Pfizer Asks FDA to Authorize COVID Vaccine for Kids Aged 5-11

Parents tired of worrying about sending their kids to crowded classrooms and telling their young children they can’t have sleepovers felt a wave of relief today when Pfizer asked the FDA to authorize its COVID-19 vaccine for kids ages 5 to 11.

If regulators give it the green-light, reduced-dose kids’ shots could begin within a matter of weeks.

Key things to keep in mind, according to epidemiologist Dr. Emily Smith:

• The FDA will meet to discuss and vote on this on October 26th.
• The data has not officially been released for any of us to look at yet. But, we do know that the Pfizer trial among 5-11 year olds included 2,269 children. There were no serious side effects.
• This is still a 2-dose regimen, similar to 12+ kids and adults. The major change is that younger kids received a third of the dose of everyone else (10 micrograms compared to 30 micrograms for older adolescents and adults). (Of note, younger children less than 5 years received a much smaller dose of 3 micrograms. This data will not be reviewed at the October 26th meeting, but I wanted to let you all know as an FYI for those of you with < 5 year olds.)
• Pfizer said the antibody levels shown after the 2nd dose among the 5-11 year olds were just as strong as older kids and adults who received the full-strength doses. Very, very good news, indeed.

BREAKING: Pfizer asked the U.S. government to allow use of its COVID-19 vaccine in children ages 5 to 11 — and if regulators agree, shots could begin within a matter of weeks. https://t.co/RVVu3jTuIO

— The Associated Press (@AP) October 7, 2021

This could bring many families a step closer to closing the door on remote learning, virus scares and repeated school shutdowns and quarantines.

“My son asked about playing sports. ‘After you’re vaccinated.’ He asked about seeing his cousins again. ‘After you’re vaccinated.’ A lot of our plans are on hold,” Sarah Staffiere of Waterville, Maine, told the Associated Press. Her 7-year-old has a rare immune disease that has forced the family to be extra cautious throughout the pandemic.

“When he’s vaccinated, it would give our family our lives back,” she said.