Pfizer CEO says COVID-19 vaccine could to be filed for emergency use approval late November

On Friday, Pfizer (NYSE: PFE) chairman and chief executive Albert Bourla issued an ‘open letter’ aiming to provide greater clarity around the development timelines for Pfizer and partner Germany’s BioNTech’s (Nasdaq: BNTX) COVID-19 vaccine, known as BNT162b2, and when it might be submitted for review by the US Food and Drug Administration.

There are three key areas where, as with all vaccines, must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, the companies must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.

May know if effective by end October