A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020.
Marco Bello | Reuters
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 potentially enable use of Pfizer and BioNTech’s vaccine in Europe before the end of 2020, BioNTech said in a press release.
Such authorization, known as a CMA, is granted to medicines or vaccines “that address unmet medical needs of patients on the basis of less comprehensive data than normally required,” the EMA says on its website.
The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the 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,” Dr. Albert Bourla, Pfizer chairman and CEO said in the 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 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-19, 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 for their coronavirus vaccine on November 20, with the FDA process expected to take a few weeks and an advisory committee meeting to review the vaccine tentatively scheduled for early December.
Rival drugmaker Moderna said Monday it will request emergency clearance from the FDA for its coronavirus vaccine after new data confirmed the vaccine was more than 94% effective in preventing Covid-19 and was safe.
This is a breaking news story, please check back later for more.
– CNBC’s Berkeley Lovelace contributed reporting to this story.