Berlin, Dec. 1, (dpa/GNA) – US firm Moderna said it has applied for emergency use authorization from the US Food and Drug Administration (FDA), for approval of the use of its Covid-19 vaccine in the United States.
The company had announced earlier in the day its plans to lodge the application, and confirmed the process later on Twitter.
The FDA said it scheduled an advisory committee meeting for December 17 to discuss the application.
The company also said on Monday it will apply for conditional approval from the European Medicines Agency (EMA).
Moderna says it has already initiated so-called rolling review processes with the EMA, as well as regulatory authorities in Canada, Switzerland, Britain, Israel and Singapore, aimed at speeding up authorization.
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 says the vaccine trials have so far raised no serious safety concerns.
With its application on Monday, Moderna will become the first pharmaceutical to apply for authorization of its vaccine in the EU.
Last week, EU Commission President Ursula von der Leyen announced that the EU had concluded a contract for up to 160 million vaccine doses with Moderna.
The contract foresees an initial delivery of 80 million vaccine doses, with the option of 80 million additional doses at a later date.
Moderna says its vaccine could be delivered to the EU as early as December, if it receives approval.
GNA