Pfizer Won’t Seek EUA for COVID-19 Vaccine Before Election
Pfizer has announced that it won’t be applying to the FDA for an Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate before the presidential election on Nov. 3.
In an open letter, CEO Albert Bourla said the company plans to file an EUA application “in the third week of November” after a safety milestone is reached in an ongoing clinical study.
Early trial data suggested that BNT162b2, which is being developed with German drugmaker BioNTech, initiates production of virus-targeting antibodies and T cells.
Last week, Pfizer said it will add participants as young as 12 to its global phase 3 trial to better understand how the treatment affects different age groups.