Pharmaceutical giant Pfizer announced Thursday that it has formally submitted data to federal health regulators that its COVID-19 vaccine is safe and effective for children ages 5-11.
The trial for the two-dose vaccine co-developed by Pfizer and the biotechnology company BioNTech included 2,268 participants between ages 5 and 11 and “demonstrated a favorable safety profile and elicited robust neutralizing antibody responses,” according to a statement Pfizer released last month on the trial’s initial study data.
The U.S. Food and Drug Administration is expected later this month or early in November to approve the vaccine for emergency use authorization, a designation under which federal regulators have approved vaccination of older cohorts prior to the vaccine’s formal approval, but which still requires detailed clinical trial data showing the immunization’s safety and efficacy.
Once approved by federal regulators, children age 5-11 will receive a slightly smaller dose of the vaccine than subjects in the vaccine’s first study, which included people age 16 and older.
The Pfizer vaccine is the only vaccine available in the U.S. that has received full authorization from the FDA in any age cohort — in this case, people ages 16 and older.
Children ages 12-15 are also currently eligible for the Pfizer vaccine under emergency use authorization. Additional clinical trials for the vaccine’s safety and efficacy among children age 4 and younger are still ongoing.
An FDA advisory panel is expected to consider the Pfizer’s trial data for children 5-11 on Oct. 26. If the panel deems the data sufficient, it will then recommend emergency use authorization by the FDA itself.