New Data Reinforces Gardasil’s Safety Profile

Canadian Business

By Canada NewsWire  | May 09, 2011

KIRKLAND, QC, May 9 /CNW Telbec/ – A real-world study evaluating the safety of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine] among 189,629 females in California found no serious adverse events related to vaccination, no safety signals for any health event resulting in an emergency room visit or hospitalization and no safety signals associated with pre-specified autoimmune conditions or pregnancy outcomes. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Lisbon, Portugal, May 8-12, 2011.

Among the attendants and presenters at the EUROGIN scientific sessions is Dr. Michel Roy, professor in the Department of Obstetrics and Gynaecology at Laval University in Quebec City. “The data from this large US study supports what the international clinical trials found: the quadrivalent HPV vaccine has a good safety profile. Available in Canada since 2006, the vaccine has been studied and used for about a decade now. The new safety data are reassuring especially regarding autoimmune and neurologic conditions.”

“This is a very helpful study that should lay to rest any lingering concerns regarding safety of the quadrivalent HPV vaccine. It is particularly relevant because it is a “real -world” test in a very large population, with good follow up” said Dr. Jennifer Blake, Professor and Associate Chair, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Toronto, presently onsite in Lisbon. “Many people have been asking for exactly this sort of evidence before getting vaccinated, or advising others to get vaccinated against HPV. This study answers that question.”

About the study
The observational database study of 189,629 females provided safety data on all females who received at least one dose of GARDASIL® at two large managed care organizations in California between August 2006 and March 2008. The study evaluated three main areas: general safety, including post-vaccination emergency room (ER) visits and hospitalizations; new onset of 16 pre-specified autoimmune conditions among all females; and pregnancy outcomes among females with inadvertent vaccination with the quadrivalent HPV vaccine during pregnancy.

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Another Merck funded study? And on the heel’s of Health Canada’s expansion of Gardasil for older women?  Marketing…..


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.