European regulator to decide Dec. 29 on 1st virus vaccine

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The European Medicines Agency will convene a meeting on Dec. 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved, the regulator said Tuesday.

The agency also said Tuesday it could decide as early as Jan. 12 whether to approve a rival COVID-19 vaccine developed by Moderna Inc.

In a statement, the EU medicines regulator said it had already begun a "rolling review" of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how well that vaccine triggers an immune response and whether it is safe enough for broad use across Europe.

"We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us," Pfizer's chief executive Albert Bourla said in a statement. The European Union's top official said around 2 billion doses of potential COVID-19 vaccines have been secured for the bloc's 27 nations, with the first deliveries likely to start before the end of the year.

The Commission, the EU's executive arm, has secured deals allowing to purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.

 

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