The European Commission has granted a conditional marketing authorisation (CMA) to COVID-19 Vaccine Moderna for active immunisation to prevent the disease in individuals aged 18 years and above.
Vaccination programmes using the Moderna jab will take place across the European Union soon.
Moderna noted that the latest development comes from the totality of scientific evidence shared by the company, including data from the Phase III clinical study.
The European Medical Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) analysed the quality, safety and efficacy data of the vaccine and recommended granting CMA.
EMA Executive Director Emer Cooke said: “This vaccine provides us with another tool to overcome the current emergency.
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public.”
Last month, the EMA increased its confirmed order commitment by 80 million vaccine doses taking it to a total of 160 million doses.
European countries should get their first deliveries of vaccine from Moderna’s dedicated non-US supply chain next week.
Moderna CEO Stéphane Bancel 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 authorisation.”
Last month, the US and Canada authorised the vaccine, while authorisations in Singapore, Switzerland and the UK are under review.