Pfizer (PFE) - Get Report and BioNTech (BNTX) - Get Report are forging forward with rolling out their Covid-19 vaccine in Europe, formally asking the European Union for regulatory clearance to distribute the vaccine before the end of the year.
The application for European conditional clearance to distribute the vaccine comes as part of a rolling review process that allowed the European Medicines Agency, Europe’s top drug regulator, to examine data on the vaccine as it emerged. The study has since shown that the shot prevented 95% of symptomatic coronavirus cases.
Conditional clearance is issued when European authorities want to get a drug to patients quickly without waiting for a more typical comprehensive data set. It is valid for one year and can be renewed. It also can be converted into a standard approval.
The formal application follows the companies' blockbuster announcement last month that their vaccine candidate, BNT162b2, had a more than 90% efficacy rate in Phase 3 trials that involved almost 44,000 people.