Merck and Co Inc (MRK)

[DewDiligence]

V114—MRK’s 15-valent pneumococcal vaccine—meets primary endpoint in phase-3 trials in healthy adults age 50+:

https://finance.yahoo.com/news/merck-announces-positive-topline-results-104500344.html

Merck…today announced that two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.

The pivotal PNEU-AGE (V114-019) study in healthy adults 50 years of age or older demonstrated that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13 [PFE’s Prevnar 13]) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13.

…The PNEU-AGE study also met the key secondary immunogenicity objective, demonstrating superiority of V114 compared to PCV13 for serotype 3, a leading cause of invasive pneumococcal disease globally.

…These findings, and additional Phase 3 data from Merck’s clinical program, will be presented at a scientific congress in the future and will form the basis of global regulatory licensure applications, beginning with the U.S. Food and Drug Administration, before the end of the year.

V114 is MRK’s replacement for the very old (1980s) Pneumovax and is intended to compete with PFE’s Prevnar 13 and PFE’s Prevnar 20, which is in late-stage development (#msg-154439687).

Currently, CDC guidelines call for healthy adults age 50+ to receive both Prevnar 13 and Pneumovax (with a waiting period between administrations). In due course, the CDC guidance will presumably be changed to either V114 or Prevnar 20 (or possibly both).

p.s. People who developed viral pneumonia from COVID-19 and were previously vaccinated with Prevnar 13 and/or Pneumovax may have saved their lives by averting a case of secondary bacterial pneumonia.