Moderna's experimental coronavirus vaccine gets FDA's 'fast track' status
Moderna Inc announced the U.S. Food and Drug Administration granted “fast track” designation to its experimental coronavirus vaccine to speed up the regulatory review process.
A late-stage study of the vaccine in early summer
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 COVID-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.