- 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.
- BNTX +6% PM.