Merck announced FDA granted breakthrough therapy designation for V116, investigational 21-valent pneumococcal conjugate vaccine, for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults

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On Apr. 14, 2022, Merck announced that V116, the companyメs investigational 21-valent pneumococcal conjugate vaccine, had received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. Phase 3 clinical trials for V116 were to be initiated later in the year.

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Source: Merck
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