Pfizer and BioNTech to submit emergency authorization request to FDA today
Pfizer and partner BioNTech announced they will submit a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.
The submission, which is based on a vaccine efficacy rate of 95% demonstrated in the Phase 3 clinical study with no serious safety concerns to date, will potentially enable use of the drug in high-risk populations in the United States by the middle to end of December.
"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, said in a statement Friday. "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."
The companies have already initiated rolling submissions with several drug regulatory agencies around the world, including in Australia, Canada, Europe, Japan and the United Kingdom, and plan to submit applications to others in the coming days. The companies said they will be ready to distribute the vaccine within hours after authorization.
Based on current projects, the companies said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 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, said in a statement Friday. "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."