EU regulator set to approve Pfizer/BioNTech COVID-19 vaccine on Dec. 23

[December 15, 2020]  By Andreas Rinke

BERLIN (Reuters) - The European Medicines Agency (EMA) is set to approve its first COVID-19 vaccine on Dec. 23, a German government source told Reuters on Tuesday, putting EU countries on track to start to catch up with the United States and Britain, where immunisation campaigns are under way.

"Yes, the EMA will be done on December 23," the source said, referring to the watchdog's review of a vaccine developed by U.S. company Pfizer and its German partner BioNTech.

German Health Minister Jens Spahn told a news conference that he hoped European Union approval for the vaccine would be in place before Christmas, clearing a path for innoculations before the end of the year.

"It is good news that the approval can be granted on December 23," Jens Spahn said at a news conference when asked about the reported date.

The goal was still to have a regular approval, not an emergency approval.

"It will be the first regular approval of a (COVID-19) vaccine in the world," Spahn added.

An EMA official said they were discussing possible dates before Christmas for a decision on the Pfizer/BioNTech vaccine.

Britain was the first to approve the shot for emergency use on Dec. 3, followed by Canada on Dec. 9 and the U.S. Food and Drug Administration (FDA) on Dec. 11.

EMA said in early December it planned to issue its view on the BioNTech/Pfizer vaccine by Dec 29, and on another candidate developed by Moderna by Jan. 12.

EMA's mandate is to issue recommendations on new medical treatments. The European Commission has the final say on approval and typically follows EMA's advice.

German newspaper Bild earlier reported that a positive EMA verdict was slated for Dec 23, citing government and European Commission sources. Bild added that Dec. 26 was seen a possible launch day for vaccinations in Germany.

(Additional reporting by Thomas Seythal, Ludwig Burger, Patricia Weiss and Kirsti Knolle; editing by Thomas Escritt and Keith Weir)

[© 2020 Thomson Reuters. All rights reserved.]

Copyright 2020 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.