Global Security Newswire

The U.S. government is weighing whether to test its anthrax vaccine on children in order to gauge potential side affects of the treatment prior to a national crisis, the Washington Post reported on Monday (see GSN, Sept. 23).

The sole Food and Drug Administration-licensed vaccine for anthrax has only been tried on adults, meaning there is a lack of information regarding the product's effectiveness on minors, appropriate amounts to use, and any potential negative effects.

Last month, a specially convened National Biodefense Science Board working group advised the Obama administration not to wait until there is an anthrax outbreak to gather data on the health risks and effectiveness of the anthrax vaccine on children. That recommendation is opposed by some who view it as unwarranted and risky.

The National Biodefense Science Board is slated to decide on Friday whether to back the working group's advice.

"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?" asked the working group's chairman, Daniel Fagbuyi of the Children's National Medical Center in Washington, D.C. "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."

"A lot of things have happened that we didn't think could happen," said Fagbuyi, who teaches pediatrics and emergency medicine at the George Washington University School of Medicine. "I think the threat is real, and we should be prepared."

While children are known to contract diseases such as mumps and measles, they might never be exposed to anthrax through an act of terrorism or other means. Therefore, the risk-benefit analysis of administering the vaccine in a study to children is less clear.

"It's hard to believe that it's something that makes a great deal of sense," Northwestern University Feinberg School of Medicine bioethicist Joel Frader told the Post. "It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack."

The United States has allocated $1.1 billion for delivering anthrax vaccine to the Strategic National Stockpile. While antibiotics would be utilized to combat infections, the vaccine would be administered after an event to protect against any potential surviving spores that could re-emerge over a period of time.

Health and Human Services Assistant Secretary Nicole Lurie asked the working group to study the implications of conducting trial anthrax vaccinations in children.

"If there were an anthrax release and we needed to administer anthrax vaccine, we have no experience with kids," Lurie said. "I started asking myself, 'Is this the right way to respond in an emergency?'"

Lurie acknowledged "there is a lot of skepticism on the part of the public about vaccines in general."

"If you had a situation where a vaccine has never been given to a child, it's pretty hard to think what you could say to people about its safety and efficacy," she said.

Physician Meryl Nass, a vehement critic of trying the treatment on children, said there are significant questions about the vaccine's ability to confer immunity on adults and its potential to cause serious side effects. Approximately 2.6 million U.S. service members have received the anthrax vaccine, and some have reported significant negative health impacts, she said.

Fagbuyi and others disagree with raised worries over the safety of the vaccine. The National Academy of Sciences, the Food and Drug Administration and other organizations have determined that the health risks of BioThrax are similar to those of other frequently employed vaccines, and that major side effects do not occur often, according to proponents.

"Our role is to protect the children. If the military is telling us there is a credible threat, the best way to protect children is to have the data," said John Bradley of the American Academy of Pediatrics.

Should the National Biodefense Science Board give its backing to the working group's advice, Lurie will convene with officials from the National Institutes of Health, the Food and Drug Administration and other agencies to develop the specifics of the study. Those would include the number of minors involved, their ages and vaccine dosage levels.

"To be honest, the safest and easiest thing to do would be to not make a decision and kick the can down the road," Lurie said. "But it seemed to me that would be socially irresponsible. I would hate for a lot of children to die because we didn't have enough information for the public to feel comfortable getting [the] vaccine" (Rob Stein, Washington Post, Oct. 24).