STUDY REVEALS IMPORTANT SIDE EFFECT OF MASS VARICELLA VACCINATION OF HEALTHY CHILDREN: Reduction in chickenpox may increase incidence of shingles.

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The results of a new study published in the October 1, 2003 issue of the European journal Vaccine indicate that a higher than expected number of shingles cases was reported among children with a previous history of chickenpoxÂ?approaching the incidence rate normally seen only in older adults. Results of the study suggest mass vaccination with varicella (chickenpox) vaccine may be responsible for this adverse effect.

– The results of a new study published in the October 1, 2003, issue of the European journal Vaccine indicate that a higher than expected number of shingles cases was reported among children with a previous history of chickenpox. The rates observed approach those normally seen only in older adults. Results of the study suggest mass vaccination with varicella (chickenpox) vaccine may be responsible for this adverse effect. Complications from shingles, which is caused by the reactivation of the chickenpox virus that lies dormant in the body, result in about three times the number of hospitalizations and five times the number of deaths as those from chickenpox disease itself. Shingles, usually mild in children, can be severe in adults.

On March 17, 1995, the U.S. Food and Drug Administration (FDA) approved the live varicella vaccine, and shortly thereafter 38 states mandated that every infant be inoculated at twelve months of age. The CDC-funded Varicella Active Surveillance Project (VASP) of the Los Angeles County Department of Health Services was established to study trends in varicella disease among the 300,000 residents in the Antelope Valley health district. Because this high desert community, including the primary cities of Lancaster and Palmdale, is geographically distinct with few individuals seeking healthcare outside the region, it is nearly ideal for scientists to detect preliminary disease trends.

“Because the vaccine is eliminating chickenpox disease, children and adults no longer receive the natural boost to their immune systems that they received from periodic exposures to the disease,” says Gary S. Goldman, Ph.D., author of the study and former research analyst with VASP. “Due to the dramatic decline in chickenpox, children are now experiencing a higher incidence of shingles.”

To compensate for this, vaccine manufacturers plan to license a booster "shingles" vaccine to substitute for the natural boost in immunity that occurred when chickenpox disease was previously circulating in the population. Goldman expresses doubts about the effectiveness of this approach to the impending problem.

"This will likely lead to endless disease-and-cure cycles," says Goldman. "Varicella vaccination would have been less problematic if all children had the opportunity to gain natural immunity and only those still susceptible at twelve years-of-age were vaccinated."

Previous research shows that Japanese pediatricians who were exposed to patients with chickenpox demonstrated shingles incidence rates one-half to one-eighth that of the general population. In 2002, researchers in England and Wales also found a lower incidence of shingles among adults living with children compared to those living without children.

According to a spokesperson from the FDA, "There is no legal precedent requiring a vaccine manufacturer to perform studies on individuals who have not received their product."

However, Goldman insists that, “To assess the safety of chickenpox vaccine, continued study of the effect of widespread vaccination on increasing shingles incidence is critical.” Goldman hopes this study encourages other investigators to examine shingles rates not only among vaccine recipients, but also among those who have not received vaccine.

Dr. Goldman concludes, "If a clear vaccine-associated increase in shingles is confirmed in further studies in broader populations, this should be considered by public health authorities in evaluating vaccine use strategies."

For more information on the current study, see the three reports published on 18 consecutive pages in Vaccine (Volume 21, Issue 27/28) or contact Gary S. Goldman, Ph.D., at (661) 944-5661 or via e-mail at pearblossominc@aol.com.

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About Gary S. Goldman, Ph.D.:

From 1995 to 2000, shingles was not studied, and positive aspects of vaccination contributed by Dr. Goldman were published in the Journal of the American Medical Association (JAMA) and other medical journals. In 2000, after hearing reports of school nurses observing cases of shingles in children for the first time, Goldman suggested shingles be added to the active surveillance project. After two years of shingles data collection, Goldman documented the adverse effects that might well be associated with the universal varicella vaccination program.

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Gary Goldman
GARY S. GOLDMAN, PH.D.
661-944-5661
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