Announcement • 4h
Merck Receives U.S. FDA Approval for Expanded Indication of CAPVAXIVE Pneumococcal 21-Valent Conjugate Vaccine in Children and Adolescents Aged 2 Through 17 At Increased Risk for Pneumococcal Disease
Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the U.S. for use in this patient population. CAPVAXIVE is indicated for: Active immunization for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older and individuals 2 through 17 years of age who are at increased risk for pneumococcal disease; Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The approval is based on data from the Phase 3 STRIDE-13 trial, which evaluated CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 through 17 years who completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. STRIDE-13 (NCT06177912) is a randomized, double-blind, active comparator-controlled Phase 3 study that evaluated individuals 2 through 17 years of age with one or more prespecified medical conditions (diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease) known to increase the risk of pneumococcal disease and who have previously completed a primary pneumococcal vaccination regimen at least 8 weeks prior to enrollment (n=874). Participants were randomized 3:2 to receive a single dose of CAPVAXIVE (n=527) or PPSV23 (n=347). Results from the study include: CAPVAXIVE was noninferior to PPSV23 for the 12 shared serotypes and induced statistically significantly greater OPA GMTs compared to PPSV23 for the 9 serotypes unique to CAPVAXIVE; CAPVAXIVE also elicited immune responses to serotype 15B (cross-reactive to serotype 15C). In a post hoc analysis utilizing the same prespecified noninferiority criterion that was used for the shared serotypes, CAPVAXIVE was noninferior to PPSV23 for serotype 15B; The safety profile of CAPVAXIVE was generally comparable to PPSV23. Solicited adverse reactions following administration of CAPVAXIVE lasted a median of 2 days with most reactions lasting =3 days; The proportion of individuals reporting 1 or more serious adverse events (SAE) within 6 months postvaccination was 5.5% (n=29) in individuals vaccinated with CAPVAXIVE and 7.2% (n=25) in individuals vaccinated with PPSV23. There were no notable patterns or imbalances between vaccine groups for SAEs. One individual (0.2%) who received CAPVAXIVE had an SAE considered related to vaccination. This SAE was syncope (Grade 2, required hospitalization) and occurred approximately 3 minutes postvaccination. CAPVAXIVE helps provide coverage against the serotypes responsible for approximately 82% of IPD cases in adults 50 years of age and older, compared to ~54% by PCV20, based on national-level CDC data from 2019-2023. These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20. With this approval, CAPVAXIVE is also indicated for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. Select Safety Information for CAPVAXIVE in Children and Adolescents at Increased Risk for Pneumococcal Disease in the U.S.: Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. Syncope may occur with administration of injectable vaccines. Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). The most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%). Vaccination with CAPVAXIVE may not protect all vaccine recipients.