By Colin Kellaher
Moderna Inc. on Monday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to its mRNA-1345 investigational vaccine candidate for respiratory syncytial virus, or RSV.
The Cambridge, Mass., vaccine maker said the designation covers mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease in adults ages 60 and older.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
Moderna said mRNA-1345, which uses the same messenger RNA technology as its blockbuster Covid-19 vaccines, won the designation based on positive topline data from a Phase 3 study that showed vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by two or more symptoms in older adults.
The company said it plans to file for FDA approval of the vaccine in the first half of the year.
RSV, a common respiratory virus that people get many times over the course of their lives, can cause serious illness in the very old and young. There are currently no FDA-approved prophylactic, therapeutic or vaccine options for RSV for older adults.
Moderna rival Pfizer Inc. in December said the FDA had granted priority review with a target action date in May for its RSV vaccine candidate for the prevention of lower respiratory tract disease in older adults.
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(END) Dow Jones Newswires