Pfizer and biontech complete submission to european medicines agency for omicron ba.4/ba.5 adapted bivalent vaccine

New york and mainz, germany, august 26, 2022 — pfizer inc. (nyse: pfe) and biontech se (nasdaq: bntx) today announced they have completed a submission to the european medicines agency (ema) for a booster dose of an omicron ba.4/ba.5-adapted bivalent covid-19 vaccine for individuals 12 years of age and older. this application for a variation of the conditional marketing authorization (cma) follows guidance from the ema and international coalition of medicines regulatory authorities (icmra) to work towards introducing omicron-adapted bivalent vaccines.
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