Pfizer and BioNTech submit emergency authorization requests
COVID-19 vaccine candidates request emergency authorizations to FDA
LINCOLN, Neb. (KLKN)- Pfizer and their partner, BioNTech, the pharmaceutical companies in the race to create a vaccine to the coronavirus, have announced that they are submitting a request to the U.S. Food and Drug Administration on Friday for emergency use authorization (EUA) of their vaccine candidates.
Pfizer announced Wednesday that their coronavirus vaccine in Phase 3 of a clinical study had been proven to be 95% effective in preventing infection while causing no severe safety concerns.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Dr. Albert Bourla, chairman and CEO of Pfizer, says. “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 and BioNTech have begun submitting requests for emergency use countries around the world, including Canada, Australia, Europe, Japan, and the United Kingdom, with plans to submit more in the next few days.
Once authorization is given to the companies, they say they are prepared to distribute the vaccine within hours. Based on projections, Pfizer and BioNTech are expected to produce 50 million doses this year and up to 1.3 billion doses in 2021.
“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, says. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”