Occurred during day 1-15 of any vaccination visit.Īccording to EMEA’s CHMP, the general safety profile of Gardasil is considered favourable. One case of bronchospasm and 2 cases of asthma were reported as serious adverse experiences that 0.01% Placebo ), pelvic inflammatory disease ( 0.02% Gardasil vs. 0.01% Placebo ), appendicitis ( 0.02% Gardasil vs. 0.02% Placebo ), gastroenteritis ( 0.03% Gardasil vs. The most frequently reported serious adverse experiences for Gardasil compared to placebo and regardless of causality were: headache ( 0.03% Gardasil vs. Most deaths are in poor women who have seldom or never been screened.Īccording to Gardasil's label, a total of 102 subjects out of 21,464 total subjects ( 9- to 26-year-old girls and women and 9- to 15-year-old boys ) who received both Gardasil and placebo reported a serious adverse experience on day 1-15 following any vaccination visit during the clinical trials. Nevertheless, the US has about 10 000 new cases of cervical cancer a year, and about 3700 women die. Most papillomavirus infections do not cause cancer or, if they cause precancerous changes, are caught by cervical cancer screening.
Infection with papillomaviruses is common: more than six million new infections occur each year, and nearly three quarters of the US population aged between 15 and 49 have been infected with one of the papillomaviruses at some time. Gardasil protects against human papillomavirus ( HPV ) infection with the types 16 and 18, which cause about 70% of cervical, anal, and genital cancers, and it protects against types 6 and 11, which cause about 90% of genital warts. “ A careful review of the literature reveals a sufficient number of unanswered questions to lead us to conclude that a universal immunization program is, at this time, premature and could possibly have unintended negative consequences for individuals and for society as a whole," said Lippman. In a commentary published in the Canadian Medical Association Journal ( CMAJ ), Abby Lippman, an epidemiologist at McGill University in Montreal, Canada, and colleagues wrote that there is no urgent need for wide-scale cervical cancer vaccinations because deaths from the disease have been declining.
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