Merck To Start Pivotal Trial For Next-Gen Pneumococcal Vaccine Next Month

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  • Merck & Co Inc MRK presented results from the Phase 1/2 study, evaluating V116 in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). 
  • Data were shared at the International Symposium on Pneumococci and Pneumococcal Diseases.
  • V116 targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by licensed vaccines.
  • V116 met the primary immunogenicity objectives in both populations and was well-tolerated with an overall safety profile comparable to Pneumovax 23 (Pneumococcal Vaccine Polyvalent) across age groups. 
  • In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to Pneumovax 23 for all shared serotypes and superior immune responses for the serotypes included in V116 but not included in Pneumovax 23. 
  • In both parts of the trial, V116 was well tolerated with an overall safety profile comparable to Pneumovax 23. 
  • Merck plans to start a broad Phase 3 program for V116 in vaccine-naïve and vaccine-experienced adults in July 2022.
  • Price Action: MRK shares are up 1.54% at $85.92 on the last check Tuesday.
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