A total of 600 children will be enrolled by Maryland and five other sites around the country to test the pediatric vaccine. For years, little medical research was done on children due to worries about what might happen to them. But this put them at a disadvantage, as doctors were left without guidance as to how much of a certain medication, for example, a sick child should receive.
Dr. Holly Taylor, who is on the faculty at the Johns Hopkins Berman Institute of Bioethics, said many factors have to be considered when determining whether something should be tested on children, but the risk to the child should be as small as possible, and there should be a benefit to the child and to children at-large.
"We're always more careful when we conduct research with children," she said. "We learned a long time ago that kids are not mini-adults and might have different kinds of responses" to medications or vaccines than adults.
On Tuesday, the National Institute of Allergy and Infectious Diseases said it had reviewed enough data from adult trials of the H1N1 vaccine that began two weeks ago to determine there were "no safety concerns in those trials that would preclude trials from proceeding in children."
The children being tested in Maryland will receive vaccines at three sites: pediatric practices in Annapolis, Frederick and at the University of Maryland, Baltimore. They will get either 15 or 30 micrograms per shot and two doses spaced three weeks apart. Older children will have their blood drawn over five separate visits. For their trouble, the children will receive $40 Target gift cards at each visit - not a small carrot, several said.
"The purpose of these tests, yes, are to assess whether there are any safety issues or reactions to these vaccinations," Chen said. "Our real scientific question is what are the best doses of vaccine to use for these vaccines because we have a limited supply and the government wants to know how to use this best come October."
Officials had planned to have 120 million doses available in October, but factory problems have cut that estimate to 45 million doses. Chen expects to start a trial next month that would add a substance called an adjuvant to the vaccine, which is designed to boost the effectiveness of the inoculation. That could mean smaller doses of vaccine would be needed for each person and more people could ultimately be vaccinated. But the adjuvant has not been approved for use in the United States as it has been in Europe and Chen worries it could be controversial.
