Last data update: Jun 03, 2024. (Total: 46935 publications since 2009)
Records 1-30 (of 57 Records) |
Query Trace: Harpaz R [original query] |
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Update on herpes zoster vaccine: licensure for persons aged 50 through 59 years
Centers for Disease Control and Prevention , Harpaz R , Hales CM , Bialek SR . MMWR Morb Mortal Wkly Rep 2011 60 (44) 1528 Herpes zoster vaccine (Zostavax, Merck & Co., Inc.) was licensed and recommended in 2006 for prevention of herpes zoster among adults aged 60 years and older. In March 2011, the Food and Drug Administration (FDA) approved the use of Zostavax in adults aged 50 through 59 years. In June 2011, the Advisory Committee on Immunization Practices (ACIP) declined to recommend the vaccine for adults aged 50 through 59 years and reaffirmed its current recommendation that herpes zoster vaccine be routinely recommended for adults aged 60 years and older. |
American College of Rheumatology Guidance for COVID-19 vaccination in patients with rheumatic and musculoskeletal diseases: Version 5
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Bass AR , Calabrese C , Gravallese EM , Harpaz R , Kroger A , Sadun RE , Turner AS , Williams EA , Mikuls TR . Arthritis Rheumatol 2023 75 (1) E1-e16 OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious diseases specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines, including supplemental/booster dosing, in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients. |
Reply.
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Gravallese EM , Bass AR , Calabrese C , Harpaz R , Kroger A , Sadun RE , Turner AS , Williams EA , Mikuls TR . Arthritis Rheumatol 2021 73 (9) 1769-1770 We appreciate the comment by Dr. Mortezavi and colleagues describing COVID‐19 vaccine response and the frequency of disease worsening in patients receiving tofacitinib. The ACR COVID‐19 Vaccine Clinical Guidance Task Force was aware of the 2 studies cited and appreciate their summary of the results. We would point out that in the rheumatoid arthritis study by Winthrop et al (1), patients receiving tofacitinib in Study A had a lower likelihood of a satisfactory response to pneumococcal vaccination (45.1%) compared to placebo‐treated patients (68.4%), a difference of 23.3% (95% confidence interval [95% CI] −36.6, −9.6%). The differences were numerically even larger for patients receiving concomitant tofacitinib and methotrexate (31.6% of patients with a satisfactory response, difference of −30.2% [95% CI] −47.3, −11.4%) compared to methotrexate monotherapy. Our challenge was in considering the appropriateness of extrapolating results from vaccine studies of influenza, pneumococcal, and tetanus toxoid vaccines to make inferences regarding the anticipated response to vaccination against SARS–CoV‐2, a novel antigen to which most individuals have not previously been exposed. | | The Task Force recognized that infection rates, and perhaps response to vaccinations against those infections, might be heterogeneous according to pathogen. For example, JAK inhibitors approximately double the incidence of herpes zoster compared to biologics such as tumor necrosis factor inhibitors, yet they do not meaningfully increase rates of other infections (e.g., pneumonia) (1, 2, 3). We noted that in the Oral Strategy study, adalimumab‐treated patients receiving vaccination with the live herpes zoster vaccine had lower incidence rates of herpes zoster (0.0 per 100 patient‐years) compared to non‐vaccinated patients (incidence rate 2.1 per 100 patient‐years) (4). In contrast, and recognizing that numbers were small, tofacitinib‐treated patients had similar rates of herpes zoster regardless of vaccination (incidence rate 3.0 per 100 patient‐years in vaccinated versus 2.2 per 100 patient‐years in unvaccinated patients). | | We also appreciate the data provided by Dr. Mortezavi and colleagues regarding the rate of disease worsening in patients whose treatment with tofacitinib was briefly interrupted. At ~ 2 weeks, the mean worsening in the 4‐variable DAS28 of 0.7 units was of smaller magnitude than typically considered the minimum clinically important difference (MCID) for the DAS28 (i.e., >1.2 units) (5). The MCID for defining disease worsening using the CDAI in patients who had moderate disease activity at the start of treatment is undefined, although a 1‐unit change in each of the 4 CDAI components (tender joint count, swollen joint count, patient global, and physician global) is often considered to be the measurement error for each of these (6). Taken together, the mean amount of disease worsening associated with brief interruptions in therapy seems small and likely not of clinical importance for most patients, especially in light of the guidance recommending that JAK inhibitors be withheld for 1 week at the time of each vaccine administration, rather than for 2 consecutive weeks. | | Ultimately, we await prospective data regarding the influence of JAK inhibitors and other immunomodulatory therapies used at the time of COVID‐19 vaccination on immunogenicity and correlates of serologic protection. Since the ACR COVID‐19 Vaccine Guidance is a living document, our plan is to rapidly update it and incorporate new evidence as it accumulates. |
American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3.
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Bass AR , Calabrese C , Gravallese EM , Harpaz R , Kroger A , Sadun RE , Turner AS , Williams EA , Mikuls TR . Arthritis Rheumatol 2021 73 (10) e60-e75 OBJECTIVE: To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID-19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients. |
The impact of universal varicella vaccination on herpes zoster incidence in the United States: Comparison of birth cohorts preceding and following varicella vaccination program launch
Leung J , Dooling K , Marin M , Anderson TC , Harpaz R . J Infect Dis 2022 226 S470-s477 When the US varicella vaccination program was introduced in 1995, its impacts on the epidemiology of herpes zoster (HZ) were not precisely known. We used a large claims database to examine HZ incidence in the US during 1998-2019 among persons aged ≥30 years (the prevaccine cohort, born before 1990), and aged 1-29 years (includes the postvaccine cohort, born since 1990). We defined incident HZ as the first instance of an outpatient or emergency department (ED) claim with an HZ diagnostic code. Additionally, we examined the proportion of HZ visits among all ED visits as a complementary method to assess for healthcare-seeking artifacts in the findings. In persons aged ≥30 years (prevaccine cohort), we observed age-specific increases in HZ incidence during the earlier study years, with decelerations in later years, starting in 2007 with oldest age groups. Similar patterns were seen when we examined HZ visits as a proportion of all ED visits. For persons aged 1-29 years, age-specific HZ incidence increased early in the study period for the oldest age groups who were born prevaccine, but later declined in a stepwise pattern once each age group was comprised of persons born in the postvaccine period. Our results, corroborated with previously published studies, do not support prior modeling predictions that the varicella vaccination program would increase HZ incidence among adult cohorts who previously experienced varicella. Our findings also suggest that continued declines in age-specific HZ incidence as varicella-vaccinated cohorts age are likely. |
Active post-licensure safety surveillance for recombinant zoster vaccine using electronic health record data
Nelson JC , Ulloa-Prez E , Yu O , Cook AJ , Jackson ML , Belongia EA , Daley MF , Harpaz R , Kharbanda EO , Klein NP , Naleway AL , Tseng HF , Weintraub ES , Duffy J , Yih WK , Jackson LA . Am J Epidemiol 2022 192 (2) 205-216 Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster and its complications in older adults. In this prospective, post-licensure Vaccine Safety Datalink (VSD) study using electronic health records, we sequentially monitored a real-world population of adults aged 50 years and older who received care at multiple VSD health systems in the United States to identify potential increased risks of 10 pre-specified priority outcomes, including stroke, anaphylaxis, and Guillain-Barr Syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative either to historical (2013-2017) recipients of Zoster Vaccine Live (ZVL), a live-attenuated virus vaccine (Zostavax; Merck & Co., Inc., Kenilworth, New Jersey), or contemporary non-RZV vaccinated persons who had an annual well-visit during the 2018-2019 study period. We confirmed pre-licensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed. |
American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 4.
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Bass AR , Calabrese C , Gravallese EM , Harpaz R , Kroger A , Sadun RE , Turner AS , Williams EA , Mikuls TR . Arthritis Rheumatol 2022 74 (5) e21-e36 OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines, including supplemental/booster dosing, in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients. |
Risk of Guillain-Barr syndrome following herpes zoster, United States, 2010-2018
Anderson TC , Leung JW , Harpaz R , Dooling KL . Hum Vaccin Immunother 2021 17 (12) 1-7 Epidemiologic data regarding the risk of Guillain-Barré syndrome (GBS) following herpes zoster (HZ) are limited. We conducted a self-controlled case series analysis using two large national data sources to evaluate the risk of GBS following HZ among U.S. adults. We analyzed medical claims from the IBM® MarketScan® Commercial Claims and Encounters (persons 18-64 years during 2010-2018) and Centers for Medicare and Medicaid Services Medicare (persons ≥65 years during 2014-2018) databases. HZ cases were defined as persons with an outpatient claim with a primary or secondary ICD-9 or ICD-10 diagnostic code for HZ. GBS cases were defined as persons with an inpatient claim with a principle diagnostic code for GBS and an associated procedural code. We compared the rates of GBS following HZ in the 1-42-day risk window versus primary (100-365-day) or secondary (43-99-day) control windows. We identified 489,516 persons 18-64 years of age and 650,229 persons ≥65 years of age with HZ, among whom 11 and 41, respectively, developed GBS 1-365 days following HZ. The risk of GBS following HZ was increased during the risk window as compared to the primary control window for both groups, with a rate ratio of 6.3 (95% CI, 1.8-21.9) for those 18-64 years and 4.1 (95% CI, 1.9-8.7) for those ≥65 years. This study provides new and methodologically rigorous epidemiologic support for an association between HZ and GBS, and useful context regarding the benefits versus potential risks of zoster vaccination. |
American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2.
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Bass AR , Calabrese C , Gravallese EM , Harpaz R , Kroger A , Sadun RE , Turner AS , Williams EA , Mikuls TR . Arthritis Rheumatol 2021 73 (8) e30-e45 OBJECTIVE: To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID-19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients. |
American College of Rheumatology Guidance for COVID-19 Vaccination in Patients with Rheumatic and Musculoskeletal Diseases - Version 1.
Curtis JR , Johnson SR , Anthony DD , Arasaratnam RJ , Baden LR , Bass AR , Calabrese C , Gravallese EM , Harpaz R , Kroger A , Sadun RE , Turner AS , Anderson Williams E , Mikuls TR . Arthritis Rheumatol 2021 73 (7) 1093-1107 OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 1 to 9 point numerical rating scale using a modified Delphi process and the RAND/UCLA appropriateness method, with refinement and iteration over two sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, seventy-four draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology healthcare providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients. |
How adequate is measles surveillance in the United States Investigations of measles-like illness, 2010-2017
McKay SL , Leung J , Gastañaduy PA , Routh JA , Harpaz R . Hum Vaccin Immunother 2020 17 (3) 1-7 Given the availability of an effective and safe vaccine, the World Health Organization (WHO) declared that global measles eradication is achievable, and measles elimination goals have since been established as interim steps toward eradication. As part of a strategy to maintain elimination, the Pan American Health Organization (PAHO) and WHO stipulate a minimum annual reporting rate of discarded non-measles cases of ≥2 per 100,000 population, in order to ensure sensitive surveillance and adequate investigative effort. With its effective vaccination program, the United States in 2000 was among the first countries to verify elimination, although subsequently, it has not routinely reported discarded rates. We estimated MLI investigation rates among insured individuals during 2010-2017, using data from the MarketScan® databases. We defined "MLI investigations" as measles serologic testing within 5 days following diagnostic codes for measles-compatible symptoms and conditions. We provide a rationale for pre-specifying three subgroups for analysis: children aged ≤15 years; males aged 16-22 years excluding data from summer months; and males aged ≥23 years. MLI investigation rates ranged from 6.6─26.4 per 100,000, remaining stable over time except during the 2015 measles outbreaks when rates increased, particularly among young children. In addition to high vaccine uptake, measles elimination requires ongoing vigilance by clinicians and high-quality, case-based surveillance. Estimated rates of MLI investigations in this U.S. population suggesting that the quality of measles surveillance is sufficiently sensitive to detect endemic measles circulation if it were to be occurring. |
Aggregate health and economic burden of herpes zoster in the United States: illustrative example of a pain condition
Harvey M , Prosser LA , Rose AM , Ortega-Sanchez IR , Harpaz R . Pain 2019 161 (2) 361-368 Our objective was to develop comprehensive national estimates of the total burden of HZ among US adults, including direct (ie, medical costs) and indirect (ie, productivity losses) costs, as well as its psychosocial impact (ie, quality of life losses).Using a patient-level microsimulation model, we projected health and economic outcomes among US adults aged 18 years and older using a 10-year time horizon. We conducted a comprehensive systematic literature review to generate parameter values and conducted simulation modeling to generate our outcomes, including numbers of cases of uncomplicated HZ, postherpetic neuralgia (PHN), and ocular complications, productivity losses, and losses in quality adjusted life years (QALYs). We used a societal perspective for outcomes; the costing year was 2015.Projected outcomes for an unvaccinated population included 1.1 million HZ cases, 114,000 PHN cases, and 43,000 ocular complications annually, resulting in approximately 67,000 QALYs lost. HZ and its complications would incur costs of $2.4 billion in direct medical costs and productivity losses annually.Projected QALY-losses were most sensitive to HZ and PHN health utility values in the model. Cost estimates were most sensitive to the probability of HZ and to the costs per episode of PHN.The national burden of direct, indirect, and psychosocial HZ costs is substantial. Our results can inform economic analyses for HZ vaccines. Comprehensive, national assessments of the total burden of other painful conditions would be very informative. |
The epidemiology of herpes zoster in the United States during the era of varicella and herpes zoster vaccines: Changing patterns among older adults
Harpaz R , Leung JW . Clin Infect Dis 2019 69 (2) 341-344 Historic herpes zoster incidence trends in US adults have been hard to interpret. Using administrative databases, we extended previous descriptions of these trends through 2016. We observed an age-specific transition, with ongoing increases among younger adults but deceleration in older adults. The patterns are not readily explained. |
Do varicella vaccination programs change the epidemiology of herpes zoster A comprehensive review, with focus on the United States
Harpaz R . Expert Rev Vaccines 2019 18 (8) 793-811 Introduction: Policy-makers in many countries have been wary of introducing varicella vaccination programs because of concerns that reduced exposures to varicella zoster virus could increase incidence herpes zoster (HZ) incidence. The U.S. introduced varicella vaccination in 1996 and has empiric evidence regarding this concern. Areas covered: This comprehensive review provides background emphasizing the epidemiology of varicella and of HZ in the U.S. before and after introduction of their respective vaccines. The epidemiology is complex, and interpretation is complicated by methodologic challenges, by unexplained increases in age-specific HZ incidence that preceded varicella vaccination, and by introduction of vaccines for prevention of HZ. Nonetheless, observations from studies using different platforms and designs have yielded consistent findings, suggesting they are robust. Expert opinion: There has been no evidence that the U.S. varicella vaccination program increased HZ incidence in the general adult population over baseline trends. Furthermore, HZ incidence in children is declining. The U.S. experience can inform development of new generations of models to predict HZ trends. More importantly, it provides reassurance for countries considering varicella vaccination that an effective program can reduce varicella morbidity and mortality while reducing the likelihood of HZ among children, and potentially, over time, across the entire population. |
Patient report of herpes zoster pain: Incremental benefits of zoster vaccine live
Bruxvoort KJ , Liang AS , Harpaz R , Qian L , Sy LS , LaRussa P , Schmid DS , Luo Y , Takhar H , Tseng HF . Vaccine 2019 37 (26) 3478-3484 INTRODUCTION: Pain following herpes zoster (HZ) can persist for months and negatively impact quality of life. To evaluate the effect of zoster vaccine live (ZVL) on progression of pain following HZ, we conducted a prospective cohort study of HZ cases at Kaiser Permanente Southern California. METHODS: ZVL vaccinated and unvaccinated members aged >/=60years with laboratory-confirmed HZ from January 18, 2012 to February 26, 2015 were followed up within 5days of HZ diagnosis, and at 30, 60, and 90days after diagnosis. Pain was assessed with the Zoster Brief Pain Inventory (ZBPI) on a 0-10 scale, using cut-points of >/=3, >/=5, and >/=7, with postherpetic neuralgia (PHN) defined as pain >/=3 at 90days. Log binomial regression was used to estimate adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) associated with pain, comparing vaccinated versus unvaccinated HZ patients. RESULTS: We interviewed 509 vaccinated and 509 unvaccinated HZ patients. ZVL was associated with significantly lower risks of HZ-related pain at all time-points. The risk of PHN in vaccinated and unvaccinated patients, respectively, was 9.2% and 15.4% (aRR=0.594, 95% CI: 0.413, 0.854); 2.0% and 4.8% of these patients reported pain >/=7 (aRR=0.332, 95% CI: 0.153, 0.721). Irrespective of vaccination, the risk of PHN was lower in adults aged <70years versus those >/=70years and was similar or lower in females versus males. CONCLUSION: We used laboratory confirmation of HZ cases and patient survey to show that aside from preventing HZ, ZVL reduced HZ-related pain and prevented PHN among vaccine recipients who experienced HZ. Observational studies will be needed to evaluate long-term effectiveness of the new recombinant zoster vaccine and its benefits in protecting patients against PHN. |
A cost-effectiveness analysis of vaccination for prevention of herpes zoster and related complications: Input for national recommendations
Prosser LA , Harpaz R , Rose AM , Gebremariam A , Guo A , Ortega-Sanchez IR , Zhou F , Dooling K . Ann Intern Med 2019 170 (6) 380-388 Background: The U.S. Advisory Committee on Immunization Practices recently developed recommendations for use of a new recombinant zoster vaccine (RZV). Objective: To evaluate the cost-effectiveness of vaccination with RZV compared with zoster vaccine live (ZVL) and no vaccination, the cost-effectiveness of vaccination with RZV for persons who have previously received ZVL, and the cost-effectiveness of preferential vaccination with RZV over ZVL. Design: Simulation (state-transition) model using U.S. epidemiologic, clinical, and cost data. Data Sources: Published data. Target Population: Hypothetical cohort of immunocompetent U.S. adults aged 50 years or older. Time Horizon: Lifetime. Perspective: Societal and health care sector. Intervention: Vaccination with RZV (recommended 2-dose regimen), vaccination with ZVL, and no vaccination. Outcome Measures: The primary outcome measure was the incremental cost-effectiveness ratio (ICER). Results of Base-Case Analysis: For vaccination with RZV compared with no vaccination, ICERs ranged by age from $10 000 to $47 000 per quality-adjusted life-year (QALY), using a societal perspective and assuming 100% completion of the 2-dose RZV regimen. For persons aged 60 years or older, ICERs were less than $60 000 per QALY. Vaccination with ZVL was dominated by vaccination with RZV for all age groups 60 years or older. Results of Sensitivity Analysis: Results were most sensitive to changes in vaccine effectiveness, duration of protection, herpes zoster incidence, and probability of postherpetic neuralgia. Vaccination with RZV after previous administration of ZVL yielded an ICER of less than $60 000 per QALY for persons aged 60 years or older. In probabilistic sensitivity analyses, RZV remained the preferred strategy in at least 95% of simulations, including those with 50% completion of the second dose. Limitation: Few data were available on risk for serious adverse events, adherence to the recommended 2-dose regimen, and probability of recurrent zoster. Conclusion: Vaccination with RZV yields cost-effectiveness ratios lower than those for many recommended adult vaccines, including ZVL. Results are robust over a wide range of plausible values. Primary Funding Source: Centers for Disease Control and Prevention. |
The epidemiology of herpes zoster in the United States during the era of varicella and herpes zoster vaccines: Changing patterns among children
Harpaz R , Leung JW . Clin Infect Dis 2018 69 (2) 345-347 Varicella vaccination can have complex direct and indirect influences on the epidemiology of herpes zoster among children. We evaluated pediatric herpes zoster trends using administrative databases. Incidence declined in a step-wise pattern since the varicella vaccination program was introduced, suggesting that rates may eventually decline in the entire population. |
Point-Counterpoint: The Hope-Simpson hypothesis and its implications regarding an effect of routine varicella vaccination on herpes zoster incidence
Harpaz R , van Hoek AJ . J Infect Dis 2018 218 S57-s62 Some 50 years ago, Edgar Hope-Simpson published his hypothesis regarding the interactions between varicella and herpes zoster. As part of this hypothesis, Hope-Simpson postulated that reactivation of varicella zoster virus (VZV) was under immunological control, and that this immunological control could be boosted "endogenously" due to reactivation of latent VZV, and "exogenously" due to exposure to varicella. This hypothesis has important policy implications and remains a source of debate today; namely, does reducing VZV circulation through effective pediatric varicella vaccination programs lead to unintended increases in herpes zoster (HZ) incidence? This article provides 2 very different perspectives on this issue. The first perspective (Rafael Harpaz: Evidence Against an Effect) highlights the empiric experience of the United States, with its population of >300 million, a highly effective national varicella vaccination program lasting >20 years, and with several credible sources of data regarding HZ incidence. The US data have shown an increase in HZ incidence that preceded the availability of varicella vaccination by decades; indeed, HZ rates appear to have plateaued among older adults since varicella vaccination was introduced. Furthermore, HZ rates are not different in states having higher vs lower preschool varicella vaccination rates. The second perspective (Albert J. van Hoek: Evidence for an Effect) cites data that persons with close exposure to children appear to be at lower risk of HZ before universal VZV vaccination, but not so thereafter. Due to historic demographic changes, exogenous boosting could play a role in explaining the observed increase in HZ before varicella vaccination. Thus, it might be difficult to separate declines in exogenous boosting due to demographic changes from those caused by the varicella vaccination program. Additional data will be needed to conclusively rule out an impact of varicella vaccination on HZ. |
Chronic pain among suicide decedents, 2003 to 2014: Findings from the National Violent Death Reporting System
Petrosky E , Harpaz R , Fowler KA , Bohm MK , Helmick CG , Yuan K , Betz CJ . Ann Intern Med 2018 169 (7) 448-455 Background: More than 25 million adults in the United States have chronic pain. Chronic pain has been associated with suicidality, but previous studies primarily examined nonfatal suicidal behaviors rather than suicide deaths associated with chronic pain or the characteristics of such deaths. Objective: To estimate the prevalence of chronic pain among suicide decedents in a large multistate sample and to characterize suicide decedents with and without chronic pain. Design: Retrospective analysis of National Violent Death Reporting System (NVDRS) data. The NVDRS links death certificate, coroner or medical examiner, and law enforcement data collected by investigators, who often interview informants who knew the decedent to gather information on precipitating circumstances surrounding the suicide. Information is abstracted by using standard coding guidance developed by the Centers for Disease Control and Prevention. Setting: 18 states participating in the NVDRS. Participants: Suicide decedents with and without chronic pain who died during 1 January 2003 to 31 December 2014. Measurements: Demographic characteristics, mechanism of death, toxicology results, precipitating circumstances (mental health, substance use, interpersonal problems, life stressors), and suicide planning and intent. Results: Of 123 181 suicide decedents included in the study, 10 789 (8.8%) had evidence of chronic pain, and the percentage increased from 7.4% in 2003 to 10.2% in 2014. More than half (53.6%) of suicide decedents with chronic pain died of firearm-related injuries and 16.2% by opioid overdose. Limitation: The results probably underrepresent the true percentage of suicide decedents who had chronic pain, given the nature of the data and how they were captured. Conclusion: Chronic pain may be an important contributor to suicide. Access to quality, comprehensive pain care and adherence to clinical guidelines may help improve pain management and patient safety. Primary Funding Source: None. |
Administrative Data to Explore the Role of Family History as a Risk Factor for Herpes Zoster.
Harpaz R , Dahl RM . Mayo Clin Proc 2018 93 (6) 747-751 We used administrative data to study the impact of family history on the risk of herpes zoster (HZ). Our HZ cases and our HZ family history were both ascertained on the basis of medically attended diagnoses, without reliance on self-report or recall bias. Family history was associated with HZ risk among both siblings and parents. The strength of the association differed when the index child was latently infected with vaccine-strain vs wild-type varicella zoster virus. |
Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines
Dooling KL , Guo A , Patel M , Lee GM , Moore K , Belongia EA , Harpaz R . MMWR Morb Mortal Wkly Rep 2018 67 (3) 103-108 On October 20, 2017, Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline, [GSK] Research Triangle Park, North Carolina), a 2-dose, subunit vaccine containing recombinant glycoprotein E in combination with a novel adjuvant (AS01B), was approved by the Food and Drug Administration for the prevention of herpes zoster in adults aged >/=50 years. The vaccine consists of 2 doses (0.5 mL each), administered intramuscularly, 2-6 months apart (1). On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) recommended the recombinant zoster vaccine (RZV) for use in immunocompetent adults aged >/=50 years. |
Family History of Zoster Risk of Developing Herpes Zoster.
Tseng HF , Chi M , Hung P , Harpaz R , Schmid DS , LaRussa P , Sy LS , Luo Y , Holmquist K , Takhar H , Jacobsen SJ . Int J Infect Dis 2017 66 99-106 BACKGROUND: Studies have investigated a possible association between family history of HZ and the occurrence of HZ. However, the results were inconclusive and susceptible to bias. We evaluated this association in an elderly population. METHODS: The matched case-control study conducted at Kaiser Permanente Southern California in 2012-2015 included 656 incident HZ patients ≥60 whose skin lesion tested positive for varicella zoster virus by polymerase chain reaction. Half of the HZ patients were vaccinated with zoster vaccine as achieved by stratified sampling. The controls were randomly selected and 1:1 matched to the cases on sex, age (+/-1year), and zoster vaccination (+/-3 months of the case's vaccination date). Conditional logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI). RESULTS: Having any blood relative with a history of HZ was associated with a slightly increased risk of HZ (adjusted OR=1.37, 95% CI 1.05-1.79). The adjusted OR associated with having one and two categories of first-degree blood relatives with a history of HZ was 1.30 (95% CI: 0.97-1.73) and 2.53 (95% CI: 1.17-5.44), respectively. CONCLUSIONS: Our results suggested a weak association between the development of HZ and a positive family history of HZ among the elderly population. |
Revisiting the genotyping scheme for varicella-zoster viruses based on whole-genome comparisons.
Jensen NJ , Rivailler P , Tseng HF , Quinlivan ML , Radford K , Folster J , Harpaz R , LaRussa P , Jacobsen S , Schmid DS . J Gen Virol 2017 98 (6) 1434-1438 We report whole-genome sequences (WGSs) for four varicella-zoster virus (VZV) samples from a shingles study conducted by Kaiser Permanente of Southern California. Comparative genomics and phylogenetic analysis of all published VZV WGSs revealed that strain KY037798 is in clade IX, which shall henceforth be designated clade 9. Previously published single nucleotide polymorphisms (SNP)-based genotyping schemes fail to discriminate between clades 6 and VIII and employ positions that are not clade-specific. We provide an updated list of clade-specific positions that supersedes the list determined at the 2008 VZV nomenclature meeting. Finally, we propose a new targeted genotyping scheme that will discriminate the circulating VZV clades with at least a twofold redundancy. Genotyping strategies using a limited set of targeted SNPs will continue to provide an efficient 'first pass' method for VZV strain surveillance as vaccination programmes for varicella and zoster influence the dynamics of VZV transmission. |
When zoster hits close to home: Impact of personal zoster awareness on zoster vaccine uptake in the U.S
Harpaz R , Leung J . Vaccine 2017 35 (27) 3457-3460 U.S. zoster vaccine uptake has been sluggish. Most adults are aware of zoster but unaware of its distressing manifestations. We found that vaccine uptake is markedly increased immediately following occurrence of zoster in a spouse. Thus, personal zoster awareness can prompt vaccination. Our findings have implications in terms of both vaccine promotion and interpretations of vaccine performance. |
Surveillance of vaccination coverage among adult populations - United States, 2015
Williams WW , Lu PJ , O'Halloran A , Kim DK , Grohskopf LA , Pilishvili T , Skoff TH , Nelson NP , Harpaz R , Markowitz LE , Rodriguez-Lainz A , Fiebelkorn AP . MMWR Surveill Summ 2017 66 (11) 1-28 PROBLEM/CONDITION: Overall, the prevalence of illness attributable to vaccine-preventable diseases is greater among adults than among children. Adults are recommended to receive vaccinations based on their age, underlying medical conditions, lifestyle, prior vaccinations, and other considerations. Updated vaccination recommendations from CDC are published annually in the U.S. Adult Immunization Schedule. Despite longstanding recommendations for use of many vaccines, vaccination coverage among U.S. adults is low. PERIOD COVERED: August 2014-June 2015 (for influenza vaccination) and January-December 2015 (for pneumococcal, tetanus and diphtheria [Td] and tetanus and diphtheria with acellular pertussis [Tdap], hepatitis A, hepatitis B, herpes zoster, and human papillomavirus [HPV] vaccination). DESCRIPTION OF SYSTEM: The National Health Interview Survey (NHIS) is a continuous, cross-sectional national household survey of the noninstitutionalized U.S. civilian population. In-person interviews are conducted throughout the year in a probability sample of households, and NHIS data are compiled and released annually. The survey objective is to monitor the health of the U.S. population and provide estimates of health indicators, health care use and access, and health-related behaviors. RESULTS: Compared with data from the 2014 NHIS, increases in vaccination coverage occurred for influenza vaccine among adults aged ≥19 years (a 1.6 percentage point increase compared with the 2013-14 season to 44.8%), pneumococcal vaccine among adults aged 19-64 years at increased risk for pneumococcal disease (a 2.8 percentage point increase to 23.0%), Tdap vaccine among adults aged ≥19 years and adults aged 19-64 years (a 3.1 percentage point and 3.3 percentage point increase to 23.1% and to 24.7%, respectively), herpes zoster vaccine among adults aged ≥60 years and adults aged ≥65 years (a 2.7 percentage point and 3.2 percentage point increase to 30.6% and to 34.2%, respectively), and hepatitis B vaccine among health care personnel (HCP) aged ≥19 years (a 4.1 percentage point increase to 64.7%). Herpes zoster vaccination coverage in 2015 met the Healthy People 2020 target of 30%. Aside from these modest improvements, vaccination coverage among adults in 2015 was similar to estimates from 2014. Racial/ethnic differences in coverage persisted for all seven vaccines, with higher coverage generally for whites compared with most other groups. Adults without health insurance reported receipt of influenza vaccine (all age groups), pneumococcal vaccine (adults aged 19-64 years at increased risk), Td vaccine (adults aged ≥19 years, 19-64 years, and 50-64 years), Tdap vaccine (adults aged ≥19 years and 19-64 years), hepatitis A vaccine (adults aged ≥19 years overall and among travelers), hepatitis B vaccine (adults aged ≥19 years, 19-49 years, and among travelers), herpes zoster vaccine (adults aged ≥60 years), and HPV vaccine (males and females aged 19-26 years) less often than those with health insurance. Adults who reported having a usual place for health care generally reported receipt of recommended vaccinations more often than those who did not have such a place, regardless of whether they had health insurance. Vaccination coverage was higher among adults reporting one or more physician contacts in the past year compared with those who had not visited a physician in the past year, regardless of whether they had health insurance. Even among adults who had health insurance and ≥10 physician contacts within the past year, depending on the vaccine, 18.2%-85.6% reported not having received vaccinations that were recommended either for all persons or for those with specific indications. Overall, vaccination coverage among U.S.-born adults was higher than that among foreign-born adults, with few exceptions (influenza vaccination [adults aged 19-49 years and 50-64 years], hepatitis A vaccination [adults aged ≥19 years], and hepatitis B vaccination [adults aged ≥19 years with diabetes or chronic liver conditions]). INTERPRETATION: Coverage for all vaccines for adults remained low but modest gains occurred in vaccination coverage for influenza (adults aged ≥19 years), pneumococcal (adults aged 19-64 years with increased risk), Tdap (adults aged ≥19 years and adults aged 19-64 years), herpes zoster (adults aged ≥60 years and ≥65 years), and hepatitis B (HCP aged ≥19 years); coverage for other vaccines and groups with vaccination indications did not improve. The 30% Healthy People 2020 target for herpes zoster vaccination was met. Racial/ethnic disparities persisted for routinely recommended adult vaccines. Missed opportunities to vaccinate remained. Although having health insurance coverage and a usual place for health care were associated with higher vaccination coverage, these factors alone were not associated with optimal adult vaccination coverage. HPV vaccination coverage for males and females has increased since CDC recommended vaccination to prevent cancers caused by HPV, but many adolescents and young adults remained unvaccinated. PUBLIC HEALTH ACTIONS: Assessing factors associated with low coverage rates and disparities in vaccination is important for implementing strategies to improve vaccination coverage. Evidence-based practices that have been demonstrated to improve vaccination coverage should be used. These practices include assessment of patients' vaccination indications by health care providers and routine recommendation and offer of needed vaccines to adults, implementation of reminder-recall systems, use of standing-order programs for vaccination, and assessment of practice-level vaccination rates with feedback to staff members. For vaccination coverage to be improved among those who reported lower coverage rates of recommended adult vaccines, efforts also are needed to identify adults who do not have a regular provider or insurance and who report fewer health care visits. |
Effectiveness and duration of protection provided by the live-attenuated herpes zoster vaccine in the Medicare population ages 65 years and older
Izurieta HS , Wernecke M , Kelman J , Wong S , Forshee R , Pratt D , Lu Y , Sun Q , Jankosky C , Krause P , Worrall C , MaCurdy T , Harpaz R . Clin Infect Dis 2017 64 (6) 785-793 Background: Tens of millions of seniors are at risk of herpes zoster (HZ) and its complications. Live attenuated herpes zoster vaccine (HZV) reduces that risk, although questions regarding effectiveness and durability of protection in routine clinical practice remain. We used Medicare data to investigate HZV effectiveness (VE) and its durability. Methods: This retrospective cohort study included beneficiaries ages ≥65 years during January 2007 through July 2014. Multiple adjustments to account for potential bias were made. HZV-vaccinated beneficiaries were matched to unvaccinated beneficiaries (primary analysis) and to HZV-unvaccinated beneficiaries who had received pneumococcal vaccination (secondary analysis). HZ outcomes in community and hospital settings were analyzed, including ophthalmic zoster (OZ) and postherpetic neuralgia (PHN). Results: Among eligible beneficiaries (average age 77 years), the primary analysis found VE for community HZ of 33% (95% CI: 32%-35%) and 19% (95% CI: 17%-22%), for the first 3, and subsequent 4+ years postvaccination, respectively. In the secondary analysis, VE was, respectively, 37% (95% CI: 36%-39%) and 22% (95% CI: 20%-25%). In the primary analysis, VE for PHN was 57% (95% CI: 52%-61%) and 45% (95% CI: 36%-53%) in the first 3 and subsequent 4+ years, respectively; VE for hospitalized HZ was, respectively, 74% (95% CI: 67%-79%) and 55% (95% CI: 39%-67%). Differences in VE by age group were not significant. Conclusions: In both the primary and secondary analyses, HZV provided protection against HZ across all ages, but effectiveness declined over time. VE was higher and better preserved over time for PHN and HZ-associated hospitalizations than for community HZ. |
Prevalence of immunosuppression among US adults, 2013
Harpaz R , Dahl RM , Dooling KL . JAMA 2016 316 (23) 2547-2548 The number of immunosuppressed adults in the United States is unknown but thought to be increasing because of both greater life expectancy among immunosuppressed adults due to improvements in medical management, as well as new indications for immunosuppressive treatments.1-4 Immunosuppression increases the risks and severity of primary or reactivation infections; its prevalence has implications for food and water safety, tuberculosis control, vaccine programs, infection control strategies, outbreak preparedness, travel medicine, and other facets of public health.1 We present data on the prevalence of self-reported immunosuppressed adults in the United States. |
National and state-specific shingles vaccination among adults aged ≥60 years
Lu PJ , O'Halloran A , Williams WW , Harpaz R . Am J Prev Med 2016 52 (3) 362-372 INTRODUCTION: Shingles (herpes zoster) causes substantial morbidity, especially among older adults. The shingles vaccine has been recommended for people aged ≥60 years since 2006. This study assessed recent shingles vaccination at national and state levels among adults aged ≥60 years. METHODS: The 2014 Behavioral Risk Factor Surveillance System data were analyzed in 2015 to assess shingles vaccination coverage among adults aged ≥60 years at national and state levels. Multivariable logistic regression and predictive marginal models identified factors independently associated with vaccination. RESULTS: Shingles vaccination coverage among adults aged ≥60 years was 31.8% (95% CI=31.4%, 32.2%). Among states, shingles vaccination coverage ranged from 17.8% (95% CI=15.8%, 20.0%) in Mississippi to 46.6% (95% CI=44.3%, 48.8%) in Vermont, with a median of 33.3%. Coverage was <25% in four states and >40% in nine states. For all states, coverage was significantly higher among non-Hispanic whites compared with non-white races except for Oregon, with coverage differences ranging from -33.2% in the District of Columbia to 0.9% in Oregon and a median of -16.0%. Characteristics independently associated with vaccination were age, race/ethnicity, sex, education, employment status, household income, region, perceived health status, health insurance status, personal healthcare provider, routine checkup status, and whether reporting that cost was a barrier to seeing a doctor. CONCLUSIONS: Coverage varied dramatically by state. State-level comparisons may aid in designing tailored intervention programs through sharing of best practices. Strategies are needed to mitigate financial barriers for both provider and patients, improve awareness, and increase provider recommendation of the vaccine. |
Update on incidence of herpes zoster among children and adolescents after implementation of varicella vaccination, Antelope Valley, CA, 2000 to 2010
Civen R , Marin M , Zhang J , Abraham A , Harpaz R , Mascola L , Bialek SR . Pediatr Infect Dis J 2016 35 (10) 1132-6 BACKGROUND: Changes in herpes zoster (HZ) epidemiology are expected with childhood varicella vaccination. We reported previously that during 2000 to 2006 HZ incidence decreased 55% in children <10 years of age, while among 10- to 19-year olds it increased by 63%. We update the analysis with 4 additional years of data. METHODS: Population-based active surveillance was conducted for HZ in Antelope Valley, California. Structured telephone interviews and medical chart reviews collected data on demographics, varicella vaccinations, disease histories and clinical information. We calculated HZ incidence for 2007 to 2010 and assessed trends since 2000. RESULTS: Among children <10 years of age, HZ incidence continued the decreasing trend previously reported. During 2007 to 2010, the average incidence was 12.8 cases/100,000 children compared with 41.6 cases/100,000 children during 2000 to 2006, a 69% decline (P < 0.0001). For the 10- to 19-year olds, during 2007 to 2010 HZ incidence did not continue the increasing trend reported from 2000 to 2006; lower rates than in 2006 were observed in 3 of the 4 additional years evaluated. During 2007 to 2010 the average incidence was 78.2 cases/100,000 children compared with 68.0 cases/100,000 children during 2000 to 2006, a 13% increase (P = 0.123), with substantial fluctuation in annual rates throughout the 11 years of surveillance. CONCLUSIONS: During the mature varicella vaccination program, declines in HZ incidence among children <10 years of age continued through 2010. Among the 10- to 19-year olds, the increase reported through 2006 did not continue further and lower rates than in 2006 were observed through 2010. Widespread use of varicella vaccine could reduce HZ incidence among vaccinated populations. Ongoing monitoring of HZ incidence is needed to detect and understand changes in HZ epidemiology in the varicella vaccine era. |
Risk factors for herpes zoster among adults
Marin M , Harpaz R , Zhang J , Wollan PC , Bialek SR , Yawn BP . Open Forum Infect Dis 2016 3 (3) ofw119 Background: The causes of varicella-zoster virus reactivation and herpes zoster (HZ) are largely unknown. We assessed potential risk factors for HZ, the data for which cannot be obtained from the medical sector. Methods: We conducted a matched case-control study. We established active surveillance in Olmsted County, Minnesota to identify HZ occurring among persons age ≥50 years during 2010-2011. Cases were confirmed by medical record review. Herpes zoster-free controls were age- and sex-matched to cases. Risk factor data were obtained by telephone interview. Results: We enrolled 389 HZ case patients and 511 matched controls; the median age was 65 and 66 years, respectively. Herpes zoster was associated with family history of HZ (adjusted odds ratio [aOR] = 1.65); association was highest with first-degree or multiple relatives (aOR = 1.87 and 3.08, respectively). Herpes zoster was also associated with prior HZ episodes (aOR = 1.82), sleep disturbance (aOR = 2.52), depression (aOR = 3.81), and recent weight loss (aOR = 1.95). Stress was a risk factor for HZ (aOR = 2.80), whereas a dose-response relationship was not noted. All associations indicated were statistically significant (P < .05). Herpes zoster was not associated with trauma, smoking, tonsillectomy, diet, or reported exposure to pesticides or herbicides (P > .1). Conclusions: We identified several important risk factors for HZ; however, the key attributable causes of HZ remain unknown. |
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