The European Commission has granted a conditional marketing authorisation (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.
The authorisation is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.
Stéphane Bancel, CEO of Moderna, said: “The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization.
“I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”
The European Union is the fourth jurisdiction to authorize Moderna’s COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021.
Additional authorisations are currently under review in Singapore, Switzerland and the United Kingdom.