Drug Database
PN

pneumococcal vaccine (Prevenar 13 / 13vPnC / PCV 13)

✓ Approved

Takeda · Vaccine · Vaccine

What is pneumococcal vaccine?

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

Drug Profile

Brand NamesPrevenar 13, 13vPnC, PCV 13
CompanyTakeda
Drug ClassVaccine
RouteInjectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Takeda

Therapeutic Indications

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

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

Related Research Articles

PubMedClinical pediatrics2026-11-11

Clinical Characteristics, Risk Factors, and Outcomes of Complicated Pneumonia in Children: A 10-Year Retrospective Cohort Study.

Caka Canan C, Yalcin Ebru E, Emiralioglu Nagehan N, Kukul Musa Gurel MG et al.

Complicated pneumonia (CP) is associated with substantial morbidity in children. This retrospective cohort study evaluated demographic, clinical, and laboratory predictors of CP and factors associated with delayed recovery among children hospitalized at a tertiary pediatric pulmonology center between 2008 and 2018. Of 303 patients, 204 (67.3%) developed CP, most commonly parapneumonic effusion. Malnutrition was associated with CP in univariate analysis, while independent predictors included lack of pneumococcal vaccination, prolonged symptom duration, chest pain, anemia, thrombocytosis, and hypoalbuminemia. Malnutrition, anemia, hypoalbuminemia, hyponatremia, prolonged pre-admission fever, prior antipyretic use, elevated inflammatory markers, and positive pleural fluid microbiology were associated with delayed recovery. Readily available admission parameters may facilitate early risk stratification, whereas maintaining high pneumococcal vaccination coverage may contribute to reducing the burden of CP in children. Radiological recovery typically occurred after approximately 60 days, supporting continued clinical observation despite persistent radiographic abnormalities.

PMID 43012385
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PubMedNPJ vaccines2026-11-11

A structure-guided trivalent subunit vaccine confers maternal protection to neonatal piglets against PEDV and PDCoV.

Liu Jia J, Chen Longping L, Li Dan D, Wang Zhuo Z et al.

Antigenic divergence among porcine epidemic diarrhea virus (PEDV) genotypes and porcine deltacoronavirus (PDCoV) limits the cross-protection provided by current commercial vaccines. Here, employing a structure-guided antigen design strategy, we developed a trivalent subunit vaccine concurrently targeting PEDV G2a, PEDV G2b, and PDCoV. The vaccine antigen set comprises optimized spike ectodomain antigens, featuring stabilizing mutations, a heptad repeat 2 (HR2) deletion, a fused neutralizing epitope, and a flagellin adjuvant fused to the N-terminus. Formulated with MF59+CpG adjuvants, this trivalent vaccine elicited robust PEDV- and PDCoV-specific neutralizing antibody responses and Th1/Th2-associated cellular immune responses characterized by IFN-γ, IL-2, and IL-4 production in mice. Immunization of pregnant sows with 300 μg dose induced high-titer IgG, IgA, and colostral secretory IgA (SIgA) against all three target viruses. Although neutralizing antibody titers were comparable between the 100 μg and 300 μg dose groups, the 300 μg group showed higher and more persistent levels of colostral binding IgG and SIgA. Following maternal immunization, piglets that acquired maternal antibodies through colostrum exhibited reduced clinical diarrhea, lower fecal viral RNA shedding, and less severe intestinal lesions after challenge with PEDV G2a, PEDV G2b, or PDCoV. These findings support this structure-guided trivalent subunit vaccine as a promising candidate for maternal immunization against co-circulating porcine enteric coronaviruses.

PMID 43009510
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PubMedHealth communication2026-11-11

Spiritual Health Locus of Control and COVID-19 Booster Intentions Among Hispanic Americans: A Culturally Grounded Extension of the Extended Parallel Process Model.

Kim Joon J, Jun Jungmi J, Zambrano Rodriguez Viviana Carolina VC

Declining uptake of COVID-19 boosters poses significant public health concerns. Hispanic Americans, who have experienced disproportionate pandemic impacts, report lower uptake of updated boosters than non-Hispanic White adults, partly attributable to vaccine hesitancy. Although religiosity plays a central role in Hispanic communities, little is known about how spiritually grounded beliefs shape cognitive and emotional responses to vaccination. This study integrates the extended parallel process model (EPPM) with spiritual health locus of control (SHLOC) to examine how exposure to faith-based and governmental vaccine information influences booster intention through spiritually grounded efficacy appraisals. Using an online survey of Hispanic American adults (N = 349), we tested a structural equation model linking SHLOC, perceived threat, efficacy beliefs, fear, and vaccination intentions. Results indicated that active SHLOC, reflecting beliefs in divine partnership in health, increased response efficacy and indirectly promoted booster intention and vaccine advocacy, whereas passive SHLOC, reflecting divine determinism, reduced self-efficacy and indirectly discouraged booster intention. Perceived threat was positively associated with fear, and efficacy beliefs emerged as the strongest predictors of booster intention. Mediation analyses supported serial pathways from message exposure to SHLOC to efficacy to intention, identifying spiritually grounded control beliefs as a culturally embedded mechanism in vaccine decision making. Findings suggest that faith-based engagement can function as either a protective or risk communication channel, depending on whether messages reinforce divine partnership or determinism. The study advances EPPM by identifying SHLOC as a culturally grounded antecedent to efficacy appraisal and offers implications for culturally responsive vaccine communication in Hispanic communities.

PMID 43012739
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PubMedBMC infectious diseases2026-11-11

Nafithromycin in community-acquired bacterial pneumonia: a focused systematic review of the human clinical development program.

Sethubaskaran Anupriya A, Kishor Allu Ravi AR, Murugadoss Hariharan H, Sadiqbasha Mohammed Fayaz MF et al.

Nafithromycin is a novel lactone ketolide being developed as a short-course oral treatment for community-acquired bacterial pneumonia (CABP). Its clinical development program includes early pharmacokinetic studies in healthy adults and later-phase efficacy trials in patients with CABP. This systematic review aimed to synthesize the available human clinical evidence on its pharmacology, safety, and efficacy. This systematic review was conducted in accordance with PRISMA 2020 and registered in PROSPERO (CRD420261367133). PubMed/MEDLINE, Embase, Scopus, CENTRAL, ClinicalTrials.gov, and the Clinical Trials Registry - India were searched from inception to 12 April 2026. Clinical studies evaluating nafithromycin in humans at any stage of development were eligible. Study selection and data extraction were performed independently by two reviewers. Given heterogeneity in study phase, design, population, and outcomes, findings were synthesized narratively. Four studies were included: two Phase 1 studies in healthy adults, one Phase 2 randomized comparative study, and one Phase 3 randomized non-inferiority trial in adults with CABP. Early-phase studies suggested that nafithromycin was generally well tolerated in the short term and had pharmacokinetic properties supportive of once-daily dosing, including high pulmonary exposure in epithelial lining fluid and alveolar macrophages. In the Phase 2 study, early clinical response rates were high with both 3-day and 5-day nafithromycin regimens. In the Phase 3 trial conducted in India, a 3-day oral nafithromycin regimen was non-inferior to 7-day moxifloxacin for early clinical response at Day 4, with no severe TEAEs, serious TEAEs, or deaths reported in either treatment arm. However, the evidence base remains limited in size and geographic diversity, and data in older adults, patients with renal or hepatic impairment, and microbiologically confirmed macrolide-resistant pneumococcal disease were sparse. Nafithromycin is a short-course oral candidate for CABP with supportive early clinical and pharmacokinetic data, but the current evidence base remains limited. Further evidence is needed to clarify its generalisability, rare or delayed safety profile, and effectiveness in microbiologically confirmed macrolide-resistant pneumococcal disease.

PMID 43009825
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PubMedInternational journal for equity in health2026-11-11

Reaching zero-dose children through the Big Catch-Up initiative in the Eastern Mediterranean Region.

Elmahdy Eman E, Mere Osama O, Farrukh Saadia S, Alyousfi Mohamad Nihad MN et al.

Routine immunization (RI) is one of the most effective public health interventions for reducing childhood morbidity and mortality. However, recent disruptions to RI have created immunity gaps in the Eastern Mediterranean Region (EMR), increasing the number of zero-dose (ZD) and under-immunized children, particularly in countries affected by conflict, displacement, service disruption, and ongoing vaccine-preventable disease outbreaks. The Big Catch-Up (BCU) initiative aimed to identify and vaccinate missed children, close immunity gaps, and strengthen RI systems. In the six Gavi-supported EMR countries included in this study (Afghanistan, Pakistan, Somalia, Sudan, Syria, and Yemen), implementation targeted children aged 12-59 months. This study assessed progress in reaching ZD children during BCU implementation in these six countries. A descriptive, multi-country programmatic analysis was conducted using quantitative and qualitative data from BCU quarterly reports covering implementation from Q4 2024 to Q1 2026. Additional data sources included World health Organization (WHO and United Nations Children's Fund (UNICEF) Estimates of National Immunization Coverage (WUENIC), Gavi-approved vaccine dose data, and UNICEF vaccine shipment data. Quantitative analysis summarized administered doses, zero-dose targets, BCU coverage, vaccine consumption, and performance by country and antigen among children aged 12-59 months. Age-disaggregated analyses were conducted for children aged 12-23 months and 24-59 months. Qualitative information from country reports on implementation successes, challenges, and lessons learned was summarized by country and thematic area. During the BCU implementation period, 3.5 million zero-dose children were reached with Penta1 across the six countries, representing 53% of the estimated cumulative population of 6.6 million ZD children. Of the 57 million Gavi-approved vaccine doses, 98% were shipped to countries, and 47.7 million doses were administered, equivalent to 84% of approved doses. Implementation success was supported by targeted identification of areas with high numbers of zero-dose children, integrated outreach, integration with other health services, and recruitment of vaccinators and deployment of community health workers. Key challenges included insecurity, population movement, inaccessible districts, community refusal, and limited community engagement. Substantial progress in reaching missed children was reported during BCU implementation in high-priority EMR countries. Lessons learned highlight the importance of integrating catch-up vaccination with RI, strengthening microplanning, ensuring timely vaccine supply and financing, improving community engagement, and institutionalizing catch-up vaccination.

PMID 43009985
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PubMedmSphere2026-11-11

Carbon source-dependent growth heterogeneity across Streptococcus pneumoniae serotypes revealed through interactive data visualization.

Sayegh Fadi M FM, Scott Chloe C, Ochoa Klariza K, Bae S Sandra SS et al.

Bacteria at the host-pathogen interface must continuously adapt their metabolism to the nutrient landscape of the host environment. More than 30% of the Streptococcus pneumoniae genome is dedicated to carbohydrate transport and metabolism, thus underscoring the importance of central carbon metabolism in host adaptation and survival. Despite this, comprehensive comparisons of carbon source-dependent growth dynamics across diverse pneumococcal serotypes remain limited. In this study, we used Biolog phenotype microarray plates together with a physiologically relevant defined medium, RPMI 1640, to characterize carbon source utilization and growth phenotypes across encapsulated serotypes and non-encapsulated strains. While several carbon sources supported conserved growth patterns across serotypes or strains, substantial serotype-specific variation was observed in carbon source utilization, maximal growth achieved, growth kinetics, and the timing of the death phase or the extent of autolysis. To address limitations in conventional data presentation, we present an interactive visualization framework for bacterial growth analysis. In the web version of this article, readers can dynamically explore carbon source-dependent phenotypes through interactive heatmaps linked to full growth curves, enabling detailed examination of growth phases, kinetic transitions, and autolysis events, alongside Venn diagrams that highlight serotype- and carbon source-specific phenotypic differences. The underlying code is publicly available via GitHub, providing a template for interactive data exploration. Together, these findings provide a valuable resource for investigating pneumococcal metabolic adaptation in host-relevant nutrient environments and demonstrate how interactive publication can enhance exploration and interpretation of complex bacterial growth data sets. IMPORTANCE As bacteria adapt their metabolism to nutritional environments, comprehensive comparisons across experimental data sets are often limited by their scale and complexity. Here, we characterize carbon source utilization across Streptococcus pneumoniae serotypes and strains, revealing both conserved and strain-specific growth dynamics that likely contribute to colonization and disease potential. We also address a broader challenge: how large, high-dimensional data sets are presented and interpreted in peer-reviewed publications. Current figures compress multidimensional kinetic data into single, static representations, limiting a reader's ability to independently evaluate the underlying dynamics. To overcome this limitation, we developed an interactive data visualization platform directly into the web-based article, enabling readers to explore the data while maintaining full data transparency. This approach advances data presentation in peer-reviewed research by providing a generalizable framework to improve the accessibility, interpretability, and evaluation of complex biological data sets.

PMID 43012512
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