An important panel of government advisers Friday recommended that the government should 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.
According to the National Biodefense Science Board, which advises the federal government on issues related to bioterrorism, there was a 12-1 vote in favor of a recommendation to the Health and Human Services Department to go ahead with a study aimed at determining whether the vaccine is safe and effective in children and identifying the best dose.
Anthrax is a potentially fatal infection caused by toxin-producing bacteria. Anthrax is among several potential bioterror weapons and is of special interest because it was used in letters sent to the media and others in 2001. The attack eventually claimed the lives of 5 people and sickened nearly 20. The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. Infection in humans most often involves the skin, gastrointestinal tract, or lungs. Most people with anthrax are treated with antibiotics. Several antibiotics are effective, including penicillin, doxycycline, and ciprofloxacin. While antibiotics would help protect those immediately exposed, the vaccine would defend against lingering spores.
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.
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.
While an overwhelming majority of the panel endorsed conducting a study, several critics said 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 advocacy group.
The panel recommendation comes as doctors have questioned whether children’s immune systems respond to the shots well enough to signal protection. Children tested under the program would not be exposed to anthrax and the program could provide further insight into the deadly bacteria.
There is no deadline for the government to decide whether to go along. And if it does agree, it's not clear how much time it would take to find money for such research and get clearance from review boards at medical centers that would conduct studies. Another big question is whether parents would sign up their children to test a vaccine when there is no immediate threat. It's not possible to get anthrax from the vaccine, but there are side effects. In adults, shot-site soreness, muscle aches, fatigue and headache are the main ones, and rare but serious allergic reactions have been reported.
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