RAHWAY, N.J. - Merck & Co. (NYSE: MRK) has presented new data from its Phase 3 STRIDE-10 trial of V116, an investigational vaccine aimed at preventing invasive pneumococcal disease in adults. The findings, announced at the European Society of Clinical Microbiology and Infectious Diseases meeting in Barcelona, Spain, suggest that V116 could be a significant advancement in adult pneumococcal disease prevention.
The STRIDE-10 study compared the immunogenicity, tolerability, and safety of V116 with the current PPSV23 vaccine in adults aged 50 and older who had not previously received a pneumococcal vaccine. The trial involved 1,484 participants who were randomized to receive a single dose of either V116 or PPSV23.
Results from the trial indicated that V116 triggered immune responses that were noninferior to those of PPSV23 for the 12 serotypes common to both vaccines. Moreover, V116 showed superior immune responses for the nine serotypes unique to it, not included in PPSV23. The safety profile of V116 was also comparable to that of PPSV23.
These results build upon previous Phase 3 trial data and suggest that V116 could offer broader protection against pneumococcal disease, a significant health concern, especially among older adults and those with certain health conditions. The serotypes targeted by V116 account for approximately 83% of invasive pneumococcal disease in individuals aged 65 and older, based on U.S. Centers for Disease Control and Prevention data from 2018-2021.
V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA has granted the vaccine priority review, with a target action date of June 17, 2024.
Merck also presented research suggesting that V116 may help to reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in several European countries.
The development of V116 is part of Merck’s broader commitment to pneumococcal disease prevention. The company has a history of over 40 years in vaccine development and is focused on addressing the specific needs of different populations through its vaccine program.
The information in this article is based on a press release statement from Merck & Co., Inc.
InvestingPro Insights
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