FDA Approves V116 for Prevention of Invasive Pneumococcal Disease and Pneumonia

The FDA has approved V116, a pneumococcal 21-valent conjugate vaccine (Capvaxive; Merck) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae for those aged 18 years and older. The serotypes covered in the vaccine include 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B for the invasive disease indication, and serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B for the pneumonia indication.¹

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“Complications from invasive pneumococcal disease can lead to hospitalization, organ damage, and even death. Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter Orenstein, MD, professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, said in the news release. “[V116] is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”¹

The approval is based on data from the STRIDE-3 (NCT05425732), STRIDE-5 (NCT05526716), and STRIDE-6 (NCT05420961) trials. According to data from the trials, V116 elicited higher immune responses than the comparator for the serotypes that are unique to V116. Furthermore, V116 demonstrated immunogenicity for all 21 serotypes in patients aged 50 to 84 years who were vaccine naïve.^1,2

For those who were vaccine experienced, the study results showed that V116 elicited a comparable response to both the pneumococcal 15-valent conjugate vaccine and the pneumococcal vaccine polyvalent 23-valent, according to an article on Pharmacy Times.²

Additionally, in the STRIDE-3 trial, V116 had a non-inferior immune response compared with pneumococcal 20-valent conjugate vaccine (Prevanar 20, PCV20; Wyeth Pharmaceuticals, Pfizer) in all 10 common serotypes. For 10 of 11 serotypes not included in PCV20, V116 demonstrated superiority to PCV20 at 30 days. The safety of both vaccines was comparable, with individuals reporting at least 1 adverse event (AE) for either vaccine at a rate of 61.7% for V116 and 67.2% for PCV20. There were no serious vaccine-related AEs reported in the study.³

Furthermore, results of a review published in Infectious Diseases and Therapy showed that the serotypes included in V116 had higher clinical and economic burden for invasive pneumococcal disease compared with PCV20 and could reduce the residual burden of invasive disease in the United States. The authors found that the 8 serotypes unique to V116 accounted for nearly 40% of estimated invasive pneumococcal disease cases and deaths in the United States, but vaccination with V116 could lead to substantial economic savings due to fewer cases and associated health care costs. The authors estimated that the potential lifetime cost savings could be over $10 billion compared to PCV20.⁴

References

1. US FDA approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. News release. Merck. June 17, 2024. Accessed June 18, 2024. https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/

2. Gallagher A. V116 Demonstrates Positive Immunogenicity for 21 Pneumococcal Serotypes. Pharmacy Times. March 22, 2024. Accessed June 18, 2024. https://www.pharmacytimes.com/view/v116-demonstrates-positive-immunogenicity-for-21-pneumococcal-serotypes

3. Gallagher A. Investigational Vaccine Has Non-Inferior Immune Response Compared to PCV20 for Pneumococcal Disease. Pharmacy Times. December 13, 2023. Accessed June 18, 2024. https://www.pharmacytimes.com/view/investigational-vaccine-has-non-inferior-immune-response-compared-to-pcv20-for-pneumococcal-disease

4. Gallagher A. Study: Larger Lifetime Cost Savings for V116 Compared With PCV20. Pharmacy Times. June 8, 2024. Accessed June 18, 2024. https://www.pharmacytimes.com/view/study-larger-lifetime-cost-savings-for-v116-compared-with-pcv20