Pfizer (PFE) - Get Report and BioNTech (BNTX) - Get Report, the biopharmaceutical duo first to the finish line with a viable Covid-19 vaccine trial, formally asked the European Union for regulatory clearance for their Covid-19 vaccine, putting it on track for potential approval there before the end of the year.
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.
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.
Regulators globally are racing to review inoculation data, with governments eager to begin vaccinating their populations to curb the pandemic, which as of Monday has claimed the lives of more than 1.46 million people worldwide, according to data compiled by John Hopkins University.
Moderna (MRNA) - Get Report, another Covid-19 vaccine maker, requested clearance in the U.S. and Europe on Monday. The U.K. invoked a special rule to allow its own regulator to bypass its EU counterpart and sign off on the Pfizer-BioNTech vaccine. A U.S. Food and Drug Administration panel is set to meet Dec. 10 to discuss the vaccine as well.
If the EMA concludes that the benefits of the Pfizer-BioNTech shot outweigh its risks, it will recommend granting a conditional clearance that could enable the shot to be rolled out in Europe before the end of the year, the companies said in a statement.
Pfizer and BioNTech last month struck a deal to provide 200 million doses of their Covid-19 vaccine candidate to the European Union, with an option to request an additional 100 million doses.
Pfizer and BioNTech are also seeking regulatory approval in other countries including Australia, Canada and Japan, with deals already inked to deliver hundreds of millions of doses of their vaccine.
Shares of Pfizer were up 3.92% at $39.81 in trading on Tuesday, while shares of BioNTech were down 4.27% at $118.93.