Pfizer Seeks Emergency Nod In U.S. For COVID-19 Vaccine In Children 5 - 11

(RTTNews) - Pfizer and BioNTech have formally requested emergency authorization from the U.S. Food and Drug Administration to use their COVID-19 vaccine in children 5 to 11 years old.

"We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12," Pfizer tweeted.

Last month, the companies had announced positive results from the pivotal trial, which included 2,268 participants 5 to <12 years of age.

In the trial, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 g doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 g doses.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.