BioNTech, Pfizer file for EU approval of COVID-19 vaccine
Updated 20:04, 01-Dec-2020
CGTN

On Tuesday, Germany's BioNTech and its U.S. partner Pfizer said they had applied for EU regulatory approval for their COVID-19 vaccine, raising hopes that the first jabs could be administered in December. 

The two companies said in a statement that they had submitted an application to the European Medicines Agency on Monday "for Conditional Marketing Authorization (CMA)" for their vaccine after tests showed it was 95 percent effective against the novel coronavirus. 

If approved, the jab could potentially be rolled out "in Europe before the end of 2020," the statement said. 

Pfizer and BioNTech already filed for emergency use authorization with the U.S. Food and Drug Administration on November 20. 

The duo reported final trial results on November 18 that showed their vaccine candidate was 95 percent effective in preventing COVID-19, with no major safety concerns.

Read more:

Pfizer is first to apply for U.S. emergency use for COVID-19 vaccine

Pfizer says final results show vaccine 95% effective

UK regulators are also screening the BioNTech/Pfizer vaccine. 

"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," Pfizer CEO Albert Bourla said. 

In their pursuit of a European launch, potentially this year, the partners are neck-and-neck with rival Moderna, which said on Monday it would ask the EU regulator to recommend conditional approval for its shot.

Read more:

Moderna to seek U.S., EU emergency use after COVID-19 vaccine shows 94.1% protection

Source(s): AFP ,Reuters