Pfizer, BioNTech apply for approval of coronavirus vaccines in Europe
A volunteer is injected with a vaccine while participating in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America in Hollywood, Florida, United States, on September 24, 2020.
Marco Bello | Reuters
The US pharmaceutical company Pfizer and its German partner BioNTech have applied to the European Medicines Agency for conditional approval to place their coronavirus vaccine on the market.
If approval is given, it could potentially enable Pfizer and BioNTech’s vaccine to be used in Europe before the end of 2020, BioNTech said in a press release.
One such approval, known as the CMA, is given to drugs or vaccines that “meet unmet medical needs of patients based on less comprehensive data than is normally required,” the EMA’s website says. The available data must show that the benefits of the medicinal product outweigh the risks and that the applicant should be able to provide comprehensive clinical data in the future.
The news comes almost two weeks after Pfizer and BioNTech said final data analysis from their coronavirus vaccine late clinical trial showed it was 95% effective at preventing Covid-19 infection.
The vaccine, called BNT162b2, becomes highly effective against the virus 28 days after the first dose, the drug manufacturers said in mid-November. Its effectiveness was the same across all ages, races, and ethnicities.
In addition, older people who are at higher risk of serious illness due to Covid-19 saw the vaccine greater than 94% effectiveness. Pfizer and BioNTech filed for emergency approval for their coronavirus vaccine with the U.S. Food and Drug Administration on November 20.
Competing drug maker Moderna said Monday it would ask the FDA for emergency clearance for its coronavirus vaccine after new data confirmed that the vaccine was more than 94% effective at preventing Covid-19 and was safe.
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– CNBC’s Berkeley Lovelace contributed to this story.