An outside advisory panel to the US Food and Drug Administration has voted in favor of approving a smaller-dose Pfizer-BioNTech mRNA Covid-19 vaccine for children between the ages of 5 and 11, saying benefits outweighed the risks.
The FDA vaccines advisory committee overwhelmingly agreed with Pfizer’s proposal on Tuesday, with 17 votes in favor, no one opposed and one abstention. The FDA is expected to issue an emergency use authorization for the jab within the next couple of days, while the final recommendation by the Centers for Disease Control and Prevention (CDC) is due next week.
The vaccine would be administered three weeks apart, in two 10-microgram doses – a third of the dose currently recommended for everyone 12 and older.
The panel studied the data presented by Pfizer, which tracked 2,268 children in the 5-11 age group that received either the recommended regimen or a placebo. Those vaccinated developed antibodies on par with the adult cohort, and only three developed symptomatic Covid-19 compared to 16 in the placebo group, according to the data. The study was conducted in August and September.
Last week, the FDA voted to authorize “mix and match” boosters for Americans who have previously received two two-dose Pfizer, Moderna jabs or the single-shot Janssen vaccines.
Both the boosters and vaccinations for school-age children have been laid out as priorities by the Biden administration, which has blamed the surge in US coronavirus cases on “the unvaccinated.”
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