Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA's December 17 meet

FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/


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CAMBRIDGE, Mass. (Reuters) — Moderna's COVID-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator's advisory committee meeting, Chief Executive Officer Stéphane Bancel said on Wednesday.

The Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company's request for emergency use authorization 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 authorizations both in the United States and the EU after full results from a late-stage study showed its vaccine was 94.1% effective with no serious safety concerns.

A shot developed by Pfizer and BioNTech that was 95% 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 authorizations 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% at $142.47. They have risen more than seven-fold this year, valuing the company at $55.80 billion as of Tuesday's closing price.

(Reporting by Mrinalika Roy and Trisha Roy in Bengaluru; Editing by Anil D'Silva)

© Copyright Thomson Reuters 2020


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