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Merck's 21-valent Pneumococcal Conjugate Vaccine Gets FDA Breakthrough Therapy Designation

Merck & Co. Inc. (MRK) said that its investigational 21-valent pneumococcal conjugate vaccine ,V116, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease (IPD) 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.

The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of products intended for serious or life-threatening conditions.

Phase 3 clinical trials for V116 will be initiated later this year.

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