Should the anthrax vaccine be tested in children? It will be a while longer before the government decides.
An advisory board said Friday that ethical issues need to be resolved -- but if that can be accomplished the vaccine can be tested in children to be sure it's safe and to learn the proper dose in case it's needed in a terrorist attack.
Because of concerns that terrorists might use the potentially deadly bacteria, the government has stockpiled the vaccine. It has been widely tested on adults but never on children.
The question is whether to do tests so doctors will know if children's immune systems respond to the shots well enough to signal protection. The children would not be exposed to anthrax.
The National Biodefense Science Board said Friday a separate review board should look into the ethical issues of doing such tests in children. If that is completed successfully, the panel, said, the Department of Health and Human Services should develop a plan for a study of the vaccine in children.
How to protect young people after an anthrax attack is a challenging issue, said Dr. Nicole Lurie, a member of the board and assistant secretary for preparedness and response at the Public Health Service. "Protecting children still stands, for me, among the most important responsibilities that we have as a nation."
The board gives advice to the Department of Health and Human Services on preparations for chemical, biological and nuclear events. Its vote was 12-1.
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.
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, claiming five lives and sickening 17. That prompted extensive screening of mail and better ventilation and testing at postal facilities and government agencies.
The FBI has blamed the attacks-by-mail on Bruce Ivins, a scientist at an Army biodefense laboratory, who committed suicide before he could be charged.
Anthrax can be difficult to treat, especially if someone has breathed anthrax spores. Millions of doses of antibiotics have been stockpiled since the 2001 episode, and two experimental toxin-clearing treatments also are being stored.
U.S. troops deploying to Iraq, Afghanistan and some other countries are required to get anthrax shots. Since 1998, more than 1 million have been vaccinated. After lawsuits objecting to the requirement, a federal judge suspended the program in 2004, finding fault in the Food and Drug Administration's process for approving the drug. The next year, the FDA reaffirmed its finding that the vaccine was safe.