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
LONDON – US pharmaceutical company Pfizer and its German partner BioNTech have applied to the European Medicines Agency (EMA) for conditional marketing authorization for their coronavirus vaccine.
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 granted to drugs “that meet unmet medical needs of patients based on less comprehensive data than is normally required,” the EMA’s website says.
‘In the interest of public health, applicants may be granted conditional marketing authorization for such medicines if the benefits of immediate availability outweigh the risk of less comprehensive data than normally needed, “he adds. However, the applicant should be able to provide comprehensive clinical data in the future.
“Today’s announcement marks another important milestone in our efforts to deliver on our promise to do all we can to address this dire crisis in the face of the critical public health need,” said Dr. Albert Bourla, Chairman and CEO of Pfizer, in the press release.
“We have known since the beginning of this journey that patients are waiting and we are ready to ship Covid-19 vaccine doses as soon as possible approvals allow us.”
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 with the U.S. Food and Drug Administration on November 20 for emergency approval to use their coronavirus vaccine. The FDA process is expected to take a few weeks and an advisory committee meeting to review the vaccine is expected to take place in early December.
In addition to filings with the EMA, the US Food and Drug Administration (FDA), and the UK Medicines and Health Products Regulator (MHRA), BioNTech noted Tuesday that it and Pfizer have “initiated ongoing filings worldwide, including in Australia , Canada and Canada Japan and plan to file applications with other regulatory agencies around the world. “
Competing drug maker Moderna said Monday it would ask the FDA and its European equivalent (the EMA) for an emergency clearance for its coronavirus vaccine after new data confirmed that the vaccine was more than 94% effective at preventing Covid-19 and was sure.
Later on Tuesday, Reuters reported that the EMA said that if its experts had enough data from Pfizer and Moderna on their vaccine candidates, they would complete their reviews no later than December 29 and January 12, respectively.
– CNBC’s Berkeley Lovelace contributed to this story.