The US FDA Accepts Merck’s BLA for V116 and Grants Priority Review for the Prevention of Pneumococcal Disease
Shots:
- The BLA based on the results from the P-III (STRIDE-3) trial evaluating the immunogenicity, tolerability & safety of V116 vs PCV20 in pneumococcal vaccine-naïve adult patients aged ≥50yrs. in Cohort 1 & 18-49yrs. in Cohort 2
- In Cohort 1, V116 showed non-inferior immune responses vs PCV20 in all 10 serotypes (in both vaccines) & superior responses for 10/11 serotypes included in V116 (not in PCV20) at Day 30 whereas in Cohort 2, V116 depicted non-inferior immune responses vs Cohort 1
- V116 is a 21-valent pneumococcal conjugate vaccine that targets multiple serotypes of Streptococcus pneumoniae incl. 15A, 15C, 16F, 23A, 23B, 24F, 31 & 35B thereby allowing prevention from invasive pneumococcal disease & pneumococcal pneumonia
Ref: Merck | Image: Merck
Related News:- Merck Reports the Results of V116 in P-III trial (STRIDE-3) for the treatment of Pneumococcal Infection in Adults
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
