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Syracuse hospital one of four sites worldwide testing Pfizer vaccine on young children

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Upstate Medical University in Syracuse is one of four sites in the world participating in a study to determine the safety and effectiveness of the Pfizer COVID-19 vaccine in children under the age of 12.

Upstate pediatrician Dr. Joseph Domachowske is leading the trial at the Syracuse hospital, which starts Monday with children between the ages of 2 and 5. He said the big question right now is dosage. Children will be given less of the vaccine than adults at first, to see how they react.

“We look at a very low dose the first week, monitor the side effect profile,” said Domachowske. “During the second week, as long as the side effect profile looks okay, we give them a little bit more. This is done sequentially, until we get to the adult dose, if they continue to tolerate the other doses.”

Domachowske said children currently receive adult vaccine doses for many infectious diseases.

“It won’t surprise me at all if we do end up with that decision. But we have to test it, because there is a possibility the adult dose would be reactogenic, too many side effects, if we start right away with that in younger kids,” he said.

Domachowske expects the FDA to fast track vaccines for those ages 12 and up sometime this summer.  But he expects it will take longer to get approval for younger children, because the placebo part of the trial for kids 11 and younger doesn’t begin until June.

“So it won’t be September or even October before there’s enough data in that age group for the FDA to be willing to look at see if it’s a possibility,” he said.

Domachowske says Moderna is also conducting trials regarding vaccination of children at about the same pace, but other vaccine developers are way behind as far as studying safety and efficacy of the vaccine among young children.