FDA fast-tracks experimental virus vaccine by Moderna
The biotech company expects to start a late-stage study of the vaccine early in the northern hemisphere summer
Bengaluru — Moderna said on Tuesday that the US Food and Drug Administration (FDA) granted “fast-track” designation to its experimental coronavirus vaccine to speed up the regulatory review process.
The company has been racing to develop a safe and effective vaccine against the novel coronavirus that has killed more than 288,000 people globally. It expects to start a late-stage study of the vaccine early in the northern hemisphere summer.
There are no approved treatments or vaccines for Covid-19, though some drugs are being used on patients under an emergency-use authorisation.
The FDA’s fast-track status is designed to expedite the review of treatments and vaccines meant for serious conditions. A vaccine or treatment that gets the status is eligible for more frequent meetings with the FDA.
Moderna’s shares rose 1.6% to $67.92 before the bell.
Would you like to comment on this article or view other readers' comments?
Register (it’s quick and free) or sign in now.
Please read our Comment Policy before commenting.