A Phase 1, Randomized, Double-Blind, Comparator-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V132 in Healthy Older Participants

The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.

Start Date17 Aug 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06271681

/ Not yet recruitingPhase 4IIT

Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans

The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster with of 21-valent pneumococcal conjugate vaccine . Immune response will be assessed by opsonophagocytic assay reactivity.

Start Date01 Jan 2026

Sponsor / Collaborator

VA Sierra Nevada Health Care Systems

[+1]

CTIS2024-515363-63-00

/ Not yet recruitingPhase 4IIT

(BIPAS) A prospective trial to assess Pneumococcal vaccine B cell response in patients without a spleen: a controlled study.

Start Date07 Nov 2025

Sponsor / Collaborator

Leids Universitair Medisch Centrum

100 Clinical Results associated with Pneumococcal 21-valent Conjugate Vaccine

100 Translational Medicine associated with Pneumococcal 21-valent Conjugate Vaccine

100 Patents (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

Literatures (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

31 Dec 2026·Expert Review of Vaccines

The health and economic burden of invasive pneumococcal diseases attributable to PCV21 versus PCV20 serotypes among adults aged ≥18 in Germany

Article

Author: de Lepper, Marion ; Owusu-Edusei, Kwame ; Johnson, Kelly D. ; Cossrow, Nicole ; Simuzingili, Muloongo ; Yi, Zinan

BACKGROUND:

Significant residual burden of invasive pneumococcal disease (IPD) is attributable to Streptococcus pneumoniae serotypes not included in any available vaccines in Germany. This study quantified the burden of invasive pneumococcal disease attributable to PCV21 and PCV20 serotypes among German adults.

RESEARCH DESIGN AND METHODS:

A published state-transition Markov model estimated the lifetime cases, deaths, and direct costs (2023 Euros) of IPD by age (18-49, 50-59, and 60 years and older) and risk group (low-risk, at-risk, and high-risk) in Germany. One-way sensitivity analysis on PCV21 cost was conducted.

RESULTS:

Across all age groups, there were 50,462 more IPD cases and 8895 deaths attributable to the serotypes in PCV21 compared to PCV20. The eight unique serotypes to PCV21 accounted for approximately 22% of disease. Higher direct costs were associated with PCV21 serotypes versus PCV20 serotypes (€505,094,685 versus €389,835,550, respectively). Discount rate of costs was the most influential input.

CONCLUSIONS:

Serotypes in PCV21 compared to PCV20 are associated with greater health and economic burden in Germany, primarily driven by the eight unique serotypes included in PCV21 and no other licensed vaccine. Including PCV21 in the national German vaccination guidelines may substantially reduce IPD-related health and economic burden among adults.

31 Dec 2026·Human Vaccines & Immunotherapeutics

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)

Article

Author: Euler, Danielle ; Papa, Melanie ; Tapiero, Bruce ; Atwi, Jibran E. ; Platt, Heather L. ; Pathirana, Jayani ; Korbal, Piotr ; Perez Yepes, Carlos Alberto ; Kantele, Anu ; Lopez-Medina, Eduardo ; Fernsler, Doreen ; Zeng, Tiantian ; Navarro, Juan Andres ; Park, Jun ; Baquero-Artigao, Fernando ; Inui, Ayano ; Jagannath, Vinita ; Phongsamart, Wanatpreeya ; Esteves-Jaramillo, Alejandra ; Alabaz, Derya

Pneumococcal disease (PD) causes significant illness and death, especially in young children, older adults, and individuals with chronic medical conditions. Due to increased risk, children with chronic conditions are often advised to receive additional pneumococcal vaccination beyond the routine primary series. This phase 3 study evaluated the safety and immunogenicity of V116, a 21-valent pneumococcal conjugate vaccine, compared to PPSV23 in children aged 2 to <18 y with certain medical conditions that increase risk of PD who had previously completed a primary pneumococcal vaccination regimen. Individuals with diabetes mellitus, chronic heart, chronic lung, chronic kidney, and/or chronic liver disease were randomized 3:2 to receive a single dose of either V116 (n = 531) or PPSV23 (n = 351). Immunogenicity was assessed at 30 d postvaccination comparing opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) between groups. Safety was evaluated by the proportion of participants with adverse events (AEs). The V116 group met the statistical noninferiority criterion for each of the 12 pneumococcal vaccine serotypes shared between V116 and PPSV23 and additionally met superiority criterion for each of the 9 serotypes unique to V116 based on OPA GMTs. IgG GMCs were consistent with the OPA results. The safety profile was generally comparable between groups. 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.

31 Dec 2026·Human Vaccines & Immunotherapeutics

Invasive Pneumococcal Disease burden, clinical characteristics, serotypes’ distribution, immunization status and antimicrobial resistance: Evidence from 12-year hospital-based surveillance and cost analysis

Article

Author: Cecconami, Lorella ; Riboli, Simona ; Deandrea, Silvia ; Cereda, Danilo ; Baldanti, Fausto ; Bertuccio, Paola ; Iskandar, Elizabeth ; Cambieri, Patrizia ; Gentile, Leandro ; Odone, Anna ; Muzzi, Alba ; Vecchio, Riccardo ; Daprai, Laura

We aimed to evaluate 12-y (2012-2024) burden, clinical and microbiological characteristics of Invasive Pneumococcal Disease (IPD) at one large research hospital - IRCCS Fondazione Policlinico San Matteo - in northern Italy, with focus on serotypes' distribution, resistance trends, and vaccination impact on outcomes and costs. The study included 234 IPD cases. Data were obtained from medical records, microbiological reports, and vaccination registries. Statistical analyses included descriptive measures, multivariate regression models for risk factors (adjusted for sex, age group, comorbidities), and comparison of length of stay and costs between vaccinated and unvaccinated patients. Most cases occurred in males aged ≥65. Bacteremia with pneumonia was the most frequent presentation (55.6%). Obesity and splenectomy were associated with higher risk of severe outcome. The most common serotypes overall were 3 and 8. Among vaccinated patients serotypes 15A, 14, 19A, and 15C were more frequent. Macrolide resistance was detected in 26.9% of isolates and beta-lactam resistance in 14.9%. Collectively, 34.5% of cases were caused by serotypes preventable with Pneumococcal Conjugate Vaccine 13 (PCV13), an additional 5.1% by PCV15, 21% by PCV20 and 14.4% by V116 preventable serotypes. Vaccine-preventable serotypes accounted for 64% of cases, mostly (56%) in patients aged ≥65. Vaccinated patients reported shorter hospital stay (median 8 vs 16 d) and lower associated costs (€3313 vs €5101). IPD surveillance is critical to inform prevention strategies. Our findings quantify how much vaccination reduces disease severity and healthcare costs but highlight gaps in vaccine coverage against emerging serotypes due to replacement mechanisms.

117

News (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

24 Jun 2026

·www.globenewswire.com

Next-Generation DNA Repair Inhibitors Could Capture Billions in Emerging Market

AUSTIN, Texas, June 24, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Oncology research is moving through one of its most active stretches in years. DNA Damage Response (“DDR”) inhibitors, a category of drugs that work by blocking cancer cells' capacity to fix their own damaged DNA, are growing well beyond the poly ADP ribose polymerase (“PARP”) inhibitor that first defined the category. DDR-inhibiting therapies generated an estimated $7 billion-plus in worldwide sales in 2025, and the wider oncology, diagnostics and precision medicine markets are expected to approach about $750 billion by 2030. A fresh wave of inhibitor classes is now taking shape as the next major opportunity. Standing at the leading edge of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (profile), a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor designed to target a DNA repair enzyme that participates in several distinct repair pathways. As the industry works toward the next generation of synthetic lethality assets, Onco-Innovations occupies a distinctive niche as it builds out its position within the biopharmaceutical and biotechnology space, alongside other established companies such as Merck & Co. Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GSK plc (NYSE: GSK) and Gilead Sciences Inc. (NASDAQ: GILD), all of which are focused on developing therapies for serious illnesses, including cancer. PARP inhibitors reshaped oncology when they first reached patients some 10 years ago, but they represent just one entry point into a much larger and more intricate biological network.Onco-Technologies owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies.The company’s preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.Onco-Innovations holds global rights across three separate layers of protection, with each layer reinforcing the others. Click here to view the custom infographic of the Onco-Innovations editorial. DNA Repair Science Expands Past the PARP Era PARP inhibitors reshaped oncology when they first reached patients some 10 years ago. They put into practice a concept known as synthetic lethality, in which cancers carrying particular DNA repair defects could be selectively destroyed by disabling a secondary repair pathway. The effect was striking in BRCA-mutated cancers, and the drug class has since grown into a market worth billions of dollars. Yet PARP inhibitors represent just one entry point into a much larger and more intricate biological network. The DNA Damage Response system involves dozens of proteins and pathways that cancer cells depend on to withstand chemotherapy, radiation and other forms of cellular stress. Researchers have spent years systematically charting this network in search of new drug targets. A field once confined to academic circles is now attracting serious investment and clinical interest. Artios Pharma, for instance, closed a $115 million Series D financing round late last year to advance mid-stage studies of experimental cancer drugs targeting DNA repair mechanisms beyond PARP, one of the strongest signals yet that this segment has matured into an investable category. The clinical pipeline backs up that narrative. Last month, Artios dosed its first patient in a randomized phase 2 trial of ART6043, a DNA polymerase theta inhibitor, in patients with gBRCA-mutated, HER2-negative breast cancer, advancing a non-PARP DDR target into mid-stage, biomarker-guided development. Also last month, MD Anderson released phase 1 proof-of-concept results for RO7589831, a Werner helicase inhibitor, in cancers exhibiting high microsatellite instability. These are not minor announcements; they demonstrate that novel DDR mechanisms can produce real clinical responses in actual patients. Interest from potential partners in DDR assets has remained resilient even amid broader market turbulence. Last year, Repare Therapeutics out-licensed lunresertib to Debiopharm in a deal worth $10 million upfront, plus up to $257 million tied to milestones. Debiopharm went on to secure U.S. Food and Drug Administration (“FDA”) Fast Track designation for a lunresertib combination in April 2026, converting a licensing arrangement into a formal regulatory achievement. The takeaway for investors appears straightforward: Biomarker-defined DDR assets backed by a credible scientific mechanism can still attract partners and earn regulatory recognition, even when funding conditions remain cautious. Polynucleotide Kinase Phosphatase, or PNKP, is a DNA repair enzyme that functions across numerous repair pathways, addressing both single-strand and double-strand break repair. This broader scope gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which act primarily on single-strand break repair. Inhibiting PNKP has already shown preclinical activity in colorectal, lung, breast, prostate, ovarian and blood cancers. With worldwide PARP inhibitor revenue forecast to total roughly $12 billion by 2030, PNKP inhibitors are surfacing as a significant drug class positioned to capture share within the expanding DNA Damage Response segment. Onco-Innovations has established itself as the recognized leader for this novel DDR target. Holding First-Mover Ground in Wide-Open Category Most competitive space in oncology drug development becomes crowded quickly. PARP inhibitors, PD-1 checkpoint drugs and CDK4/6 inhibitors each drew dozens of rivals once their commercial promise became evident. PNKP inhibitors stand apart from that pattern. The target has been described in academic literature for years, yet the drug-development community has been slow to act on it. That hesitancy created an opening, and Onco-Innovations has moved directly into it. The company owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies. This encompasses the core inhibitor compounds, the nanoparticle delivery science needed to carry those compounds effectively to tumors, and the synthetic lethality applications that define how the therapy is meant to function. Holding rights across molecular design, delivery mechanism and therapeutic application simultaneously is uncommon at this stage of oncology development. The competitive value of this position becomes clearer with added information. Once a new DDR target draws widespread industry attention, patent landscapes become congested, valuations climb and the window for first movers closes. Onco-Innovations entered the PNKP space while that window was still open. The company's patents cover the PNKP inhibitor technology as well as the ONC010 program, extending protection across the small molecule inhibitors themselves, the delivery system and the clinical applications, which together form a wide and durable competitive barrier. The broader DDR market supplies the commercial backdrop. Per the company, DDR-inhibiting products surpassed $7 billion in global sales last year. The global oncology market overall is forecast to approach $500 billion by 2032, representing growth of 131% across a 10-year span. Within that landscape, PNKP inhibitors occupy a category with no approved competitor and no entrenched incumbent. Rather than fighting for share in an already mature market, the company is effectively building the market itself. Laboratory Evidence Lays Groundwork for Clinical Trials Among the central risk factors in early-stage oncology investing is the distance separating laboratory findings from clinical reality. Onco-Innovations has worked methodically to close that gap. The company’s preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors. The standout finding from animal studies relates to survival outcomes in colorectal cancer. Published preclinical data show that the company's novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared with 23 days in untreated animals, more than double the survival duration. The same body of research showed substantial tumor growth reduction relative to placebo, paired with a favorable toxicity profile. The lack of observed toxicity in animal models carries particular weight. DDR inhibitors have generally run into off-target effects that constrain their clinical usefulness. Onco-Innovations' nanoparticle delivery system was built specifically to deal with this challenge. By pairing the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and encourages preferential buildup within tumor tissue while reducing exposure to healthy cells. The company has continued advancing its Chemistry, Manufacturing and Controls program alongside its preclinical research. Onco-Innovations is carrying out manufacturing scale-up and formulation development with Dalton Pharma Services, while running IND-enabling studies, including pharmacokinetic and biodistribution work, with Nucro-Technics. The company recently reported successful API process development and intermediate-scale production for its PNKP inhibitor technology, the kind of key manufacturing announcements that reduce risk on the path toward a first-in-human trial. The company has also set up a subsidiary in Australia to back anticipated phase 1 development through the Therapeutic Goods Administration regulatory pathway. Activation of a first-in-human phase 1 trial is planned later this year. The anticipated clinical approach is underpinned by validated preclinical data, a clear regulatory roadmap and the possibility of pursuing Fast Track designation, considering the substantial unmet need across the target indications. Intellectual Property Designed to Protect Exclusivity Intellectual property forms the foundation of value in early-stage drug development. Without critical IP, clinical achievements fail to result in commercial exclusivity. Onco-Innovations has constructed its IP portfolio with that principle firmly in place. The company owns global rights across three separate layers of protection, with each layer reinforcing the others. The first layer covers the core PNKP inhibitor molecules, the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, specifically the polymer-based micellar carrier system that enables effective tumor-targeted delivery of the inhibitors. This delivery technology is not a peripheral feature; it is central to the program's ability to achieve efficacy without unacceptable toxicity. The third layer protects synthetic lethality applications, which outlines how the therapy is matched to specific tumor biology to maximize selective destruction of cancer cells. Collectively, these patents provide comprehensive protection for the PNKP technology and the ONC010 program. The portfolio is designed to included not just the current lead compound but the main platform itself, supporting the company's specified objective of increasing its PNKP inhibitor technology across additional cancer types. For example, the company has wrapped up a collaborative project with Kuano, applying a quantum-based computational chemistry platform to generate insights aimed at optimizing PNKP inhibitor technology, further reinforcing the molecular foundation underlying the program. Causal AI Speeds Up Precision-Focused Trial Design Drug development remains costly and slow. The typical oncology drug requires more than a decade and over $1 billion to reach the market, and most candidates that enter clinical trials ultimately fail. Artificial intelligence is being applied with growing frequency to improve those odds, not by substituting for biology but by making it easier to identify the right patients, design more effective trials and interpret results more rapidly. With this in mind, last year Onco-Innovations acquired Inka Health Corp. Inka Health's SynoGraph(TM) platform prototype is a proprietary causal AI engine built specifically for oncology applications. Unlike standard machine learning, which identifies statistical correlations, causal AI is designed to reason about cause-and-effect relationships, a difference that carries significant weight in clinical research, where the gap between association and true causation can be the reason a drug appears effective or ineffective. The SynoGraph offering is designed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The exclusive prototype will combine real-world data, clinical evidence and molecular insights to help predict trial outcomes, treatment efficacy and safety, as well as adverse events. For a company preparing to launch a first-in-human trial, the ability to pinpoint the right patient population before the trial even begins represents a meaningful reduction in clinical risk rather than a mere convenience. Inka Health is also working with both AstraZeneca and GlaxoSmithKline in collaborations centered on predictive modeling, real-world evidence and AI-enabled cancer study. These companies are far from minor partners. And last month, Inka Health started a research partnership within PROmAI, additionally broadening the range of applications for the SynoGraph platform. Folding SynoGraph into the ONC010 development program means Onco-Innovations can use AI-driven patient stratification across its planned clinical studies. This provides the potential to shorten enrollment timelines, enhance the signal within early efficacy data and increase the overall potential for success. Precision-focused trial design is increasingly becoming a significant differentiator within oncology, and Onco-Innovations is working to build that capability internally. Biotech Innovation Continues Advancing Patient Care Recent developments across the biotechnology industry highlight continued progress in the development of innovative therapies and preventive treatments for a wide range of serious diseases. Companies are achieving important regulatory milestones, reporting encouraging clinical trial results and advancing next-generation treatment approaches designed to improve patient outcomes. Merck & Co. Inc. (NYSE: MRK) announced that the FDA has approved an expanded indication for CAPVAXIVE(R) (Pneumococcal 21-valent Conjugate Vaccine). The indication will 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 United States for use in this patient population. Pfizer Inc. (NYSE: PFE) announced that the FDA has approved an expanded indication for HYMPAVZI(R) (marstacimab-hncq). The expanded indication includes the treatment of patients, diagnosed with hemophilia A or B, who are 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. HYMPAVZI is now indicated in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. GSK plc (NYSE: GSK) is reporting interim phase 2 data from the global phase 2/3 ROSETTA Lung-02 clinical trial. The trial evaluated the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig, also known as BNT327 or BMS-986545, plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (“NSCLC”). The data showed encouraging anti-tumor activity, with high response rates observed in both nonsquamous and squamous NSCLC and at each PD-L1 expression level. The data was presented at the 2026 American Society of Clinical Oncology Annual Meeting. Gilead Sciences Inc. (NASDAQ: GILD) announced that the primary efficacy endpoint at Week 48 was met in both the phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY(R) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. As scientific innovation continues to accelerate, the biotechnology sector remains at the forefront of transforming healthcare through novel medicines, advanced biologics and precision treatment strategies. These achievements reflect a growing pipeline of therapies that have the potential to reshape treatment standards and deliver meaningful benefits to patients across diverse disease areas. For more information, visit Onco-Innovations. 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Clinical ResultPhase 1Phase 2Phase 3

18 Jun 2026

·allsci.com

Merck’s Capvaxive becomes first PCV approved specifically for high-risk children aged 2-17

Merck (NYSE: MRK) has received US FDA approval for an expanded indication related to Capvaxive (pneumococcal 21-valent conjugate vaccine), extending its use to children and adolescents aged 2 through 17 years at increased risk for pneumococcal disease — making it the only pneumococcal conjugate vaccine (PCV) specifically indicated and studied in the US for this high-risk pediatric population. The expanded indication covers individuals who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions — including diabetes, chronic heart disease, chronic kidney disease, chronic liver disease, or chronic lung disease — that elevate their risk for invasive pneumococcal disease (IPD). Capvaxive is administered as a single dose and is intended to complement, rather than replace, existing primary pediatric vaccination schedules. The vaccine targets 21 Streptococcus pneumoniae serotypes, including 8 not covered by other approved pneumococcal vaccines. The approval was supported by STRIDE-13 (NCT06177912), a Phase III randomized trial in 874 high-risk pediatric participants who had completed a primary pneumococcal vaccination series. Capvaxive demonstrated noninferiority to PPSV23, with a broadly comparable safety profile. The pediatric competitive landscape is occupied primarily by Pfizer’s Prevnar 20 (PCV20), approved for children aged 6 weeks through 17 years in April 2023, and Merck’s own Vaxneuvance (PCV15), approved in the same age range in April 2022. Capvaxive’s 22-serotype panel offers broader coverage than either, though the clinical significance of that expanded serotype breadth in terms of disease prevention outcomes remains to be established in efficacy trials. Pfizer is also advancing a 25-valent pneumococcal conjugate vaccine into Phase III, with a pediatric program underway, and has disclosed a 35-valent fifth-generation candidate entering early clinical development — signaling continued serotype escalation across the field. Capvaxive’s broader serotype coverage could provide an advantage in high-risk pediatric populations, although the clinical impact of that expanded coverage on disease prevention outcomes remains to be established. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

18 Jun 2026

·www.biospace.com

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

CAPVAXIVE is the only Pneumococcal Conjugate Vaccine (PCV) specifically indicated and studied in the U.S. for use in this population CAPVAXIVE, when added to existing primary pediatric pneumococcal vaccination series, helps deliver additional protection by including serotypes not contained in approved primary pediatric PCV series RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today 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; see additional Select Safety Information below. 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. “Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,” said Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus, investigator, STRIDE-13 trial. “This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.” 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. See “STRIDE-13 Clinical Data Supporting Approval” below for additional details. “While CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “The approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages, not only addressing an unmet need, but also reinforcing Merck’s longstanding commitment to public health and infectious diseases.” The expanded indication for CAPVAXIVE complements existing primary pediatric pneumococcal vaccination series for children and adolescents at increased risk for pneumococcal disease. According to a 2025 study of 2015-2019 CDC ABC surveillance data, including three groups, one of which consisted of children 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. STRIDE-13 Clinical Data Supporting Approval 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 pro 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. About Pneumococcal Disease Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae . There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). Please see the Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at and the Patient Information/Medication Guide for CAPVAXIVE at . Contacts Media Contacts: Olivia Finucane 004 7881 262476 olivia.finucane@msd.com Alayna Shamy (732) 403-0397 alayna.shamy@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Damini Chokshi (732) 594-1577 damini.chokshi@merck.com

Drug ApprovalClinical ResultPhase 3VaccineAccelerated Approval

100 Deals associated with Pneumococcal 21-valent Conjugate Vaccine

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Indication	Country/Location	Organization	Date
Pneumococcal Infections	United Kingdom	Merck Sharp & Dohme LLC	15 May 2025
Pneumonia, Pneumococcal	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	05 Feb 2025
invasive Streptococcus pneumoniae infection	United States	Merck Sharp & Dohme LLC	17 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06177912 (V116-013 \| STRIDE-13, CTgov)	Phase 3	Pneumococcal Infections	882	V116 (V116)	iqxxrjsked = dqqcgifshc bvkquhaifk (zujxlfzyzg, oclwapmcma - ekimixznzb) View more	-	11 Mar 2026
				PPSV23 (PPSV23)	iqxxrjsked = xoujhfenze bvkquhaifk (zujxlfzyzg, ldflbcxtgh - bdjpbmubdo) View more
NCT06177912 (STRIDE-13, BusinessWire) Manual	Phase 3	Pneumococcal Infections	882	CAPVAXIVE	msgbpjieki(llonrwmgyo) = CAPVAXIVE was immunogenic for all 21 serotypes as assessed by serotype-specific OPA GMTs at 30 days post-vaccination rxtyoqhnjj (uazdoliact ) View more	Positive	11 Sep 2025
				PPSV23
NCT05696080 (V116-008 \| STRIDE-8, CTgov)	Phase 3	Pneumococcal Infections	518	Placebo+V116 (V116 + Placebo)	bavcayrqal = ozuuaqvibl mybxllvhjv (caxcrsltaw, xihjgppcym - yvqtaxapia) View more	-	26 Feb 2025
				PPSV23+PCV15 (PCV15 + PPSV23)	bavcayrqal = qminordbeb mybxllvhjv (caxcrsltaw, dsswmhvovt - lrphipucuq) View more
NCT05569954 (V116-010 \| STRIDE-10, CTgov)	Phase 3	Pneumococcal Infections	1,484	V116 (Base Study: V116)	eyntkmgsyx = cfemwmtjjm jtncctsaed (yncminifpv, tmabxwhpbu - qrvxjjgviz) View more	-	31 Oct 2024
				PPSV23 (Base Study: PPSV23)	eyntkmgsyx = xqscugudxe jtncctsaed (yncminifpv, capgqmrzzf - ajwzooswwd) View more
NCT05526716 (V116-005 \| STRIDE-5, CTgov)	Phase 3	Pneumonia, Pneumococcal	1,080	QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo))	ojbhsxbnjg = aadxusiewj kxdcqpwacs (ggngusvwhs, dajiyrpysh - smkbxkubid) View more	-	05 Sep 2024
				QIV+V116 (Sequential Group (Placebo + QIV Followed by V116))	ojbhsxbnjg = prdonqjxlu kxdcqpwacs (ggngusvwhs, bzzzodfjsl - sndjljfznc) View more
NCT05393037 (V116-007 \| STRIDE-7, CTgov)	Phase 3	Pneumococcal Infections	313	Placebo+V116+PCV15 (V116 + Placebo (Part A), PCV15 (Part B))	inimpyfkdy = uybhpeovma ojbzjirxvl (wpwvzzqajx, qbsburuwzg - mkejhfpuci) View more	-	25 Jul 2024
				PPSV23+PCV15 (PCV15 + PPSV23 (Part A))	inimpyfkdy = gebwkwnzga ojbzjirxvl (wpwvzzqajx, rspbojllcl - edlknzbdsd) View more
NCT05633992 (STRIDE-9 \| V116-009, CTgov)	Phase 3	Pneumococcal Infections	450	V116 (V116)	xhojpczzvh = yfkwkftwcw bbsqenfopc (jqnujyyhin, nzrddjobbg - dfbfggpcub) View more	-	30 May 2024
				PPSV23 (PPSV23)	xhojpczzvh = xgwsmtqmqh bbsqenfopc (jqnujyyhin, yigtbegdhr - mfxuywornr) View more
NCT05464420 (V116-004 \| STRIDE-4, CTgov)	Phase 3	Pneumococcal Infections	2,162	V116 (V116 Lot 1)	mjpwjkmisl = irpzehiecq tpatonvruf (fryqgjlawi, dydrnxlmsa - dvzwwryngw) View more	-	24 May 2024
				V116 (V116 Lot 2)	mjpwjkmisl = dvmgioqlwu tpatonvruf (fryqgjlawi, hlzwktagmp - cubnotfxhf) View more
NCT05420961 (V116-006 \| STRIDE-6, CTgov)	Phase 3	Pneumonia, Pneumococcal	717	V116 (Cohort 1: V116)	fhxrmebyld = iyivbehvlx zghmxwskxc (saljasaxgo, tuqohumisf - uorjqmyswj) View more	-	01 May 2024
				PCV15 (Cohort 1: PCV15)	fhxrmebyld = qmfkcjvutd zghmxwskxc (saljasaxgo, cflyzscqcf - vrgdnojgfc) View more
NCT05569954 (STRIDE-10, Biospace) Manual	Phase 3	Pneumococcal Infections	1,484	V116	atmkvtzpof(azkjptadir) = V116 had a comparable safety profile to PPSV23. lwoeyomain (qdcddnkmgt )	Non-inferior	29 Apr 2024
				PPSV23

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