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#EU agency moves forward meeting on Moderna COVID-19 vaccine

#EU agency moves forward meeting on Moderna COVID-19 vaccine

EU agency moves forward meeting on Moderna COVID-19 vaccine
The facade of Moderna, Inc. headquarters is seen, Tuesday, Dec. 15, 2020, in Cambridge, Mass. The Food and Drug Administration said that a second potential COVID-19 vaccine, developed by Moderna, appears safe and highly effective, bringing it to the cusp of U.S. authorization. A panel of outside experts is expected to vote to recommend the formula on Thursday, with the FDA’s green light coming soon thereafter. (AP Photo/Elise Amendola)

The European Union’s medicines agency announced Thursday that it has moved forward a meeting to consider authorizing a coronavirus vaccine made by Moderna for use in the 27-nation bloc.

The Amsterdam-based agency, which is meeting Monday to consider authorizing a vaccine made by Pfizer Inc. and German company BioNTech for use in the EU, had scheduled a meeting to discuss the Moderna vaccine on Jan. 12, but that has now been brought forward to Jan. 6.

The decision came after Moderna sent that last package of data on the vaccine needed for the agency to assess it for the EU market, the EMA said.

“We have constantly revised our planning to further streamline all the procedural aspects that need to be in place for a robust scientific assessment that leads to a marketing authorization in all EU countries,” EMA Executive Director Emer Cooke said. “The number of infections is increasing across Europe and we are aware of the huge responsibility we have to get a vaccine to the market as quickly as is feasible, whilst maintaining the robustness of our scientific review.”

The EMA’s approval is valid in all 27 EU countries and once it is granted, countries can start receiving vaccines for immunization campaigns.


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EU agency moves forward meeting on Moderna COVID-19 vaccine (2020, December 17)
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