European Advisory Committee Backs Pfizer/BioNTech's COVID Shot For Younger Kids

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approving Pfizer Inc PFE and BioNTech SE's BNTX 3-µg dose of COVID-19 vaccine for kids less than five years.
The recommendation is based on data from a Phase 2/3 trial.
Following the third dose in this age group, the companies' original COVID-19 vaccine was found to be 73.2% effective at preventing COVID-19, with a favorable safety profile similar to the placebo.
Related: Pfizer/BioNTech's Updated Omicron Adapted COVID-19 Shot Increases Neutralizing Antibodies Above Pre-Booster Levels.
The FDA granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022.
Submissions to other regulatory agencies around the world are ongoing.
Pfizer and BioNTech are also in discussions with health authorities regarding a regulatory pathway for potential authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children under five.
Price Action: BNTX stock is down 7.21% at $124.04, and PFE shares are down 2.96% at $42.79 on the last check Wednesday.