study to test the anthrax vaccine in children to see whether the inoculation would protect young Americans against a bioterrorist’s attack.
The National Biodefense Science Board, which advises the federal government on issues related to bioterrorism, voted 12-1 to recommend that the Health and Human Services Department move forward with a study aimed at determining whether the vaccine is safe and effective in children and identifying the best dose. Patricia Quinlisk of the Iowa Department of Public Health, who chairs the panel, was the only dissenter.
“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack,” said Ruth Berkelman of Emory University, a panel member.
The panel adopted Berkelman’s suggestion that the study undergo further review by another panel to specifically examine the difficult ethical concerns it would raise.
Nicole Lurie, the assistant HHS secretary for preparedness and response who requested the panel’s review, said officials would consider the panel’s recommendation, but she did not give a time-frame for a decision.
“We’re not ready to make a decision at this time,” Lurie said at the conclusion of a one-hour telephone meeting, which included input from the public.
While an overwhelming majority of the panel endorsed conducting a study, several critics said Friday that such tests would be unethical, unnecessary and dangerous.
“The trial would expose healthy children to substantial harm with no possibility of benefit,” said Vera Sharav of the Alliance for Human Research Protection, a New York-based advocacy group.
Anthrax is a life-threatening infection caused by a toxin-producing bacteria. It has been long considered a bioterrorist’s likely choice because it is relatively easy to produce and distribute over a large area and can contaminate areas for long periods with dormant spores.
The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. While antibiotics would help protect those immediately exposed, the vaccine would defend against lingering spores. The vaccine is made from a piece of a strain of anthrax that doesn’t cause the illness.
In 1998, the Pentagon began a controversial immunization program for military personnel that was challenged in court over questions about the vaccine’s safety and reliability. Currently, shots are required for personnel assigned to bioterrorism defense activities and some other special units, as well as those deployed 15 or more days in the Middle East and some nearby countries, and in South Korea.
The vaccine has been tested extensively in adults and has been administered to more than 2.6 million people in the military. But the shots have never been tested on or given to children, leaving it uncertain how well the vaccine works in younger people and at what dose, and whether it is safe.
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