A laboratory technician preparing a blood sample in August in DeLand, Florida, for a vaccine clinical trial sponsored by Moderna. Photo: Paul Hennessy/NurPhoto via Getty Images
Why it matters: Bancel told FT that the drugmaker will not seek emergency authorization for Food and Drug Administration approval for its vaccine to use in frontline medical workers and at-risk individuals until Nov. 25 at the earliest.
- He added the company would not seek FDA approval for use in the general population until late January.
- If the vaccine is proven safe and effective, approval is unlikely to come until at least late March or early April.
What they’re saying: “I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said, according to the FT.
The big picture: Moderna’s vaccine is one of four that are currently in late-stage testing in people in the U.S.
- The Trump administration in August announced it purchased 100 million doses of Moderna’s experimental coronavirus vaccine for $1.5 billion, or $15 per dose.
- The president has repeatedly claimed that a vaccine will be available for widespread distribution before the end of the year, though CDC Director Robert Redfield testified to Congress that it’s more likely a vaccine won’t be available until the second or third quarter of next 2021.