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.