WASHINGTON -The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc’s vaccine for those aged 6 months through 4 years.
The new dates for our pediatric COVID-19 vaccine advisory committee meetings will now be June 14 and June 15, the FDA said in a statement Monday.
“We know parents are anxious for us to determine if these vaccines are safe & effective. In light of the disclosure by Pfizer re: their data & anticipated dates for submission, we believe that we will complete review of both EUA requests within days of one another,” it said.
The June 14 meeting will consider Moderna’s emergency use authorization request for youth aged six to 17 years, the FDA said.
White House COVID-19 response coordinator Dr. Ashish Jha said on Sunday he expects a U.S. Food and Drug Administration decision on authorizing Moderna’s vaccine for children under age five within the next few weeks.
Moderna completed its application and FDA experts are looking closely at the data, Jha said on ABC.
(Reporting by Doina Chiacu; Editing by Mark Porter and Nick Zieminski)