The vaccine, Gardasil®, is the first vaccine developed to prevent cervical cancer and genital warts due to human papillomavirus (HPV). It works by protecting against the four types of HPV that most commonly cause these diseases. The vaccine is given in three doses. The vaccine is licensed by the FDA for girls and women ages 9 through 26 years.

Doctors recommend this vaccine for 11- and 12-year-old girls. The vaccine also can be given to girls and women ages 13 through 26 who did not get the vaccine when they were younger or who did not complete the vaccination series.

Ideally, girls/women should get this vaccine before their first sexual contact when they could be exposed to HPV. This is because the vaccine prevents disease in girls/women who have not previously acquired one or more types of HPV prevented by the vaccine. It does not work as well for those who were exposed to the virus before getting the vaccine.

This vaccine targets the types of HPV that most commonly cause cervical cancer and genital warts. This vaccine is highly effective in preventing these types of HPV in young women who have not been previously exposed to them. The vaccine will not treat existing HPV infections or existing diseases or conditions caused by HPV. The vaccine also will not protect against disease and infection caused by other HPV types not included in the vaccine.

The vaccine has been licensed as safe. Before it was approved by the FDA, the vaccine was studied in thousands of females 9 through 26 years of age in the United States and around the world. The most common side effect is soreness where the shot is given.

The vaccine is not recommended for pregnant women. There has been only limited information about how safe the vaccine is for pregnant women and their unborn babies outside of the clinical trials. For now, pregnant women should wait to complete their pregnancy before getting the vaccine. If a woman finds out she is pregnant after she has started getting the vaccine series, she should wait until after her pregnancy is completed to finish the three-dose series. Most importantly, she should continue her routine prenatal care and enroll in the registry the vaccine manufacturer is compiling of pregnant women who have received the HPV vaccine.

The Gardasil pregnancy registry has been established to collect information on the pregnancy outcomes of women who inadvertently receive the vaccine during pregnancy. The data collected will be used to monitor any effects the vaccine might have on pregnancies, so it is important that all eligible patients be enrolled. Individual patient information remains confidential.

The surest way to prevent genital HPV is to avoid sexual contact. For persons who are sexually active, condoms may lower their chances of getting HPV, if used all the time and the right way. Condoms may lower a person’s chances of developing genital warts and cervical cancer. But HPV can infect areas that are not covered by a condom—so condoms may not fully protect against HPV.

The HPV vaccine is recommended as a three-dose vaccine. It is not yet known how much protection girls/women would get if they receive only one or two doses of the vaccine. For this reason, it is very important that girls/women get all three doses of the vaccine.

The vaccine has been widely tested in 9- through 26-year-old females. But research on how well the vaccine works in older women has just recently begun. The FDA may license the vaccine for these women when there is research to show it is safe and effective for them.

We do not yet know if the vaccine is effective in boys or men. Studies are being done to find out if the vaccine is effective in males. When more information is available, this vaccine may be licensed and recommended for boys/men as well.