Pfizer-BioNTech seek EU emergency approval for COVID-19 vaccine, target December rollout
Pfizer-BioNTech seek EU emergency approval for COVID-19 vaccine, target December rollout
By Ludwig Burger
FRANKFURT: Pfizer Inc and BioNTechs COVID-19 vaccine could be rolled out in Europe this month, the companies said on Tuesday after they applied for EU emergency approval for the shot.
The application to the European Medicines Agency (EMA) comes days after the companies applied for emergency use of their vaccine in the United States. They said their candidate, BNT162b2, could be launched in the European Union this month.
If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID?19, it will recommend granting a CMA (conditional marketing authorization)that could potentially enable use of BNT162b2 in Europe before the end of 2020, they said in a joint statement.
In their pursuit of a European launch, 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.
An effective immunization is seen as the main weapon against the pandemic, which has claimed more than 1.4 million lives and ravaged economies across the globe. Close to 50 potential vaccines are being tested on volunteers worldwide.
U.S. drugmaker Pfizer and Germanys BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate was 95
