FDA Approves Pfizer/BioNTech's Bivalent COVID-19 Vaccine For Youngest Kids

• 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.

• Related: Pfizer/BioNTech Get Ready For London Court Battle With Moderna Over COVID-19 Vaccine Patents.

• 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

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