Pfizer to apply for COVID shots for kids 5-11

Published: Sep. 27, 2021 at 1:20 PM CDT|Updated: Sep. 27, 2021 at 2:57 PM CDT
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(CNN) – In just a matter of days, the head of Pfizer says the company plans to apply to the Food and Drug Administration for use of its vaccine in younger children.

“If they approve it, we would be ready with our manufacturing to provide this formulation of the vaccine,” said company CEO Albert Bourla.

For months, Pfizer has been testing a smaller dose – about one-third the amount adults get – in children ages 5 to 11.

The company says this formulation is safe for that age group, but the FDA and the Centers for Disease Control and Prevention will have the final say.

“As soon as they get submitted to the FDA, I know the FDA is urgently planning to review these data,” said CDC Director Dr. Rochelle Walensky. “It will go from the FDA to the CDC, and we will review it with similar urgency and I’m hoping in the order of weeks.”

Before a green light can be given for this vaccine in younger children, there’s a lot of data to comb through.

But if Pfizer applies this week, a decision could come by the end of October, one health expert says.

“This is a vaccine for children, so getting the dose right – in terms of efficacy and side effects – is crucial,” said Dr. Jonathan Reiner with George Washington University.

For now, Pfizer’s vaccine is only approved for use in people 12 and older.

According to the American Academy of Pediatrics, more than a quarter of all COVID-19 cases reported nationwide are now in children, increasing the urgency to get kids protected.

“I wouldn’t be so cavalier about this virus, we know that this virus has long-term consequences in a lot of people who contract it, including children,” said Dr. Scott Gottlieb, a former FDA commissioner.

Even when a vaccine becomes available, a difficult task lies ahead in getting children vaccinated.

Less than half of eligible U.S. adolescents are fully vaccinated against COVID-19, according to an analysis of CDC data. They’ve been eligible since May.

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