News Category: Regulatory news
The EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age.
This is the fifth COVID-19 vaccine that the EMA has recommended for authorisation.
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 Nuvaxovid contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.
More information is also 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.