COVID-19 Vaccine Janssen filed for conditional approval with EMA

The European Medicines Agency says it has received an application for conditional marketing authorization (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International, a unit of US healthcare giant Johnson & Johnson (NYSE: JNJ).

The EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee 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.

J&J’s Janssen unit filed for US Food and Drug Administration emergency use authorization (EUA) of the vaccine early this month, with the agency setting a review date of February 26.