Capvaxive (V116) / Merck (MSD), Ligand - LARVOL DELTA

Post-pandemic trends in Streptococcus pneumoniae serotype epidemiology and antibiotic susceptibility in adults with invasive and non-invasive pneumococcal disease in the USA (2022-2023). (PubMed, J Antimicrob Chemother) - "Based on surveillance data from the SENTRY Antimicrobial Surveillance Program, PCV21 serotypes were associated with 82% of IPD and non-IPD cases in adults although PCV21-unique serotypes had lower rates of susceptibility to commonly used antibiotics. Continued surveillance is crucial to track serotype and resistance trends."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

Cost-Effectiveness Analysis of Pediatric and Adult Pneumococcal Conjugate Vaccine Strategies in Canada (ISPOR-EU 2025) - "OBJECTIVES: In Canada, PCV15 (Vaxneuvance) and PCV20 (Prevnar 20) are approved for use in adult and pediatric populations... Funding PCV20 for both pediatric and adult public immunization programs could result in greater health and economic gains than funding PCV15 in pediatric and PCV21 in adult programs. Additionally, using one vaccine for all ages could enhance equity, simplify vaccine procurement, and improve logistical inefficiencies related to training, supply, and storage."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Otorhinolaryngology • Pediatrics • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Exploring Perspectives on Adult Pneumococcal Vaccination: A Qualitative Preference Study of Health Care Providers (HCPs) and Health Care Consumers (HCCs) in the United Kingdom, Italy, and Greece (ISPOR-EU 2025) - "This study highlights a critical gap in knowledge among healthcare consumersregarding pneumococcal disease and vaccination. Healthcare providers are overall knowledgeable about PD and prefer attributes which offer increased disease protection against IPD and PP, which may improve vaccination uptake among adults."

Clinical • Pneumococcal vaccines • Hepatocellular Cancer • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Evaluating the Potential Health and Economic Impact of V116 vs. PCV20 on Invasive Pneumococcal Disease Among Adults in the United Kingdom (ISPOR-EU 2025) - "When compared to the status quo of PPSV23, V116 would prevent significantly more IPD cases, deaths, and direct medical costs than PCV20. The complex interactions with life-expectancy, waning vaccine efficacy, as well as IPD incidence and mortality rates increasing with age, changing the age-based recommendation from 65 to 75 results in worse outcomes."

Clinical • HEOR • Infectious Disease • Pneumococcal Infections

A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. (PubMed, Clin Infect Dis) - P3 | "V116 elicits robust immune responses and is well tolerated in adults 18-64 years of age with conditions associated with an increased risk of PD."

Clinical • Journal • P3 data • Diabetes • Infectious Disease • Metabolic Disorders • Pneumococcal Infections • Pulmonary Disease • Respiratory Diseases

Cross reactivity within pneumococcal serogroups 6 and 15 following adult vaccination with pneumococcal conjugate vaccine V116. (PubMed, Commun Med (Lond)) - "V116-induced antibodies demonstrate cross-reactivity to serotypes 6C and 15B, suggesting protective immune responses may be raised against these non-vaccine serotypes."

Journal • Infectious Disease • Pneumococcal Infections

Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial. (PubMed, Lancet HIV) - P3 | "V116 was well tolerated and immunogenic for all 21 serotypes, supporting the use of this vaccine in adults living with HIV. Adults at high risk of pneumococcal disease due to underlying comorbid conditions, such as HIV, might benefit from receiving V116. The serotypes in V116, including the eight unique serotypes, are expected to provide broader protection against pneumococcal disease than currently licensed vaccines."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Pneumococcal Infections • CD4

Capvaxive® - breiter Schutz vor Pneumokokken. (PubMed, MMW Fortschr Med) - No abstract available

Journal

MSD wins Korean nod for 21-valent pneumococcal vaccine Capvaxive, expanding adult protection (Korea Biomedical Review) - "MFDS) approved Capvaxive for preventing invasive disease and pneumonia caused by pneumococcal serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B)....Capvaxive was approved based on its proven immunogenicity and safety, as demonstrated in six phase 3 clinical trials (the STRIDE program)." "

Korea approval • Infectious Disease • Pneumococcal Infections

A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naïve Japanese adults ≥65 years of age. (PubMed, Vaccine) - P3 | "In vaccine-naïve Japanese adults ≥65 years of age, V116 is well tolerated, with a safety profile comparable to PPSV23, and elicits immune responses to all V116 serotypes and the cross-reactive serotype 15B. V116 has the potential to broaden protection against PD in Japan through the inclusion of serotypes responsible for the majority of residual PD in adults."

Clinical • Journal • P3 data • Infectious Disease • Pneumococcal Infections

Low intrinsic killing activity and no impact of its positivity on phase 3 pneumococcal vaccine adult studies. (PubMed, J Infect Dis) - "Thus, eliminating the IK assay as a requirement for OPA testing could be considered in healthy adult populations where antibiotic use is well-regulated."

Journal • P3 data • Infectious Disease • Pneumococcal Infections • Pneumonia

All-Cause and Pneumococcal Community-Acquired Pneumonia Hospitalizations Among Adults in Tennessee and Georgia. (PubMed, JAMA Netw Open) - "This prospective surveillance study demonstrated a large burden of hospitalizations for CAP among US adults, with the highest burden of disease among adults age 65 years or older. A sizable fraction of CAP was caused by Streptococcus pneumoniae, especially by serotypes included in V116."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. (PubMed, Vaccine) - "In adults ≥ 50 years of age, V116 is well tolerated and immunogenic when given concomitantly with QIV. Study results support use of V116 with QIV."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). (PubMed, Med) - P3 | "V116 exhibited immunogenicity and safety profiles that were consistent across three manufacturing lots."

Journal • P3 data • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Epidemiological Impact of Increasing Vaccination Coverage Rate and Re-Vaccination on Pneumococcal Disease in Older Adults in Germany. (PubMed, Vaccines (Basel)) - "Increasing the vaccination coverage rate to 60% and strategically revaccinating previously PPSV23-vaccinated adults significantly enhanced the effectiveness of pneumococcal vaccines, with V116 showing greater overall reductions in disease incidence compared to PCV20 or PPSV23."

Journal • Geriatric Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Health Economic Impact of Introducing an Adult-Focused 21-valent PCV in the Canadian Adult Population (ISPOR 2025) - "The analysis demonstrates the benefits of adult PCV vaccination in Canada, with projections indicating V116 could substantially reduce the burden of PD while also being a cost-saving use of resources compared to PCV20 in adults ≥65 years from both the societal and payer perspective. Thus, providing a strong rationale for considering V116 in the national immunization policies."

Clinical • HEOR • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Merck receives MHRA approval for adult-specific pneumococcal vaccine Capvaxive (PMLive) - "Merck & Co – known as MSD outside the US and Canada – has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its adult-specific pneumococcal vaccine Capvaxive. The vaccine has been authorised to help protect adults aged 18 years and older against illnesses caused by Streptococcus pneumoniae bacteria, including pneumonia and meningitis, which are currently considered a “major public health problem” by the World Health Organization (WHO)."

MHRA approval • Infectious Disease • Pneumococcal Infections

A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults ≥50 Years of Age (STRIDE-10). (PubMed, Vaccines (Basel)) - P3 | "The safety profile of V116 was comparable to that of PPSV23. In regions with established vaccination programs, V116 could broaden the serotype coverage for residual pneumococcal disease in adults."

Journal • P3 data • Infectious Disease • Pediatrics • Pneumococcal Infections

Economic evaluation of PCV21 in vaccine-naïve adults aged 19-64 years with underlying medical conditions in the United States. (PubMed, J Med Econ) - "The analysis indicated that the V116 strategy prevented a substantial number of cases and deaths compared to the PCV20 or PCV15 + PPSV23 strategies among vaccine-naive AR/HR adults aged 19-49 and 50-64 years...Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings, with over 95% of simulations yielding cost-saving results and all estimated ICERs remaining below $10,000/QALY gained. The findings suggest that the use of PCV21 (Capvaxive™) in adults aged 19-64 years with underlying medical conditions in the US can prevent a significant number of pneumococcal disease cases and deaths while demonstrating favorable economic outcomes across various scenarios."

HEOR • Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Anticipated impact of novel adult-specific pneumococcal conjugate vaccine. (PubMed, Vaccine) - "Based on IPD surveillance data from key countries, serotype coverage by V116 was ∼16-33 % higher than that by PCV20 among adults 65+ years in 2022 (data for UK, France from 2019). V116 includes serotypes responsible for the majority of IPD and is expected to prevent more IPD cases than PCV20 among 65+."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections

European Commission (EC) Approves Merck’s CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults (Businesswire) - "Merck...announced today that the European Commission (EC) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia 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....The EC approval of CAPVAXIVE is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program. This decision authorizes the marketing of CAPVAXIVE in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. The timing for availability of CAPVAXIVE in individual countries will depend on multiple factors, including the completion of reimbursement procedures."

EMA approval • Infectious Disease • Pneumococcal Infections

STRIDE-13: A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (clinicaltrials.gov) - P3 | N=882 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) (clinicaltrials.gov) - P3 | N=1484 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections

Capvaxive (V116): A new frontier in the prevention of pneumococcal pneumonia and invasive disease. (PubMed, J Pak Med Assoc) - No abstract available

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Modelling the Epidemiological Impact of Different Adult Pneumococcal Vaccination Strategies in the United Kingdom. (PubMed, Infect Dis Ther) - "Projections revealed that in adults, V116 led to significantly greater reductions in IPD in the 65+ year-old population compared with PCV20 or PPSV23."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia