The Colorado Springs Gazette final

FDA panel backs Pfizer’s low-dose COVID-19 vaccine for kids

BY MANAS MISHRA AND MICHAEL ERMAN

WASHINGTON • An expert panel Tuesday voted overwhelmingly to recommend the Food and Drug Administration authorize the Pfizer COVID-19 vaccine for children ages 5 to 11, saying the benefits of the shot outweigh the risks.

An authorization for that age group 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 outside experts but usually does. The vote was 17 in favor with one abstention.

If the FDA authorizes the shots for this age group, an advisory panel to the 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.

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. Data from the American Academy of Pediatrics show that more than 500 children in the U.S. have died from COVID-19.

It “is the eighth-highest killer of kids in this age group over the past year,” said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel.

“Use of this vaccine will prevent deaths, will prevent ICU admissions and will prevent significant long-term adverse outcomes in children.”

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

In the U.S., just 57% of the population is fully vaccinated, lagging other nations. Still, the percentage of young children who receive the shots may be low. The U.S. vaccination rate for 12- to 15-yearolds trails other age groups at roughly 47%.

Pfizer is seeking clearance for a lower, 10-microgram dose of the vaccine in young children, versus 30 micrograms for ages 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 companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children ages 5 to 11.

The advisers paid close attention to the rate of a heart inflammation called myocarditis that has been linked to both the Pfizer and Moderna

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.

If authorized, the Pfizer vaccine is likely to be the only one available to the age group in the United States for some time.

FRONT PAGE

en-us

2021-10-27T07:00:00.0000000Z

2021-10-27T07:00:00.0000000Z

https://daily.gazette.com/article/281758452500414

The Gazette, Colorado Springs