The companies filed for EU conditional regulatory clearance
After their successful data regarding the potential COVID-19 vaccine, the American Pfizer and the German BioNTech have applied for conditional regulatory clearance in the European Union.
The formal application follows last month's announcement that their BNT162b2 experimental COVID-19 drug proved to be more than 90% effective in preventing the infection. The data became available after the Phase III trial that involved 44,000 volunteers ended.
Europe's drug regulator, the European Medicines Agency, has to examine the data to see if the duo can receive conditional clearance. The conditional approval differs from the regular one as it is issued when the European authorities want to give quicker access to a certain treatment to patients. This type of clearance is valid for only one year, but it can be renewed or converted into a standard one.
Moreover, last month, Pfizer and BioNTech closed a deal with the EU for 200 million doses of their experimental COVID-19 drug. The European Union has the option to buy 100 million additional doses.
But the duo is not the first one in the race. On Monday, Moderna filed for regulatory clearance in the US and Europe, while Regeneron received the FDA's emergency use authorization for its COVID-19 vaccine.
At the moment of writing, data from Johns Hopkins University shows that over 1.46 million people have been tested positive for COVID-19 infection globally.
After the news hit the wire, Pfizer stock price gained 2.92%, while BioNTech lost 2.61%.
Sources: thestreet.com, marketwatch.com
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