Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) made another big step in their fight against COVID-19 by initiating their late-stage study for their lead mRNA vaccine candidate. This trial will be testing the safety and efficacy with up to 30,000 participants around the world.
In terms of the specifics, the Phase 2/3 safety and efficacy clinical study will evaluate a single nucleoside-modified messenger RNA candidate from the BNT162 mRNA-based vaccine program, against SARS-CoV-2.
After review of the preclinical and clinical data from the Phase 1/2 clinical trial and consulting with the U.S. Food and Drug Administration (FDA), among other global regulators, Pfizer and BioNTech are advancing their BNT162b2 vaccine candidate. Note that BNT162b2 recently received Fast Track designation from the FDA. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein, which is the target of virus-neutralizing antibodies.
The companies selected BNT162b2 as the lead candidate for this Phase 2/3 trial upon evaluation of the totality of the data generated so far. Management said that this decision reflects the primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible.
Pfizer and BioNTech will continue to evaluate their other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio
Pfizer stock closed Monday at $37.54, in a 52-week range of $27.88 to $43.00. The consensus price target is $40.25. The stock was up about 2.8% at $38.61 in early trading indications Tuesday.
BioNTech stock recently closed at $86.53 and has a 52-week range of $12.52 to $105.00. Analysts have a consensus price target of $62.08. The stock was up 2.6% at $88.80 in early indications Tuesday.