Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.
The authorization 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.
“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 Stéphan Bancel, Chief Executive Officer 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 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 authorizations 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 to160 million doses. The first deliveries of COVID-19 Vaccine Moderna to European countries from Moderna’s dedicated non-U.S. supply chain are expected to begin next week.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for COVID-19 Vaccine Moderna based on the totality of scientific evidence shared by the Company including a data analysis from the pivotal Phase 3 clinical study announced on November 30.
