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FDA to review COVID-19 vaccine data for children Tuesday

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The Food and Drug Administration's (FDA) vaccine advisory committee is meeting Tuesday to review the effectiveness of Pfizer’s COVID-19 vaccine in 5 to 11-year-olds.

“I think the public needs to recognize that is just a first step of several that need to be undertaken before providers will actually be able to administer vaccines to this population,” said Mitch Rothholz from the American Pharmacists Association.

Rothholz says after Tuesday’s meeting, the Centers for Disease Control's vaccine committee will meet on Nov. 2 and Nov. 3 before its director makes a final recommendation.

“When the FDA starts its process and does its EUA authorization, the flow of supply to jurisdictions will start, but it won’t be available to providers until the final recommendation comes out of the CDC,” said Rothholz.

If everything goes smoothly, Rothholz said 5 to 11-year-olds could start getting vaccinated the first weekend in November.

“Access points will be there. The limitation is, is again, it’s a new vaccine supply. Getting it, it will be phased in, not at the extent that it was, a year ago where we really had a supply limitation that’s not to be expected but it’s going to take two, three weeks for it to get throughout the system,” said Rothholz.

The vaccine will be available at pediatrician offices, local pharmacies and through state and local governments.

There are some important differences between the vaccine adults received versus the one younger kids could get.

“Whether it’s the original vaccine or the booster dose now or the first doses for kids the amounts we’re giving are really tailored to what people’s bodies need so they get a nice vigorous response and then when they see the virus they’re ready for it,” said Dr. Aaron Milstone, an infectious disease specialist with Johns Hopkins Children’s Center.

Milstone said the dose for kids is about a third of what adults receive. That’s because kids' immune systems tend to respond more aggressively than adults so they don’t need as much.

"I continue to see people who are having kids come home from school and daycare and spreading it to their families and their parents. So COVID is not gone and we will continue to rely on vaccinating children and adults to get us out of this pandemic," said Milstone.

Milstone said people should reach out to their pediatrician ahead of time and ask any questions about the vaccine so they are ready when it becomes available.
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