Prognosis
Pfizer, BioNTech Seek EU Clearance for Covid-19 Vaccine
- BioNTech could ship first doses within hours of approval: CFO
- If cleared, vaccine could be rolled out by end of the year
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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.