The conditional marketing authorisation is based on the recommendation of the European Medicines Agency (EMA) for use of the Covid-19 Vaccine Moderna for active immunisation to prevent Covid-19 disease.
The Covid-19 Vaccine Moderna is an mRNA vaccine against Covid-19 designed to encode a prefusion stabilised form of the Spike (S) protein. It was co-developed by Moderna and investigators from NIAID’s Vaccine Research Centre.
Moderna’s Covid-19 vaccine has already been authorised in the US, Canada and Israel. It is also currently under assessment in Singapore, Switzerland and the UK.
In December, the EMA exercised its option to expand its confirmed order commitment by 80 million doses of Moderna’s Covid-19 vaccine and its confirmed order now reached 160 million doses.
Moderna is planning to start the first deliveries of its Covid-19 vaccines in the next week via its non-US supply chain.
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. I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”
In December 2020, Moderna’s mRNA-1273 vaccine has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for the prevention of Covid-19.
According to the EUA, the mRNA-1273 vaccine can be administered to individuals aged 18 years or older.