An Advisory Board of the US Department of Health and Human Services this user afternoon urged the US government to launch a controversial trial of the vaccine against anthrax in children. The 12-1 vote supports a recommendation in September from a working group that spent about 3 months weighing the pros and cons of such a study and is in favor of it.
Today's recommendation by the National Biodefense Science Board (NBSB), is not binding, and even if a study goes ahead, it will have to jump through many hoops before that it can get up and running. Indeed, a trial like this is almost unprecedented in modern medical research: It is to give children a vaccine that is almost certain not to the benefits, and that could hurt them, all to protect other children from a scenario of a Large- scale anthrax attack unlikely.
However, "science is clear that we need to," said Daniel Fagbuyi, medical director of disaster preparedness and emergency management at the Children's National Medical Center in Washington, DC Fagbuyi chaired the Anthrax Vaccine NBSB working group with seven voting members, who are also part of the NBSB. The only dissenting vote was on Patricia Quinlisk, epidemiologist of the State and medical director of the Iowa Department of Public Health. Quinlisk chairs the NBSB and also served on the working group, but said without specifying that it could not support the recommendation.
The working group began to consider a trial of pediatric anthrax in the spring, at the request of the government. The concern was that the researchers tested other childhood vaccines in advance to ensure that they are both safe and effective, but the vaccine against anthrax has never been given to children . In a disaster, medical staff would be decisions on the fly, uncertain whether children would react like adults in the vaccine dose. For some vaccines, like tetanus, "the same dose administered to infants 2 months, and an NFL football player," said John Grabenstein, senior medical director for adult vaccines at Merck, who also sat on working group and voted in favor of the recommendation this afternoon. Other vaccines, such as hepatitis B and influenza, are determined differently in children.
"In my opinion, this decision is up to, would I rather the first exhibitions [in children] occur before exposure to mass or not, and I would like," said Grabenstein during a conference telephone this afternoon before the vote. "I prefer to know what the response to the vaccine is before offering it to many, many, many thousands of children."
In adults, studies have suggested that the vaccine against anthrax is quite safe;. it is made with inactivated proteins by bacteria of anthrax, a bit like vaccines that protect against diphtheria and tetanus in general, however, studies in children must meet a standard higher than the test for adults to protect children against the risks, particularly if treatment is unlikely to provide benefits. And this is some fear that the trial of anthrax proposed does not meet the ethical standards .
"I do not see how you can ethically do a study on a child where there is no chance the child has of this study," said Paul Offit, an infectious disease specialist at 'children's Hospital of Philadelphia in Pennsylvania, who often speaks for the vaccination of children. Offit attended one of the meetings of the working group and denounced a study. "I will prevail," he said.
Another big question is who would enroll their children in a clinical trial like this. Fagbuyi, who served in Iraq as a major in the US Army and received the vaccine against anthrax itself, said some military members, first responders and scientists working with anthrax many get the vaccine now expressed interest to vaccinate their children, too. They may be comfortable to them to volunteer for a study of anthrax, if it takes off.
0 Komentar