Pfizer’s COVID vaccine for younger kids meets FDA bar, with CDC panel next week being key to wide rollout

COVID-19 vaccine
The Pfizer-BioNTech COVID-19 vaccine is the only one approved for Americans under the age of 18. (Kunal Mahto/iStock/Getty Images Plus/Getty Images)

Kids ages 5-11 in the United States are now eligible for vaccination against COVID-19. On Friday afternoon, the FDA authorized the Pfizer-BioNTech mRNA vaccine, Comirnaty. The Pfizer shot is the only COVID jab with an FDA nod for those younger than 18.

The shot could be made available for kids soon. First it must pass muster with the CDC, which will conduct an advisory meeting next week.

The endorsement opens up the vaccine to a population of 28 million kids in the U.S. The Pfizer dosage for children is one-third the size of that for those 12 years and older. The second of the two-shot series is to be administered three weeks after the first.

RELATED: FDA panel recommends Pfizer's COVID-19 vaccine for kids, setting it up for approval

It will be interesting to see how the shot is received considering the rousing debate on whether inoculating kids would reduce transmission of the virus. There also is some hesitancy from parents who have questions about the shot’s safety.

“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA commissioner Janet Woodcock said in a statement.

On Nov. 2, the CDC's Advisory Committee on Immunization Practices will discuss the merits of the vaccine for this age group and whether there should be any restrictions on its use. After that, CDC director, Rochelle Walensky, will make a final decision before the vaccine becomes widely available.

A positive recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday set the vaccine up for a green light. The panel voted 17-0, with one abstention, to extend the vaccine to kids of this age group.

The committee’s recommendation was based on data showing efficacy of 90.7% and a strong safety profile in a trial of 2,268 kids between five and 11 years. Additionally, the shot “effectively neutralized the delta variant,” William Gruber, M.D., Pfizer’s VP of vaccine clinical research and development, told the panel.

RELATED: Pfizer requests FDA nod for COVID-19 shot in kids 5 to 11, but convincing parents might be a tough sell

Kids ages 5-11 have accounted for 9% of cases reported in the U.S., and the current rate is “near the highest” of any age group, Doran Fink, M.D., told the committee on Tuesday.

But Pfizer's ability to capitalize on a green light for its COVID vaccine in kids could be hampered by resistance among many parents. Only 34% of parents in the U.S. said they would vaccinate their children “right away,” according to a poll conducted last month by the Kaiser Family Foundation. The survey was done after Pfizer released its data in this age group. In the same poll, 24% of parents said they definitely would not vaccinate their children while 32% would “wait and see” how the vaccine is working.

Moderna's competing mRNA vaccine is not yet approved in the pediatric setting. A decision in the 12 to 17 age group was due this month but got delayed after four Nordic countries suspended use of the Moderna shot in those under age 30 because of myocarditis concerns. In the company's study of 3,700 children between the ages of 12 and 17, there were no reports of myocarditis. 

On Monday, Moderna announced positive data from a trial testing the shot in kids between the ages of 6 and 11. The company added that it will submit the data to regulators soon.