FDA Grants Breakthrough Therapy Designation to Pneumococcal Vaccine

This morning, Merck (MSD) announced their investigational pneumococcal conjugate vaccine received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The 21-valent vaccine, V116, targets serotypes responsible for 85% of all pneumococcal disease.

The vaccine prevents invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by the 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, and 35B. Pneumococcal disease can range in severity from ear and sinus infections to pneumonia, meningitis, and bloodstream infections.

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