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 the use of the drug in high-risk populations in the United States by the middle to end of December, according to a joint press release.
"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."
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