(CercleFinance.com) – Merck announces that the US FDA has granted Breakthrough Therapy Designation for V116, the vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.
V116 is designed to target the serotypes responsible for 85% of all invasive pneumococcal infections in people age 65 and older in the United States. Phase 3 clinical trials of V116 will be launched in 2022.
‘ The FDA’s decision is based on data from a two-part, randomized, comparator-controlled, double-blind Phase 1/2 study, V116-001 (NCT04168190), which evaluated the safety, tolerability and the immunogenicity of a single dose of V116 in adults aged 18-49 years (phase 1) and 50 years and older (phase 2) who have never received a pneumococcal vaccine ‘ indicates the group.
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