CDC suppression of deleterious data associated with the US universal varicella vaccination program: the effect of declining exogenous exposures on herpes zoster incidence rates (Preprint)

2019 ◽  
Author(s):  
Gary S. Goldman
Keyword(s):  
Herpes Zoster ◽  
Los Angeles ◽  
Vaccine Efficacy ◽  
Varicella Vaccine ◽  
Incidence Rates ◽  
Vaccination Program ◽  
Varicella Vaccination ◽  
The Us ◽  
Capture Recapture ◽  
Herpes Zoster Incidence

BACKGROUND A Research Analyst provides evidence that the Universal Varicella Vaccination Program dramatically altered the epidemiology of herpes zoster (HZ, or shingles) in the first decade following varicella vaccine licensure in March 1995, and describes how CDC misrepresented data to conceal the significance of exogenous (external) exposures in (1) augmenting varicella vaccine efficacy, and (2) helping to prevent or postpone reactivation of HZ. OBJECTIVE Provide data demonstrating the significant effect that the Universal Varicella Vaccination Program and concomitant decline in exogenous exposures had on augmenting varicella vaccine efficacy and on increasing herpes zoster incidence rates among children, adolescents, and adults with a history of varicella during the first decade following varicella vaccine licensure. METHODS The Varicella Active Surveillance Project (VASP) was one of three CDC-funded projects in the US whose mission was to monitor the effects of the varicella vaccine on the Antelope Valley (Los Angeles, California) population of 300,000 residents. In 1995, VASP started collecting baseline epidemiological data pertaining to varicella disease (excluding herpes zoster). Active surveilliance for HZ began in 2000. Since reporting sites consisted of schools and medical providers, two-source capture-recapture statistics were applied to determine reporting completeness of varicella and HZ cases among children and adolescents, and compute ascertainment-corrected incidence rates. RESULTS Deleterious trends in vaccine efficacy due to declines in exogenous exposures were masked by averaging varicella vaccine efficacy over several years instead of stratifying efficacy by year. High HZ incidence rates among children who previously had varicella were initially masked by reporting a crude HZ incidence rate that included varicella-vaccinated children. True rates in the population were approximately two-fold higher since capture-recapture estimated a reporting-completeness of 50%. VASP calculated a statistically significant increase of 56.1% in adult HZ case reports from 2000-2002. CONCLUSIONS CDC mainly published selective studies with misrepresented data to support universal varicella vaccination and aggressively blocked the Research Analyst’s attempt to publish deleterious trends or outcomes, prompting his resignation in protest against what he perceived was research fraud.

scholarly journals 2767. Variation in Incidence of Pediatric Herpes Zoster by First- and Second-Dose Varicella Vaccine Formulations

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S975-S976
Author(s):  
Sheila Weinmann ◽  
Stephanie Irving ◽  
Padma Koppolu ◽  
Allison Naleway ◽  
Edward Belongia ◽  
...  
Keyword(s):  
Herpes Zoster ◽  
Varicella Vaccine ◽  
Vaccine Dose ◽  
Varicella Vaccination ◽  
Vaccine Formulation ◽  
Wild Type ◽  
Varicella Zoster ◽  
Dose Formulation ◽  
Using Data ◽  
Rate Ratios

Abstract Background Varicella (VAR) and measles-mumps-rubella (MMR) vaccines are recommended for children at ages 12–15 months and 4–6 years. These are administered as separate MMR and VAR vaccines (MMR+VAR) or as combined measles-mumps-rubella-varicella (MMRV) vaccine. Herpes zoster (HZ), caused by wild-type or vaccine-strain varicella-zoster virus, can occur in children after varicella vaccination. It is unknown whether HZ incidence after varicella vaccination varies by vaccine formulation or simultaneous receipt of MMR. Methods Using data from six integrated health systems, we examined HZ incidence among children who turned 12 months old during 2003–2008 and received varicella and MMR vaccines according to routine recommendations. All HZ cases ≥ 21 days after first varicella vaccination were identified using ICD-9 codes from inpatient, outpatient, emergency room encounters, and claims data, through 2014. HZ incidence was examined by vaccine formulation (MMR+VAR, MMRV, or VAR without same-day MMR) and doses received and compared using incidence rate ratios (IRR). Results Among 199,797 children, we identified 601 HZ cases. Crude HZ incidence after first-dose MMR+VAR (18.6 [95% CI 11.1–29.2] cases/100,000 person-years) was similar to the rate after first-dose MMRV (17.9 [95% CI 10.6–28.3] cases/100,000 person-years), but approximately double the rate among those with first-dose VAR without same-day MMR (7.5 [95% CI 3.1–15.0] cases/100,000 person-years); see Table 1. The IRR for HZ after first-dose MMR+VAR or MMRV, compared with VAR, was 2.5 (95% CI 1.4–4.4; P = 0.002). When examining any first or second dose formulation, crude HZ incidence was lower after the second varicella vaccine dose (13.9 cases/100,000 person-years), than in the period before the second dose (i.e., between first and second doses or after the first dose in children with only one dose; 21.8 cases/100,000 person-years, P < 0.0001). HZ incidence was also lower after two varicella vaccine doses in each of the three first-dose formulation groups. Conclusion HZ incidence among children varied by first-dose varicella vaccine formulation and number of varicella vaccine doses. Regardless of the first-dose varicella vaccine formulation, children who received two vaccine doses had lower HZ incidence after the second dose. Disclosures All authors: No reported disclosures.

scholarly journals Varicella disease after introduction of varicella vaccine in the US, 1995-2000

2002 ◽  
Vol 6 (7) ◽  
Author(s):  
N Noah
Keyword(s):  
Herpes Zoster ◽  
Infectious Diseases ◽  
Early Life ◽  
Varicella Vaccine ◽  
Age Distribution ◽  
Age Groups ◽  
Subsequent Development ◽  
Effective Vaccine ◽  
Routine Immunisation ◽  
The Us

Chickenpox is now one of the last of the infectious diseases of childhood that remain mostly uncontrolled. An effective vaccine has been available for many years but has not been used for routine immunisation in many countries. This is because the effect of giving the vaccine in early life on the subsequent development of herpes zoster is not known; high immunisation rates are important to ensure that the age distribution does not shift towards older age groups in whom the disease is more serious; and the disease is generally considered innocuous, especially in childhood when about 95% of infections occur.

scholarly journals Universal varicella vaccination in the Sicilian paediatric population: rapid uptake of the vaccination programme and morbidity trends over five years

2009 ◽  
Vol 14 (35) ◽  
Author(s):  
G Giammanco ◽  
S Ciriminna ◽  
I Barberi ◽  
L Titone ◽  
M Lo Giudice ◽  
...  
Keyword(s):  
Vaccination Programme ◽  
Vaccine Coverage ◽  
Varicella Vaccine ◽  
Age Groups ◽  
Vaccination Strategy ◽  
Paediatric Population ◽  
Incidence Rates ◽  
Universal Vaccination ◽  
Varicella Vaccination ◽  
Local Health

Following the licensure of the Oka/Merck varicella vaccine in Italy in January 2003, the Sicilian health authorities launched a universal vaccination programme in all nine Local Health Units. A two-cohort vaccination strategy was adopted to minimise the shift of the mean age of varicella occurrence to older age groups, with the goal of vaccinating with one dose at least 80% of children in their second year of life and 50% of susceptible adolescents in their 12th year of life. Two studies were implemented in parallel to closely monitor vaccination coverage as well as varicella incidence. Overall, the programme achieved its target, with 87.5% vaccine coverage for the birth cohort 2005 and 90.2% for adolescents born in 1995 and 1996. Varicella surveillance data obtained from a total of 28,188 children (0-14 years-old) monitored by family paediatricians showed a decline in incidence rates from 95.7 (95% confidence interval (CI): 72.2-126.8) for 1,000 person-years (PY) in 2004 to 9.0 (95% CI: 6.4-12.6) for 1,000 PY in 2007. In Europe, the only similar experience is the routine childhood varicella vaccination programme in Germany that started in 2004 with a single dose at the age of 11-14 months. The two-cohort universal vaccination programme implemented in Sicily, as well as the network for the surveillance study, can offer a model to other European countries that are considering introducing universal childhood varicella vaccination.

scholarly journals Effects of varicella vaccination on herpes zoster incidence

2004 ◽  
Vol 10 (11) ◽  
pp. 954-960 ◽  
Author(s):  
S. Wagenpfeil ◽  
A. Neiss ◽  
P. Wutzler
Keyword(s):  
Herpes Zoster ◽  
Varicella Vaccination ◽  
Herpes Zoster Incidence

Varicella in Infants After Implementation of the US Varicella Vaccination Program

PEDIATRICS ◽  
2011 ◽  
Vol 128 (6) ◽  
pp. 1071-1077 ◽  
Author(s):  
S. S. Chaves ◽  
A. S. Lopez ◽  
T. L. Watson ◽  
R. Civen ◽  
B. Watson ◽  
...  
Keyword(s):  
Vaccination Program ◽  
Varicella Vaccination ◽  
The Us

Varicella: Complications and Costs

PEDIATRICS ◽  
1986 ◽  
Vol 78 (4) ◽  
pp. 728-735 ◽  
Author(s):  
Stephen R. Preblud
Keyword(s):  
High Risk ◽  
Varicella Vaccine ◽  
Risk Groups ◽  
Vaccination Program ◽  
Varicella Vaccination ◽  
Effective Vaccine ◽  
Normal Children ◽  
Live Attenuated Vaccine ◽  
Increased Risk ◽  
The Cost

Vanicella (chickenpox) has long been considered a benign, inevitable disease of childhood. Complications are generally mild and rarely severe, and virtually every individual is infected by adulthood. Infection is associated, however, with a high risk of serious complications in certain high-risk groups, such as leukemic children. Concerns about the severity of varicella in this population have led to the development and testing of a live, attenuated vaccine. Because of the favorable results thus far available, the vaccine may soon be licensed for use in high-risk individuals. The fact that a vaccine may soon be available has led to an increased interest in the potential benefits of a childhood varicella vaccine program. The costs associated with varicella infection in normal persons without a varicella vaccination program have been estimated to be approximately $400 million, 95% of which is the cost of caring for a child at home. Vaccination of normal 15-month-old children with a safe and effective vaccine with long-lasting immunity could reduce the cost by 66% and result in a savings of $7 for every dollar spent on the vaccination program. This assumes that vaccine would be administered only once with measles, mumps, and rubella vaccine, that there would be no increase in the number of varicella cases in older persons who are at increased risk for complications, and that there would be no deleterious effect on the occurrence and severity of herpes zoster. If the assumptions cited above hold true, then it would appear that normal children would benefit from prevention of varicella by vaccination, not by virtue of the severity of the disease but rather because of the inevitability of the disease and its associated expense.

Population-based incidence of herpes zoster after introduction of a publicly funded varicella vaccination program

Vaccine ◽  
2011 ◽  
Vol 29 (47) ◽  
pp. 8580-8584 ◽  
Author(s):  
Peter Tanuseputro ◽  
Brandon Zagorski ◽  
Kevin J. Chan ◽  
Jeffrey C. Kwong
Keyword(s):  
Herpes Zoster ◽  
Population Based ◽  
Vaccination Program ◽  
Varicella Vaccination ◽  
Publicly Funded

scholarly journals Varicella Vaccine Effectiveness in the US Vaccination Program: A Review

2008 ◽  
Vol 197 (s2) ◽  
pp. S82-S89 ◽  
Author(s):  
Jane F. Seward ◽  
Mona Marin ◽  
Marietta Vázquez
Keyword(s):  
Varicella Vaccine ◽  
Vaccine Effectiveness ◽  
Vaccination Program ◽  
The Us
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