Pfizer and biontech granted fda emergency use authorization of omicron ba.4/ba.5-adapted bivalent covid-19 vaccine booster for ages 12 years and older

New york and mainz, germany, august 31, 2022 — pfizer inc. (nyse: pfe) and biontech se (nasdaq: bntx) today announced that the u.s. food and drug administration (fda) granted emergency use authorization (eua) of a 30-Μg booster dose of the pfizer-biontech covid-19 vaccine, bivalent (original [15 Μg] and omicron ba.4/ba.5 [15 Μg]) for individuals ages 12 years and older. an application for an omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the fda in early october. the companies are working with the fda to prepare an application for an omicron-adapted bivalent vaccine in children 6 months through 4 years of age.
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