“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 L. 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 on whether to conduct the study.
“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.
critics today saidthe study 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 bacterium. 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 anthrax 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 does not 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.
In April, Lurie asked the board to evaluate whether the vaccine should be tested in children. A federal simulation of an anthrax attack on San Francisco, called Dark Zephyr, raised questions about how to handle children. Those concerns were heightened by the public wariness that had been shown toward the H1N1 influenza pandemic vaccine.
Testing drugs and vaccines in children is problematic. Parents generally are allowed to let their children participate in studies only if they would face minimal risk or would be likely to benefit directly or indirectly in some way.
Some question whether conducting such a study is ethical, given that the risk is theoretical. While the Pentagon and others maintain that the vaccine is safe, critics say it has been linked to serious complications.
After sifting through the scientific, social and ethical conundrums raised by this question, an eight-member working group concluded that it would be ethically justifiable to conduct a study, which would provide crucial information, such as whether the vaccine is safe and how many doses would be needed. Military personnel, or perhaps workers exposed to hides — the natural mode of exposure — might be the most interested in having their children participate, said Daniel B. Fagbuyi of the Children’s National Medical Center, who chaired the working group.