December 01, 2020
Pfizer and BioNTech are asking Europe's regulatory agency to authorize their COVID-19 vaccine as part of an effort to make the vaccine available across the globe.
If the European Medicines Agency grants a conditional marketing authorization, the vaccine could be used in Europe by the end of the year. The companies filed a formal application Monday.
The companies already have applied for use in the United States and United Kingdom, and sent rolling submissions to Australia, Japan and Canada. The companies said more applications are in the works.
"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 CEO Dr. Albert Bourla said in a press release. "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."
The two-dose vaccine has not yet been approved for use in any country.
The vaccine has an efficacy rate of 95% and has not caused any safety concerns, according to data from its Phase 3 clinical study. The efficacy rate was consistent across age, gender, racial and ethnic demographics.
"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," BioNTech CEO Dr. Ugur Sahin said in a statement.
Pfizer said it could distribute as many as 50 million vaccines globally by the end of the year, and another 1.3 billion next year. The vaccine requires a storage temperature of -94 degrees Fahrenheit.
In the U.S., an advisory board is scheduled to meet Dec. 8-10 to review the vaccine's efficacy and safety data. It will deliver an opinion before the U.S. Food and Drug Administration decides whether to grant an emergency use authorization.
Moderna also has applied for an emergency use authorization with the FDA. Its COVID-19 vaccine has been found to be 94.1% effective and does not require freezer storage.
If the FDA approves both vaccines, distribution could start within weeks, U.S. Health and Human Services Secretary Alex Azar told "CBS This Morning" on Monday.
"We could be seeing both of these vaccines out and getting into people's arms before Christmas," Azar said.