May 12, 2020 / 12:20 PM / 2 months ago

Moderna's potential coronavirus vaccine gains FDA's 'fast track' status

FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/

(Reuters) - Moderna Inc said on Tuesday the U.S. Food and Drug Administration granted “fast track” designation to its experimental coronavirus vaccine, a move that speeds up the regulatory review process.

Moderna has been racing to develop a safe and effective vaccine against the novel coronavirus that has killed more than 285,000 people globally.

A vaccine or treatment that gets the “fast track” designation is eligible for the agency’s “priority review” status, under which the FDA aims to take a decision on approving the drug within six months.

More than 100 potential COVID-19 vaccines are being developed, including several in clinical trials, but the World Health Organization in April had warned that a vaccine would take at least 12 months.

Moderna expects to start a late-stage study of the vaccine in early summer and says there is potential for a marketing application approval in 2021.

The vaccine works on the messenger RNA (mRNA) technology, which instructs cells in the body to make specific coronavirus proteins that then produce an immune response. The approach can be used in many types of treatments but has not yet been approved for any medicine.

Drugmakers such as Johnson & Johnson and Pfizer Inc, which is working with Germany’s BioNTech SE, are also working to develop vaccines for the novel coronavirus.

Last month, Moderna received $483 million funding from a U.S. government agency to accelerate development of the vaccine.

(This story refiles to correct company name in paragraph 8 to “Moderna” from “Morderna”)

Reporting by Manas Mishra in Bengaluru; Editing by Amy Caren Daniel

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