2/16, 4:50 PM (Source: TeleTrader)
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J&J applies for COVID-19 vaccine approval in EU

Johnson & Johnson's subsidiary Janssen-Cilag International N.V. has submitted an application for the conditional marketing authorization of its COVID-19 vaccine in the European Union, the European Medicines Agency announced on Tuesday.

The EMA noted its human medicines committee (CHMP) will review it under an "accelerated timetable," stressing it "could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust."

European Commission President Ursula von der Leyen welcomed the news and added the Commission "will be ready to grant authorisation as soon as EMA delivers a positive scientific opinion."

Breaking the News / NP