Panel Backs Pfizer Vaccine in Younger Kids

FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0 to recommend the agency authorize the use of Pfizer’s Covid-19 lower-dose vaccine in children ages 5 to 11 years. Panel members agreed that the vaccine’s benefits outweighed the risks, but some seemed concerned that the decision will be based on data involving a few thousand children studied in clinical trials. The committee reviewed clinical data showing a favorable safety profile and high vaccine efficacy of 90.7% in children aged five to 12 years.

One concern addressed was the risk of an inflammatory heart condition called myocarditis. No incidents were observed likely because the number of children evaluated was too small to record any occurrence. “We've identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditis,” said committee chair and University of Michigan professor Arnold Monto.