The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.
"You know, the EUA (Emergency Use Authorization) may be approved in the middle of December or so", stated Moncef Slaoui, Operation Warp Speed chief.
"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", Pfizer CEO Albert Bourla said.
Pfizer reports COVID-19 vaccine 95% effective as Phase 3 trial concludes
The scientific head of the U.S. operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December - a timeframe echoed by Sahin. "Today is a special day", Bucci said.
The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer's vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
Ontario's Minister of Health says the province is expected to receive 2.4 million COVID-19 vaccines from Pfizer and Moderna between January and March 2021. The companies are also submitting two months of follow-up data on 38,000 people, far more than the minimum of half the participants in their 44,000-person trial.
"We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks", US Health and Human Services Secretary Alex Azar said. Pfizer, AstraZeneca and Moderna are among the front-runners in the global race to produce a vaccine to fight the infection.More news: See why fans aren't too happy about the 'Sharkboy and Lavagirl' sequel
If the FDA authorizes a vaccine, it "could in theory start rolling off the assembly line into the arms of the American public by the end of December", said Paul Offit, a vaccine expert from the Children's Hospital of Philadelphia who is on the FDA's advisory vaccine panel.
A key challenge with BioNTech/Pfizer vaccine lies in the distribution, since it needs to be stored at minus 70 degrees Celsius (-94 degrees Fahrenheit).
About four percent experienced severe fatigue and two percent got severe headaches after their second dose. These symptoms are classified as Grade 3 or "severe" adverse events because they can interfere with daily activity.
"These are extraordinary results, and the safety data look good", said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.More news: Federal Reserve in battle against US Treasury over emergency funds
The first two to show any results - made by Pfizer-BioNTech and Moderna - both use an experimental approach, called mRNA, which involves injecting part of the virus's genetic code into the body to train the immune system. Johnson & Johnson said it is on track to deliver data this year.
The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said. The Pfizer and BionTech vaccine went into tests shortly thereafter. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.More news: WHO advises against Gilead's remdesivir for all hospitalised COVID-19 patients