HPV Vaccine Safety
Recent Media Stories about the HPV Vaccine (July 2008)
The HPV vaccine prevents cervical cancer and is recommended for girls 11- to 12-years old. It is also recommended for young women up to 26 years of age who have not received it previously. A recent wave of media coverage has suggested that the HPV vaccine might not be safe. These reports were based on information gathered from a vaccine surveillance program called the Vaccine Adverse Events Reporting System or VAERS.
VAERS is a program administered by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Any person who suffers an adverse event following administration of a vaccine should report it to this program. The occurrence can be reported by anyone, not just healthcare providers. The strength of the VAERS program is that it provides information regarding any clustering of events surrounding a certain vaccine. However, the VAERS program is limited in that no association of causality can be determined. Specifically, the VAERS data are not complete because they do not contain the number of doses of vaccine that have been administered or adverse events that occur in people who do not receive vaccines. The result is that VAERS data are very good at determining when something may be a problem, but are not able to establish the cause of a problem. If a cluster of similar events reported to VAERS is found to exceed what is expected in the general population, further studies are initiated using either specially designed epidemiological studies or a system called the Vaccine Safety Datalink.
Since the start of immunizations with the HPV vaccine in June 2006, there have been 7,802 reports to VAERS. Of these, about 550 were classified as serious, meaning they involved hospitalization, death, permanent disability, or a life-threatening illness. The most common events reported to VAERS included a sore arm or fainting. Severe events included Guillain-Barré Syndrome (or GBS) and death. After reviewing the deaths, none of them could be linked to receipt of the HPV vaccine. In addition, the number of cases of GBS reported did not exceed the number expected to occur in the same age group by chance.
VAERS reports will continue to be monitored; however, the HPV vaccine is considered to be safe and effective, and parents should continue to immunize their daughters with this vaccine.
Learn more about HPV and the vaccine »
Learn more about VAERS »
Reviewed: July 2008
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