Moderna applies to FDA, EMA for emergency use of COVID-19 vaccine

U.S. pharmaceutical firm Moderna said it would submit on Monday its Coronavirus (COVID-19) vaccine for emergency use authorisation.

The applications will go to the U.S. Food and Drug Administration and the European Medicines Agency (EMA) on Monday.

The company said it would only seek conditional approval from EMA.

Moderna said it had already initiated so-called rolling review processes with the EMA, as well as with regulatory authorities in Canada, Switzerland, Britain, Israel, and Singapore, aimed at speeding up authorisation.

Moderna also released results of its follow-up phase 3 COVE study, involving 30,000 participants, which show its vaccine is 94.1-per cent effective in preventing infection with COVID-19.

Earlier interim results said it was 94.5-per cent effective against the virus.

The company said the vaccine trials have so far raised no serious safety concerns.