Pfizer and BioNTech seek FDA EUA for Omicron-based Covid-19 vaccine

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution.