U.S. regulators are inching closer to authorizing Pfizer’s COVID-19 vaccine for emergency use in children ages five to 11. On October 26 an FDA advisory committee voted to recommend emergency use authorization, and the head of the FDA is expected to issue a ruling in the coming days. Before the shots can begin to roll out, the CDC will weigh in on the matter in a meeting next week.
The FDA panel’s vote in favor of the recommendation was near-unanimous, with one abstention. However, the New York Times reports that some committee members questioned whether all children in the age group need to be vaccinated and suggested authorizing shots only for those with underlying conditions that made them more susceptible to severe COVID-19. However, they concluded that the benefits outweigh the risks given the nearly two million children who have been infected so far.
The news comes a few days after the FDA released Pfizer’s analysis of its clinical trials of 2,268 participants showing that the vaccine is 90.7 percent effective at preventing symptomatic disease in kids in this age group. The analysis also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.
The company had previously announced that its analysis shows the vaccine is safe and elicits “robust” neutralizing antibodies. The vaccine follows a two-dose regimen of 10 milligram doses—a third of the dosage that is given to adults.
The White House has announced its plans to roll out the vaccines to children by working with more than 25,000 pediatricians and other primary care sites, children’s hospitals, pharmacies, school clinics, and more.