Pfizer and biontech submit request to expand conditional marketing authorization of comirnaty® in the eu to adolescents

New york a nd mainz, germany , april 30 , 202 1 (globe newswire) — pfizer inc. (nyse: pfe) and biontech se (nasdaq: bntx) today announced they have submitted a variation to the conditional marketing authorization (cma) in the european union (eu) to the european medicines agency (ema) for the pfizer-biontech vaccine comirnaty® (bnt162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. if ema approves the variation, the amended cma will be valid in all 27 member states of the eu. the companies have already submitted a similar request to the u.s. food and drug administration (fda) for the emergency use authorization (eua) and plan to request additional amendments with other regulatory authorities worldwide.
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