Pfizer, BioNTech Seek EU Clearance for Covid-19 Vaccine

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Source: Bloomberg

By Naomi Kresge

  •  BioNTech could ship first doses within hours of approval: CFO
  •  If cleared, vaccine could be rolled out by end of the year

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.The latest Covid updatesMake sense of the headlines and the outbreak’s global response with the Coronavirus Daily.EmailSign UpBy submitting my information, I agree to the Privacy Policy and Terms of Service and to receive offers and promotions from Bloomberg.

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.

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Categories: Vaccine

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