EMA Confirms Moderna’s COVID-19 Vaccine is Eligible for Rolling EU Review

EMA Confirms Moderna’s COVID-19 Vaccine is Eligible for Rolling EU Review

Moderna’s Covid-19 candidate vaccine, mRNA-1273 has obtained confirmation from the European Medicines Agency (EMA) to apply for a marketing authorization from the European Union.

The EMA’s confirmation highlights Moderna’s commitment to make the vaccine accessible to the entire European Union and, as reported by the company, Moderna’s application for authorization will include updated clinical information on mRNA-1273.

Specifically, the results obtained from a preclinical study on the virus will be included, as well as the provisional analysis of phase 1 of the study of mRNA-1273 in adults (18-55 years) and the elderly (56-70 and 71+ years) published in the ‘New England Journal of Medicine’.

Also, as of October 9, 22,194 participants in phase 3 of the ‘COVE’ study of the candidate vaccine, mRNA-1273, have received their second vaccine. In Europe, the company is working with its strategic partners, the Swiss, Lonza, and the Spanish, ROVI, to manufacture and supply the vaccine.

It is a supply chain dedicated entirely to supporting Europe and countries that, apart from the United States, have purchasing agreements with Moderna.

“We are satisfied with the productive interactions with the European regulatory authorities at the national level and at the EMA level. We are committed to developing an effective vaccine following the guidance of regulatory bodies and will continue our ongoing dialogue with the EMA,” said the Managing Director of Moderna, Stéphane Bancel.

Moderna has announced that the Canadian Ministry of Health will begin the evaluation of its vaccine candidate. Additionally, it is expanding globally in manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, starting in 2021.

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