U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have submitted an application for conditional approval of their COVID-19 vaccine with the European Medicines Agency.
The submission, which occurred Monday, completes the rolling review process that the two companies initiated with the regulator on Oct. 6.
“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Pfizer chairman and CEO Albert Bourla said in a statement Tuesday. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”
If the vaccine candidate, called BNT162b2, is approved, the companies said it could potentially be available for use in Europe before the end of the year.
“As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” BioNTech CEO and co-founder Ugur Sahin said in a statement Tuesday. “We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”