The FDA has expanded the emergency use authorization (EUA) of Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) bivalent COVID-19 vaccine as a single booster dose in children under five years of age.
The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot.
In December, the agency approved Pfizer/BioNTech's updated shot as a third dose for kids aged six months through four years who have not completed their primary vaccination series or are yet to receive the third dose.
The amended authorization is based on data from 60 children from the expanded age group, who completed primary vaccination with three doses, received a booster shot of Pfizer/BioNTech, and showed an immune response to both the original SARS-CoV-2 virus strain and Omicron BA.4/BA.5.
Last month, the companies submitted an FDA supplemental marketing application for approval of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for 12 years and older.
Price Action: PFE shares are down 0.38% at $39.75, and BNTX shares are down 0.47% at $129.77 during the premarket session on the last check Wednesday.
Photo via Wikimedia Commons
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
This article FDA Approves Pfizer/BioNTech's Bivalent COVID-19 Vaccine For Youngest Kids originally appeared on Benzinga.com
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.