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EMA starts review of Sanofi-GSK COVID vaccine application

The European Union's drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline's application seeking conditional authorization for their COVID-19 vaccine, the agency said on Wednesday. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be used as a booster as well as a standalone two-dose shot. In support of the companies' application, the final data package comprising a late-stage trial of the vaccine and another trial testing it as a booster was submitted to the European Medicines Agency (EMA) on March 29, the drugmakers said in an email to Reuters.

Reuters - March 31, 2022

View the full story here: https://www.reuters.com/world/europe/ema-starts-review-sanofi-gsk-covid-vaccine-application-2022-03-30/