On one of his last days of summer vacation, Hunter Sears would have preferred to still be in bed at 10 a.m., or maybe just settling in for a few good hours of television.
So why, exactly, was the 13-year-old Anne Arundel County boy sitting in his Annapolis pediatrician's office yesterday, his orange T-shirt rolled up to his shoulder as a nurse first took blood from his arm and then gave him a shot he didn't need to get?
Hunter was pediatric volunteer No.1 of an expected 600 nationwide for an experimental vaccine against the H1N1 influenza virus, a new strain of flu that appeared in April and which officials fear will be widespread come fall. But before a mass vaccination can be rolled out - one that could involve hundreds of millions of inoculations - hundreds of adults and children have volunteered for clinical trials to test the vaccine's safety.
Officials with the University of Maryland, Baltimore, which is running the trials, strongly believe the vaccine is harmless.
"There really is no scientific rationale to believe it is going to be unsafe," said Dr. Wilbur Chen, a flu researcher at the at Maryland's Center for Vaccine Development, who was handling some of the trial paperwork yesterday. "The vaccine is being manufactured in exactly the same way as the seasonal flu vaccine," which is approved for children 6 months and older.
Still, the vaccine is considered experimental, not yet approved by the Food and Drug Administration and could have unknown risks; that's why it is being tested on a small group first.
While being on the cutting edge of something unproven might be frightening for some parents, especially when the trial starts with babies as young as 6 months old, many have lined up to put their kids' arms out to further science. Besides, some said, if there's a shortage of vaccine coupled with a severe swine flu outbreak, they won't have to worry. Their children will already be protected - and they won't have to miss school and sports.
"If it works, then we have a leg up," said Kate Houley, an Annapolis mother who signed up her three boys - ages 7, 10 and 11 - for the trial. "If it doesn't, it doesn't. And these guys don't really mind shots."
Researchers have only had difficulty recruiting one group of children: those ages 6 months to 3 years; about 20 are needed locally. Some parents might be more reluctant to give babies and toddlers an unproven vaccine, researchers said. And parents of such young children might already be overburdened with doctors' appointments, and unwilling to participate in a trial that would require an extra three (as well as taking the child's temperature daily).
