Judul : Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA's Dec 17 meet - CNA
link : Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA's Dec 17 meet - CNA
Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA's Dec 17 meet - CNA
WASHINGTON: Moderna's COVID-19 vaccine could be approved for emergency use within 24 to 72 hours after the US health regulator's advisory committee meeting, Chief Executive Officer Stéphane Bancel said on Wednesday (Dec 2).
The Food and Drug Administration is scheduled to hold the meeting on Dec 17 to discuss the company's request for emergency use authorisation for its vaccine.
Moderna currently has millions of doses of vaccines that can be shipped as soon as its request is granted, Bancel said, while speaking at the Piper Sandler healthcare conference.
Moderna, which is one of the front-runners in the race to develop a coronavirus vaccine, has applied for emergency authorisations both in the United States and the EU after full results from a late-stage study showed its vaccine was 94.1 per cent effective with no serious safety concerns.
READ: HSA evaluating initial data on COVID-19 vaccine submitted by Moderna for use in Singapore
A shot developed by Pfizer and BioNTech SE that was 95 per cent effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the authorisations after the advisers make their recommendations.
Bancel said Moderna was in a position to ramp up production quickly and would generate a lot of cash next year.
"We have the platform, and now is the time to scale," he said.
Moderna shares were up 1 per cent at US$142.47. They have risen more than seven-fold this year, valuing the company at US$55.80 billion as of Tuesday's closing price.
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