EU Grants Emergency Use for Moderna’s mRNA COVID-19 Vaccine

January 11, 2021 - Moderna recently announced that the European Commission (EU) granted conditional marketing authorization (CMA) for its mRNA COVID-19 vaccine. 

The authorization of COVID-19 Vaccine Moderna, previously mRNA-1273, is based on recommendations from the European Medicines Agency (EMA) to use the candidate for active immunization to prevent the coronavirus in individuals 18 years of age and older. 

Health officials can now roll out the vaccine across the EU throughout 2021, including to its 27 member states. 

“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,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“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,” Bancel continued. 

The EU’s decision comes just weeks after the Canadian Government announced that it will now acquire an additional 20 million doses of COVID-19 Vaccine Moderna, bringing the total to 40 million doses. 

The decision to double the doses of the vaccine candidate was due to the government’s confidence that the vaccine was proven safe and effective in providing protection against the coronavirus, officials said in the December announcement. 

The EU is the fourth jurisdiction to authorize COVID-19 Vaccine Moderna, following the US in mid-December, Canada at the end of December, and most recently, Israel’s Ministry of Health (MOH). 

 MOH secured 6 million doses of the vaccine candidate last week, with distribution planned to begin shortly. 

The decisions from both the MOH and the EU were based on a rolling submission of data of Moderna’s Phase 3 study of COVID-19 Vaccine Moderna at the end of November, which found that the candidate was 94.1 percent effective against the coronavirus.

The study, which enrolled over 30,000 participants in the US, was based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of the vaccine. 

Specifically, vaccine efficiency was seen in a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group. 

A secondary endpoint analyzed 30 severe COVID-19 cases of COVID-19, all of which occurred in the placebo group and none in the group that received the mRNA-1273 injections. 

Additional authorizations for COVID-19 Vaccine Moderna are currently under review in Singapore, Switzerland, and the United Kingdom, Moderna stated. 

In mid-December, Moderna stated that it expected to have nearly 20 million doses of COVID-19 Vaccine Moderna to ship in the US. At the time, the company was on track to manufacture 500 million to 1 billion doses globally by the end of this year. 

But just last week, the company released a COVID-19 vaccine manufacturing update for its vaccine candidate, increasing the base-case global production estimate from 500 to 600 million doses for 2021. 

Nearly 100 million of these doses are expected to be available in the US by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. 

Due to the distribution increase globally, Moderna has developed specific distribution plans alongside drug development in order to get an approved vaccine into the hands of providers as soon as possible.

In mid-August, for example, HHS and the Department of Defense (DoD) announced an agreement with Moderna for large-scale production and nationwide delivery of 100 million doses of COVID-19 Vaccine Moderna in the US.

The agreement also includes fill-finish manufacturing in US-based facilities, which ensures vaccine doses are packaged and ready to ship immediately once the vaccine showed success in clinical trials.