Berlin: Pfizer Inc. and partner BioNTech SE sought regulatory clearance for their Covid-19 vaccine in the European Union, putting the shot on track for potential approval there before the end of the year.
The formal application submitted on Monday caps a rolling review process that started on Oct. 6 and allowed Europe’s drugs regulator to examine data on the vaccine as it emerged. In November, a study of almost 44,000 people showed the shot prevented 95% of symptomatic coronavirus cases. BioNTech shares rose in German trading.
Regulators around the world are racing to review inoculation data, with governments eager to start vaccinating their populations to curb the pandemic. Rival Moderna Inc. requested clearance in the U.S. and Europe on Monday. The U.K. invoked a special rule to allow its regulator to bypass its EU counterpart and may be the first to sign off on the Pfizer-BioNTech product. The U.S. isn’t far behind, with a Food and Drug Administration panel set to meet on Dec. 10 to discuss the vaccine.
BioNTech can start shipping the first doses “within hours” after regulatory clearance, Chief Financial Officer Sierk Poetting said at a press conference.
If the European Medicines Agency 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.
Vaccine race
Pfizer and BioNTech also started regulatory submissions in other countries including Australia, Canada and Japan, they said. The partners have signed deals to deliver hundreds of millions of doses of the vaccine, including an agreement with the EU for 200 million doses, with an option for an additional 100 million.
A conditional clearance is issued when European authorities want to get a drug to patients quickly without waiting for as comprehensive a data package as would normally be required for standard authorization. It’s valid for one year and can be renewed — and eventually converted into a standard approval.- Bloomberg
Also read: Astra-Oxford vaccine prevents average of 70% of Covid cases