GARDASIL

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Your Questions Answered

As a parent, you have your child’s health as one of your top concerns. So it’s no surprise that you may have a few more questions you want answered about GARDASIL and human papillomavirus (HPV). Here are some answers to questions we’ve heard from parents just like you.

Also talk to your child’s doctor or health care professional for more information about GARDASIL and any HPV questions you may have. In addition, read the Patient Product Information or the Prescribing Information for GARDASIL.

  1. Does HPV affect males and females?

  2. Is GARDASIL only for girls and young women?

  3. Is the same vaccine given to both girls and boys?

  4. How safe is GARDASIL?

  5. What do medical organizations say about HPV vaccination?

  6. Could my child get HPV or any disease caused by HPV from GARDASIL?

  7. Why should I be concerned for my child about genital warts?

  8. I have children aged 11 and 12. Aren’t they too young to be vaccinated with GARDASIL?

  9. Why do I need to vaccinate my child now if he or she is not sexually active?

  10. What if I can’t afford GARDASIL?

  11. Will my daughter still need to get Pap tests in the future?

Does HPV affect males and females?

Yes. HPV will affect an estimated 75% to 80% of males and females in their lifetime. For most, HPV clears on its own. But, for others, certain HPV diseases—such as cervical, vaginal, and vulvar cancers and genital warts—can develop. There is no way to predict who will or won't clear the virus.

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Is GARDASIL only for girls and young women?

No. GARDASIL was approved by the Food and Drug Administration (FDA) for use in boys and young men ages 9 to 26 to help protect against 90% of genital warts cases.

GARDASIL may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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Is the same vaccine given to both girls and boys?

Yes, boys will receive the same vaccine that girls do. GARDASIL is given as 3 injections over 6 months. GARDASIL helps protect males and females from 90% of genital warts cases. GARDASIL also helps protect females ages 9 to 26 from about 75% of cervical, 70% of vaginal, and up to 50% of vulvar cancer cases.

Anyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.

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How safe is GARDASIL?

The safety of a vaccine is an important part of its story.

The common side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.

The Centers for Disease Control and Prevention (CDC) and the FDA have reviewed all the safety information available to them. Based on data available to them as of May 2009, the CDC and FDA determined that GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks. In August 2009, the CDC reaffirmed its continued recommendation for vaccination with GARDASIL in females. In October 2009, the FDA approved the use of GARDASIL in boys and young men ages 9 to 26 to protect against 90% of genital warts cases.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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What do medical organizations say about HPV vaccination?

The CDC recommends routine vaccination with GARDASIL for girls ages 11 to 12, and for young women ages 13 through 26 who have not already been vaccinated.

The CDC states that GARDASIL can be given to boys and young men ages 9 through 26, if you and the doctor decide it’s right for your son.

Additional recommendations for females include:

  • American Academy of Pediatrics (AAP)
  • American Academy of Family Physicians (AAFP)
  • American Congress of Obstetricians and Gynecologists (ACOG)

The AAP and AAFP have not issued a statement on the FDA approval for use of GARDASIL in boys and young men.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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Could my child get HPV or any disease caused by HPV from GARDASIL?

No. He or she cannot get HPV or any disease caused by HPV from GARDASIL. That’s because there is no live virus in the vaccine.

Instead, GARDASIL contains a protein that helps the body’s immune system produce antibodies against HPV—without causing an infection.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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Why should I be concerned for my child about genital warts?

You do everything you can to help protect your child. It is estimated that each minute in the United States, there is a new case of genital warts. About 2 out of 3 people will get genital warts after having any kind of genital contact with someone infected. Treatment for genital warts can be a painful process and can involve cutting, freezing, or burning the warts. Even after treatment, genital warts can come back. In fact, 25% of cases come back within 3 months.

By getting your child vaccinated with GARDASIL you’ll help guard him or her against 90% of genital warts cases.

GARDASIL may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV.

For more information on GARDASIL and HPV, talk to your child’s doctor or health care professional.

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I have children aged 11 and 12. Aren’t they too young to be vaccinated with GARDASIL?

Like other vaccines, GARDASIL works to help prevent illness. GARDASIL works when given before there is any contact with the relevant HPV types. Girls and boys as young as 9 can get vaccinated.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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Why do I need to vaccinate my child now if he or she is not sexually active?

It may be hard to think about your child coming into contact with HPV. After all, he or she isn’t sexually active.

But, like other vaccines your child may have received, GARDASIL works to help prevent illness. That means GARDASIL works when given before there is any contact with the relevant HPV types. It’s important to help guard your child now, before he or she’s old enough to worry about HPV.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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What if I can’t afford GARDASIL?

GARDASIL is part of the Vaccines for Children Program, a federal program that helps to provide free vaccines to children and adolescents 18 years and younger who are either Medicaid eligible, American Indian or Alaskan Native, or uninsured, or whose health insurance does not cover shots.

Additional information regarding the Vaccines for Children Program can be found at www.cdc.gov/vaccines/programs/vfcBy clicking on this link, you will be leaving this siteThis link will take you to a site outside of Merck & Co., Inc. Merck does not review or control the content of any non-Merck site. Merck does not endorse and is not responsible for the accuracy, content, practices, or standards of any non-Merck site.
Proceed.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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Will my daughter still need to get Pap tests in the future?

Yes. Pap testsPap testA Pap test, also known as a Pap smear, is part of the gynecological exam and helps detect abnormal cells in the lining of the cervix before they have a chance to become precancers or cervical cancer.
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See Full Glossary (cervical cancer screenings) will play a key role in protecting your daughter’s health as she gets older since GARDASIL does not protect against all types of HPV. Pap tests are proven to help save lives by looking for abnormal cells in the lining of the cervix before they have the chance to become precancers or cancer.

Your daughter’s doctor or health care professional can tell you when your daughter’s first Pap test should be. In the meantime, it’s never too early to teach your daughter good health care habits.

For more information on GARDASIL, talk to your child’s doctor or health care professional.

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INFORMATION ABOUT GARDASIL

GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV. In girls and young women ages 9 to 26, GARDASIL helps protect against 2 types of HPV that cause about 75% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. In boys and young men ages 9 to 26, GARDASIL helps protect against 90% of genital warts cases.

GARDASIL also helps protect girls and young women ages 9 to 26 against 70% of vaginal cancer cases and up to 50% of vulvar cancer cases.

GARDASIL may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL does not prevent all types of cervical cancer, so it’s important for women to continue routine cervical cancer screenings. GARDASIL does not treat cancer or genital warts. GARDASIL is given as 3 injections over 6 months.

IMPORTANT SAFETY INFORMATION

Anyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.

The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.

Only a doctor or health care professional can decide if GARDASIL is right for you or your child.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Read the Patient Product Information or the Prescribing Information for GARDASIL.



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