A key working group of federal advisers in September endorsed testing, sparking objections from those who consider that step unethical, unnecessary and dangerous. The National Biodefense Science Board (NBSB), which advises the federal government, is to meet Friday to vote on its working group’s recommendation.
“At the end of the day, do we want to wait for an attack and give it to millions and millions of children and collect data at that time?” said Daniel B. Fagbuyiof Children’s National Medical Center in Washington, who chaired the group. “Or do we want to say: ‘How do we best protect our children?’ We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children.”
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. Unlike with measles, mumps and other diseases, the chance that children will be exposed to anthrax is theoretical, making the risk-benefit calculus of testing a vaccine on them much more questionable.
“It’s hard to believe that it’s something that makes a great deal of sense,” said Joel Frader, a pediatrician and bioethicist at Northwestern University’s Feinberg School of Medicine. “It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack.”
Anthrax is a life-threatening infection caused by a toxin-producing bacteria long considered a bioterrorist’s likely choice because it is relatively easy to produce and distribute over a large area. A week after the Sept. 11, 2001, attacks, letters containing anthrax spores arrived at several media offices and two Senate offices, killing five people and sickening 17 others. The FBI eventually concluded that the letters were mailed by Bruce Ivins, a disgruntled scientist at Fort Detrick in Maryland who committed suicide in 2008, although some experts question the FBI’s findings.
As part of broad effort to better protect Americans against bioterrorism, the Pentagon began a controversial military anthrax immunization program in 1998 that was challenged in court over questions about the vaccine’s safety and reliability. Currently, the Pentagon requires the shots 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 federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. Antibiotics would help protect those immediately exposed. The vaccine would defend against lingering spores, which is how the pathogen lurks in a dormant state. The vaccine is made from a piece of a strain of anthrax that doesn’t cause the illness.