EC authorisation follows European Medicines Agency recommendation and CHMP positive opinion for Moderna’s Covid-19 Vaccine
US-based biotechnology firm Moderna has received the European Commission (EC) conditional marketing authorisation (CMA) for its Covid-19 vaccine Moderna.
The authorisation allows the use of Covid-19 vaccine Moderna for vaccination programmes across the European Union (EU), said the company.
EU authorisation is based on the European Medicines Agency (EMA) recommendation for use of the Covid-19 Vaccine Moderna for immunisation in people aged 18 years and older.
EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the vaccine based on the totality of scientific evidence, including a data analysis from the Phase 3 clinical study.
Moderna chief executive officer 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.”
The Covid-19 Vaccine Moderna, also called Moderna Covid-19 vaccine in the US, is an mRNA-based vaccine against Covid-19, jointly developed by Moderna and investigators from NIAID’s Vaccine Research Centre.
EU is the fourth territory to authorise Covid-19 vaccine Moderna, following the US, Canada and Israel. The vaccine is currently being reviewed in Singapore, Switzerland and the UK for additional authorisation.
The US FDA authorised the emergency use of the Moderna Covid-19 Vaccine on 18 December 2020, Health Canada on 23 December 2020, under an Interim Order, Israel’s MOH authorised the vaccine recently, all for people aged 18 years and older.
Furthermore, EMA has executed its option to increase its order for Moderna’s Covid-19 vaccine by 80 million doses, making its total confirmed order reach 160 million doses.
The company is expected to begin the delivery of the first Covid-19 vaccine to European countries from its dedicated non-US supply chain in next week.