V116 FDA Approval Status
Last updated by Judith Stewart, BPharm on April 17, 2024.
FDA Approved: No
Brand name: V116
Generic name: pneumococcal 21-valent conjugate vaccine
Company: Merck
Treatment for: Pneumococcal Disease Prophylaxis
V116 (pneumococcal 21-valent conjugate vaccine) is a 21-valent pneumococcal conjugate vaccine in development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.
- Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different serotypes of pneumococcal bacteria, and certain serotypes put more people at risk for invasive pneumococcal illnesses, such as bacteremia, bacteremic pneumonia, and meningitis, as well as non-invasive pneumonia.
- V116 is a 21-valent pneumococcal conjugate vaccine specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B.
Development timeline for V116
| Date | Article |
|---|
| Apr 29, 2024 | Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults |
| Mar 19, 2024 | Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults |
| Dec 19, 2023 | FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults |
| Nov 28, 2023 | Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older |
| Jul 27, 2023 | Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials |
| Jun 21, 2022 | Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults |
| Apr 14, 2022 | Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine, for the Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults |
Further information
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