The European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of Moderna’s mRNA-1273 vaccine candidate against COVID-19. This follows confirmation of eligibility of mRNA-1273 for submission on October 14, 2020.
On 16 November Moderna announced that the independent, US NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase III study of mRNA-1273 had informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
“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, Chief Executive Officer of Moderna.
“We will continue our ongoing dialogue with the 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.”
Image credit: Hennie Stander