EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine known as Moderna COVID-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news