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

Safety and Immunogenicity of V116, an Adult-specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults ≥50 Years of Age: Post-hoc Analysis of Phase 3 Data in the Overall and East Asian Populations (IDWeek 2026) - No abstract available

Clinical • P3 data • Pneumococcal vaccines • Retrospective data • Infectious Disease • Pneumococcal Infections

Projected epidemiological impact of lowering the adult pneumococcal vaccination age from 60 to 50 years in Germany. (PubMed, Hum Vaccin Immunother) - "When vaccinating ages ≥60 and ≥50 with V116, the projected incidence of IPD in year 10 declined to 22.1 and 20.5 per 100,000, respectively, and when using PCV20 in the same conditions, incidence was 23.0 and 21.8, respectively. In summary, lowering the adult vaccination age enhanced the epidemiological impact of pneumococcal vaccination in Germany, with V116 showing the greatest overall reductions in disease."

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

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Varicella Zoster

Comparison chart: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

21‑Valent Pneumococcal Conjugate Vaccine V116 (CAPVAXIVE®): Pediatric First Approval. (PubMed, Paediatr Drugs) - "Subsequently, in June 2026, the US approval for V116 was extended to include use in individuals 2-17 years of age who are at increased risk for pneumococcal disease. This article summarizes the milestones in the development of V116 leading to these first pediatric approvals for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae."

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

A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13). (PubMed, Hum Vaccin Immunother) - "In children and adolescents aged 2 to <18 y with certain medical conditions, V116 is well tolerated and immunogenic. These findings support the use of V116 to broaden pneumococcal serotype coverage in populations at increased risk of pneumococcal disease."

Clinical • Journal • P3 data • Diabetes • Hepatology • Infectious Disease • Metabolic Disorders • Nephrology • Pneumococcal Infections

U.S. FDA Approves an Additional Indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal Disease (Financial Times) - "The approval is based on data from the Phase 3 STRIDE-13 trial..."

FDA approval • Pneumococcal Infections

Epidemiological impact of a 20- or 21-valent pneumococcal conjugate vaccine in the Japan adult population: insights from a dynamic transmission model. (PubMed, Expert Rev Vaccines) - "Further gains were projected when expanded recommendations were combined with increased vaccination coverage (from 39.1% to 53.2%-93.8%), with IPD reductions of 2.6%-6.5% for PCV20 and 8.5%-18.2% for V116. Results highlight the value of broader age recommendations and higher vaccine uptake in Japan and indicate that V116 can achieve greater reductions in pneumococcal disease burden than PCV20 or PPSV23, supporting consideration of V116 for adult vaccination in Japan."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections

Serotype distribution and coverage by pneumococcal vaccines in hospitalised adults with pneumococcal pneumonia in Germany. (PubMed, ERJ Open Res) - "Among adults hospitalised with CAP in Germany, S. pneumoniae was detected in 13% of cases by SSUAD assays. While the findings suggest that V116 may offer broader serotype coverage compared with PCV20, these differences were not statistically significant."

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

SAFETY OF V116, A 21 VALENT ADULT-SPECIFIC PNEUMOCOCCAL CONJUGATE VACCINE, IN ADULTS ≥18 YEARS: A POOLED SECONDARY ANALYSIS FROM THE PHASE 3 PROGRAM (ISPPD 2026) - "There were 7 total deaths, and none were considered vaccine related.Conclusions Across a large phase 3 program, V116 was well tolerated in adults with and without conditions that increase pneumococcal disease risk. Results support the use of V116 in adults."

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

EVALUATING THE POTENTIAL HEALTH AND ECONOMIC IMPACT OF DIFFERENT STRATEGIES WITH V116 USE AMONG ADULTS IN JAPAN (ISPPD 2026) - "If one additional V116 vaccination were given either 5, 10, or 15 years later, the number of IPD cases would reduce to 863, 842, or 847, respectively, and NBPP deaths would reduce to 4,346, 4,288, and 4,259, respectively (Table 3).Conclusions V116 would prevent more health outcomes and reduce more treatment costs than PCV20 for both younger and older adults. Following PCV vaccination at age 65, the optimal timing for a single revaccination was found to be around 10-15 years."

Clinical • HEOR

HEALTH AND ECONOMIC IMPACT OF RESTRICTING COVERAGE OF PCV21, AN ADULT SPECIFIC 21-VALENT PNEUMOCOCCAL CONJUGATE VACCINE, IN ADULT PROGRAMS AGAINST PNEUMOCOCCAL DISEASE IN QUEBEC, CANADA (ISPPD 2026) - "Conclusions The results showed that vaccination with PCV21 was dominant over alternate strategies, yielding improved outcomes while generating savings. These results suggest that adding PCV21 to the Québec schedule for all adults aged ≥65 could reduce the health and economic burden of IPD and pCAP."

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

IMPACT OF INCLUDING PCV21, AN ADULT-SPECIFIC 21-VALENT PNEUMOCOCCAL CONJUGATE VACCINE, IN OLDER ADULTS IMMUNIZATION PROGRAMS AGAINST PNEUMOCOCCAL DISEASE IN ONTARIO, CANADA (ISPPD 2026) - "Vaccination with PCV21 was dominant over PCV20 for the ≥65 cohort, yielding improved outcomes while generating savings. Delaying PCV21 inclusion may lead to significant avoidable health events and costs."

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

A SUBGROUP ANALYSIS OF A PHASE 3, RANDOMIZED TRIAL INVESTIGATING SAFETY AND IMMUNOGENICITY OF V116 IN VACCINE-NAÏVE ADULTS AT INCREASED RISK OF PNEUMOCOCCAL DISEASE (STRIDE-8) (ISPPD 2026) - "The overall safety profile was comparable between groups.Conclusions In pneumococcal vaccine-naïve adults with chronic medical conditions, V116 was well tolerated and immunogenic compared to PCV15+PPSV23, regardless of the subgroup evaluated. V116 has the potential to broaden disease coverage in this vulnerable population."

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

SECONDARY ANALYSIS OF A PHASE 3, RANDOMIZED STUDY OF V116, A PNEUMOCOCCAL CONJUGATE VACCINE, IN CHILDREN AND ADOLESCENTS WITH INCREASED RISK OF PNEUMOCOCCAL DISEASE (STRIDE-13) (ISPPD 2026) - "OPA GMTs were evaluated within the following subgroups: age (2 to <6, 6 to <12, or 12 to <18), chronic medical condition (diabetes mellitus or chronic heart, kidney, liver, or lung disease), prior pneumococcal vaccine (PCV7, PCV10, PCV13), and prior pneumococcal vaccination regimen (2+1 or 3+1). V116 is immunogenic in children and adolescents aged 2 to <18 years with chronic medical conditions that increase risk of IPD, irrespective of age, prior pneumococcal vaccination regimen, or at-risk condition. V116 could address an unmet need in prevention of IPD in this population."

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

SEROTYPE DISTRIBUTION OF PNEUMOCOCCAL COMMUNITY-ACQUIRED PNEUMONIA IN HOSPITALIZED ADULTS IN SPAIN, FRANCE AND ITALY DURING THE SARS-COV-2 PANDEMIC (ISPPD 2026) - "These SSUAD assays combined, include all serotypes in PCV15, PCV20 and PCV21(V116)... In hospitalized adults with CAP in Spain, Italy and France during the SARS-CoV-2 pandemic, S. pneumoniae was detected in 21% of cases by all diagnostic tests. Considering documented serotypes, during this period, the potential coverage proportion of PCV21 was broader (92.5%) compared with earlier pneumococcal conjugate vaccines (75.4 and 51.7%)."

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 (clinicaltrials.gov) - P3 | N=4049 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal Infections

Ligand Reports Fourth Quarter and Full Year 2025 Financial Results (The Manila Times) - "Royalties for the fourth quarter of 2025 were $50.5 million, compared with $34.8 million for the same period in 2024, with the 45% increase primarily attributable to increases in sales of Travere Therapeutics’ Filspari, and Merck’s Capvaxive and Ohtuvayre....Royalties for the full year 2025 were $161.0 million, compared with $108.8 million for the full year 2024, with the increase primarily attributable to increases in sales of Travere Therapeutics’ Filspari, Recordati’s Qarziba, and Merck’s Capvaxive and Ohtuvayre."

Commercial • Chronic Obstructive Pulmonary Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease

Cost-effectiveness analysis of the use of PNEU-C-21 in adults aged ≥50 years in Canada. (PubMed, Expert Rev Vaccines) - "For both vaccine-naïve cohorts the ICERs were dominant for both PNEU-C-21 vs. PNEU-C-20 and PNEU-C-21 vs. PNEU-P-23; among adults aged 70 years, previously vaccinated with PNEU-P-23, PNEU-C-21 was dominant over PNEU-C-20. These results demonstrate that PNEU-C-21 can prevent a substantial number of cases and deaths while remaining highly cost-effective over a range of inputs and scenarios in Canada."

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

The health and economic burden of invasive pneumococcal diseases attributable to V116 versus PCV20 serotypes among adults aged ≥18 in Germany. (PubMed, Expert Rev Vaccines) - "Serotypes in V116 compared to PCV20 are associated with greater health and economic burden in Germany, primarily driven by the eight unique serotypes included in V116 and no other licensed vaccine. Including V116 in the national German vaccination guidelines may substantially reduce IPD-related health and economic burden among adults."

HEOR • Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: Vaxcyte, Inc.

New P3 trial • Infectious Disease • Pneumococcal Infections

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