CAPVAXIVE™ Approved by FDA
Introduction
Pneumococcal disease, caused by the bacterium Streptococcus pneumoniae, remains a significant public health concern, particularly among older adults. This disease can manifest as either invasive or non-invasive, with invasive pneumococcal disease (IPD) spreading to other organs and non-invasive forms being confined to specific locations. The recent FDA approval of CAPVAXIVE™, a novel pneumococcal vaccine, marks a crucial advancement in the prevention of this disease among adults.
Vaccine Overview
CAPVAXIVE™ is specifically formulated for adults, targeting serotypes responsible for approximately 84% of pneumococcal disease cases in individuals aged 50 years and older. Administered as a single dose, CAPVAXIVE™ provides active immunization against a wide array of S. pneumoniae serotypes, offering broad protection against both invasive pneumococcal disease and pneumonia.
Clinical Trials and Results
The approval of CAPVAXIVE™ is supported by data from four Phase 3 clinical trials, demonstrating its robust immune responses and favorable safety profile.
STRIDE-3 Trial
The STRIDE-3 trial assessed the immune responses of CAPVAXIVE™ in two age cohorts:
Ages 50 and Older: CAPVAXIVE™ was found to be non-inferior to PCV20 for selected serotypes one month post-vaccination.
Ages 18 to 49: Immune responses in this group were non-inferior compared to those in patients aged 50 to 64.
Safety outcomes in both age groups were comparable to PCV20, indicating a similar safety profile.
STRIDE-5 Trial
The STRIDE-5 trial evaluated the concomitant administration of CAPVAXIVE™ with the quadrivalent influenza vaccine (QIV). The results showed that CAPVAXIVE™ administered with QIV was non-inferior to sequential administration. Additionally, the rates of adverse reactions were similar regardless of whether CAPVAXIVE™ was given with or without QIV.
STRIDE-6 Trial
In the STRIDE-6 trial, two cohorts were analyzed:
Cohort 1: CAPVAXIVE™ demonstrated opsonophagocytic activity (OPA) responses comparable to PCV15 for six common serotypes.
Cohort 2: CAPVAXIVE™ showed OPA responses comparable to PPSV23 for twelve common serotypes and serotype 15B.
Across all cohorts, including those who had previously received one or more pneumococcal vaccines, CAPVAXIVE™ maintained a consistent safety profile similar to PCV15 and PPSV23.
Safety and Adverse Events
The most commonly reported adverse events in patients aged 18 to 49 years included:
Injection site pain (73.1%)
Fatigue (36%)
Headache (27.5%)
Myalgia (16.4%)
Redness at the injection site (13.1%)
Swelling at the injection site (13.3%)
For patients aged 50 years and older, the most common adverse events were:
Injection site pain (41.2%)
Fatigue (19.7%)
Headache (11%)
Future Recommendations
The CDC Advisory Committee on Immunization Practices is expected to review and make recommendations regarding the use of CAPVAXIVE™. This step will further guide healthcare providers in the optimal administration of this vaccine to prevent pneumococcal disease effectively.