Pfizer and BioNTech will submit an emergency use authorization for their COVID-19 vaccine today. Earlier this week, the companies reported that the vaccine was 95% effective. The emergency use authorization will be requested in the United States, Australia, Canada, Europe, Japan, and the United Kingdom.
The Food and Drug administration’s emergency authorization program allows companies to seek early approval when certain standards are met. The FDA requires supporting information and safety data for approval.
Pfizer and BioNTech vaccine recently entered a phase 3 clinical trial with 43,661 participants. The company is submitting data from participants, including safety information and supplementary data.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Albert Bourla, Pfizer CEO, said in a statement.