Merck & Co. · Vaccine · Vaccine
Varicella zoster vaccine is a vaccine developed by Merck & Co.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or subcutaneous injection.
| Brand Names | V210, Varivax, Varivax ISF |
| Company | Merck & Co. |
| Drug Class | Vaccine, Large Molecules |
| Route | Injectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection |
| Status | Approved |
Varicella zoster vaccine is developed for 1 unique indication across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Infections and infestations | Varicella zoster virus infection | ✓ Approved |
Therán-León Juan Sebastián JS, Hernández-Cañas María Camila MC, Quintero-Arévalo Bárbara Yuliana BY
Kulthanachairojana Nattanichcha N, Phothong Pattheera P, Promkladphanao Pitch P, Singharerg Chollakarn C et al.
Patients with end-stage renal disease (ESRD) are increased risk of herpes zoster (HZ). The economic value of HZ vaccines in Thai patients with ESRD has not been assessed. This study evaluated the cost-utility and budget impact of two HZ vaccination strategies - zoster vaccine live (ZVL) and recombinant zoster vaccine (RZV) - compared with no vaccination in Thailand. A Markov model was developed to estimate lifetime health and economic outcomes in patients with ESRD. Cost-utility analysis was conducted from a societal perspective, while budget impact analysis was performed from a payer perspective over a 5-year time horizon. Model inputs were derived from published literature and Thai data sources. Uncertainty was assessed using deterministic, probabilistic, and scenario sensitivity analyses. In the base-case analysis, both ZVL and RZV were cost-effective compared with no vaccination, with incremental cost-effectiveness ratios (ICER) of USD 1,599.14 (THB 51,912.56) and USD 2,920.09 (THB 94,794.30) per quality-adjusted life year (QALY) gained, respectively - both below Thailand's willingness-to-pay threshold. RZV generated greater health benefits but was associated with higher costs. Sensitivity analyses confirmed the robustness of cost-effectiveness results across key assumptions. Over a 5-year period, the estimated budget impact ranged from USD 4.99-9.55 million (THB 161.86-310.02 million) for ZVL and USD 28.92-55.42 million (THB 938.95-1,799.09 million) for RZV, depending on vaccine uptake assumptions, with expenditures largely concentrated in the first year due to vaccination of prevalent patients. Both HZ vaccines are cost-effective options for preventing HZ in Thai patients with ESRD. While RZV provides greater health gains, it requires substantially higher budgetary investment. These findings support prioritising HZ vaccination for patients with ESRD and initiating pilot implementation within dialysis care settings to assess system-level impact and feasibility.
Paulino-Ramirez Robert R, Matias Wilfredo R WR, Chaumette Alexandre A, Lora-Rodríguez Hector H et al.
Mpox disproportionately affects people with HIV (PWH), yet little is known about mpox vaccine awareness and uptake in low- and middle-income countries. We evaluated mpox-related knowledge, attitudes and practices (KAP) among PWH in the Dominican Republic to identify determinants of vaccine awareness and uptake. We conducted a cross-sectional online survey of 98 PWH recruited through HIV clinics, community-based organizations and social networks (January-May 2025). The questionnaire assessed sociodemographic characteristics, mpox-related KAP, structural barriers and vaccination status. Univariable and multivariable logistic regression were used to examine factors associated with mpox vaccine awareness. Half of the participants (49/98) were aware of the mpox vaccine. Individuals aged 31-40 years had significantly lower odds of awareness compared with those aged 21-30 years. Despite high levels of formal education, 79% rated their mpox knowledge as low, and most perceived minimal personal risk. Among participants aware of the vaccine, 71% had been vaccinated. Structural barriers, including inconvenient site locations and logistical challenges, were frequently reported, even among vaccinated individuals, indicating that access limitations rather than hesitancy were the dominant constraints. Trust in vaccinating organizations was high overall, and healthcare providers and community organizations were the primary sources of vaccine information. Peer and community influence emerged as notable facilitators of uptake, while lack of reliable information and concerns about vaccine safety contributed to hesitancy. Mpox vaccine awareness among PWH in the Dominican Republic was low, but willingness to vaccinate was high when individuals were informed and able to access services. Strengthening mpox preparedness will require expanding accessible vaccination sites, improving disease-specific health literacy, and leveraging trusted community and clinical networks. Integrating mpox vaccination into routine HIV care delivery and enhancing community-led outreach may substantially improve uptake in this and similar low-middle income countries (LMIC) settings.
Bahrs Christina C, Rose Norman N, Barten-Neiner Grit G, Fleischmann-Struzek Carolin C et al.
The main burden of non-invasive pneumococcal diseases in adults is largely due to community-acquired pneumonia (CAP). This study aimed to investigate the distribution and dynamics of pneumococcal vaccine serotypes and to determine the proportion of CAP cases attributable to serotypes covered by 13-valent conjugate vaccine (PCV13), the 20-valent conjugate vaccine (PCV20), and the 23-valent polysaccharide vaccine (PPV23) among adults in Germany from 2020 to 2023. In this prospective multicenter cohort study, we analyzed all adult patients with CAP enrolled between January 1, 2020, and December 31, 2023, at 26 centers in Germany who provided urine samples for serotype-specific urine antigen detection (SSUAD) testing. Annual trends of pneumococcal vaccine serotypes from 2020 to 2023 were calculated for all patients and patient groups at risk using cluster-robust generalized linear models with heteroscedasticity-consistent standard errors. Of the 2,028 patients with all-cause CAP, 1,504 (1,008 patients aged ≥ 60 years, 373 younger patients with at least one comorbidity) had urine samples analyzed with SSUAD tests. Overall proportion of vaccine-type pneumococcal pneumonia among all-cause CAP for PCV13, PCV20, and PPV23 serotypes was 5.41% (95% CI 4.12-7.06%), 8.11% (95% CI 6.35-10.31%), and 8.31% (95% CI 6.27-10.93%), and serotype 3 was the most prevalent serotype (52 cases). Among patients aged ≥ 60 years, an increasing annual trend was observed for serotype 3 (OR 1.84, 95% CI 1.01-2.67), PCV13 (OR 1.89, 95% CI 0.89-2.89), PCV20 (OR 1.57, 95% CI 0.99-2.14), and PPV23 serotypes (OR 1.47, 1.04-1.91). The findings demonstrate that vaccine serotypes, particularly serotype 3, continued to circulate and reemerged among older adults with CAP in Germany.
Castellana Eleonora E, Chiappetta Maria Rachele MR
To describe the distribution and characteristics of adverse events following immunization (AEFI) using a large US pharmacovigilance database. A retrospective descriptive analysis of Individual Case Safety Reports (ICSRs) from the FDA AEMS database (January 2017-March 2026) was conducted. Reports were analyzed by vaccine type, adverse event terms, demographics, reporting year, and reporter category. A total of 2 169 603 ICSRs were identified, with 44.0% classified as serious. COVID-19 vaccines accounted for 78.4% of reports, reflecting mass vaccination campaigns. The most frequently reported events were headache (12.8%), pyrexia (11.8%), and fatigue (11.1%), predominantly non-serious and consistent with known reactogenicity profiles. Reporting peaked in 2021 (48.8%). Females accounted for 60.6% of reports. Non-COVID vaccines contributed substantially fewer reports. Most vaccine-associated adverse events were mild and expected. Findings support a favorable benefit-risk profile and highlight the importance of continuous pharmacovigilance systems for vaccine safety monitoring.
Gadelha Carolina S E CSE, Terreri Maria Teresa MT, N Burian Ana Paula AP, da Fraga Aline C M ACM et al.
COVID-19 vaccines have significantly reduced mortality and are safe for healthy children; however, research in pediatric populations with juvenile immune-mediated inflammatory diseases (IMIDs) is limited. The Brazilian multicenter longitudinal SAFER-Study evaluates immunogenicity and safety of the BNT162b2/Pfizer vaccine in IMID patients. The juvenile cohort enrolled patients aged 12-17 years between August and December 2021 and compared them with adults under 40 years from the adult cohort. Safety was assessed by monitoring post-vaccination adverse events (AEs), immunogenicity was measured by IgG antibodies against the SARS-CoV-2 spike receptor-binding domain and seroconversion rates. A total of 123 participants were included: 86 adolescents and 37 adult controls. In adolescents, local AEs were most frequent; no serious or life-threatening AEs occurred. Significant increases in IgG-S levels were observed after the two doses in both cohorts (p < 0.001). Seroconversion after the second dose reached 97% overall and 100% after the third dose. In juvenile SLE and JIA patients, vaccination did not significantly affect disease activity. The BNT162b2 vaccine was safe and immunogenic in adolescents with IMIDs, including those with high immunosuppression and comorbidities, showing similar responses to adults. These findings support vaccination in this vulnerable population and contribute to evidence-based recommendations. BNT162b2 COVID-19 vaccine demonstrated a favorable safety profile and immunogenicity in adolescents with juvenile immune-mediated inflammatory diseases (IMID), with responses comparable to those observed in adults. Real life data on this population remain limited, and further evidence regarding vaccine safety and immunogenicity is needed. This study represents the first multicenter, longitudinal registry of Brazilian adolescents with IMID receiving BNT162b2. Comprehensive data on the safety and immunogenicity of BNT162b2 in highly immunosuppressed adolescents with IMID and comorbidities are crucial to guide clinical decision-making, mitigate vaccine hesitancy, and enhance vaccination coverage within this vulnerable population.
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