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Zostavax patients sue Merck, claiming shingles vaccine caused injuries and death
1. Cost–benefit analysis of universal varicella vaccination in the U.S. taking into account the closely related herpes–zoster epidemiology
“Many models concur that universal varicella vaccination of children is beneficial from the perspective of reducing societal costs. Yet, the majority of such cost analyses have been modeled under the assumption that varicella vaccination has no adverse effect on the closely related herpes–zoster (HZ) epidemiology. Historical models have assumed that asymptomatic endogenous reactivation is the chief mechanism of boosting that suppresses the reactivation of HZ and that immunity wanes due to the aging process. Recent studies suggest instead that periodic exogenous exposures to wild-type varicella are the predominant factor influencing the curve of increasing HZ incidence rate with advancing age among individuals”
Goldman, G.s. “Costâ€“benefit Analysis of Universal Varicella Vaccination in the U.S. Taking into Account the Closely Related Herpesâ€“zoster Epidemiology.” Vaccine 23.25 (2005): 3349-355
2. Decreased varicella and increased herpes zoster incidence at a sentinel medical deputising service in a setting of increasing varicella vaccine coverage in Victoria, Australia, 1998 to 2012
“We performed an ecological study using sentinel consultation data from a medical deputising service to assess the impact of increasing coverage with childhood varicella vaccine on the incidence risk of varicella and zoster in the population served by the deputising service in Victoria, Australia from 1998 to 2012. Following a successful vaccination programme, the incidence of varicella in Australia was modelled to decrease and the incidence of zoster to increase, based on a theoretical decrease in boosting of zoster immunity following a decrease in wild varicella virus circulation due to vaccination. Incidence risks (consultation proportions for varicella and zoster) were directly age-standardised to the Melbourne population in 2000, when varicella vaccine was first available. Age-standardised varicella incidence risk peaked in 2000 and halved by 2012. Age-standardised zoster incidence risk remained constant from 1998 to 2002, but had almost doubled by 2012. The increase in zoster consultations largely reflected increases in people younger than 50 years-old. Although causality cannot be inferred from ecological studies, it is generally agreed that the decrease in varicella incidence is due to increasing varicella vaccine coverage. The possible indirect effect of the vaccine on zoster incidence is less clear and ongoing monitoring of zoster is required.”
Kelly, H., K. Grant, H. Gidding, and K. Carville. “Decreased Varicella and Increased Herpes Zoster Incidence at a Sentinel Medical Deputising Service in a Setting of Increasing Varicella Vaccine Coverage in Victoria, Australia, 1998 to 2012.” Eurosurveillance 19.41 (2014): 20926.
3. Dual role of infections as risk factors for coronary heart disease
The aim of the study was to explore whether exposure to microbial agents determines the prevalence of acute coronary events.
Methods and results:
Patients with unstable angina pectoris and myocardial infarction (N= 335) and their paired controls were investigated. The subjects answered a questionnaire about their childhood contagious diseases: varicella, scarlet fever, measles, rubella, mononucleosis and mumps. Blood samples were taken for bacterial and viral serology. The odds ratio for CHD was highest in the upper quartile of the enterovirus (EV), herpes simplex virus (HSV) and Chlamydia pneumoniae HSP60 IgG antibody titers (1.86, p = 0.001, 1.57, p < 0.048 and 1.70, p = 0.016, respectively). The antibody titers increased cumulatively the risk for CHD (odds ratios 1.89, 2.24, 3.92 and p-values”
Pesonen, Erkki, Eva Andsberg, Hans Ã–hlin, Mirja Puolakkainen, Hilpi Rautelin, Seppo Sarna, and Kenneth Persson. “Dual Role of Infections as Risk Factors for Coronary Heart Disease.” Atherosclerosis 192.2 (2007): 370-75.
4. Herpes Zoster–Related Hospitalizations and Expenditures Before and After Introduction of the Varicella Vaccine in the United States
With childhood varicella vaccination in the United States have come concerns that the incidence of herpes zoster may increase, because of diminishing natural exposure to varicella and consequent reactivation of latent varicella zoster virus. We wanted to estimate the rate of herpes zoster–related hospitalizations and the associated hospital charges before and during the promotion of varicella vaccination in the United States. design. A retrospective study of patients from the Nationwide Inpatient Sample for the years 1993–2004 who were hospitalized due to herpes zoster infection. methods. We searched for diagnoses of herpes zoster (using the International Classification of Diseases, Ninth Revison, Clinical Modification codes starting with 053) in all 15 diagnostic-code fields included for hospital discharges in the Nationwide Inpatient Sample during 1993– 2004. We designed our analysis to examine the rates of severe illness due to herpes zoster that resulted in hospitalization, as measured by the rates of herpes zoster-related hospital discharges (HZHDs). The annual population-adjusted rate of HZHDs (per 10,000 US population) and the annual inflation-adjusted total charges for HZHDs were the primary outcomes. Secondary outcomes included mean charges for HZHDs and the distribution of total charges for HZHDs by expected primary payer. Varicella-related hospital discharges (VRHDs) were identified by use of similar diagnosis-based methods, which were described in our previous study. results. Population-adjusted rates of HZHDs did not change significantly from the prevaccination years (1993–1995) through the initial 5 years of the varicella vaccination period. Beginning in 2001, however, the rate of HZHDs overall began to increase, and by 2004 the overall rate was 2.5 HZHDs (95% confidence interval, 2.38–2.62) per 10,000 US population, significantly higher than any of the rates calculated during the years prior to 2002. Hospital charges for HZHDs overall increased by more than $700 million annually by 2004; in particular, we found that the herpes zoster vaccine–eligible population (ie, persons aged 60 years or older) accounted for 74% of the total annual hospital charges in 2004. The annual rate of VRHDs and the associated hospital charges decreased significantly from 1993 through 2004, but the decrease in hospitalizations and charges for VRHDs was less than the increase in hospitalizations and charges for HZHDs.
As the rates of VRHDs and the associated charges have decreased, there has been a significant increase in HZHDs and associated charges, disproportionately among older adults. Herpes zoster vaccine may mitigate these trends for HZHDs.”
Patel, Mitesh S., Achamyeleh Gebremariam, and Matthew M. Davis. “Herpes Zoster Related Hospitalizations and Expenditures Before and After Introduction of the Varicella Vaccine in the United States.” Infection Control and Hospital Epidemiology 29.12 (2008): 1157-163.
5. Integrating between-host transmission and within-host immunity to analyze the impact of varicella vaccination on zoster
“Varicella-zoster virus (VZV) causes chickenpox and reactivation of latent VZV causes herpes zoster (HZ). VZV reactivation is subject to the opposing mechanisms of declining and boosted VZV-specific cellular mediated immunity (CMI). A reduction in exogenous re-exposure ‘opportunities’ through universal chickenpox vaccination could therefore lead to an increase in HZ incidence. We present the first individual-based model that integrates within-host data on VZV-CMI and between-host transmission data to simulate HZ incidence. This model allows estimating currently unknown pivotal biomedical parameters, including the duration of exogenous boosting at 2 years, with a peak threefold to fourfold increase of VZV-CMI; the VZV weekly reactivation probability at 5% and VZV subclinical reactivation having no effect on VZV-CMI. A 100% effective chickenpox vaccine given to 1 year olds would cause a 1.75 times peak increase in HZ 31 years after implementation. This increase is predicted to occur mainly in younger age groups than is currently assumed.”
Ogunjimi, Benson, Lander Willem, Philippe Beutels, and Niel Hens. “Integrating Between-host Transmission and Within-host Immunity to Analyze the Impact of Varicella Vaccination on Zoster.” ELife 4 (2015)
6. Review of the United States universal varicella vaccination program: Herpes zoster incidence rates, cost-effectiveness, and vaccine efficacy based primarily on the Antelope Valley Varicella Active Surveillance Project data
“In a cooperative agreement starting January 1995, prior to the FDA’s licensure of the varicella vaccine on March 17, the Centers for Disease Control and Prevention (CDC) funded the Los Angeles Department of Health Services’ Antelope Valley Varicella Active Surveillance Project (AV-VASP). Since only varicella case reports were gathered, baseline incidence data for herpes zoster (HZ) or shingles was lacking. Varicella case reports decreased 72%,from 2834 in 1995 to 836 in 2000 at which time approximately 50%of children under 10 years of age had been vaccinated. Starting in 2000, HZ surveillance was added to the project. By 2002, notable increases in HZ incidence rates were reported among both children and adults with a prior history of natural varicella. However, CDC authorities still claimed that no increase in HZ had occurred in any US surveillance site. The basic assumptions inherent to the varicella cost–benefit analysis ignored the significance of exogenous boosting caused by those shedding wild-type VZV. Also ignored was the morbidity associated withevenrare serious events following varicella vaccinationas well as themorbidity from increasing cases of HZ among adults. Vaccine efficacy declined below 80% in 2001. By 2006, because 20% of vaccinees were experiencing breakthrough varicella and vaccine-induced protection was waning, the CDC recommended a booster dose for children and, in 2007, a shingles vaccination was approved for adults aged 60 years and older. In the prelicensure era, 95% of adults experienced natural chickenpox (usually as children)—these cases were usually benign and resulted in long-term immunity. Varicella vaccination is less effective than the natural immunity that existed in prevaccine communities. Universal varicella vaccination has not proven to be cost-effective as increased HZ morbidity has disproportionately offset cost savings associated with reductions in varicella disease. Universal varicella vaccination has failed to provide long-term protection from VZV disease”
Goldman, G.s., and P.g. King. “Review of the United States Universal Varicella Vaccination Program: Herpes Zoster Incidence Rates, Cost-effectiveness, and Vaccine Efficacy Based Primarily on the Antelope Valley Varicella Active Surveillance Project Data.” Vaccine 31.13 (2013): 1680-694.
7. The Case against Universal Varicella Vaccination
“In 1995, the United States became the first country to implement a Universal Varicella Vaccination Program. Several questions remain: Is the varicella (chickenpox) vaccine needed? Is it cost effective as a routine immunization for all susceptible children? Or is it more beneficial for the disease to remain endemic so that adults may receive periodic exogenous exposures (boosts) that help suppress the reactivation of herpes zoster (shingles). In addition, as vaccination coverage becomes widespread, does loss of immunologic boosting cause a decline in vaccine efficacy and result in a reduced period of immunity? Scientific literature regarding safety of the varicella vaccine and its associated cost-benefit analysis have often reported optimistic evaluations based on ideal assumptions. Deleterious outcomes and their associated costs must be included when making a circumspect assessment of the Universal Varicella Vaccination Program.”
Goldman, Gary. “The Case against Universal Varicella Vaccination.” International Journal of Toxicology 25.5 (2006): 313-17.
8. The incidence of varicella and herpes zoster in Massachusetts as measured by the Behavioral Risk Factor Surveillance System (BRFSS) during a period of increasing varicella vaccine coverage, 1998–2003
The authors sought to monitor the impact of widespread varicella vaccination on the epidemiology of varicella and herpes zoster. While varicella incidence would be expected to decrease, mathematical models predict an initial increase in herpes zoster incidence if re-exposure to varicella protects against reactivation of the varicella zoster virus.
In 1998–2003, as varicella vaccine uptake increased, incidence of varicella and herpes zoster in Massachusetts was monitored using the random-digit-dial Behavioral Risk Factor Surveillance System.
Between 1998 and 2003, varicella incidence declined from 16.5/1,000 to 3.5/1,000 (79%) overall with ≥66% decreases for all age groups except adults (27% decrease). Age-standardized estimates of overall herpes zoster occurrence increased from 2.77/1,000 to 5.25/1,000 (90%) in the period 1999–2003, and the trend in both crude and adjusted rates was highly significant (p < 0.001). Annual age-specific rates were somewhat unstable, but all increased, and the trend was significant for the 25–44 year and 65+ year age groups.
As varicella vaccine coverage in children increased, the incidence of varicella decreased and the occurrence of herpes zoster increased. If the observed increase in herpes zoster incidence is real, widespread vaccination of children is only one of several possible explanations. Further studies are needed to understand secular trends in herpes zoster before and after use of varicella vaccine in the United States and other countries.”
Yih, W. Katherine, Daniel R. Brooks, Susan M. Lett, Aisha O. Jumaan, Zi Zhang, Karen M. Clements, and Jane F. Seward. “The Incidence of Varicella and Herpes Zoster in Massachusetts as Measured by the Behavioral Risk Factor Surveillance System (BRFSS) during a Period of Increasing Varicella Vaccine Coverage, 1998â€“2003.” BMC Public Health 5.1 (2005)
9. Universal Varicella Vaccination: Efficacy Trends and Effect on Herpes Zoster
“In 1995, the Varicella Active Surveillance Project (VASP) was established in Antelope Valley (California), a geographically distinct high-desert community of 300,000 residents, as one of three sites in the nation in a cooperative agreement with the Centers for Disease Control and Prevention (CDC) to collect baseline demographic and clinical data and to monitor trends in varicella (chickenpox) following introduction of varicella vaccine. Herpes zoster (shingles) was added to the active surveillance January 1, 2000. The universal varicella program has proven effective in terms of reducing the number of reported verified varicella cases by 85%, from 2,934 in 1995 to 412 in 2002. Prior to tbis dramatic reduction, immunologic boosting due to exogenous exposures to wild-type varicella-zoster virus (VZV) in the community (1) caused mean serum anti-VZV levels among vaccines to increase witb time after vaccination and (2) served as a mecbanism that belped suppress the reactivation of berpes zoster (HZ), especially among individuals witb a previous bistory of wild-type varicella.Tbat immunologic boosting migbt play a significant role in both varicella and tbe closely related HZ epidemiology is evidenced by (1) a decline in vaccine efficacy by over 20%, from 95.7% (95% C.I., 82.7% to 98.9%) in 1999 to 73.9% (95% C.I., 57.9% to 83.8%) in 2001 and (2) an unexpectedly bigb cumulative (2000 to 2003) true incidence rate of 223 (95% C.I. 180-273) per 100,000 person-years (p-y) among cbildren”
Goldman, Gary. “Universal Varicella Vaccination: Efficacy Trends and Effect on Herpes Zoster.” International Journal of Toxicology 24.4 (2005): 205-13.
10. Vaccination to prevent varicella: Goldman and King’s response to Myers’ interpretation of Varicella Active Surveillance Project data
There is increasing evidence that herpes zoster (HZ) incidence rates among children and adults (aged <60 years) with a history of natural varicella are influenced primarily by the frequency of exogenous exposures, while asymptomatic endogenous reactivations help to cap the rate at approximately 550 cases/100,000 person-years when exogenous boosting becomes rare. The Antelope Valley Varicella Active Surveillance Project was funded by the Centers for Disease Control and Prevention in 1995 to monitor the effects of varicella vaccination in one of the three representative regions of the United States. The stability in the data collection and number of reporting sites under varicella surveillance from 1995-2002 and HZ surveillance during 2000-2001 and 2006-2007 contributed to the robustness of the discerned trends.
Varicella vaccination may be useful for leukemic children; however, the target population in the United States is all children. Since the varicella vaccine inoculates its recipients with live, attenuated varicella-zoster virus (VZV), clinical varicella cases have dramatically declined. Declining exogenous exposures (boosts) from children shedding natural VZV have caused waning cell-mediated immunity. Thus, the protection provided by varicella vaccination is neither lifelong nor complete. Moreover, dramatic increases in the incidence of adult shingles cases have been observed since HZ was added to the surveillance in 2000. In 2013, this topic is still debated and remains controversial in the United States.
When the costs of the booster dose for varicella and the increased shingles recurrences are included, the universal varicella vaccination program is neither effective nor cost-effective.
Goldman, G., and P. King. “Vaccination to Prevent Varicella: Goldman and King’s Response to Myers’ Interpretation of Varicella Active Surveillance Project Data.” Human & Experimental Toxicology 33.8 (2013): 886-93.
11. Varicella and Varicella Vaccination in South Korea
“With continuing occurrence of varicella despite increasing vaccine coverage for the past 20 years, a case-based study, a case-control study, and an immunogenicity and safety study were conducted to address the impact of varicella vaccination in South Korea. Varicella patients under the age of 16 years were enrolled for the case-based study. For the case-control study, varicella patients between 12 months and 15 years of age were enrolled with one control matched for each patient. For the immunogenicity and safety study, otherwise healthy children from 12 to 24 months old were immunized with Suduvax (Green Cross, South Korea). Fluorescent antibody to membrane antigen (FAMA) varicella-zoster virus (VZV) antibody was measured before and 6 weeks after immunization. In the casebased study, the median age of the patients was 4 years. Among 152 patients between 1 and 15 years of age, 139 children received varicella vaccine and all had breakthrough infections. Clinical courses were not ameliorated in vaccinated patients, but more vaccinated patients received outpatient rather than inpatient care. In the case-control study, the adjusted overall effectiveness of varicella vaccination was 54%. In the immunogenicity and safety study, the seroconversion rate and geometric mean titer for FAMA antibody were 76.67% and 5.31. Even with increasing varicella vaccine uptake, we illustrate no upward age shift in the peak incidence, a high proportion of breakthrough disease, almost no amelioration in disease presentation by vaccination, and insufficient immunogenicity of domestic varicella vaccine. There is need to improve the varicella vaccine used in South Korea”
Oh SH, Choi EH, Shin SH, et al. Varicella and Varicella Vaccination in South Korea. Plotkin SA, ed. Clinical and Vaccine Immunology : CVI. 2014;21(5):762-768. doi:10.1128/CVI.00645-13.
12. Varicella Vaccination Alters the Chronological Trends of Herpes Zoster and Varicella
Population studies on trends of varicella and herpes zoster (HZ) associated with varicella zoster vaccination and climate is limited.
This study used insurance claims data to investigate the chronological changes in incident varicella and HZ associated with varicella zoster vaccination. Poisson regression was used to estimate the occurrence of varicella associated with the occurrence of HZ and vice versa by year, season, sex, temperature, and sunny hours.
The varicella incidence declined from 7.14 to 0.76 per 1,000 person-years in 2000–2009, whereas the HZ incidence increased from 4.04 to 6.24 per 1,000 person-years. Females tended to have a higher risk than men for HZ (p,0.0001) but not varicella. The monthly mean varicella incidence was the lowest in September (160 cases) and the highest in January (425 cases), while the mean HZ incidence was lower in February (370 cases) and higher in August (470 cases). HZ was negatively associated with the incidence of varicella before and after the varicella zoster vaccination (p,0.001), increased 1.6% within one week post-vaccination. The effect of temperature on HZ was attenuated by 18.5% (p,0.0001) in association with vaccination. The varicella risk was positively associated with sun exposure hours, but negatively associated with temperature only before vaccination.
Conclusions: The varicella vaccination is effective in varicella prevention, but the incidence of HZ increases after vaccination. HZ has a stronger association with temperature and UV than with seasonality while varicella risk associated with temperature and UV is diminished”
Wu, Po-Yuan, Hong-Dar Isaac Wu, Tzu-Chieh Chou, and Fung-Chang Sung. “Varicella Vaccination Alters the Chronological Trends of Herpes Zoster and Varicella.” PLoS ONE 8.10 (2013)
13. Varicella-zoster virus vaccination under the exogenous boosting hypothesis: Two ethical perspectives
“The varicella-zoster virus (VZV) causes two diseases: varicella (‘chickenpox’) and herpes zoster (‘shingles’). VZV vaccination of children reduces exposure to chickenpox in the population and it has been hypothesized that this could increase the prevalence of shingles. This ‘exogenous boosting’ effect of VZV raises an important equity concern: introducing a vaccination program could advance the health of one population group (children) at the expense of another (adults and elderly). We discuss the program’s justifiability from two ethical perspectives, classic utilitarianism and contractualism. Whereas the former framework might offer a foundation for the case against introducing this vaccination, the latter offers a basis to justify it.”
Luyten, Jeroen, Benson Ogunjimi, and Philippe Beutels. “Varicella-zoster Virus Vaccination under the Exogenous Boosting Hypothesis: Two Ethical Perspectives.” Vaccine 32.52 (2014): 7175-178.
New Shingrix Vaccine for Shingles Fails 97% of Time.
On the CDC website it also states that the shingles vaccine is safe. “No serious problems have been identified with shingles vaccine.”
Despite the CDC claim that the shingles vaccine carries no real risks, the FDA wrote to Merck in February 2016 telling them to add, ‘Eye Disorders: necrotizing retinitis (patients on immunosuppressive therapy)’ to their product information.’ 
Lawyers Hanging Out Their Shingles for Shingles Vax Lawsuits