Pfizer, BioNTech apply for Covid vaccine approval in Europe
- If authorization is granted, it could enable use of the vaccine in Europe this month, BioNTech said.
LONDON — U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have applied to the European Medicines Agency for the conditional marketing authorization of their coronavirus vaccine.
If the authorization is granted, it could enable use of the vaccine in Europe this month, BioNTech said.
Such authorization is granted to medicines "that address unmet medical needs of patients on the basis of less comprehensive data than normally required," the EMA says on its website.
"In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required," it adds. The applicant should be in a position to provide comprehensive clinical data in the future.
"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 Dr. Albert Bourla said in a statement.
"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 news comes almost two weeks after Pfizer and BioNTech said that final data analysis from the late-stage clinical trial of their coronavirus vaccine showed it was 95% effective in preventing Covid-19 infection.
The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, the drugmakers said in mid-November, and its effectiveness was consistent across all ages, races and ethnicities.
Additionally, the elderly, who are at a higher risk of severe illness from Covid, saw vaccine effectiveness of more than 94%, the companies said.
Pfizer and BioNTech applied for an emergency use authorization from the U.S. Food and Drug Administration on Nov. 20. The FDA process is expected to take a few weeks and an advisory committee meeting to review the vaccine is tentatively scheduled for early December.
In addition to submissions to the EMA, the FDA and U.K. Medicines and Healthcare Products Regulatory Agency, BioNTech noted on Tuesday that it and Pfizer "have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world."
Rival drugmaker Moderna said Monday it will request emergency clearance from the FDA, and the EMA for its vaccine after new data confirmed it was safe and more than 94% effective in preventing Covid.
The EMA said if its experts have received enough data from Pfizer and Moderna about their candidate vaccines, it would complete its reviews by Dec. 29 and Jan. 12, respectively, at the latest, Reuters reported.
- CNBC's Berkeley Lovelace contributed reporting to this story.