Europe’s medical agency eyes safety of 2 COVID-19 vaccines

Coronavirus

FILE – This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. The German pharmaceutical company BioNTech and its U.S. partner Pfizer say they have submitted an application for conditional approval of their coronavirus vaccine with the European Medicines Agency. (Courtesy of University of Maryland School of Medicine via AP, File)

BERLIN (AP) — The European Medicines Agency said it would 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 agency also said Tuesday it could decide as early as Jan. 12 whether to approve an experimental COVID-19 vaccine developed by Moderna Inc.

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

The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the vaccine at a meeting scheduled for Jan. 12.

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