Allergic reactions to Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) are uncommon and most young women who have a suspected allergic reaction can tolerate subsequent doses, according to the results of a study published in an early online issue of the British Medical Journal.
Human papillomaviruses (HPV) consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer. The types of HPV most commonly linked with cervical cancer are HPV 16 and HPV 18, but several other high-risk types contribute to cancer as well.
Gardasil is approved for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18 in girls and young women nine through 26 years of age.
In April 2007, the Australian national immunization program administered more than 380,000 doses of Gardasil to girls ages 12-26 in secondary schools. In compliance with Australian protocols of reporting vaccine-related adverse events, 35 schoolgirls with suspected hypersensitivity to the drug were reported to the specialized immunization services. Of those 35 girls, 25 agreed to further evaluation.
Upon further evaluation the researchers found that most cases (23) of the suspected hypersensitivity occurred after the first dose of the vaccine. These events included rash, hives, swelling and in two cases, anaphylaxis. However, after undergoing skin prick and injection testing, only three of the 25 girls were found to have probable hypersensitivity to the vaccine. The hypersensitivity in these three girls was defined as anaphylaxis, positive skin test, or a reproducible reaction to “challenge” doses with the vaccine.
Because only three girls out of more than 300,000 who received Gardasil experienced true hypersensitivity to the vaccine, the researchers concluded that true hypersensitivity to Gardasil is uncommon and most girls tolerate subsequent doses. Although allergic reactions appear to be rare following vaccination with Gardasil, suspected allergic reactions should be evaluated before additional doses are given.
 Kang LW, Crawford N, Tang MLK, et al. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: Retrospective cohort study. British Medical Journal. 2008;337:a2642, doi: 10.1136/bmj.a2642 (Published 2 December 2008)
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