In a strong vote Tuesday an expert panel recommended the U.S. Food and Drug Administration should authorize the Pfizer Inc and BioNTech SE COVID-19 vaccines for children ages 5 to 11, saying the benefits of getting the vaccine outweigh the risk.
The authorization would be an important regulatory step toward vaccinating 28 million children who are, for the most part back in school for in-person learning.
The vaccine could be available to primary school-aged children as soon as next week. The FDA is not obligated to follow the advice of outside experts but typically does.
If the FDA authorizes the shots for this age group, an advisory panel to the U.S. Centers for Disease Control and Prevention will meet next week to make a recommendation on administering the vaccine. The CDC director will make the final decision.
The companies claim their vaccines showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
While cases of serious illness and death from COVID-19 in children are fewer than in adults, there have been complications and deaths among the age group. Infections in unvaccinated kids have been on the rise due to the highly contagious Delta variant of the coronavirus.
“To me, the question is pretty clear,” said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel. “We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU.”
Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose of the vaccine for younger children, compared to 30 micrograms for those age 12 and older. The vaccine was authorized for ages 12-15 in May after being cleared for those age 16 and older in December.
The advisory panel paid close attention to the rate of a heart inflammation called myocarditis that has been linked to both the Pfizer/BioNTech and Moderna vaccines, particularly in young men.
