U.S. FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children By Reuters

By Manas Mishra and Michael Erman

(Reuters) – An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer Inc (NYSE:) and BioNTech SE (NASDAQ:) COVID-19 vaccine for children ages 5 to 11, saying the benefits of inoculation outweigh the risks.

An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.

The vaccine could be available to the younger age group as soon as next week. The FDA is not obligated to follow the advice of its outside experts, but usually 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 the administration of the vaccine. The CDC director will make the final call.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

While children becoming seriously ill or dying from COVID-19 is relatively rare compared with adults, some develop complications, and infections in unvaccinated kids have risen due to the easily transmitted 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 in children, versus 30 micrograms for those age 12 and older. The shot has been authorized for ages 12-15 since May after being cleared for those age 16 and older in December.

The advisers paid close attention to the rate of a heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna (NASDAQ:) vaccines, particularly in young men.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said in documents prepared ahead of Tuesday’s meeting.