COVID-19: Moderna applies vaccine authorisation in U.S., Europe
U.S. firm Moderna said it would submit its Coronavirus (COVID-19) vaccine for emergency use authorisation by the U.S. Food and Drug Administration and conditional approval from the European Medicines Agency (EMA) on Monday.
The company said it planned to submit the necessary applications for approval of the use of its vaccine in the U.S. and European Union.
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 percent effective in preventing infection with COVID-19.
Earlier interim results said it was 94.5 percent effective against the virus.
The company says the vaccine trials have so far raised no serious safety concerns.
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