Pfizer Seeks Approval for Experimental COVID-19 Vaccine
This chart indicates Pfizer plans to file for full US Food and Drug Administration (FDA) Approval of its experimental COVID-19 vaccine (BNT162b2) in May 2021, about six months after receiving an FDA Emergency Use Authorization (EAU).
According to the FDA, the average time to Approve a new vaccine's Biologics License Application is about 10 months.
Furthermore, Pfizer may seek a EUA for vaccinating toddlers in November'21.
From a production capability perspective, Pfizer expects to manufacture at least 3 billion vaccine doses in 2022 (vs. 2.5B doses in 2021). Per Pfizer's slide #6, anticipated revenue from the Pfizer-BioNTech COVID-19 vaccine could reach $26 billion in 2021.