Pfizer, BioNTech seek EU clearance for Covid-19 vaccine

by BLOOMBERG

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 European Medicines Agency said on Tuesday it could issue an opinion within weeks, with a meeting on the assessment scheduled for Dec. 29 at the latest. Submitted on Monday, the formal application 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.

Governments around the world are 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. BioNTech shares rose 2.3% in German trading.

In November, a study of almost 44,000 people showed the shot prevented 95% of symptomatic coronavirus cases.

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. The agency said it would work “over the Christmas period” on the assessment.

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.

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.

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