Following calls for a review, a federal panel announced over the weekend that an anthrax vaccination program should face testing on children.
The National Biodefense Science Board, which provides advice to the Department of Health and Human Services on preparations for chemical, biological and nuclear events, announced Friday that government officials should consider testing the vaccine on children, noting that officials should address a series of ethical issues before pursuing the program.
The move comes just months after the Obama administration called for a review of the proposed program, citing concerns with a recommendation to test the vaccine on children.
The board provides advice and guidelines to The Department of Health and Human Services on issues relating to preparations for chemical, biological and nuclear emergencies.
The U.S. government — which currently maintains a large collection of the vaccine and has tested it on adults and members of the military — is considering a test that would determine whether the vaccination could be effectively distributed in the event of a terrorist attack involving the deadly anthrax bacteria.
The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack and the antibiotics could serve to protect those immediately exposed, while the vaccine would defend against lingering spores.
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.
The panel issued the recommendation, saying the vaccine will be used on a large number of children in the event of a bioterrorist attack, and that it is prudent to test whether the vaccine is safe to be administered to the children. The vote was 12 to 1 in favor of moving forward with the vaccination program.
The recommendation comes as the board recommended earlier this year that the U.S. establish a vaccination program.
“The U.S. Government must do a better job of preparing for anticipated emergencies…. Some scenarios can be anticipated and it is incumbent upon the U.S. Government to plan for them,” the panel said at the time. “Such scenarios include the potential exposure of children to anthrax spores; therefore, the U.S. Government should undertake clinical trials to determine the appropriate pediatric dose of anthrax vaccine.”
The Anthrax vaccine has already been provided to nearly 2.5 million military members, and researchers say are familiar with the vaccine’s safety and immunogenicity profiles in adults. However, the vaccination has yet to be tested on children, raising concerns that the vaccine may not suffice in the event of an attack.
The tests have faced legal questions in the past. After lawsuits objecting to requiring the anthrax vaccine for military members, a federal judge suspended the program in 2004, finding fault in the Food and Drug Administration’s process for approving the drug. The FDA reaffirmed its finding that the vaccine was safe.
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 U.S. has since held large stocks of vaccination in the event of another widespread attack. The attack 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 is an infectious disease due to a type of bacteria called Bacillus anthracis. 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.
The White House did not issue a statement on the panel’s recommendation.
