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'Vaccines are the way out of this' | Pfizer shot for kids 5-11 could get FDA approval by end of October

A Cone Health pediatrician said parents should understand kids can get very sick from COVID-19 and weigh the benefits of getting the vaccine.

GREENSBORO, N.C. — As health experts continue to comb through the data, parents with kids under 12 will have to wait until it gets submitted and approved by the FDA before getting their kids protected against COVID-19. 

Former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb said Pfizer could be ready to file for emergency use authorization within days of getting the data for kids age 5-11 years old. 

"FDA has said it's going to be a matter of weeks not months in terms of their evaluation of that clinical data to make a determination whether they’re going to authorize vaccines for kids 5-11," he said. 

Dr. Gottlieb said it's ultimately up to the FDA to make a decision on the data, but it's possible it could come by the end of October. 

"You could potentially have a vaccine available to children age 5 to 11 by Halloween if everything goes well, if the Pfizer data package is in order, and FDA ultimately makes a positive determination," he said. 

Dr. Mike Cinoman, Medical Director of Pediatric ICU with Cone Health said it's likely the FDA will approve Pfizer's vaccine for kids 5 to 11 if the data looks good.

"There’s probably little to no reason to expect that the vaccine would not be very similar to its benefits risk ratio in other populations. I think we learned in adolescent studies that the side effects were almost exactly the same as they were in adults and the effectiveness was just as high if not higher in terms of preventing serious COVID infection so we don’t know the data yet but I think there’s very little about this that would make children different," said Dr. Cinoman. 

Dr. Cinoman said while the risk of hospitalization is less likely in children compared to adults, parents still need to look at the benefits of getting their kids vaccinated and the risks if they don't. 

"This is just not something to be trifled with and we have over a year of experience seeing that," he said, "What I don’t think all people realize is it's still very serious. We do see children hospitalized with this. We see children in the intensive care unit and, unfortunately, we see children get very sick and die from it."

Dr. Cinoman said the vaccines have proven to be highly effective and cause short-lived side effects.

"The benefit of getting the vaccine far outweigh the risk of getting COVID. From a public health standpoint, not just looking at the individual, it's very important. We all want to stop wearing masks," he said.

Dr. Cinoman said the vaccines are the way out of this pandemic. 

Pfizer has information on its website about the COVID-19 vaccine in different groups of people, including children.

Pfizer said it hopes to submit data for emergency use authorization in kids 5-11 sometime during September or October, and shortly thereafter for children 6 months and older.

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