Is Gardasil® the Right Vaccine for Your Child?*

Gardasil is a vaccine designed to reduce the chances of getting cervical cancer and genital warts. It does this by preventing infection by four specific types of Human Papillomavirus (HPV): HPV types 6, 11, 16, and 18. Types 16 and 18 are responsible for 70% of cervical cancers, and types 6 and 11 cause 90% of genital warts. Although your child may be too young to be sexually active, it is still important for you to learn about this vaccine. By becoming informed about HPV, you can decide if your child should receive this vaccine now for the prevention of cervical cancer.

What is Human Papillomavirus (HPV)?

HPV is a group of viruses that includes more than 100 different types. Some of these viruses can cause cervical cancer while other types can cause genital warts. More than 30 types of these viruses can be passed from one person to another through sexual contact.

For most women, the body’s own defense system will clear these viruses, without any health consequences. However, for some individuals, the virus remains in the body and may lead to formation of either genital warts, abnormal cells in the lining of the cervix, or cervical cancer.

What groups are at risk of getting HPV?

Most people who have sex may get HPV. People are at higher risk if they have:

Sex at an early age,
Many sex partners, or
A sex partner who has had many partners.
Use of condom reduces the risk of HPV infection but does not eliminate the risk.

Why should we consider this vaccine for our child at such a young age?

Gardasil only works for prevention. Therefore, it should be given prior to infection with the four specific subtypes of HPV. Once a person becomes sexually active, the risk of acquiring the infection increases. The 2002 National Survey of Family Growth and 2003 Youth Risk Behavioral Survey indicate that of those responded to the surveys, approximately 7% of young persons have had sex before age 13, 25% by age 15, and 48% by age 17. Although these percentages do not represent the actual infection rate, it demonstrates that the potential risk for the infection is real for some children.

How effective is Gardasil?

In four clinical trials involving women between the ages of 16-26, Gardasil was able to prevent pre-cancerous cervical lesions, and genital warts caused by types 16, 18, 6 and 11 in women that had not been previously infected with these four types of HPV viruses. Because it prevents pre-cancerous lesions, it is highly likely that Gardasil will prevent cervical cancers caused by these specific viral subtypes.

It is important to note that women who have already been infected by any one of the four subtypes prior to the vaccination are not protected from that specific one type, but will receive protection on the other remaining subtypes contained in the vaccine.

When Gardasil was administered to girls between the ages of 9-15, the immune response was similar to that of the 16-26 age groups, suggesting the vaccine was equally effective in this younger group of females. It is important to note that these trials did not actually look at the prevention of pre-cancerous lesions in the younger population.

How long does Gardasil’s protective effect last?

We do not know. Currently, we have four years of data. The manufacturer continues to collect data beyond the four years to determine its long term safety and efficacy. The need to have booster dose remains to be determined.

Will Gardasil help patients that already have a disease related to HPV types 6, 11, 16, or 18?

No. Gardasil works by preventing the disease but not treating the disease once it has developed.

Are there any risks of getting the virus from the vaccine?

No. The vaccine does not contain the virus. It is a recombinant vaccine that contains a protein, and not the actual virus. Therefore, the vaccine cannot cause the HPV infection. The body develops antibodies to the recombinant protein. These antibodies then act to prevent infection by the naturally occurring virus.

How is Gardasil administered?

Gardasil is given as three intramuscular injections over a six-month period. The second dose is given two months after the initial dose. The last dose is given four months after the second dose. It is important to complete the whole series in order to ensure the maximum benefit.

What are the side effects of Gardasil?

Most of the reactions reported from the clinical trials are mild to moderate local reactions, such as pain or tenderness at the site of the injection. These symptoms can intensify with subsequent doses, but are generally mild. As always, unexpected, rare adverse events can occur, as with any vaccine. It is important to call your doctor immediately if you notice any unusual reaction upon receiving the vaccine.

Who should not be immunized with Gardasil?

Females who are allergic to yeast or to any component of the vaccine should not receive Gardasil. Gardasil is not recommended for pregnant women. Gardasil is only FDA approved for females ages 9-26.

Does Gardasil contain Thimerosal?

No. Gardasil does not contain Thimerosal or any other preservative.

Does my insurance company cover this vaccine?

Most insurance companies are covering the vaccine if you are a female between the ages of 9-26, although some may cover it only if you have a vaccine coverage included in your medical benefit. When in doubt, you may call your insurance company’s member service to verify.

*partially adapted from the FDA website information on HPV and Gardasil Questions & Answers – 2006