Moderna Inc said on Tuesday the U.S. Food and Drug Administration 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 285,000 people globally. It expects to start a late-stage study of the vaccine in early summer.
There are no approved treatments or vaccines for the CVOID-19 respiratory illness caused by the new coronavirus, though some drugs are being used on patients under an emergency-use authorization.
The agency'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.
© 2024 Thomson/Reuters. All rights reserved.