The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for vaccine based on the totality of scientific evidence shared by the company
The European Commission has granted a conditional marketing authorisation (CMA) for the Moderna COVID-19 vaccine, 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 vaccine for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.
“I want to thank the European Commission for its engagement and endorsement and the EMA for its recommendation, which is another significant moment in our company’s history,” said Stéphane Bancel, CEO of Moderna. “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 authorisation. 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 authorise Moderna’s COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021. Authorisations are currently under review in Singapore, Switzerland and the United Kingdom.
On December 18, the EMA exercised its option to increase its confirmed order commitment by 80 million doses of Moderna’s vaccine against COVID-19, bringing its confirmed order commitment to 160 million doses. The first deliveries to European countries from Moderna’s non-US supply chain are expected to begin next week.