MODERNA SEEKS EMERGENCY USE AUTHORIZATION FOR VACCINE IN EU, U.S.
US firm Moderna says it will submit its COVID-19 vaccine for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The company plans to submit the necessary applications for approval of the use of its vaccine in the European Union (EU) and United States, it said in a statement, Deutsche Presse-Agentur (dpa) reported.
Moderna says it has 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 authorization.
Moderna also released results of its follow-up phase 3 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 says the vaccine trials have so far raised no serious safety concerns.