U.S. Health Officials Reiterate Safety Of Gardasil After Recent Studies

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 24 Aug 2009 - 0:00 PDT

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FDA and the Centers for Disease Control and Prevention on Thursday issued a joint statement reiterating the benefits of Merck's human papillomavirus vaccine, Gardasil, after the release of a government study analyzing the safety of the vaccine, the Wall Street Journal reports (Loftus, Wall Street Journal, 8/20). The three-dose vaccine is FDA-approved for girls and women ages nine to 26 to protect against two strains of HPV that can lead to cervical, vulvar and vaginal cancers, as well as two other strains that can lead to genital warts. CDC recommends routine vaccination for girls ages 11 and 12. The vaccine also is recommended for girls and women ages 13 through 26 who have not yet been vaccinated or who have not received all three doses (FDA/CDC statement, 8/20).

The study -- conducted by the two agencies and published in the Journal of the American Medical Association -- found that rates of most adverse events after vaccination with Gardasil were not higher than expected. However, the study showed that girls and women who received the vaccine had higher rates of fainting and blood clots compared with other similar vaccines. According to the statement, although reports of those two events were elevated compared with other vaccines, they were not higher than expected for the age group when contributing factors were taken into account. For example, 90% of the confirmed reports of blood clots were among patients with underlying risk factors for clots, such as smoking, obesity or use of hormonal birth control.

The study also found that there were 32 deaths after administration of the vaccine. FDA and CDC said that there was no pattern to suggest that Gardasil was the cause of the deaths. The statement said, "Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks." It also recommended that health care providers adopt measures to prevent fainting episodes and potential injuries that could be sustained from them (Wall Street Journal, 8/20).

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