Moderna to submit coronavirus vaccine candidate for EU approval
The firm already initiated a rolling submission of its vaccine to Canada.
By JERUSALEM POST STAFFFILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020(photo credit: BRIAN SNYDER/REUTERS)
Biotech firm Moderna received confirmation from the European Medicine Agency (EMA) Wednesday that its coronavirus vaccine candidate is eligible for submission for European Union Marketing Authorization, which would allow it to be approved for use in Europe.The vaccine candidate, known as mRNA-1273, has shown positive results from clinical trials and studies in both adults aged 18-55 and aged 56 onward, which were published in the academic periodical New England Journal of Medicine.“We are pleased with the productive interactions with the European regulatory authorities at the national level and at the EMA level to date and we appreciate their valuable guidance and confidence in Moderna to pursue an MAA submission for approval in Europe for our COVID-19 vaccine candidate, mRNA-1273. European partners, investors and citizens have been part of Moderna from the beginning of the company and have played an important role in Moderna’s progress,” CEO Stéphane Bancel said in a statement.“We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies and we will continue our ongoing dialogue with the EMA," he said. "Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”The firm will work with European manufacturers Lonza (based in Switzerland) and ROVI (based in Spain) to manufacture vaccines outside the US, which has its own supply chain.This comes in the wake of Tuesday's announcement, where Moderna stated it had initiated a rolling submission of its vaccine candidate to Canada's health body. The submission was accepted under the Canadian health minister's interim order and is currently under review, though no decision will be made regarding vaccine authorization until all necessary evidence supporting its efficacy and safety has been received. Despite being close to the US, Canada's Moderna doses, which it has already committed to obtaining back in September, will be supplied by the European supply chain.“We are pleased with the interactions with the Canadian regulatory authorities and we appreciate their guidance and confidence in Moderna to pursue a rolling submission in Canada for our COVID-19 vaccine candidate, mRNA-1273,” Bancel said at the time.“We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies around the world and we will continue working closely with Health Canada.”
