Signaling that Pfizer Inc. (NYSE:PFE) and BioNTech SE – ADR (NASDAQ:BNTX) are nearing the finish line, the companies announced plans Friday to apply for emergency use authorization for the coronavirus vaccine candidate BNT162b2.
First To File: The filing means the vaccine could be available for high-risk populations in the U.S. by the middle or end of December.
"Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," Albert Bourla, Pfizer's chairman and CEO, said in a statement.
What's Next For Pfizer, BioNTech: FDA's Vaccines and Related Biological Products Advisory Committee discussion is scheduled to discuss the application before the regulatory agency gives its verdict.
The companies have initiated rolling BLA submissions in Europe, the U.K., Australia, Canada and Japan. Regulatory applications will be submitted to other regulatory agencies worldwide in the coming days, the companies said.
Pfizer and BioNTech said they are ready to distribute the investigational vaccine within hours after authorization.
Is Moderna Close Behind? Moderna Inc (NASDAQ:MRNA), which is the other vaccine developer that has released an interim Phase 3 readout, is also expected to file for emergency use authorization.
An interim readout released Monday showed 95% vaccine efficiency. Once the mandated safety data accrues, the company could move ahead with a filing. This is expected anytime next week.
PFE, BNTX, MRNA Price Action: In premarket trading Friday, Pfizer was adding 1.82% to $36.85. BioNTech shares were rallying 6.63% to $101.22. Moderna shares were up 3.05% at $95.60.