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Potential public health impact of the adjuvanted recombinant zoster vaccine among people aged 50 years and older in Beijing.

ABSTRACT: Herpes zoster (HZ) is a painful, unilateral rash which occurs upon reactivation of latent varicella zoster virus due to age-related immunity decline or immuno-suppression. In 2019, the recombinant zoster vaccine (RZV) was the first vaccine to be approved in China for HZ prevention. This study aimed to estimate the potential public health impact of RZV vaccination, compared with the status quo of no vaccination, in individuals ≥50 years of age (YOA) in Beijing, by adapting the published ZOster ecoNomic Analysis (ZONA) model. We considered 5% and 50% vaccination coverage for the private market (near-term post-launch) and mass vaccination (long-term) settings respectively. In the base-case analysis of both market settings, second-dose compliance was set to 80%. Coverage and second-dose compliance rates were varied under scenario and sensitivity analyses. In the base case, mass vaccination with RZV was estimated to prevent 435,681 HZ cases, 51,558 postherpetic neuralgia (PHN) cases, and 15,703 cases of other HZ-related complications in the overall ≥50 YOA cohort over their remaining lifetime, compared with no vaccination. Under the same base-case scenario, 14,247 hospitalizations and 1,031,387 outpatient visits could be avoided. The 50-59 YOA cohort had the highest contributions to the overall reduction in HZ cases, its complications and related healthcare resource utilization. Results were robust under numerous scenario and sensitivity analyses. This analysis demonstrates the potential of RZV vaccination to substantially reduce the public health burden of HZ among individuals ≥50 YOA, and may inform appropriate vaccination strategies for HZ prevention, particularly in urban settings within China.

SUBMITTER: Lee C

PROVIDER: S-EPMC8437530 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Abstract Background The recombinant herpes zoster (HZ) subunit vaccine (HZ/su) has shown efficacy against HZ in adults ?50 and ?70 years of age (YOA), in two pivotal Phase III clinical trials (NCT01165177, NCT01165229). A pooled safety analysis of data from these two efficacy studies was performed, including a comparative analysis on HZ/su vs. placebo groups, to provide a comprehensive understanding of the HZ/su safety profile. Methods Two pivotal, randomized, placebo-controlled Phase III studies, assessed the efficacy, reactogenicity and safety of HZ/su, administered intramuscularly according to a 0, 2-month schedule. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each dose, respectively; serious AEs (SAEs) for 1 year after last dose; fatal and related SAEs and potential immune-mediated diseases (pIMDs) during the entire study period. Reactogenicity was assessed in a subset of participants; safety was assessed in all vaccinated participants. Results 29,305 participants ?50 YOA (HZ/su: 14,645; placebo: 14,660) were included in the pooled analysis. HZ/su was more reactogenic than placebo. Local reactions were mostly mild to moderate in intensity and transient (median duration = 3 days); the percentages of participants reporting SAEs, fatal SAEs and pIMDs were similar in both groups, at 30 days and 1 year after last dose (Figures 1 and 2). Percentages of fatal SAEs ranged between 4.3% (95% Confidence Interval [CI]: 4.0–4.7) and 4.6% (95% CI: 4.3–5.0) and pIMDs between 1.2% (95% CI: 1.1–1.4) and 1.4% (95% CI: 1.2–1.6), in HZ/su and placebo groups, respectively. In both groups, the most frequent causes of death were neoplasms, cardiac disorders, and respiratory tract infections and infestations, and most frequent pIMDs were polymyalgia rheumatica, rheumatoid arthritis and psoriasis. Conclusion No safety concern was identified. Together with the high efficacy against HZ (97.2% [95% CI: 93.7–99.0],1 91.3% [95% CI: 86.8–94.5]2), the safety data supports a favorable benefit/risk profile of HZ/su in participants ?50 YOA. Funding GlaxoSmithKline Biologicals SA Disclosures M. López-Fauqued, GSK Biologicals’: Employee, Salary; ?L. Campora, GSK Biologicals’: Employee, Salary; F. Delannois, GSK Vaccines: Employee, Salary; M. El Idrissi, GSK Vaccines: Employee, Salary; E. Ledent, GSK Vaccines: Employee, Salary; J. Diez-Domingo, GSK Vaccines: Consultant and Investigator, Educational support and Research grant; J. McElhaney, GSK Vaccines: Scientific Advisor, Speaker honorarium; S. McNeil, GSK/Merck: Grant Investigator, Investigator and Scientific Advisor, Consulting fee, Grant recipient, Research grant, Research support and Speaker honorarium; F. De Looze, GSK Vaccines: Investigator and Research Contractor, Research support; F. Tavares Da Silva, GSK Vaccines: Employee, restricted shares and Salary

Project description:INTRODUCTION:The incidence of herpes zoster (HZ) rises steeply after the age of 50 years and the number of HZ cases and complications such as postherpetic neuralgia (PHN) is predicted to increase because of the ageing population. The objective of this study was to estimate the cost-effectiveness of recombinant zoster vaccine (RZV) compared with no vaccine for the Japanese population aged ≥ 65 years. METHODS:A multi-cohort static Markov model with a cycle length of 1 year was used to follow a hypothetical cohort of 1 million people aged ≥ 65 years over their remaining lifetime. Vaccination at ≥ 65 years was used in alignment with the influenza and pneumococcal vaccines recommended from 65 years. Japan-specific data inputs for the model were obtained from local data sources. Age-stratified vaccine efficacy and waning rates were based on published clinical trial data. In the base-case analysis, vaccine coverage was assumed to be 40% with a second dose compliance of 95%. Costs and outcomes were discounted at 2% annually and the incremental cost-effectiveness ratio (ICER) was calculated from both a payer's and the societal perspective. Sensitivity analyses were carried out to explore the overall uncertainty in the model. RESULTS:Vaccination with RZV was projected to prevent 48,943 HZ cases and 12,136 PHN cases per million people aged ≥ 65 years compared with no vaccination. The incremental costs and quality-adjusted life years (QALYs) gained were ¥9.99 billion and 2314 QALYs from a payer's perspective and ¥9.34 billion and 2314 QALYs from a societal perspective. The resulting ICERs were approximately ¥4,320,000 and ¥4,040,000 per QALY gained from a payer's and the societal perspective, respectively. The ICER remained below a willingness-to-pay threshold of ¥5,000,000 for most sensitivity analyses carried out. CONCLUSION:Vaccination against HZ with RZV would be cost-effective compared with no vaccination for the Japanese population aged ≥ 65 years. TRIAL REGISTRATION:GSK study identifier: HO-16-17837. FUNDING:GlaxoSmithKline Biologicals SA.

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Potential public health impact of the adjuvanted recombinant zoster vaccine among people aged 50 years and older in Beijing.

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