Pfizer COVID-19 vaccine candidates nab accelerated review status in U.S.

The FDA grants Fast Track designation to Pfizer’s (NYSE:PFE) and collaboration partner BioNTech’s (NASDAQ:BNTX) two of the four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against COVID-19.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Early data from the German trial of BNT162b1 are expected this month.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100M doses by year-end and potentially more than 1.2B doses by the end of 2021.

https://seekingalpha.com/news/3590476-pfizer-covidminus-19-vaccine-candidates-nab-accelerated-review-status-in-u-s