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www.fdanews.com/articles/200080-ema-begins-rolling-review-of-modernas-mrna-vaccine-candidate

EMA Begins Rolling Review of Moderna’s mRNA Vaccine Candidate

November 18, 2020

The European Medicines Agency (EMA) has launched a rolling review of Moderna’s vaccine candidate mRNA-1273, on the heels of the Cambridge, Mass., drugmaker’s announcement that the vaccine demonstrated 94.5 percent efficacy in early results from a phase 3 trial.

Based on the interim data, the messenger RNA-based vaccine appears to have greater efficacy than the Pfizer/BioNTech vaccine, BNT162b2, and it does not need to be stored at a super-cold temperature.

Moderna CEO Stéphane Bancel said the company is scaling up global manufacturing with Lonza of Switzerland and ROVI of Spain to “be able to deliver approximately 500 million doses per year [or] possibly up to 1 billion doses per year, beginning in 2021.”

Moderna has received more than $1 billion in payments from governments securing doses of the experimental vaccine (DID, Oct. 30). The company plans to file for Emergency Use Authorization from the FDA as soon as this month. ― Jason Scott