FDA issues emergency use authorization for Pfizer vaccine in children 5 to 11

Pfizer Children Vaccines
Posted at 7:28 PM, Oct 29, 2021
and last updated 2021-10-29 23:16:50-04

CLEVELAND — The U.S. Food and Drug Administration issued an emergency use authorization Friday for the Pfizer COVID-19 vaccine for children ages five to 11.

The FDA’s vaccine advisers based that decision on data from Pfizer. However, this is not the final regulatory step in getting the vaccine to kids in this age group.

More experts in vaccines, pediatrics and infectious diseases are set to convene to review that data further. That includes a recommendation from the Centers for Disease Control and Prevention, as well as approval from the CDC director, Dr. Rochelle Walensky.

“We're anticipating all those events will happen by early next week,” Walensky told WXYZ. “What we're hoping should all of this go through is this vaccine will make a real difference.”

'We have the tools now to protect the kids'

Dr. Claudia Hoyen is the director of pediatric infection control at University Hospitals Rainbow Babies & Children’s, as well as co-director of University Hospitals Health System.

She said that among her infectious disease colleges and other physicians with whom she’s talked, “it’s like Christmas came early.”

“When you think about how much these vaccines have been used in the last year, it's really incredible, and the fact that they are as efficacious as we've seen and really have minimal side effects, when you think about what can actually happen to you if you have COVID, we're very excited,” Hoyen said.

Still, Hoyen said it’s understandable that some people may have questions or hesitations. But she says in the 25 years she’s been in the field of infectious diseases, she has seen children die of vaccine-preventable diseases.

“We have the tools now to protect the kids. We know that children who are vaccinated are so much less likely to end up in the hospital and even less likely to be in an ICU or die,” Hoyen said.

Pfizer has made modifications to its vaccine in order to make it work more effectively for this age group. That’s meant lowering the dose to about one-third of what it is for older kids and for adults—not just because of kids’ smaller body sizes, but because their immune systems respond differently than adults’ immune systems. It’s also been created in a different concentration than for older kids and adults. The goal: to find a dose that’s effective but with minimal side effects.

'At what cost?'

“There will be three groups. There will be one group that says, ‘I really, I want it. I wanted it a month ago,’ and there will be a second group that will say, ‘I will never take this vaccine for my children,” said Dr. Shelly Senders, founder and CEO of Senders Pediatrics in South Euclid. “And then there'll be a third group, which hopefully will be thoughtful about how they're going about it and decide to make decisions that work for their family.”

Senders’ practice was one of 50 groups across the country that enrolled children in a trial for ages five to 11.

“We actually enrolled people in the adult group, in the adolescent group, in the five to 11, and we're now still enrolling in the six months to five year group,” Senders said. “We enrolled about 100 of the total of 4,000. So we had a significant imprint.”

Senders said studies have shown children who have died from COVID-19 are usually those with underlying medical conditions.

“The good news is that children are resilient and they've been able to bounce back. But the question is at what cost?” Senders said. “And so do we vaccinate children to prevent those types of of issues?”

He added, “My plea is that we all respect each other and respect that there can be differences of opinion, and it doesn't mean that you are a terrible person if you want to vaccinate your child, nor does it mean that you're a terrible person if you don't want to vaccinate your child,” Senders said.

Both Hoyen and Senders urged parents to reach out to their physicians with any questions or concerns they may have about vaccinating their children.

The CDC’s recommendation and potential approval is likely to come early next week.

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