Pfizer and biontech receive positive chmp opinion for omicron xbb.1.5-adapted covid-19 vaccine in the european union

New york and mainz, germany, august 30, 2023 — pfizer inc. (nyse: pfe, “pfizer”) and biontech se (nasdaq: bntx, “biontech”) today announced that the committee for medicinal products for human use (chmp) of the european medicines agency (ema) has recommended marketing authorization for the companies' omicron xbb.1.5-adapted monovalent covid-19 vaccine (comirnaty® omicron xbb.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior covid-19 vaccination history. the committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a covid-19 primary vaccination course or prior sars-cov-2 infection.
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