News Category: Regulatory news
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age. This is the fourth vaccine recommended in the EU for preventing COVID-19.
After a thorough evaluation, the EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality.
View EMA Press Release
The CHMP incorporates scientific expertise from all the national competent authorities in Europe, including the HPRA.
The product information approved by the CHMP for COVID-19 Vaccine Janssen contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of the conditions of the vaccine’s authorisation.
More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks, and why the EMA recommended its authorisation in the EU.