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FDA hopeful younger children can get COVID-19 shots by year’s end

Jacksonville pediatric infectious diseases says he hopes to see approval of Pfizer vaccine for those ages 5-11 very soon

File photo (AP Photo/Robert F. Bukaty)
File photo (AP Photo/Robert F. Bukaty) (Copyright 2021 The Associated Press. All rights reserved.)

JACKSONVILLE, Fla. – The U.S. Food and Drug Administration is hopeful that younger children will be able to get vaccinated against COVID-19 by the end of the year. It could happen as early as Halloween.

Pfizer is expected to turn over its study results by the end of September. Pfizer’s partner BioNTech said that it was on track “in the coming weeks” to seek approval of the companies’ COVID-19 vaccine for 5- to 11-year-olds.

“I think the FDA will do its due diligence and the appropriate review before it gives any sort of approval,” said Dr. Mobeen Rathore, co-chair of the infection control committee at Baptist Health. “I also hope they’ll put more resources into it to get the vaccine approved sooner rather than later.”

In May, those ages 12 to 15 in the U.S. became eligible for the Pfizer shot.

Vaccines for children could be approved soon
Vaccines for children could be approved soon

Rathore, who specializes in pediatric infectious diseases, told News4Jax that he’s not seeing as many pediatric cases as he saw in July and August, but he hopes to see approval of the shot for those ages 5 to 11 very soon.

The delta variant of the coronavirus continues to surge as children are back in the classrooms.

“With the delta variant, the virus is more contagious, so there are more children who are being infected. That meant that more children are going to be sicker, and more are going to be in the hospital,” said Rathore. “The more that are going to be in the hospital, many of them are going to end up in the ICU and be on a respirator.”

Since the start of the pandemic, Rathore said, he has seen seven pediatric COVID-19 deaths at Wolfson Children’s Hospital.

Rathore said the approval of the Pfizer vaccine for 5- to 11-year-olds “would mean that almost all children in the school system could get the COVID vaccine — which is important.”

But he added: “I think the COVID vaccine update, unfortunately, is still low, so I think the fact that the vaccine is approved in and of itself doesn’t mean a whole lot unless people take the vaccine.”

Since Duval County students returned to the classroom on Aug. 10, there have been 2,334 cases, the school district’s COVID-19 dashboard showed Monday afternoon. Some parents say that as soon as COVID-19 shots are available for younger children, their children will get their kids will get vaccinated — including Stephanie Vihlen’s 8- and 10-year-old.

“Absolutely,” Vihlen said. “There’s been already multiple outbreaks in my children’s school, and if we can all get vaccinated, it’ll help us all past COVID if we can all get vaccinated.”

Rathore said that while Duval County Public Schools’ mask mandate was just implemented, and neither St. Johns nor Clay counties’ school districts require masks, he expects to see cases continue at the level they are seeing now.

While parents may be eager to get their younger child the shot before the FDA’s green light, the agency is warning against that. Pediatric clinical trials are currently underway to help determine the right dose for younger children. Those trials will find out whether children ages 5 to 11 will need a different dose or different strength formulations than the shot already approved for those ages 12 and older.

Moderna is currently under FDA review for children ages 12 to 17. Its clinical trial for children ages 6 to 11 is fully enrolled.

Both Pfizer and Moderna are also testing their vaccines down to age 6 months.

The Associated Press contributed to this report.


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Multi-media journalist with a special interest in Georgia issues.