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 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 (sbla) to the u.s. food and drug administration (fda) for the approval of a booster (third) dose of comirnaty ® (covid-19 vaccine, mrna) to prevent covid-19 in individuals 16 years of age and older. the companies intend to complete submission of the sbla by the end of this week.
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