Drug Database
PN

pneumococcal vaccine (V114 / PCV15, Merck / Vaxneuvance)

✓ Approved

Merck & Co. · Vaccine · Vaccine

What is pneumococcal vaccine?

pneumococcal vaccine is a vaccine developed by Merck & Co.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesV114, PCV15, Merck, Vaxneuvance
CompanyMerck & Co.
Drug ClassVaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Merck & Co.

Therapeutic Indications

pneumococcal vaccine is developed for 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsPneumococcal infection✓ Approved
Infections and infestationsOtitis media✓ Approved
Ear and labyrinth disordersMiddle ear inflammation✓ Approved

Related Research Articles

PubMedAAPS PharmSciTech2026-09-19

Comprehensive Stability Assessment of Squalene in a Nanoemulsion Adjuvant and the SpiN-Tec Vaccine: HPLC Quantification, Stress Testing, and Stability Studies.

Gomes Isabela Pereira IP, Rivelli Graziella Gomes GG, Bagno Flávia Fonseca FF, Hojo-Souza Natália Satchiko NS et al.

Squalene-based nanoemulsions are widely used as adjuvants in vaccine formulations, but their stability can be affected by environmental factors such as pH, oxidative stress, temperature, and light. We have produced a squalene nanoemulsion (CTVad1) to support the clinical development of new vaccines. This study aimed to develop and validate an HPLC method for squalene quantification in SpiN-Tec, a recombinant protein vaccine against COVID-19. We also aimed to evaluate the stability of the CTVad1 adjuvant and SpiN-Tec under controlled storage conditions. A reversed-phase HPLC method was developed and validated, and comprehensive forced degradation studies were performed on the raw material and SpiN-Tec under acidic, basic, oxidative, thermal, and photolytic conditions to demonstrate the stability-indicating capability of the method. Physicochemical, morphological, and biological characteristics were assessed, and stability studies of both the vaccine and the CTVad1 adjuvant were performed under accelerated and long-term conditions. The HPLC method was selective, precise, accurate, linear, and robust. Squalene raw material degraded under all tested conditions, whereas formulation in nano-sized globules improved its stability, with degradation observed only under hydrogen peroxide and light exposure. CTVad1 remained stable over time, exhibiting only minor, non-critical changes within the specification limits in both accelerated and long-term stability studies, regardless of the glass packaging used (clear or amber). In addition, the SpiN-Tec vaccine maintained its physicochemical and biological integrity under all tested conditions, with all evaluated parameters remaining within the established specification ranges. Our findings demonstrate that proper formulation, packaging, and storage conditions can preserve squalene stability in nanoemulsion-based vaccines, ensuring the quality, safety, and efficacy of the SpiN-Tec vaccine and its adjuvant throughout shelf life.

PMID 42760453
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PubMedOcular immunology and inflammation2026-09-19

Bilateral Maculopathy in an Infant Following Measles, Mumps, Rubella, and Varicella-Zoster (MMRV) Vaccination.

Ben-Avi Ravid R, Amer Radgonde R

To report on the long-term clinical outcome of a healthy infant who presented with posterior uveitis following the administration of the combined measles, mumps, rubella, and varicella (MMRV) vaccine. Descriptive case report. A 13-month-old infant presented with bilateral visual loss two weeks after receiving the MMRV vaccine. Ophthalmic examination revealed bilateral retinitis and retinal vasculitis with exudative retinal detachment. Extensive infectious work-up was conducted including serologic exams and PCR testing of blood, aqueous humor, cerebrospinal fluid and urine. Serological tests for measles yielded positive IgM and IgG titers. PCR testing for measles in the aqueous humor and urine was negative. Neurologic assessment and neuroimaging were unremarkable, excluding central nervous system involvement. Empiric systemic antiviral and corticosteroid therapy was initiated. Gradual resolution of posterior uveitis ensued, culminating in bilateral macular scars. Over a six-year follow-up period, the patient demonstrated stable ocular findings with no evidence of recurrent inflammation or systemic autoimmune disease. Final visual acuity was 6/9 in each eye. This case represents a rare occurrence of non-necrotizing retinitis following MMRV vaccination. To our knowledge, this is the first report describing the sequential OCT characteristics of presumed measles vaccine-associated retinitis. The prolonged follow-up period supports the absence of an alternative etiology and provides valuable insight into the long-term course and visual prognosis of vaccine-associated retinopathy.

PMID 42760840
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PubMedEuropean journal of pediatrics2026-09-19

Genetic and clinical spectrum of progressive familial intrahepatic cholestasis type 1: novel ATP8B1 variants and genotype-phenotype correlations.

Lin Hui H, Peng Xiao-Rong XR, Qin Xiao-Mei XM, Zhang Hai-Ming HM et al.

Progressive familial intrahepatic cholestasis type 1 (PFIC1) is a rare genetic disorder caused by variants in ATP8B1. The aim of this study was to characterize the clinical and genetic spectrum of PFIC1 and to investigate genotype-phenotype correlations in affected individuals. Clinical manifestations and laboratory findings from 15 newly identified individuals with PFIC1, together with data from 70 previously reported cases retrieved from the PubMed and CNKI databases, were collected and analyzed. A total of 10 novel pathogenic or likely pathogenic ATP8B1 variants were identified. Clinical manifestations included cholestatic jaundice, pruritus, hepatomegaly, diarrhea, deafness, and pancreatitis, accompanied by elevated serum transaminase, total/direct bilirubin, and total bile acid levels, with normal or low gamma-glutamyl transpeptidase (GGT) levels. Most patients with PFIC1 (71.2%, 42/59) showed an insufficient response to oral ursodeoxycholic acid (UDCA). Among patients who underwent liver transplantation (LT), severe postoperative complications, including hepatic steatosis (93.3%, 14/15) and intractable diarrhea (86.7%, 13/15), were common. In contrast, LT combined with surgical biliary diversion (SBD) reduced the incidence of these complications to 44.4% (4/9) for both outcomes. At the last follow-up, unfavorable clinical outcomes were observed in 64.7% (44/68) of cases. Compared with individuals carrying non-biallelic null ATP8B1 variants, those with biallelic null variants had an earlier age at onset, a lower response rate to UDCA, and reduced LT-free survival. Conclusion: This study described 15 new cases of PFIC1 carrying 10 novel ATP8B1 variants. PFIC1 involved multisystem manifestations, with normal-GGT cholestatic hepatitis representing a characteristic feature. The therapeutic efficacy of UDCA remained limited, and LT alone was associated with substantial postoperative complications, whereas combined LT and SBD appeared to reduce complication rates. Individuals with biallelic null ATP8B1 variants demonstrated earlier disease onset and poorer therapeutic and clinical outcomes.

PMID 42760445
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PubMedMedicine2026-09-19

Artificial neuro-fuzzy intelligence for dynamic tracking and prediction of HIV prevalence and new infections among individuals aged 15 to 49 years in Uganda: Computational national-level models.

Abdalla Elnazeer Ali Hamid EAH, Elsadig Muna M, Omar Umi U, Eze Val Hyginus Udoka VHU et al.

Human immunodeficiency virus (HIV) infection remains a major global health burden, and Uganda continues to experience rising new HIV incidence, making prevention and management increasingly challenging. Accurate estimation of HIV prevalence (PHIVP) and tracking new HIV incidence (PHIVN) require robust computational models to effectively inform public health interventions. This study aims to develop a computational tracking model based on a 2-level intelligent framework to dynamically monitor PHIVP and PHIVN in Uganda and to identify influential factors that contribute to HIV trends among individuals aged 15 to 49. Six datasets from 146 Ugandan districts for 2023: sex rate, antiretroviral therapy coverage, awareness, education, personal income, and historical HIV indicators (prevalence and new incidence) were analyzed. A 2-level intelligent technique was employed: level I, an upgraded clustering algorithm was used to identify optimal parameters influencing PHIVP and PHIVN and level II, a neuro-fuzzy model was trained on these parameters to construct the computational tracking model. Data were partitioned into 85% for model training and 15% for testing and validation. Model accuracy was evaluated using regression performance, error metrics, and statistical significance. The model predicted a decline in PHIVP from 5.1% to 4.92%, and accurately tracked 37,996 PHIVN cases out of 38,132 actual incidences. The computational framework demonstrated strong predictive performance, yielding high regression values of R = 0.832 to 0.987 for PHIVP and PHIVN across 3 scenarios. Statistical analysis confirmed model reliability with P < .001 and P = .001. The 2-level intelligent approach exhibits strong potential for dynamically monitoring HIV prevalence and new incidence in Uganda. The 6 analyzed datasets represent significant determinants of PHIVP reduction and PHIVN tracking among adults aged 15 to 49. These findings support the feasibility of computational modeling as a tool for enhancing HIV surveillance, guiding prevention strategies, and strengthening evidence-based public health decision-making in Uganda.

PMID 42760725
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PubMedMedScience2026-09-19

Neoantigen cancer vaccines for gastrointestinal tumors: opportunities and challenges.

Zhao Zixuan Z, Du Xinyu X, Gao Xiaoliang X, Zhao Sheng S et al.

Gastrointestinal tumors are characterized by high global incidence and mortality rates. Although immune checkpoint inhibitors (ICIs) have achieved breakthroughs in some of these cancers, their overall response rate remains low. Neoantigen cancer vaccines have emerged as a promising new strategy for immunotherapy in gastrointestinal tumors due to their high specificity and strong immunogenicity. These vaccines effectively activate specific T-cell immunity and can produce synergistic effects when combined with ICIs. Various vaccine platforms offer distinct advantages, and clinical trials have shown encouraging potential in inducing immune responses and extending progression-free survival. Meanwhile, current challenges and future directions cannot be ignored. Key challenges primarily involve the accuracy of neoantigen prediction, tumor heterogeneity, and optimal treatment timing. Future directions include artificial intelligence (AI)-assisted multi-omics screening, the development of universal vaccines, optimization of novel delivery systems, and multimodal combination strategies. These advances are expected to promote the application of neoantigen cancer vaccines in postoperative recurrence prevention and early-stage treatment, ultimately moving toward personalized precision immunotherapy. This article systematically reviews the clinical progress and prospects of neoantigen cancer vaccines in treating gastrointestinal tumors, aiming to provide insights for immunotherapy in this field and offer new perspectives for further optimization of such vaccines.

PMID 42760419
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PubMedThe AAPS journal2026-09-19

Quantitative Characterization of Innate and Adaptive Pharmacology of Allogeneic anti-CD20 Chimeric Antigen Receptor (CAR) Vδ1 γδ T cells using Multiscale Mechanistic Modeling.

Desai Devam A DA, Elashkar Omar O, Cristofoletti Rodrigo R, Mugundu Ganesh G et al.

Gamma Delta (γδ) T Cells are currently being evaluated as a therapeutic alternative to traditional alpha-beta (αβ) T-cells due to their superior safety profile and enhanced tissue retention properties. The application of CAR technology to gamma delta (γδ) T cells presents a novel therapeutic avenue with the potential to overcome some limitations of conventional CAR T-cell therapies, such as targeting solid tumors and reducing on-target, off-tumor toxicities. The objective of this manuscript is development of a translational PK-PD framework to first characterize in vitro killing potential of un-transduced and CAR transduced anti- CD20 Vδ1 γδ T cells as well as development of an in vivo mechanistic CK-PD model designed to understand the complex dynamics of CAR γδ T cells and their interaction with IL-15 and tumor cells. All the preclinical and clinical datasets along with relevant information were digitized and obtained from the published work on Adicet Bio's AD-001. The developed model was able to estimate the in vitro killing potential of untransduced and CAR transduced anti- CD20 Vδ1 γδ T cells as well as expansion, tissue distribution, the impact of lymphodepletion and interleukin-15 (IL-15), and the tumor-killing potential of CAR-modified γδ T cells. These insights offer a deeper understanding of the potential therapeutic benefits and mechanisms of γδ T cells in immunotherapy, particularly in their application against various cancers. The development of this translational framework can be paramount in understanding the underlying dose-exposure-response relationship of CAR modified γδ T cell therapy and facilitate the discovery and development of these agents.

PMID 42760488
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