EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate

Moderna reported in a Nov. 17, 2020 press release that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

CHMP’s decision to commence the rolling review of data on mRNA-1273 has been based on the preliminary results from non-clinical and early clinical studies, which have suggested the vaccine has an efficacy of 94.5%. The rolling review will be performed by the committee until there is sufficient data to support a formal marketing authorization application.

“The start of the rolling review process marks an important next step as we continue to advance mRNA-1273 in collaboration with European regulatory authorities,” said Stéphane Bancel, CEO of Moderna, in the press release. “We will continue our ongoing dialogue with EMA as we seek to develop a safe and effective vaccine. We are also scaling up global manufacturing with our strategic partners Lonza of Switzerland, and ROVI of Spain to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”