European Medicines Agency exercises its option for increasing the confirmed order commitment by 80 million doses, bringing total to 160 million.
The European Commission has granted a conditional marketing authorization (CMA) to Moderna’s coronavirus disease 2019 (COVID-19) vaccine mRNA1273. This authorization will allow vaccination programs to roll out the vaccine across the whole of the European Union.
The CMA follows the European Medicines Agency’s (EMA) recommendation of the Moderna vaccine for the use of active immunization to prevent COVID-19, which is caused by the SARS-CoV-2 virus, in individuals 18 years of age and older.
On November 30th, the EMA’s Committee for Medicinal Products for Human Use (CHMP) took on a positive opinion of mRNA1273 after reviewing Phase 3 clinical data and determining the totality of scientific evidence suggested the vaccine was efficacious. This comes after authorizations in the United States, Canada and Israel.
“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,” Stéphane Bancel, Chief Executive Officer 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.”
Additionally, Moderna has recently provided a supply update of its vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. The biotech company also stated that it is continuing to add staff and invest, hoping to reach 1 billion doses by the end of the year.
It is expected that the United States will have 100 million doses available by the end of the 1st quarter of 2021 and 200 million by the end of the 2nd quarter. With the Canadian government recently authorizing the vaccine by Health Canada's Interim Order, they have also received additional doses.
“Our effectiveness in providing early supply to the U.S. and Canadian governments and our ability to increase baseline production estimates for 2021 are both signals that our scale up of mRNA vaccine production is a success,” Juan Andres, Chief Technical Operations and Quality Officer at Moderna said. “I want to thank the many private and government collaborators, contractors and the hundreds of Moderna staff who have been working thoughtfully and tirelessly to accomplish this.”