Delaware County, Indiana

HPV Vaccine - Questions & Answers for the Public
About the Safety and Effectiveness of the Human Papillomavirus (HPV) Vaccine

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.

Questions & Answers

What is human papillomavirus (HPV)?

HPV is a common virus that is passed on through sexual contact. Most of the time HPV has no symptoms so people do not know they have it. There are many different strains or types of HPV. Some types can cause cervical cancer in women. Other types of HPV can cause genital warts in both women and men.

In most people, HPV goes away on its own and does not cause health problems. Experts do not know why HPV goes away in some cases, but not in others.

How common is HPV?

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.

How common is cervical cancer?

The American Cancer Society estimates that in 2008 more than 11,000 women will be diagnosed with cervical cancer and approximately 3,600 will die from it in the U.S.

What is the HPV vaccine?

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.

Who should get the HPV vaccine?

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.

Is the HPV vaccine effective?

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.

Is the HPV vaccine safe?

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).

How is the safety of Gardasil® monitored?

CDC has several systems in place to monitor the safety of Gardasil ®. They include:

• The Vaccine Adverse Event Reporting System (VAERS) is collaboration between CDC and the FDA. VAERS is a national system that accepts and monitors reports of possible side effects, or adverse events, following vaccination. VAERS serves as an early warning system for problems that may be related to a vaccine. It is important to know that reports of adverse events after immunization are not conclusive proof that the adverse event was caused by a vaccine. Some of the adverse events reported to VAERS may occur by chance following vaccination. Anyone can report an adverse event to VAERS by telephone at (800) 822-7967 or through the Web at www.secure.vaers.org/scripts/VAERSDataEntry.cfm

• The Vaccine Safety Datalink Project (VSD) is a collaborative effort between CDC and eight managed care organizations. It was established to monitor immunization safety and to address the gaps in scientific knowledge about rare and serious adverse events following immunization.
• The Clinical Immunization Safety Assessment Network (CISA) is collaboration with six academic centers in the U.S. that conducts research on vaccine-associated adverse events.

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

As of June 30, 2008 VAERS has received a total of 9,749 reports of potential adverse events following HPV vaccination. Ninety-four percent (94%) of these reports were about non-serious adverse events.

Six percent (6%) of adverse events reported for the HPV vaccine were considered serious, which is about half of the average number of serious reports for other vaccines. In comparison, the overall average in VAERS for any serious adverse event following vaccination ranges from 10% to 15%; therefore, the percentage of serious reports for Gardasil® is less than the overall average for other vaccines.

It is important to note that a report to VAERS does not mean there is a connection between the vaccine and the event. It means the event took place following vaccination.

VAERS data are routinely updated, and the number of reports and the type of adverse events will vary depending on the date of analysis. For the most up to date information about VAERS, please visit: www.cdc.gov/vaccinesafety/vaers/gardasil.htm

Should pregnant women receive the HPV vaccine?

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.

Should pregnant women receive the HPV vaccine?

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.

Are there other ways, besides the vaccine, to prevent HPV?

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.

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

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.

Will the girls/women who have been vaccinated still need a Pap test?

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.

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

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.

What about vaccinating boys and men?

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.