MODERATOR: “So this concludes the vote. Out of 18 voting members, 17 voted yes, and we had one abstain.”
A panel of expert FDA advisors on Tuesday voted to recommend the use of Pfizer’s COVID-19 vaccine for children ages 5 to 11.
The vote marks an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.
The U.S. Food and Drug Administration is not bound to the advice of its outside experts, but usually follows it. In a clinical trial, Pfizer’s vaccine showed 90.7% efficacy against the coronavirus of children aged 5 to 11, the company said.
While children become seriously ill or die far less often than adults from COVID-19, some develop complications, and cases in unvaccinated kids have risen due to the easily transmissible Delta variant.
One FDA official said there had been close to 100 deaths in that age group so far, and 1.9 million infections. Outbreaks also have caused school closures and disrupted the education and socialization of children.
Inoculating the age group could speed the pace of immunization in the U.S., where the percentage of fully vaccinated people has fallen behind countries like the UK and France.
FDA staff said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.
The World Health Organization since May has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID shots to poorer countries.
Pfizer is seeking clearance for a lower, 10-microgram dose of the vaccine in children, versus 30 micrograms for everyone over the age of 12.
Once the FDA authorizes the vaccine for younger children, a CDC advisory panel will make a recommendation on the administration of the vaccine. The CDC director will make the final call.