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MILWAUKEE - The U.S. Food and Drug Administration's advisory panel of experts endorsed the Pfizer-BioNTech COVID-19 vaccine for emergency use in elementary school-aged kids on Tuesday, Oct. 26.
The decision came after an all-day meeting in which the panel weighed the risks and benefits for kids ages 5-11. The decision to back emergency use was 17-0 with one abstention.
Public comment was also given. While there was support shown during the panel's meeting, skeptics also spoke up with concerns about adverse effects.
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A major step toward getting kids vaccinated, 28 million children could soon be eligible. If the shots get the green light next week, they could be at pharmacies and pediatricians' offices by Friday, Nov. 5, said Dr. Ben Weston, Milwaukee County chief health policy advisor.
"It is the first step, but it's a critical step," said Weston. "(These are) some of the most studied drugs in history. There is nothing experimental anymore about the vaccines…Parents should feel very confident getting this vaccine for their child. I know that I will."
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Dr. William Hartman, principal investigator for the UW Health Moderna pediatric COVID-19 vaccine trial, said that while research shows predictable symptoms from the Pfizer shot, the FDA panel looked into all potential issues.
"The FDA is concerned with the risk of myocarditis and the inflammation around the heart that has been associated with these vaccines," Hartman said. "They are looking very closely to that data to make sure that the benefits of the vaccine outweigh the risks of developing myocarditis."
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As for side effects, Weston said they were minor in the thousands of kids observed.
"When we looked at these thousands of kids, we saw some sore arms. We saw some headaches. We saw some low-grade fevers. We didn't see any serious adverse events," said Weston.
COVID-19 vaccine
The data that Pfizer submitted shows its vaccine, which would be administered to children at one-third of the adult dosage, is nearly 91% effective. It's a percentage that Hartman said can make a difference as the delta variant continues to spread.
"The kids themselves, while they are at less risk of developing severe disease and being hospitalized for COVID-19, in this age group, almost 2 million kids in the U.S. have been infected with COVID and almost 9,000 of those have been hospitalized with a third of those going into the ICU," said Hartman.
Dr. Margarent Hennessy, medical director for pediatrics at Ascension Wisconsin, said the news is especially encouraging as winter and the holiday season draw near – a time when most Wisconsinites spend more time indoors and around others.
"I think it's going to be really important that children are protected, not only for their own sake but for the rest of the family," Hennessy said. "We've got a deadly illness, and this is a great way to prevent this."
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Formal FDA decision pending, the recommendation will go to the U.S. Centers for Disease Control and Prevention advisory panel to deliberate and vote. That is scheduled for Nov. 2 and Nov. 3.
Milwaukee County said it is already working with Milwaukee Public Schools and health care providers for a rollout, in a statement:
We are working with MPS and other school districts to coordinate vaccine clinics for children that are pediatric friendly you’re also planning to have child vaccine incentives and we will likely announce the next week but we are making plans and working with our healthcare systems