gardasil, one dose of gardasil, gardasil vaccine, hpv vaccine
AP Photo/Harry Cabluck
One does of the vaccine Gardasil

Will New Pap Test Guidelines Result in Delayed Administration of Gardasil?

November 20, 2009 04:30 PM
by James Sullivan
New screening guidelines for cervical cancer say girls can wait until age 21 to begin Pap tests, though it is unclear how these recommendations will impact current HPV vaccination guidelines.

Pap Test Guidelines and Gardasil

The guidelines released by the American College of Obstetricians and Gynecologists (ACOG) encourage a shift toward less cervical cancer screening among women. In addition to delaying a woman’s first Pap test to the age of 21, the new guidelines recommend less frequent testing thereafter—once every two years until age 30.

The changes were made due to the rarity of contracting cervical cancer before the age of 21, and to avoid over-treatment and complications from the test. According to the ACOG, “Moving the baseline cervical screening to age 21 is a conservative approach to avoid unnecessary treatment of adolescents which can have economic, emotional, and future childbearing implications. … Although the rate of HPV infection is high among sexually active adolescents, invasive cervical cancer is very rare in women under age 21.”

The Pap test guidelines call into question the existing Centers for Disease Control and Prevention (CDC) rules for the administration of Gardasil, an HPV vaccine created by pharmaceutical giant Merck. The CDC added Gardasil to its routine vaccination schedule in 2007, recommending it for 11- or 12-year-old girls. Some physicians have previously opined that, because the effectiveness of Gardasil after five years has not been established, vaccinations should start at a later age. The ACOG’s new age guidelines would seem to strengthen the argument against early administration of Gardasil.
According to the National Cancer Institute, the previous cervical cancer screening guidelines recommended “that women have a Pap test at least once every 3 years, beginning about 3 years after they begin to have sexual intercourse, but no later than age 21. Experts recommend waiting about 3 years after the start of sexual activity to avoid overtreatment for common, temporary abnormal changes. It is safe to wait 3 years, because cervical cancer usually develops slowly. Cervical cancer is extremely rare in women under age 25.”

Background: To Gardasil or not to Gardasil?

In the wake of an August study published in the Journal of the American Medical Association (JAMA) that vouches for the relative safety of Gardasil, a human papillomavirus vaccine, health experts continued to debate the benefits of a generalized application of the vaccine, Denise Mann writes for CNN.

Merck, the manufacturer, proclaims that “only a doctor or health care professional can decide if GARDASIL is right for you or your daughter,” but the lead researcher for the study urges parents to become active participants in the decision.

The JAMA study notes that through the end of 2008, adverse side effects were reported in 12,424 cases, or 53.9 cases per 100,000 doses distributed. This is comparable to other vaccines. The study also notes that 772 of the adverse effects reported are considered serious, including 32 deaths. Cases of fainting and blood clots, in particular, are unusually high for a vaccine. Adverse event reporting is inherently imperfect, because on the one hand, an adverse event after a vaccination does not prove that the vaccine caused the outcome, and on the other hand, many adverse events never get reported.

Lead researcher Dr. Barbara Slade, a medical officer at the CDC, says that the risks posed by Gardasil should “open the dialogue that people need to have with their physician about whether they need to get the vaccine.”

In the same issue of JAMA, Dr. Charlotte Haug of Norway publishes an editorial titled “The Risks and Benefits of HPV Vaccination.” She writes that, in her opinion, “almost all HPV infections are cleared by the immune system … some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now.”

The CDC regularly reviews adverse event reports and updates its guidance on vaccines.  Based on its review of adverse events related to Gardasil through Sept. 1, 2009, the CDC saw no medical patterns that suggest that Gardasil caused the adverse events reported, and it continues to recommend the vaccine.

Most Recent Beyond The Headlines