Pfizer and BioNTech submitted an application to use their coronavirus vaccine in Europe that, if approved, could see the vaccine being used in countries by the end of the year.
Biotech company BioNTech said Tuesday that the companies had applied for a Conditional Marketing Authorization from the European Medicines Agency for their COVID-19 vaccine candidate. If the agency concludes that the vaccine’s benefits outweigh its risks, it will recommend granting the authorization, potentially enabling use of the vaccine in Europe before the end of year.
Cartoons on the Coronavirus
“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,” Dr. Albert Bourla, the CEO of Pfizer, 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.”
Monday’s submission completes a rolling review process that the company says began on Oct. 6. The vaccine candidate, BNT162b2, will now be assessed “according to EMA’s normal stringent standards for quality, safety and efficacy.”
Moderna has also filed for an EUA with the FDA for its potential coronavirus vaccine.