1. Nelson, Roxanne BSN, RN
  2. Moser, Jennifer


Experts say the HPV vaccine is safe; questions remain.


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Despite recommendations that girls ages 11 and 12 receive Gardasil, Merck's human papillomavirus (HPV) vaccine, mothers of girls ages nine to 12 are less likely to plan vaccination for their daughters than are mothers of older girls, reported researchers at Cincinnati Children's Hospital Medical Center (CCHMC) in Ohio.


Said study author Jessica Kahn in a CCHMC press release, the Centers for Disease Control and Prevention (CDC) "recommends that HPV vaccination ideally occur before a girl becomes sexually active, as the vaccine will not reverse HPV infection[horizontal ellipsis]. This discrepancy between mothers' attitudes and CDC recommendations represents a challenge for health care providers." Kahn presented her study at May's annual meeting of the Pediatric Academic Societies.


That challenge may grow as some organizations spread alarming, and perhaps alarmist, information. One conservative group, Judicial Watch, publicized records in 2007 from the Vaccine Adverse Event Reporting System (VAERS) of the CDC and the Food and Drug Administration (FDA). These records indicated that 3,461 adverse events and 11 deaths following Gardasil vaccination had been reported to VAERS.


However, the CDC cautions, anyone can make a VAERS report without verification; an adverse event occurring after a vaccination isn't necessarily caused by it (see The CDC reported in April that VAERS had received 5,070 adverse-event reports about Gardasil, including 13 deaths, but only four deaths were verified and none "appear to have been caused by the vaccine." The report added that fewer than 7% of reported events were serious; that's half the average for all vaccines.


One such death occurred in March 2007. Brooke Petkevicius was a healthy 19-year-old college student who was training for a half-marathon. She suddenly collapsed, was rushed to a hospital, and died. An autopsy revealed a pulmonary embolism. "I think I'm always going to wonder" whether Brooke's death was linked to the HPV vaccine she'd received two weeks earlier, says her mother, Debra Sonner. Sonner urges that HPV risk be considered before girls and young women are vaccinated.


According to University of Washington epidemiologist Laura Koutsky, "There's no new clustering of adverse events with Gardasil. Blood clots are rare in young women, but they can be caused by oral contraceptives or genetic traits. We need to accept the conclusions of the investigators while continuing to monitor the girls."


Gardasil is the first HPV vaccine. It is licensed for use in girls and women ages nine to 26. Three injections are given over six months. Major health organizations have endorsed it since its 2006 FDA approval. A CDC review of safety data named injection-site reactions as the most commonly reported adverse events. Of more than 21,000 subjects in prelicensure trials, 11 deaths occurred in those given Gardasil and seven in those given placebo, but the CDC's report stated that no deaths were considered vaccine related.


Monitoring will continue. The CDC-sponsored Vaccine Safety Datalink Project will conduct surveys for selected outcomes of vaccination. Phase IV studies are planned to investigate the short-term adverse effects of Gardasil in 44,000 young women and girls. A study linking national registries in Scandinavian countries will evaluate long-term safety.

Figure. Brooke Petke... - Click to enlarge in new windowFigure. Brooke Petkevicius died of pulmonary embolism at age 19, two weeks after receiving the Gardasil vaccine. It hasn't been determined whether her death was a result of the vaccine; researchers are studying its short- and long-term effects.

Roxanne Nelson, BSN, RN


Jennifer Moser