careful. a new report examines the ethics of testing a vaccine against anthrax in children.
Bioethics Committee President Barack Obama said that the US government might consider testing the vaccine against anthrax in children, if certain conditions are met.
Whether and how to test treatments for biodefense in children is controversial because such studies place children at risk of, say, a new vaccine, when they are not likely to benefit directly from the research . Yet without these tests, medical staff do not know what dose to give children if a bioterrorist attack occurred. In fall 2011, the National Biodefense Science Board (NBSB), which advises the Department of Health and Human Services (HHS), has urged the government to launch against anthrax vaccine trial in children pending approval of ethics. HHS Secretary Kathleen Sebelius then asked the Presidential Commission for the Study of Bioethical Issues to take a look at that possible trials and broader issues. (The panel did not discuss a specific protocol.)
"It was one of the most difficult ethical reviews than any of bioethics commission has ever done," said the chairman of the commission, Amy Gutmann, president of the University of Pennsylvania. In a 146-page report released today, the Commission concludes that a vaccine trial against anthrax with children should take place if the risks are "minimal", comparable to a blood or pain around the site injection. So, consider such a test, researchers should first demonstrate with data from young adults (ages 18 to 20) that the risks are probably minimal for older teens. For example, researchers could examine young adult safety data which are among the more than 1 million US soldiers who received the vaccine against anthrax 4-decade-old, Gutmann said.
The vaccine could be tested in older children (say 16 to 17 years), then if security in increasingly younger age groups. The same principles should apply to other medical measures against trials in children, the report said.
"Many measures should be taken" for a vaccine trial against anthrax in children to be approved, Gutmann said. She added, however, that "it is not our intention to determine whether or not the government is moving forward."
A biodefense testing with children who applied more than minimal, but minor risk comparable to fever or chest x-ray, may also be possible in "extraordinary circumstances", but would require approval by a national ethics panel, as required by existing rules, the commission concluded. for guide such ethical evaluation, the report sets out a "framework". ethics for example, it asks if the study is a "serious problem", defined by the threat of exposure and the possible consequences. the report also said the United States should have in place research plans if it intends to launch a study in children following a bioterrorist attack.
the age-escalation approach is often used in testing of vaccines pediatric but "was not discussed" for the vaccine against anthrax, said a member of the Committee Christine Grady, head of bioethics at the National Institutes of Health Clinical Center in Bethesda, Maryland. She and Gutmann said the vaccine against anthrax is considered to present a minimal risk in adults; it is made of an inactive protein from anthrax, which makes it comparable to some childhood vaccines. But NBSB assumed that there was more than a minor risk in children because it considered the ages of 0-17 as a group and does not have data to show otherwise, Gutmann said.
The opinion of the panel that the vaccine against anthrax tested in increasingly younger age groups "is not surprising," said the researcher in infectious diseases Paul Offit of the Children's Hospital Philadelphia, Pennsylvania, is a proponent of vaccinating children, but opposes a vaccine trial against pediatric anthrax. He said that the report does not change its views because children "have essentially no chance of benefit. " He said the only exception might be if military families wanted their children in a trial because they thought they might be at risk of exposure to anthrax. "It would be reasonable," says Offit.
The Report of the Bioethics Committee notes that military families have been mentioned as a possible group to test the vaccine, but warned that these families should not feel pressured into volunteering their children for such a study.
0 Komentar