The European Medicines Agency (EMA) on Monday recommended the coronavirus vaccine developed by US biotechnological company Novavax for marketing authorization.
"EMA has recommended granting a conditional marketing authorization for Novavax’s COVID-19 vaccine Nuvaxovid to prevent COVID-19 in people from 18 years of age," the EU agency said in a press statement.
After evaluating scientific data on two main clinical studies involving a total of 45,000 people, the EMA concluded that the jab "met EU criteria for efficacy, safety and quality," it added.
Studies showed 90% efficacy for the vaccine in preventing COVID-19 infection.
After the EU drug regulator's green light, it is for the European Commission to officially grant the marketing authorization.
Nuvaxovid is a protein-based vaccine that prepares the body's immune system to defend against COVID-19 by using a tiny protein particle of the virus produced in a laboratory.
After vaccination, people start to produce antibodies and immune cells that can kill the virus.
The European Commission signed an advanced purchase agreement with Novavax in August for 200 million vaccines to be delivered between 2021 and 2023.
After the Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson&Johnson COVID-19 vaccines, this was the fifth vaccine authorized by the EU regulator.