Obstetrics & Gynecology

Is the HPV vaccine safe? I’ve heard that some women have gotten sick or died after receiving the vaccine

The most commonly transmitted sexual infection, human papilloma virus (HPV) includes more than 40 types of viruses. Estimates by the federal government indicate that as many as half of all sexually active men and women will acquire an HPV infection at some point in their lives. Most of these infections will cause little or no health problems in the men and women who contract them, but some types of HPV can cause genital warts and other types of the virus (often referred to as “high risk HPV”) can cause cancer, especially cancer of the cervix.

Each year in the United States, about 11,000 new cases of cervical cancer are diagnosed and the National Cancer Institute estimates that the disease will claim the lives of more than 3,800 American women this year.

In 2006, the federal Food and Drug Administration (FDA) approved a vaccine that protects against cervical cancer. The vaccine only protects against four strains of HPV, but these four strains of the virus are believed to cause 90 percent of the cases of genital warts and 70 percent of the cervical cancers. The U.S. Centers for Disease Control and Prevention (CDC) recommends the HPV vaccine for girls 11 to 12 years of age, or for women up to the age of 26 who have not been fully vaccinated (the vaccine is given as a series of three injections).

Along with the years of testing involving thousands of women that occurred before the vaccine was approved, the FDA and the CDC continue to monitor the HPV vaccine for its safety. So far studies have found no cause for alarm.

As of the end of June, the FDA had received 6,667 reports of side effects from the vaccine involving patients in the United States. Of these, 94 percent were considered non-serious and included such anticipated reactions as headache and soreness at the site of the injection. Less than six percent were considered “serious adverse events.” To put that number in perspective, it is about half of the average number of reports that the FDA typically receives for vaccines overall.

As of June 30, 2008, the FDA had received reports of 17 deaths following the HPV vaccination, but only 12 of these cases included enough information for analysis. After reviewing those cases, FDA investigators could find no evidence to indicate that the vaccine was the cause of death.

The FDA has also received reports of individuals diagnosed with Guillan Barre Syndrome following HPV vaccination. Guillan Barre Syndrome is a disorder in which the body’s immune system mistakenly attacks part of the nervous system, leading to nerve inflammation and progressive muscle weakness which can eventually paralyze the entire body. The number of these reported cases, however, is within the same range as occurs in women of the same age who have not been vaccinated for HPV.

Even though the vaccine is safe and effective for most individuals, it is not recommended for women who are pregnant.

Originally Published in The University Doctors' MedicaLink - 10/08

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