EU approves Moderna’s COVID-19 vaccine

pharmafile | January 7, 2021 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Moderna, Vaccine 

The European Commission has granted a Condition Marketing Authorisation (CMA) for Moderna’s COVID-19 vaccine, meaning the jab will soon be rolled out across the EU’s 27 states as part of its vaccination programme.

The authorisation is based upon the EMA’s recommendation for use of the company’s vaccine in individuals 18 years of age and older.

The EU is the fourth jurisdiction to authorise Moderna’s COVID-19 jab, following the US and Canada in December, and Israel just days ago. Additional 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, bringing its confirmed order commitment to 160 million doses. The first deliveries of the jab to European countries from Moderna’s dedicated non-US supply chain are expected to begin next week.

The EMA’s Committee for Medicinal Products for Human Use recommended Moderna’s COVID-19 vaccine offering based on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase III clinical study announced on November 30.

Stéphane Bancel, Chief Executive Officer of Moderna, said: “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.

“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.”

Darcy Jimenez

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