JACKSONVILLE, Fla. – Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11.
Dr. Bill Gruber, a Pfizer senior vice president, said Pfizer and its German partner BioNTech aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group.
Pfizer’s vaccine already is available for anyone 12 and older.
For elementary school-aged children, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Gruber said.
The child dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
Dr. Mobeen Rathore, a pediatric infectious disease specialist at UF Health Jacksonville, said he was expecting these results.
“There was no reason to believe the vaccine would not be safe or not be efficacious,” Rathore said Monday.
Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged children who were given two doses three weeks apart. The trial used 10-microgram doses compared to the 30-microgram doses for people 12 and older.
“They’re using a lower dose of the vaccine — which is what all of the vaccines that are being considered for younger age groups are looking at,” Rathore said.
The FDA required what is called an immune “bridging” study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That’s what Pfizer reported Monday in a news release, not a scientific publication. The study still is ongoing, and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.
“I’m sure that the FDA advisory committee will be weighing the risk benefits. We know there are lots of cases in children, but the risk of dying is still very, very low, so that risk benefit is going to be very important to be weighed,” said Admiral Dr. Brett Giroir, former assistant secretary of U.S. Department of Health and Human Services.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. FDA chief Dr. Peter Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Gruber said that once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.
If Pfizer’s vaccine is approved for children ages 5 to 11, that would mean more than 28 million additional people would be eligible to get vaccinated against COVID-19.
A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
According to the Centers for Disease Control and Prevention, 46% of all 12- to 17-year-olds have been vaccinated.
The announcement follows a Friday FDA advisory committee meeting, where a panel recommended Pfizer booster shots for patients 65 and older and for people who are at risk of severe illness.
“This is a group of other doctors who advise the FDA, essentially voted to say, listen, absolutely. Booster vaccines for Pfizer is a good idea for those over 65,” explained Dr. Jonathan Kantor.
Kantor pointed out that the CDC still hasn’t made a recommendation on that.
Notably, a new CDC-led study finds Moderna is 93% effective at keeping COVID patients out of the hospital, Pfizer is 88% effective and the J&J shot is 71% effective.