Germany’s BioNTech and its US partner Pfizer on Tuesday 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 they had submitted an application to the European Medicines Agency on Monday seeking “Conditional Marketing Authorisation (CMA)” for their vaccine.
The move comes after large-scale tests showed their vaccine was 95 percent effective against COVID-19 and triggered no serious side effects.
If approved by the Amsterdam-based EMA, the vaccine could potentially be rolled out “in Europe before the end of 2020”, the companies said in a statement.
The company has previously sought the United States on Nov. 20, taking them a step closer to launching their vaccine for public use.
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, as Reuters reported.
The British government said last week that the U.S.-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA), the report further wrote.