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The vaccine has been widely tested in 9-to-26 year-old girls/women. But research on the vaccine¡¯s safety and efficacy has only recently begun with women older than 26 years of age. The FDA will consider licensing the vaccine for these women when there is research to show that it is safe and effective for them. What about vaccinating boys? We do not yet know if the vaccine is effective in boys or men. It is possible that vaccinating males will have health benefits for them by preventing genital warts and rare cancers, such as penile and anal cancer. It is also possible that vaccinating boys/men will have indirect health benefits for girls/women. Studies are now being done to find out if the vaccine works to prevent HPV infection and disease in males. When more information is available, this vaccine may be licensed and recommended for boys/men as well. Should pregnant women get the vaccine? The vaccine is not recommended for pregnant women. There has been limited research looking at vaccine safety for pregnant women and their unborn babies. So far, studies suggest that the vaccine has not caused health problems during pregnancy, nor has it caused health problems for the infant-- but more research is still needed. For now, pregnant women should 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 complete her pregnancy before finishing the three-dose series. Efficacy of the HPV vaccine Studies have found the vaccine to be almost 100% effective in preventing diseases caused by the four HPV types covered by the vaccine¨C including precancers of the cervix, vulva and vagina, and genital warts. The vaccine has mainly been studied in young women who had not been exposed to any of the four HPV types in the vaccine. The vaccine was less effective in young women who had already been exposed to one of the HPV types covered by the vaccine. This vaccine does not treat existing HPV infections, genital warts, precancers or cancers. How long does vaccine protection last? Will a booster shot be needed? The length of vaccine protection (immunity) is usually not known when a vaccine is first introduced. So far, studies have followed women for five years and found that women are still protected. More research is being done to find out how long protection will last, and if a booster vaccine is needed years later. What does the vaccine not protect against? Because the vaccine does not protect against all types of HPV, it will not prevent all cases of cervical cancer or genital warts. About 30% of cervical cancers will not be prevented by the vaccine, so it will be important for women to continue getting screened for cervical cancer (regular Pap tests). Also, the vaccine does not prevent about 10% of genital warts¡ªnor will it prevent other sexually transmitted infections (STIs). So it will still be important for sexually active adults to reduce exposure to HPV and other STIs. Will girls/women be protected against HPV and related diseases, even if they don¡¯t get all three doses? It is not yet known how much protection girls/women would get from receiving 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. Safety of the HPV vaccine The FDA has licensed the HPV vaccine as safe and effective. This vaccine has been tested in over 11,000 females (ages 9-26 years) around the world. These studies have shown no serious side effects. The most common side effect is soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use. Does this vaccine contain thimerosal or mercury? No. There is no thimerosal or mercury in the HPV vaccine. It is made up of proteins from the outer coat of the virus (HPV). There is no infectious material in this vaccine. Cost and coverage of the HPV vaccine The retail price of the vaccine is $120 per dose ($360 for full series). Will the HPV vaccine be covered by insurance plans? While some insurance companies may cover the vaccine, others may not. Most large insurance plans usually cover the costs of recommended vaccines. However, there is often a short lag-time after a vaccine is recommended, before it is available and covered by health plans. What kind of government programs may be available to cover HPV vaccine? Federal health programs such as Vaccines for Children (VFC) will cover the HPV vaccine. The VFC program provides free vaccines to children and teens under 19 years of age, who are either uninsured, Medicaid-eligible, American Indian, or Alaska Native. There are over 45,000 sites that provide VFC vaccines, including hospitals, private clinics, and public clinics. The VFC Program also allows children and teens to get VFC vaccines through Federally Qualified Health Centers or Rural Health Centers, if their private health insurance does not cover the vaccine. Some states also provide free or low-cost vaccines at public health department clinics to people without health insurance coverage for vaccines. What vaccinated girls/women need to know The HPV vaccine is given through a series of three shots over a 6-month period. The second and third doses should be given 2 and 6 months (respectively) after the first dose. Will girls/women who have been vaccinated still need cervical cancer screening? Yes. There are three reasons why women will still need regular cervical cancer screening. First, the vaccine will NOT protect against all types of HPV that cause cervical cancer, so vaccinated women will still be at risk for some cancers. Second, some women may not get all required doses of the vaccine (or they may not get them at the right times), so they may not get the vaccine¡¯s full benefits. Third, women may not get the full benefit of the vaccine if they receive it after they¡¯ve already acquired one of the four HPV types. Should girls/women be screened before getting vaccinated? No. Girls/women do not need to get an HPV test or Pap test to find out if they should get the vaccine. An HPV test or a Pap test can tell that a woman may have HPV, but these tests cannot tell the specific HPV type(s) that a woman has. Even girls/women with one HPV type could get protection from the other vaccine HPV types they have not yet acquired. Will girls be required to get vaccinated before they enter school? There are no federal laws that require children or adolescents to get vaccinated. All school and daycare entry laws are state laws¡ªso they vary from state to state. To find out what vaccines are needed for children or teens to enter school or daycare in your state, check with your state health department or board of education. The Basics about Genital HPV & Cervical Cancer Genital HPV is a common virus that is passed on through genital contact, most often during vaginal and anal sex. About 40 types of HPV can infect the genital areas of men and women. While most HPV types cause no symptoms and go away on their own, some types can cause cervical cancer in women. These types also have been linked to other less common genital cancers¡ª including cancers of the anus, vagina, and vulva (area around the opening of the vagina). Other types of HPV can cause warts in the genital areas of men and women, called genital warts. |
