What you need to know about the HPV Vaccine

Q: What is the HPV vaccine?
A: This vaccine prevents cervical cancer and genital warts due to HPV. It works by protecting against the four types of HPV that most commonly cause these diseases. The vaccine is given in three doses.

Q: What is Gardasil?
A: Gardasil® is the first vaccine developed to prevent cervical cancer and genital warts caused by human papillomavirus (HPV). In June 2006, Gardasil® was licensed by the Food and Drug Administration (FDA). The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) monitor the safety and effectiveness of the vaccine.

Q: How common is HPV?
A: HPV is the most common sexually transmitted infection in the U.S., with about 20 million people currently infected. Women have an 80 percent chance of getting HPV by the time they are 50. HPV is most common in young people who are in their late teens and early 20s.

Q: How common is cervical cancer?
A: The American Cancer Society estimates that in 2009 about 11,270 cases of invasive cervical cancer will be diagnosed in the United States. Some researchers estimate that non-invasive cervical cancer (carcinoma in situ) is about 4 times more common than invasive cervical cancer. About 4,070 women will die from cervical cancer in the United States during 2009.

Q: Who should get the HPV vaccine?
A: 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.

Q: Is the HPV vaccine effective?
A: 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.

Q: Is the HPV vaccine safe?
A: The vaccine has been licensed as safe. Before it was approved by the FDA, the vaccine was studied in thousands of girls and women 9 through 26 years of age in the U.S. and around the world. The most common side effect is soreness where the shot is given (in the arm).

Q: How do the FDA and the CDC monitor the safety of vaccines after they are licensed?
A: There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S. These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine's clinical trials.

• The Vaccine Adverse Events Reporting System (VAERS) receives reports of possible vaccine side effects, called "adverse events" by regular, mail, fax, or through the web. Reports can be made by doctors, parents or family members, someone who got a vaccine, or by a manufacturer. Reports can be submitted at any time after someone gets a vaccine. This means a person can report a health problem that develops months or even years after they got a vaccine. All reports are reviewed by trained staff at both FDA and CDC. VAERS can detect patterns in reports to show that a vaccine might be causing a possible side effect. It cannot be used to determine for sure if the vaccine really is causing a side effect.
• The Vaccine Safety Datalink (VSD) Project is a project between CDC and 8 health care organizations. The goal of this project is to address gaps in knowledge about rare and serious side effects that may happen after someone gets a vaccine. The VSD can be used to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.
• The Clinical Immunization Safety Assessment (CISA) Network is a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Q: How many VAERS reports related to HPV vaccination have been received?

From the time the vaccine was licensed through May 1, 2009, over 24 million doses of Gardasil have been distributed in the U.S. During that time, there have been 13,758 reports made to VAERS of adverse events following vaccination with Gardasil. Of these, 93% were classified as reports of mild to moderate adverse events. 7% have been reports of serious events.

Q: Should pregnant women receive the HPV vaccine?
A: 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.

Q: Are there other ways, besides the vaccine, to prevent HPV?
A: 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.

Q: Will girls/women be protected against HPV and related diseases, even if they don’t get all three doses of the vaccine?
A: 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.

Q: Will the girls/women who have been vaccinated still need a Pap test?
A: Yes, they will still need to see their healthcare provider for a Pap test. Regular Pap tests are recommended for all women starting within three years of when a girl/woman begins sexual activity or at age 21, whichever comes first. The vaccine will NOT provide protection against all types of HPV that cause cervical cancer, so women will still be at risk for some cancers.

Q: Why is the vaccine only indicated for girls/women 9 through 26 years old?
A: 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.

Q: What about vaccinating boys and men?
A: At this time, the vaccine is not approved for use in boys or men. Studies are being done. When more information is available, this vaccine may be licensed and recommended for boys/men as well.