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Co-administration of Gardasil with Menactra: greater risk of Guillain-Barre syndrome

The National Vaccine Information Center ( NVIC ) issued a new report on HPV vaccine ( Gardasil ) safety analyzing adverse event reports to the federal Vaccine Adverse Event Reporting System ( VAERS ). The analysis gives evidence for a reported association in VAERS between Gardasil and Guillain-Barre syndrome ( GBS ), with a statistically significant increased risk of GBS and other serious adverse event reports when Gardasil is co-administered with other vaccines, especially meningococcal vaccine ( Menactra ).

Guillain-Barre syndrome is a disorder in which the body's immune system attacks part of the peripheral nervous system, and can cause total paralysis. " Our analysis of Gardasil reports to VAERS indicates there was a two to 12 times greater likelihood that serious adverse events, such as GBS, were reported when Gardasil was given in combination with Menactra rather than given alone," said Vicky Debold, NVIC director of patient safety. " In particular, the available VAERS data show there was a more than 1,000 percent increased risk of GBS reports following Gardasil administration when Menactra was given at the same time."

NVIC found that, as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS ( two more GBS reports were made in June for a total of 15 ) and 239 cases of syncope, many of which resulted in head injuries and fractures. Nearly 10 percent of all Gardasil adverse event reports to VAERS involved avoidable medical errors.

A total of 1,930 reported Gardasil adverse events involved administration of Gardasil alone, and 135 adverse events involved co-administration of Gardasil with Menactra. NVIC's comparative analysis of those two categories of VAERS reports indicates that when Gardasil was given simultaneously with Menactra rather than alone, there was a statistically significant increased risk of reported adverse events.

Source: The National Vaccine Information Center, 2007