BRIEF—EMA receives Moderna's COVID-19 vaccine CMA application

The European Medicines Agency today revealed it has received an application for conditional marketing (CMA) for a COVID-19 mRNA vaccine from Moderna.

The assessment of the vaccine, dubbed mRNA1273, will proceed under an accelerated timeline.

An opinion 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.

Such a short timeframe is only possible because the EMA has already reviewed some data on the vaccine during a rolling review.

During this phase, the EMA assessed data from laboratory studies and also started assessing data on immunogenicity (how well the vaccine triggers a response against the virus) and safety from an early study.

The Agency and its scientific committees will continue working on the assessment over the Christmas period.

If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, the EMA’s scientific committee for human medicines ( CHMP) will conclude its assessment during an extraordinary meeting scheduled for January 12 at the latest.