Is Gardasil® the Right Vaccine for You?* - For Adults
Gardasil is a vaccine designed to reduce your 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 this vaccine is highly effective, there is important information that you need to know before deciding is this vaccine is right for you.
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.
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 type, but will receive protection against the other remaining subtypes contained in the vaccine.
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.
Should Pap tests still be needed after receiving Gardasil?
Yes. Routine Pap screening remains an important part of cervical cancer prevention. Gardasil does not provide protection to all HPV viruses; therefore, it is important to continue using Pap tests.
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
©Copyright 2006 Harvard Vanguard Clinical Pharmacy Program, HealthOne Pharmacy & Therapeutics Committee

