Moderna Gets FDA Breakthrough Designation for RSV Vaccine Candidate

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By Colin Kellaher

Moderna Inc. on Monday said the US Food and Drug Administration has granted breakthrough therapy designation to its mRNA-1345 investigational vaccine candidate for respiratory syncytial virus, or RSV.

The vaccine maker of Cambridge, Mass. said the designation covers mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease in adults 60 years of age 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 that 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 top-line data from a Phase 3 study that demonstrated 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 throughout their lives, can cause serious illness in the elderly 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 of May for its RSV vaccine candidate for the prevention of respiratory tract diseases down in older adults.

Write to Colin Kellaher at

(END) Dow Jones Newswires

01-30-23 0753ET

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