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How safe is the Pfizer COVID-19 vaccine for young kids? Here’s what doctors, researchers say

The FDA will be looking for any rare side effects, says Dr. James Cutrell of UT Southwestern

Advisors to the Food and Drug Administration will on Tuesday weigh the safety and benefits of the Pfizer COVID-19 vaccine for children ages 5 to 11. If the FDA and the Centers for Disease Control and Prevention authorize the vaccine, the shot could be in the arms of millions of kids by early November. Here’s what is known about the safety of the vaccine.

A Pfizer study, which has not been peer-reviewed, found that kid-size doses of its COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, the Associated Press reported.

Dr. James Cutrell, an associate professor of medicine in the division of infectious diseases at UT Southwestern, said during a Dallas Morning News virtual event, that the vaccine appears to be quite effective in kids but that the FDA advisory panel will be looking closely at the safety of the vaccine.

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Kids aren’t typically at high risk of severe symptoms with COVID-19, so the safety of the vaccine is vitally important. Cutrell said that the FDA is looking for any rare side effects, such as myocarditis, the inflammation of the heart that has been seen in some young men.

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Cutrell said that the current data suggests that even given this rare side effect, the vaccine is still beneficial. He noted that COVID-19 can cause heart issues and other severe side effects.

A review by FDA scientists, released Friday night, found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness. However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects.

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At the urging of federal regulators, Pfizer and Moderna are expanding the size of their clinical trials for children ages 5 to 11 — a precautionary measure designed to detect rare side effects including heart inflammation problems that turned up in vaccinated people younger than 30, The New York Times reported.

Researchers estimated that for every million vaccinated boys ages 12 to 17 in the U.S., the shots might cause a maximum of 70 myocarditis cases, but they would prevent 5,700 infections, 215 hospitalizations and two deaths. Studies have also shown that the risk of heart problems after COVID-19 is much higher than after vaccination, according to reporting by Apoorva Mandavilli of The New York Times.

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“Hopefully, parents will be comforted by the level of rigor in the studies and the data showing how safe the vaccine is in children,” said Dr. Oni Blackstock, a primary care and HIV physician who recently served as assistant commissioner at the New York City Health Department. Blackstock added that she will be getting her 8-year-old son vaccinated as soon as the shots become available.

The Associated Press contributed to this report.

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