Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. Fda for Booster Dose of Comirnaty® in Individuals 16 and Older

– New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile – SARS-CoV-2 neutralizing titers against the wild-type strain one month after booster dose were 3.3 times the titers one month after the second dose – Pfizer and BioNTech intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in coming weeks NEW YORK, USA and MAINZ, GERMANY, August 25, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a supplemental Biologics License Application …

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2021-08-25 16:58:53