Source – Merck
Merck, known as MSD outside of the United States and Canada, has announced highly encouraging initial results from two Phase III trials evaluating V116, their investigational 21-valent pneumococcal conjugate vaccine, in both individuals new to vaccination and those previously vaccinated. The potential approval of V116 would mark a significant milestone as it would become the first pneumococcal conjugate vaccine designed specifically for adults.
In the STRIDE-3 trial, V116 demonstrated notable immune responses, statistically significant when compared to PCV20 (pneumococcal 20-valent conjugate vaccine), in vaccine-naïve adults. The study assessed serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination, and positive immune responses were observed for serotypes common to both vaccines as well as for serotypes unique to V116. Similarly, in the STRIDE-6 study, V116 was found to be immunogenic for all 21 pneumococcal serotypes covered by the vaccine among adults who had previously received a pneumococcal vaccine at least one year before the trial. Throughout both studies, V116 demonstrated a safety profile comparable to the comparator vaccines used.
The positive implications of V116 are significant, considering the 21 serotypes covered by the vaccine are responsible for 85% of invasive pneumococcal disease in individuals aged 65 and older, based on pre-pandemic 2019 CDC data. Moreover, V116 includes eight serotypes not currently covered by any approved pneumococcal vaccines. Some of these unique serotypes, such as 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, were responsible for approximately 30% of invasive pneumococcal disease in individuals aged 65 and older, as per pre-pandemic 2019 CDC data.
Merck plans to share the full results of these promising trials with the scientific community soon, and these findings will serve as the foundation for regulatory licensure applications worldwide. The potential approval and availability of V116 represent a significant step forward in combating pneumococcal disease, particularly in the vulnerable adult population.
“Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older. These results support the potential for V116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status, by expanding coverage to include eight serotypes not currently included in any licensed vaccine. We are very grateful to the patients and investigators who contributed to these studies.”
– Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories
