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NVIC is calling on the Centers for Disease Control (CDC) to issue anAdvisory and amend its March 12 policy by alerting the public that Gardasilhas been associated with 15 cases of GBS and an increased risk of GBS andother serious adverse event reports made to VAERS when the vaccine isadministered simultaneously with Menactra and other vaccines. "Theprecautionary principle dictates that good science should precede CDC vaccinepolicy recommendations," said Barbara Loe Fisher, NVIC co-founder andpresident. "Parents have a right to expect proof of safety and not assumptionof safety before new vaccines, like Gardasil, are given simultaneously withother vaccines to their children.
GBS is a disorder in which the body's immune system attacks part of theperipheral nervous system, and can cause total paralysis. "Our analysis ofGardasil reports to VAERS indicates there was a two to 12 times greaterlikelihood that serious adverse events, such as GBS, were reported whenGardasil was given in combination with Menactra rather than given alone," saidVicky Debold, PhD, RN, NVIC director of patient safety. "Accepted scientificstandards indicate that these findings are statistically significant andcannot be dismissed as coincidence. In particular, the available VAERS datashow there was a more than 1,000 percent increased risk of GBS reportsfollowing Gardasil administration when Menactra was given at the same time."
Reported GBS and Other Serious Adverse Events
NVIC found that, as of May 31, there have been 2,227 Gardasil adverseevents filed with VAERS, including 13 suspected or confirmed cases of GBS (twomore GBS reports were made in June for a total of 15) and 239 cases of syncope(fainting with temporary loss of consciousness), many of which resulted inhead injuries and fractures. Seven deaths have been reported after receipt ofGardasil. Nearly 10 percent of all Gardasil adverse event reports to VAERSinvolved avoidable medical errors.
A total of 1,930 reported Gardasil adverse events involved administrationof Gardasil alone, and 135 adverse events involved co-administration ofGardasil with Menactra. NVIC's comparative analysis of those two categoriesof VAERS reports indicates that when Gardasil was given simultaneously withMenactra rather than alone, there was a statistically significant increasedrisk of reported adverse events:
On February 21, NVIC expressed concern about the safety of administeringGardasil simultaneously with other vaccines because the manufacturer (Merck),the FDA and the CDC had not provided evidence to the public that co-administration was safe. (1) On March 12, the CDC published recommendationsfor Gardasil use in MMWR that acknowledged there is a lack of evidence thatGardasil can be safely administered with other vaccines, while encouragingphysicians to co-administer Menactra and other vaccines with Gardasil based onassumption of safety. (2)
Adverse Event Reports to NVIC: Shannon Nelson
Nineteen Gardasil adverse event reports from 12 states have been made toNVIC's Vaccine Reaction Registry involving unconsciousness and injury,convulsions, numbness, weakness and other neuromuscular and coordinationproblems and GBS.
Shannon Nelson, 18, a Chicago area athlete, musician and artist enteringcollege reported to NVIC that she received HPV vaccine (Gardasil),meningococcal v
