An expert panel on Tuesday voted overwhelmingly to recommend the US Food and Drug Administration (FDA) to authorise the Pfizer-BioNTech Covid-19 vaccine for children aged 5 to 11, saying the benefits of inoculation outweigh the risks.
A full authorisation for that age group would be would be an important regulatory step towards reaching about 28 million children for inoculation, most of them already 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 authorises the shots for this age group, an advisory panel to the US Centres for Disease Control and Prevention (CDC) will meet next week to make a recommendation on the administration of the vaccine, and the CDC director will make the final call.
The companies have said their vaccine showed 90.7 per cent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
“To me, the question is pretty clear,” said Dr Amanda Cohn, a paediatric 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 children, versus 30 micrograms for those aged 12 and older.
The shot has been authorised for ages 12-15 since May after being cleared for those aged 16 and older in December.
The advisers paid close attention to the rates of a condition that causes heart inflammation called myocarditis that has been linked to both the Pfizer-BioNTech and Moderna vaccines, particularly in young men.
Even if the number of myocarditis cases in the younger age group turns out to be similar to that observed among 12- to 15-year-olds, more hospital admissions would still be prevented by the Covid-19 vaccine in most scenarios analysed, FDA staff reviewers said in documents prepared before Tuesday's meeting.