An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer Inc and BioNTech SE 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.