The review from the Food and Drug Administration is a key step toward an expected decision to begin vaccinating babies, toddlers and preschoolers as soon as June 21.
In our news wrap Friday, children in the U.S. ages 5 to 11 began receiving their Pfizer COVID vaccine booster shots after the CDC gave its final approval, a federal judge rules COVID asylum restrictions must continue on the border, the Justice Department unveiled new efforts to combat hate crimes after the massacre in Buffalo, and Russia claims it's taken full control of the city of Mariupol.
The data from two studies on about 2,707 individuals aged 12 to 17 years show Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group, said Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII.