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Saturday, July 24, 2021

EU Starts Reviewing Sanofi COVID-19 Vaccine

Europe’s medicines regulator announced on Tuesday that it has begun a real-time examination of the COVID-19 vaccine which was created by Sanofi and GlaxoSmithKline of the United Kingdom. 

This is the fifth shot to be reviewed in this manner.

The European Medicines Agency (EMA) decided to conduct a “rolling review” of the vaccine Vidprevtyn based on preliminary results from laboratory investigations and early-stage clinical trials in adults.

EMA said that Vidprevtyn is expected to prepare the body to defend itself against infection with SARS-CoV-2. It is a protein-based vaccine that contains a laboratory-grown version of the spike protein found on the surface of SARS-CoV-2.

After early-stage data showed the vaccine creates a significant immune response, Sanofi and GSK hope to gain approval by the end of 2021.

“EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety, and quality,” the regulator said in a statement.

“EMA will communicate further when the marketing authorization application for the vaccine has been submitted,” it added.

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