Europe – EMA will review Moderna vaccine Jan. 6

As it faces increasing pressure to authorize vaccines to prevent COVID-19, the European Medicines Agency (EMA) on Thursday said it would speed up its assessment of Moderna’s mRNA COVID-19 vaccine by nearly a week after receiving the last outstanding data it needed to decide on the application.

The agency had initially scheduled an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) to conclude its assessment of Moderna’s conditional marketing authorization application for 12 January, which will now be held on 6 January. The original meeting date will still be held as a precautionary measure.

The announcement comes just days after the agency announced it would move up its meeting to consider Pfizer and BioNTech’s COVID-19 vaccine by eight days to 21 December and follows news of a cyberattack that resulted in unlawful access of documents submitted in relation to both Pfizer-BioNTech and Moderna’s vaccines. (RELATED: EMA hit by cyberattack, Pfizer-BioNTech documents accessedRegulatory Focus 9 December 2020; Despite data breach, CHMP set to consider Pfizer-BioNTech COVID vaccineRegulatory Focus 15 December 2020)…