scholarly journals Effectiveness of the recombinant zoster vaccine in adults aged 50 and older in the United States: a claims-based cohort study

2021 ◽  
Author(s):  
Yuwei Sun ◽  
Eric Kim ◽  
Christina L Kong ◽  
Benjamin F Arnold ◽  
Travis C Porco ◽  
...  
Keyword(s):  
Cohort Study ◽  
Herpes Zoster ◽  
Vaccine Coverage ◽  
The United States ◽  
Vaccine Effectiveness ◽  
Administrative Claims ◽  
Zoster Vaccine ◽  
Immunization Rates ◽  
History Of ◽  
Recombinant Zoster Vaccine

Abstract Background The recombinant zoster vaccine had over 90% efficacy in preventing herpes zoster in clinical trials. However, its effectiveness outside of a clinical trial setting has not been investigated. This study aimed to assess the effectiveness of the recombinant zoster vaccine in general practice. Methods A de-identified administrative claims database, the OptumLabs ® Data Warehouse, was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against herpes zoster in non-immunocompromised, vaccine age-eligible individuals enrolled in the database for ≥365 days. Results A total of 4 769 819 adults were included in this study, with 173 745 (3.6%) adults receiving two valid doses of the recombinant zoster vaccine. The incidence rate of herpes zoster was 258.8 (95% CI: 230.0 to 289.4) cases per 100 000 person-years in vaccinated persons compared to 893.1 (95% CI: 886.2 to 900.0) in unvaccinated. Recombinant zoster vaccine effectiveness was 85.5% (95% CI: 83.5% to 87.3%) overall, with an effectiveness of 86.8% (95% CI: 84.6% to 88.7%) in individuals 50 to 79-years-old compared to 80.3% (95% CI: 75.1% to 84.3%) in individuals ages 80 and older. In patients with a history of live zoster vaccine within 5 years of study inclusion, vaccine effectiveness was 84.8% (95% CI: 75.3% to 90.7%). Conclusions Recombinant zoster vaccine effectiveness against herpes zoster was high in a real-world setting. Given the low vaccine coverage and high effectiveness, a major public health effort is needed to identify and address barriers to vaccination and increase immunization rates.

scholarly journals Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure

2021 ◽  
Author(s):  
Hector S Izurieta ◽  
Xiyuan Wu ◽  
Richard Forshee ◽  
Yun Lu ◽  
Heng-Ming Sung ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
Real World ◽  
Postherpetic Neuralgia ◽  
Vaccine Effectiveness ◽  
Community Dwelling ◽  
Zoster Vaccine ◽  
Post Market ◽  
Recombinant Zoster Vaccine ◽  
Dose Vaccine

Abstract Background Shingrix™ (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as two doses given 2–6 months apart, among adults ages ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster,but post-market vaccine performance has not been evaluated. Efficacy of a single dose, delayed second dose, or among persons with autoimmune or general immunosuppressive conditions have also not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix. Methods We conducted a cohort study among vaccinated and unvaccinated Medicare Part D community dwelling beneficiaries ages >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance, and marginal structural models to estimate hazard ratios. Results We found a vaccine effectiveness of 70.1% (95% CI, 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for two and one doses, respectively. The two-dose vaccine effectiveness was not significantly lower for beneficiaries 80+ years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8). Conclusions This large real-world observational study of effectiveness of Shingrix demonstrates the benefit of completing the two-dose regimen. Second doses administered beyond the recommended 6 months did not impair vaccine effectiveness.Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

scholarly journals 07. Recombinant Zoster Vaccine (RZV) Second-Dose Completion in Adults Age 50‒64 Years in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S127-S127
Author(s):  
Jessica Leung ◽  
Elizabeth B Gray ◽  
Tara Anderson ◽  
Sarah M Sharkey ◽  
Kathleen L Dooling
Keyword(s):  
The United States ◽  
Administrative Claims ◽  
Completion Rates ◽  
Medicare Beneficiaries ◽  
Medical Provider ◽  
Zoster Vaccine ◽  
National Drug ◽  
Series Completion ◽  
Recombinant Zoster Vaccine

Abstract Background In 2018, CDC recommended a highly efficacious adjuvanted recombinant zoster vaccine (RZV, Shingrix) as a 2-dose series for prevention of herpes zoster (HZ) for immunocompetent persons age ≥50 years, with the 2nd dose recommended 2–6 months after the 1st dose. Among Medicare beneficiaries, 2-dose series completion 6 months and 12 months post initiation was 78% and 86%, respectively. Here we estimate the proportion of adults age 50–64 years who completed the 2-dose RZV series within 6 or 12 months after receiving their 1st dose, by using two administrative claims databases. Methods We used medical and pharmaceutical claims data from October 2017‒March 2020 IQVIA® PharMetrics Plus and October 2017‒October 2020 IBM® MarketScan® databases. RZV vaccination was defined using Current Procedural Terminology and National Drug Codes. We allowed for sufficient follow-up time by examining 1st doses given at least 6 or 12 months prior to the end of the study period in both databases. Place of administration was available in IQVIA data. Results Among persons age 50‒64 years, in IQVIA and MarketScan, 70% and 68% received their 2nd RZV dose within 6 months, respectively, and 79% and 81% received their 2nd dose within 12 months, respectively. The median age of 1st dose of RZV vaccination was 60 years and ~60% were female [Table 1]. When the 2nd dose was administered within 12 months, the median interval between 1st and 2nd doses was 104 and 98 days in the IQVIA and MarketScan databases, respectively. Characteristics by age, sex, or region were similar in persons who received 1 RZV dose vs. 2 RZV doses [Table 1]. Among those who received only 1 RZV dose with at least 12 months of follow-up time, 55% of vaccinations occurred at ambulatory medical provider offices and 40% at pharmacies; among 2 doses recipients, 33% of vaccinations occurred at provider offices and 62% at pharmacies. Conclusion Among 50‒64-year-olds, 2-dose RZV series completion was ~70% within 6 months and 80% within 12 months of initiation. The findings were similar across two administrative claims databases. Availability of RZV at pharmacies has potentially helped to increase RZV 2nd dose completion rates. Disclosures All Authors: No reported disclosures

scholarly journals 20. Cost-Effectiveness of Recombinant Zoster Vaccine for Vaccinating Immunocompromised Adults Against Herpes Zoster in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S134-S134
Author(s):  
Desmond Curran ◽  
Ahmed Salem ◽  
Stéphane Lorenc ◽  
Brandon Patterson ◽  
Justin Carrico ◽  
...  
Keyword(s):  
United States ◽  
Herpes Zoster ◽  
Cost Effectiveness ◽  
The United States ◽  
Hypothetical Cohort ◽  
Cell Transplant ◽  
Renal Transplant Recipients ◽  
Zoster Vaccine ◽  
Scenario Analyses ◽  
Recombinant Zoster Vaccine

Abstract Background Individuals who are immunocompromised (IC) due to disease or therapy are at increased risk of herpes zoster (HZ), with HZ cases in IC populations also resulting in increased health care resource use and costs as compared with the immunocompetent population. This study assesses the cost-effectiveness of recombinant zoster vaccine (RZV) versus no vaccine for the prevention of HZ in IC adults aged ≥ 18 years in the United States (US). Methods A Markov model with a one-year cycle length was developed to follow a hypothetical cohort of one million IC individuals for a 30-year time horizon. The model estimates health and cost outcomes associated with RZV versus no vaccine. The base-case analysis considered hematopoietic stem cell transplant (HSCT) recipients who were assumed to remain IC for five years post-transplant. Second-dose compliance was assumed to be 100%, with efficacy and waning inputs based on clinical trial data. Epidemiological, cost, and utility inputs were obtained from standard US sources and published literature. Costs and quality-adjusted life-years (QALYs) were discounted at 3% per year. Sensitivity, threshold, and scenario analyses were conducted, including scenarios of four other IC conditions. Results In the modeled hypothetical cohort of one million HSCT recipients, RZV resulted in 116,790 fewer HZ cases and 21,446 fewer postherpetic neuralgia cases versus no vaccine, 5,545 fewer QALYs lost and a societal cost-savings of &5.4 million. The number needed to vaccinate to prevent one HZ case was estimated to be 9. HSCT population results were shown to be robust in sensitivity and threshold analyses. In scenario analyses, RZV was cost saving for renal transplant recipients. Incremental cost-effectiveness ratios for other IC populations were &33,268 per QALY gained for human immunodeficiency virus, &67,682 for breast cancer, and &95,972 for Hodgkin lymphoma. Conclusion Results suggest that RZV is a cost-effective option for vaccinating US IC adults for the prevention of HZ and associated complications. Disclosures Desmond Curran, PhD, The GSK group of companies (Employee, Shareholder) Ahmed Salem, MSc, The GSK group of companies (Employee) Stéphane Lorenc, NA, GSK group of companies (Consultant) Brandon Patterson, PharmD, PhD, GSK group of companies (Shareholder) Justin Carrico, BS, GSK group of companies (Consultant)RTI Health Solutions (Employee) Katherine A. Hicks, MS, BSPH, GSK group of companies (Consultant)RTI Health Solutions (Employee) Elizabeth M. La, PhD, The GSK group of companies (Employee, Shareholder) Sara Poston, PharmD, The GSK group of companies (Employee, Shareholder) Christopher F. Carpenter, MD, MHSA, GSK group of companies (Consultant)

scholarly journals Vaccines for older adults

BMJ ◽  
2021 ◽  
pp. n188
Author(s):  
Anthony L Cunningham ◽  
Peter McIntyre ◽  
Kanta Subbarao ◽  
Robert Booy ◽  
Myron J Levin
Keyword(s):  
Older Adults ◽  
Older People ◽  
Vaccine Coverage ◽  
Relative Effectiveness ◽  
Similar Efficacy ◽  
Influenza Vaccines ◽  
Public Confidence ◽  
Zoster Vaccine ◽  
Vaccine Serotypes ◽  
Recombinant Zoster Vaccine

Abstract The proportion of the global population aged 65 and older is rapidly increasing. Infections in this age group, most recently with SARS-CoV-2, cause substantial morbidity and mortality. Major improvements have been made in vaccines for older people, either through the addition of novel adjuvants—as in the new recombinant zoster vaccine and an adjuvanted influenza vaccine—or by increasing antigen concentration, as in influenza vaccines. In this article we review improvements in immunization for the three most important vaccine preventable diseases of aging. The recombinant zoster vaccine has an efficacy of 90% that is minimally affected by the age of the person being vaccinated and persists for more than four years. Increasing antigen dose or inclusion of adjuvant has improved the immunogenicity of influenza vaccines in older adults, although the relative effectiveness of the enhanced influenza vaccines and the durability of the immune response are the focus of ongoing clinical trials. Conjugate and polysaccharide pneumococcal vaccines have similar efficacy against invasive pneumococcal disease and pneumococcal pneumonia caused by vaccine serotypes in older adults. Their relative value varies by setting, depending on the prevalence of vaccine serotypes, largely related to conjugate vaccine coverage in children. Improved efficacy will increase public confidence and uptake of these vaccines. Co-administration of these vaccines is feasible and important for maximal uptake in older people. Development of new vaccine platforms has accelerated following the arrival of SARS-CoV-2, and will likely result in new vaccines against other pathogens in the future.

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