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J&J's vaccine for respiratory virus gets US FDA breakthrough status

Johnson & Johnson received a breakthrough therapy designation from the U.S. Food and Drug Administration for its vaccine to prevent a certain virus that is linked to infection in the lungs.

The company's unit Janssen Pharmaceuticals Inc. is developing a vaccine for the prevention of the respiratory syncytial virus, or RSV, in patients 60 years of age or older.

RSV is a highly contagious and potentially life-threatening respiratory infection, which causes pneumonia, bronchiolitis and croup.

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The U.S. regulator granted the designation based on clinical data of Janssen's prophylactic RSV senior vaccine, the company noted in its Sept. 3 press release.

Johnson & Johnson is conducting a phase 2b study of the vaccine in adults 65 years and older to determine safety and efficacy in preventing RSV.

The breakthrough therapy designation will expedite the development and review of the vaccine. The designation is granted to new therapies that treat serious or life-threatening conditions and are potentially better than existing therapies.