What are the side effects of the HPV vaccines?

For almost all patients, the HPV vaccines are well-tolerated. Common side effects include pain, swelling, and redness at the injection site. These side effects were rated as mild to moderate by the majority of participants. However, if a patient is known to be hypersensitive to the active or inactive substances in the vaccine, she shouldn't receive it. Similarly, if a patient develops a hypersensitivity or allergic reaction after one injection, then the remaining injections obviously should be withheld. The HPV vaccines have not been approved for use in pregnant women, and their safety while a woman is breastfeeding is unknown. Because light-headedness or fainting can be a reaction of receiving any shot, a 15-minute wait time at the doctor's office is recommended after receiving Gardasil or Cervarix.

In the summer of 2008, news stories surfaced regarding reports of serious adverse events associated with Gardasil. However, the CDC and the FDA examined these reports, and after careful analysis, concluded that young girls still should be vaccinated. Specifically, the CDC and the FDA made the following findings.

A total of 9,749 adverse events were reported from the start of Gardasil vaccinations in June 2006 through June 2008. Approximately 94% of these adverse events were classified as non-serious. They included such complaints as injection-site pain, headaches, nausea, fever, and fainting.

The remaining 6% of the adverse events were deemed to be serious. In fact, 20 deaths reportedly occurred at some point after a girl received this HPV vaccine. This number obviously sounds very alarming. However, the CDC and the FDA analyzed these cases closely and ultimately determined that there appeared to be no common link among the causes of death in these girls and, therefore, they concluded that there wasn't anything to indicate that the vaccine was really the cause. In fact, when autopsy results were available, the cause of these deaths was shown to be unrelated to the vaccine. Keep in mind that 24 million doses of Gardasil have been given as of May 2009.

Other serious adverse events investigated by the CDC and the FDA included blood clot disorders, but most of these cases occurred in females with risk factors for clotting. There also were cases of Guillain-Barre Syndrome (GBS), a rare neurological disorder that is seen most frequently in adolescents. However, the CDC and the FDA found no increase in GBS cases beyond the number typically expected among girls who received Gardasil. It is reassuring to know that there are three vaccine safety monitoring systems that continuously collect data on all vaccines to watch for any adverse effects.

And finally, if you've been following the debate about other vaccines, you'll be happy to know that Gardasil and Cervarix contain no thimerosal.

Will insurance pay for the HPV vaccines?

Gardasil typically is covered by insurance plans. For the uninsured, the Vaccines for Children Program (which is federally funded) provides the vaccine to children who are covered by Medicaid or who are Medicaid-eligible, as well as to the uninsured, American Indians/ Native Americans, and Alaskan natives. While there is no federally funded program to cover the cost of Gardasil for uninsured adults, the manufacturer of Gardasil has established a vaccination assistance program for uninsured women whose income is below 200% of the poverty level and for others on an individual case-by-case basis. It is anticipated that Cervarix will be covered by insurance plans as well.

What exactly does an HPV infection mean to my daughter?

When my patients come in with questions about vaccinating their daughters, I try to enlighten them about the far reaching effects of HPV. I've already covered the health consequences that can result from becoming infected with HPV such as genital warts and cancer, but there even are adverse consequences that can stem from the testing and treatment of women who have HPV.

Nowadays, doctors are careful not to overtreat a young woman's cervix. However, because HPV can be persistent,

oftentimes it is necessary to perform a colposcopy on a patient. A colposcopy^[1] is an uncomfortable, longer-than-usual pelvic exam involving a careful look at the cervix that is accompanied by the performance of small biopsies. Often no further treatment is necessary other than more frequent Pap smears, but this testing requires additional visits to the doctor's office.

At other times, treatment for HPV is required, and this consists of freezing, or even removing a small portion of, the cervix. Most of the time this completes treatment and the patient is simply followed with periodic Pap smears. However, women who have had these procedures performed on them need to be followed more closely during pregnancy. Occasionally, bed rest, frequent sonograms, and even a stitch in the cervix are required to support the growing pregnancy. While most women complete their pregnancies without a problem, there is a higher incidence of preterm delivery in these types of patients.

But that's not all. Sometimes the abnormal cells caused by HPV return as patients grow older. In fact, some women decide to have hysterectomies after child bearing due to the persistence of Pap abnormalities and the presence of high-risk HPV so as to rid themselves of the risk of cervical cancer.

Should my daughter receive the HPV vaccine?

Above, I have listed the primary factors you need to weigh when making the important decision about whether your daughter should receive the HPV vaccine. You shouldn't make this decision lightly, you should do so in consultation with your own doctor, and you should be mindful of the fact that additional information could come to light in the future that could alter the equation.

But having said that, I hope you will be guided by the facts and the science related to this matter rather than by emotions, rumors, unfounded suppositions, and inertia. I don't want to paint too stark a picture, but as a physician, this is how I see it: On one side of the equation you have the downsides of the HPV vaccine—if your daughter receives it, she may experience temporary injection-site pain, headache, nausea, fever, and fainting. On the other side of the equation, however, is this simple fact—if your daughter does not receive the vaccine, she is highly likely to contract the human papillomavirus. If she does, your daughter is at increased risk for genital warts, cervical cancer, vulvar cancer, vaginal cancer, and anal cancer; she may be subjected to unpleasant examination procedures and treatments to address her HPV infection; and she may experience complications during pregnancy.

Now you must decide what's best for your daughter.

• [1] An office procedure in which the cervix is viewed through a colposcope, or magnifying instrument. A colposcopy is the test done to further evaluate the cervix after an abnormal Pap smear. Often small biopsies are performed during this procedure.