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.