bluuebunny/crossref_metadata_2025_split huggingface dataset:
07. Recombinant Zoster Vaccine (RZV) Second-Dose Completion in Adults Age 50‒64 Years in the United States
Authors: Leung Jessica , Gray Elizabeth B , Anderson Tara , Sharkey Sarah M , Dooling Kathleen L 
Published: December 2021

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
11. People Living with HIV During the COVID-19 Pandemic: Who Did (or Did Not) Receive Annual Influenza Vaccination?
Authors: Kahal Deborah A , Wharton Brian , James Christopher , Caplan Richard , Arlene Bincsik K 
Published: December 2021

Abstract

Background
Nationally, younger adults and racial minorities have lower levels of influenza vaccination (influenza vaccination = vaccine) than non-Hispanic White adults. During the 2015-16 season, most vaccine decliners in our program were male, black, and 45-66 years of age. As part of a quality improvement (QI) initiative to increase 2020-21 vaccine coverage amongst PLWH, we sought to compare patient characteristics between vaccine recipients and non-recipients.

Methods
Our program cares for 60% of Delawareans with HIV. The largest site in Wilmington was the QI site. IRB exemption was received, and pre-defined sociodemographic and HIV-specific variables were extracted from the EMR and CareWare from 1 Oct 2020 through 31 March 2021. Patient reports of external vaccine required confirmation. All PLWH ≥ 18 years of age, including those newly establishing care, met eligibility criteria. Comparisons between vaccinated and unvaccinated PLWH were performed using Wilcoxon rank sum tests for continuous variables and chi-squared tests for categorical variables. A multivariable logistic regression model, including age, sex, race, insurance, poverty level, HIV status, and virologic suppression, was used to predict vaccine.

Results
780 patients met study inclusion criteria and 86% (667/780) received vaccine. Characteristics of PLWH with and without vaccine are presented in Table 1. Older age, lower HIV viral load, and virologic suppression had a statistically significant (p&lt; 0.05) association with vaccine receipt in unadjusted analysis. Only older age (p&lt; 0.01) was significantly associated with vaccine in logistic regression modeling (Table 2), however this relationship was non-linear.
Table 1. Characteristics of patients living with HIV during the 2020-2021 Influenza vaccination season

Table 2. Multivariable Analysis of Baseline Characteristics

Conclusion
A very high rate of PLWH received vaccine, far exceeding local and national benchmarks, with EMR data unlikely to have fully captured all vaccines. The role of the COVID-19 pandemic in vaccine amongst PLWH is not yet known. While older age was associated with vaccine in adjusted analysis, the number of unvaccinated patients was small, confidence intervals wide, and associations consequently weak. Larger studies are needed to further investigate factors associated with vaccine receipt amongst PLWH.

Disclosures
Deborah A. Kahal, MD,MPH, FACP, Gilead (Speaker’s Bureau)Viiv (Speaker’s Bureau)
12. Modeled Impact of the COVID-19 Pandemic and Associated Reduced Adult Vaccinations on Herpes Zoster in the United States
Authors: La Elizabeth M , Curran Desmond , Salem Ahmed , Singer David , Lecrenier Nicolas , Poston Sara 
Published: December 2021

Abstract

Background
During the COVID-19 pandemic, adult vaccination in the United States (US) decreased substantially in 2020. Unlike other vaccine-preventable diseases where individuals may have experienced reduced risk due to COVID-related mitigation efforts (e.g., lockdown restrictions, use of face masks), individuals remained at risk of herpes zoster (HZ). This study projects the impact of reduced recombinant zoster vaccine (RZV) use on HZ cases and complications in the US.

Methods
A multi-cohort Markov model estimated the impact of missed RZV vaccinations, by comparing scenarios with and without missed vaccinations between Apr-Dec 2020, on cases of HZ, postherpetic neuralgia (PHN), and quality-adjusted life-years (QALYs) among US adults aged ≥ 50 years. Epidemiology, RZV efficacy, and utility inputs were obtained from standard US sources, clinical trial data, and published literature. Missed doses were estimated using data on RZV doses and an assumed 43% reduction in RZV vaccinations during the pandemic, based on publicly available data. Deterministic sensitivity and scenario analyses were conducted.

Results
In 2020, approximately 21 million (M) RZV distributed doses were expected, including an estimated 9.2M RZV series initiations in Apr-Dec. An estimated 3.9M RZV series initiations were missed, resulting in 31,945 projected HZ cases, 2,714 PHN cases, and 610 lost QALYs projected over a 1-year follow up. If individuals with missed RZV initiations remain unvaccinated in 2021, avoidable HZ cases will increase to 63,117 over 2 years. Further, if the same number of RZV initiations are missed in 2021, 95,062 avoidable HZ cases are expected. In a sensitivity analysis assuming 30% RZV reduction, 18,020 avoidable HZ cases and 1,531 PHN cases were observed over 1 year.

Conclusion
Adding to the substantial COVID-19 infection-related morbidity and mortality, reduced RZV use during the pandemic resulted in further burden from avoidable HZ cases. Health care providers should continue to emphasize the importance of vaccination against HZ and other preventable diseases during the pandemic.

Funding
GlaxoSmithKline Biologicals SA (GSK study identifier: [VEO-000222]).

Acknowledgement
Business & Decision Life Sciences c/o GSK (Coordination: Quentin Rayée).

Disclosures
Elizabeth M. La, PhD, The GSK group of companies (Employee, Shareholder) Desmond Curran, PhD, The GSK group of companies (Employee, Shareholder) Ahmed Salem, MSc, The GSK group of companies (Employee) David Singer, PharmD, MS, The GSK group of companies (Employee) Nicolas Lecrenier, Ing, PhD, The GSK group of companies (Employee, Shareholder) Sara Poston, PharmD, The GSK group of companies (Employee, Shareholder)
13. The Efficacy and Effectiveness of Pneumococcal Vaccines against Pneumococcal Pneumonia among Adults: A Systematic Review and Meta-Analysis
Authors: Childs Lana , Kobayashi Miwako , Farrar Jennifer Loo , Pilishvili Tamara 
Published: December 2021

Abstract

Background
Two pneumococcal vaccines are currently recommended for use in U.S. adults: 23-valent pneumococcal polysaccharide vaccine (PPSV23) and 13-valent pneumococcal conjugate vaccine (PCV13). Recommendations for adult PCV13 use were supported by a large randomized-controlled trial (RCT) demonstrating PCV13 efficacy against pneumococcal pneumonia (PnPn) and vaccine-type (VT) PnPn in older adults. New pneumococcal conjugate vaccines are expected to be licensed for adults in late 2021 and recommendations for use among adults will be reviewed and revised, as needed. We conducted a systematic review to summarize evidence on the vaccine efficacy and effectiveness (VE) of PPSV23 and PCV13 against PnPn among adults.

Methods
We conducted a search of literature published from 1998 to February 2021 on PCV13 and PPSV23 VE studies using eight reference databases. Studies targeting adults with immunocompromising conditions were excluded. VE results with 95% confidence intervals (CI) were abstracted and stratified by vaccine product, outcome evaluated (PnPn and VT PnPn), study design, and effect measure. When applicable, random effects models were used to estimate pooled VE and I-squared statistic was reported to assess heterogeneity.

Results
Of 3,422 screened studies, we included 15 studies: three on PCV13 and 12 on PPSV23 (Table 1). In addition to the RCT, we identified two observational studies for PCV13 (Table 1); however, pooled VE of the observational studies was not estimated due to differences in methods for reporting results. Pooled PPSV23 VE against PnPn from two RCTs was 63% (95% CI: 31, 80 I2=0%). Pooled VE of PPSV23 against VT PnPn from three observational studies was 18% (95% CI: -35, 35 I2=38%). PPSV23 effectiveness against PnPn was limited with a pooled VE of 25% (95% CI: 7, 39 I2=78%) from nine observational studies.

Conclusion
Findings from observational studies supported PCV13 VE against VT PnPn reported in the RCT. Differences in the study design made the magnitude of PPSV23 effectiveness against PnPn and VT PnPn difficult to assess; however, findings from recent observational studies suggest PPSV23 provides limited protection against VT PnPn.

Disclosures
All Authors: No reported disclosures
14. Postmarketing Safety Experience With MenACWY-TT
Authors: Serra Lidia , Mather Susan , Burman Cindy , Webber Chris 
Published: December 2021

Abstract

Background
MenACWY-TT (Nimenrix®), a quadrivalent meningococcal tetanus toxoid conjugate vaccine, was first licensed in 2012 and is available in 82 countries but not in the United States. MenACWY-TT is administered in infants as a 2 + 1 (6 weeks to &lt; 6 months of age) or 1 + 1 (6 to &lt; 12 months of age) schedule with the booster dose at 12 months of age, and from 12 months of age as a single dose. In addition to its widespread use to protect against meningococcal serogroups A, C, W, and Y, MenACWY-TT is a constituent of an investigational pentavalent meningococcal (MenABCWY) vaccine currently undergoing clinical development.

Methods
Using the MenACWY-TT Periodic Safety Update Report (PSUR) with format and content in accordance with Good Pharmacovigilance Practice Module VII and International Council for Harmonisation Guideline E2C, for data up to April 19, 2020, postmarketing safety experience with MenACWY-TT is considered. The PSUR data included herein are spontaneous adverse events (AEs) from the Pfizer safety database. AEs were coded by system organ class (SOC) and preferred term (PT) using MedDRA v.22.1J.

Results
The cumulative estimated exposure of MenACWY-TT was nearly 26 million doses, with the majority administered in 0- to 16-year-olds and in the Western European Union (Figure 1). Over the reporting period, 13,301 cumulative AEs occurred. The most common SOCs in the reporting period were general disorders and administration site conditions (n=5169; 39%); nervous system disorders (n=1986; 15%); injury, poisoning and procedural complications (n=1266; 10%); and gastrointestinal disorders (n=1031; 8%) (Figure 2). By PT, the most common AEs were pyrexia (n=1613; 12%), headache (n=738; 6%), and vaccination site pain (n=394; 3%) (Figure 3). Of the 3299 serious AEs reported, the most common were pyrexia (n=317; 10%) and headache (n=209; 6%).

Conclusion
Based on cumulative safety data in conjunction with existing efficacy and effectiveness data, the benefit-risk profile of MenACWY-TT remains favorable and is consistent with the safety profile of MenACWY-TT established in clinical studies.

Disclosures
Lidia Serra, MS, Pfizer Inc (Employee, Shareholder) Susan Mather, MD, Pfizer Inc (Employee, Shareholder) Cindy Burman, PharmD, Pfizer Inc (Employee, Shareholder) Chris Webber, MD, Pfizer (Employee, Shareholder)
16. An Ambulatory Quality Improvement Initiative to Optimize Influenza Vaccination Amongst Adults Living with HIV During the COVID-19 Pandemic
Authors: Kahal Deborah A , James Christopher , Wharton Brian , Eaddy Sherine , Gaines Elizabeth , Henry Karen , Juarez Luis , Arlene Bincsik K 
Published: December 2021

Abstract

Background
Seasonal influenza vaccination decreases individual and population-level morbidity and mortality, mitigates risk of acquiring influenza-like illness, and prevents healthcare system overburdening. Vaccination is important for people living with HIV (PLWH) who have increased risk for severe disease, hospitalization, and poor outcomes. Moreover, influenza vaccination has been associated with decreased COVID-19 mortality in older patients. Historical annual adult influenza vaccinations rates at the study site were 65%, exceeding local and national benchmarks. Amidst COVID-19, we recognized a need to increase influenza vaccination rates.

Methods
A multifaceted, bundled quality improvement (QI) initiative aimed to achieve ≥ 80% influenza vaccination coverage for the 2020-21 season in PLWH ≥18 years of age at our Wilmington site (N=750). Stakeholders were identified, and a voluntary multidisciplinary team formed to lead the initiative (Fig. 1). Fishbone diagram outlined clear, rapidly implementable, and reproducible levers for change (Fig. 2). Physical and virtual space changes included: diverse clinical displays (visuals, patient materials), phone messaging, and virtual platform use. Staff education and updates were consistently provided by the team. Institutional Review Board exemption was received, and electronic medical record and CareWare data were extracted from 1 Oct 2020 through 31 March 2021. All external vaccinations were confirmed. Overall and eligible in-clinic vaccination rates were updated and displayed weekly.

Results
86% vaccination coverage was achieved (Fig. 3) with a median weekly in-clinic vaccination rate of 67% (Fig. 4).

Conclusion
A QI project to improve 2020-21 influenza vaccination rates exceeded our goal in adult PLWH at an urban mid-Atlantic HIV clinic during the COVID-19 pandemic. A multidisciplinary approach that engaged stakeholders was vital to success. Rapid roll-out of changes was challenging, requiring flexibility and clear communication. Data collection was consistent, albeit imperfect, and needs enhancement. Elucidating the effects of each change and the COVID-19 pandemic on vaccination rates is not yet known. Lessons learned may be applicable to other ambulatory settings and will inform future vaccination efforts.

Disclosures
Deborah A. Kahal, MD,MPH, FACP, Gilead (Speaker’s Bureau)Viiv (Speaker’s Bureau)
17. A Retrospective Cohort Study of Influenza Infected Multiple Myeloma Patients Comparing Clinical Outcomes Between Vaccinated and Unvaccinated
Authors: Wilson Taylor D , Leffert Jacob , Crescencio Juan Carlos Rico , Jenkins Mitchell , Burgess Mary J 
Published: December 2021

Abstract

Background
The current standard of care for multiple myeloma (MM) patients is to administer the influenza vaccine (InfV) annually. While in immunocompetent patients, the influenza vaccine is associated with significant benefit in morbidity and mortality, the inherent immunodeficiency from MM and its treatments reduce the InfV efficacy but it is thought to have some benefit. The effect on morbidity and mortality in MM patients has not been evaluated. Our study aims to investigate whether InfV vaccination status affects outcomes of MM patients diagnosed with Influenza A or B (FluA, FluB).

Methods
This was a retrospective study, using Arkansas Clinical Data Repository, which identified all MM patients diagnosed with FluA or FluB during five consecutive flu seasons from September 1st to April 30th, 2015-2020. Those with hospital-acquired influenza were excluded. The outcome data were collected for 30 days following the initial diagnosis. Fisher Exact test was used to compare categorical variables, and Mann Whitney U test to compare continuous variables.

Results
We identified 194 MM patients diagnosed with FluA or FluB. Sixty-five (34%) were vaccinated and 129 (66%) were not vaccinated. A total of 87 (45%) were admitted to the hospital. Twenty-five (38%) of the vaccinated vs. 62 (48%) of the unvaccinated group were hospitalized (p=0.22), and 4/65 vaccinated vs. 12/129 unvaccinated required ICU treatment (p=0.59). Two patients in the vaccinated and 3 in the non-vaccinated group were intubated (p=1). The mean length of stay (LOS) for the vaccinated and unvaccinated was 10 days and 14 days, respectively, which was not significantly different (p=0.197). Two (3%) patients died within 30 days of diagnosis in the vaccinated group while four (3%) died in the unvaccinated group (p=1).

Conclusion
The InfV status of MM patients had no effect on outcomes including the need for hospital admission, ICU stay, mechanical ventilation, LOS, and death. Hospitalization was common, but severe illness requiring ICU care and intubation were less common. Six patients died within 30 days of influenza diagnosis. Vaccination strategy, including high-dose and repeat doses, should be examined in MM patients.

Disclosures
All Authors: No reported disclosures
20. Cost-Effectiveness of Recombinant Zoster Vaccine for Vaccinating Immunocompromised Adults Against Herpes Zoster in the United States
Authors: Curran Desmond , Salem Ahmed , Lorenc Stéphane , Patterson Brandon , Carrico Justin , Hicks Katherine A , La Elizabeth M , Poston Sara , Carpenter Christopher F 
Published: December 2021

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)