The European Commission (EC) has handed Moderna a conditional marketing authorisation for its COVID-19 vaccine, after a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) was issued yesterday.
The CHMP recommendation was supported by Moderna’s phase III clinical trial, evaluating its COVID-19 vaccine in individuals aged 18 to 94 years of age.
The trial demonstrated a 94.1% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine, compared with people who received placebo, reflecting a 94.1% efficacy rate for the jab.
In participants at risk of developing severe COVID-19, including people with chronic lung disease, heart disease, obesity and liver disease, the trial showed an efficacy rate of 90.9%.
The EC has ordered a total of 160 million doses of the Moderna vaccine for use in the European Union, with the first deliveries to European countries expected to begin next week.
The EU is the fourth jurisdiction to approve Moderna’s COVID-19 vaccine in some capacity, following the US, Canada and Israel.
The vaccine is also currently under review for authorisation in Singapore, Switzerland and the United Kingdom.
“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,” said Stéphane Bancel, chief executive officer of Moderna.
“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,” he added.