Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) have progressed in their COVID-19 vaccine effort, according to the U.S. Food and Drug Administration on Monday. Two of the companies’ four coronavirus vaccine candidates received Fast Track Designation from the FDA.
This vaccine news is also helping lift the broad markets, as the Dow Jones industrial average and S&P 500 each posted healthy gains to start out the week.
It goes without saying that COVID-19 vaccines and treatments are being fast-tracked by the FDA. Moderna Inc. (NASDAQ: MRNA) and other major players in vaccine development have received this designation as well.
In terms of the specifics, two of the four BioNTech investigational vaccine candidates from the BNT162 mRNA-based vaccine program received the Fast Track Designation. BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.
This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing, as well as animal immunogenicity studies. The companies released early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 at the beginning of this month.
Some quick background: Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need. In this case, the need is great for a coronavirus vaccine as cases are continuing to pile up.
Pfizer stock traded up about 5% to $35.49 on Monday, in a 52-week range of $27.88 to $43.23. The consensus price target is $40.04.
BioNTech was last seen up about 15%, at $81.03 in a 52-week range of $12.52 to $105.00. Analysts have a consensus price target of $42.78.