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"Protecting the health and informed consent rights of children since 1982."

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BL Fisher Note:

This study will apparently try to "judge effectiveness" of the live nasal FLUMIST vaccine in schoolchildren, but is anyone tracking how many of the children who didn't get the FLUMIST vaccine come down with flu symptoms because they got vaccine strain flu from their recently vaccinated fellow classmates? This live virus vaccine can produce flu symptoms in the vaccinated as well as transmit live vaccine strain flu virus to others and be especially dangerous for those who are immune compromised. Hopefully, there were no immune compromised children in the classes that participated in this study.

http://www.sunspot.net

Carroll Co., Maryland school kids snort vaccine to prevent flu Needle-free inoculation seems favored; study will judge effectiveness

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By Jennifer McMenamin

Sun Staff

Originally published November 5, 2003

They flinched and coughed, fought back watery eyes and wiggled itchy noses.

But the children being vaccinated for the flu yesterday at Elmer Wolfe Elementary School agreed that all of that was worth it because of the one thing that was not in the room - a needle.

"It just felt a little weird in my nose," said Michael Schaeffer, 7, still wriggling his nostrils a few minutes after receiving the nasal spray vaccination. "But it felt good 'cause it was like I wasn't having a shot."

Michael was one of the first 14 children nationwide to be vaccinated at school for the flu with two little squirts to the nose.

He is part of a study conducted by the University of Maryland's School of Medicine that will compare absenteeism at Elmer Wolfe Elementary in Union Bridge during this winter's flu season with absences at two other Carroll County elementary schools where children have not received the nasal vaccination.

Researchers who administered the nasal spray to the first batch of children yesterday will return to the school several times over the next two months to finish the vaccinations.

The parents of about 130 Elmer Wolfe pupils have signed up to have their children vaccinated, and Dr. James C. King Jr., a professor of pediatrics at the University of Maryland and a pediatrician at the University of Maryland Medical Center, hopes to enroll at least another 70 in his study.

The needle-free nasal vaccine, called FluMist, was approved by Food and Drug Administration this year for healthy people between the ages of 5 and 49.

This is the first flu season the new immunization is available. Although children and adults can request FluMist from their doctors, Elmer Wolfe is the only school in the country where children are receiving the new vaccination.

Michael, a second-grader, said he was happy to participate in the study as long as it keeps him from becoming as sick as he did two years ago when he last caught the flu.

"It made me really sick," he said. "Sick enough to keep me away from school for a day."

That wasn't so much of a problem then, Michael said, because it was kindergarten, and he didn't like kindergarten much. But now he's a second-grader, and that changes everything.

"It's just a matter of the work," he explained. "I like that I can write a lot better, and that makes the work much easier for me, so I don't want to miss school now."

Asked what the nasal spray does, Michael said, "I understand that it will help my body make more antibodies for the winter and also help fight colds."

Others had a somewhat less firm grasp of how the immunization works.

"It may be some kind of poison thing, or it may be something that will work for us to stop the flu," said 7-year-old Connor Carr. "I'm not really sure."

Connor said he had not wanted to participate in the vaccination but that "my mom just threw me into it."

Looking on during her son's interview, Ann Carr laughed.

"That's not true," she told her son. "At first, you said you didn't want to do it. I said you could get a shot instead. I give choices."

Connor rolled his eyes.

Researchers chose Elmer Wolfe as their test school because parents there responded the most enthusiastically to surveys distributed during the last two school years to families at several elementary schools in Carroll and Howard counties.

Only children whose parents have granted permission for them to participate in the study are receiving the vaccinations at Elmer Wolfe.

The study covers the $46-per-vaccination cost of the nasal mist.

The research team - they call themselves the "Flu Crew" - recruited three Carroll County doctors to help them pinpoint when this year's influenza officially hits the area.

"We gave them flu kits to diagnose the flu ,and we'll call them every week," said King, the pediatrician conducting the study. "When it hits, we'll know."

After the official start of flu season is declared, researchers will distribute questionnaires to parents of the vaccinated children, as well as to pupils at Westminster's Cranberry Station Elementary and at Runnymede Elementary, located between Westminster and Taneytown.

Parents will be asked to document how many times they take their children to the doctor and how many missed school days and work days result from any winter illnesses.

Hoping to track the cost of contracting the flu, researchers also will ask parents to keep track of how much they spend on doctors visits, over-the-counter medications and prescription drugs.

Meanwhile, school administrators will track absences through a computer database at Elmer Wolfe and the two "control group" schools.

Elmer Wolfe Principal Mary Stong said that as many as half her 472 pupils are absent at any given time during flu season. Others come to school despite their runny noses and sore throats, infecting classmates, teachers and parents, Stong said.

"It can run right through our school," the principal said. "I'm really hoping this will make a difference and we can keep our kids healthy this year."

One by one, oftentimes with their mothers in tow, the youngsters received a quick squirt to each nostril, sniffed (to make sure the liquid didn't drip out of their nose) and drank a packaged fruit drink (meant to usher them quickly past the apparently bad smell of the nasal spray).

Waiting for them after the vaccination was a table of toys and sugary snacks.

Surveying the classroom-turned-clinic, Dr. Elizabeth Ruff, a physician with the Carroll County health department, noticed another distinct difference between yesterday's vaccinations and the hundreds she's witnessed.

"There's no screaming," she said. "I've never been in an immunization clinic where there's no screaming and no crying."

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