
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (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.
Read more Important Safety Information.
There are more than 30 genital HPV types and about 6 million new cases of genital HPV in the United States each year. While GARDASIL doesn't protect against all types of HPV, it offers protection against the 4 HPV types that cause the most HPV-related diseases.
GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it's important to continue routine cervical cancer screening. GARDASIL will not protect against diseases caused by other HPV types or against diseases not caused by HPV.
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Approximately 30 women a day in the United States are diagnosed with cervical cancer. Many people who have HPV don't even know it, since the virus often has no signs or symptoms. That means HPV transmission can happen without anyone knowing it.
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Thanks to cervical cancer screening, cervical cancer is one of the most preventable cancers. But, because screening may not detect all abnormalities, it doesn't always ensure early detection of disease. Some women with cervical precancer or even cancer can have normal Pap tests, due to false negatives (sampling or detection error). Also, one type of cervical cancer (cervical adenocarinoma) is difficult to detect through Pap tests. Another concern is that some women do not get screened regularly.
Pap tests look for abnormal cervical cells in the lining of the cervix before they have a chance to become precancers and then cervical cancer. Most often this change takes a number of years. But in rare cases it can happen within a year.
GARDASIL helps protect against 70% of cervical cancer cases. But, GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it's important to continue routine cervical cancer screenings.
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Merck has created a vaccine patient assistance program for its line of vaccines for use in adults, including GARDASIL. Through this program, Merck provides free vaccines to adults who are 19 and older who are uninsured or unable to afford vaccines.
Additional information regarding the Merck Vaccine Patient Assistance Program can be found at http://www.merck.com/merckhelps/vaccines/home.html.
GARDASIL is also 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.
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Like other vaccines, GARDASIL works to help prevent illness. That's why it's recommended that girls 11 to 12 years of age get vaccinated. HPV vaccination is a part of the recommended vaccination schedule by the Centers for Disease Control and Prevention (CDC).
Leading medical organizations recommend HPV vaccination, including the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG).
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Women who are already sexually active may still benefit from GARDASIL because, even if they have been exposed to HPV, it's unlikely that they have been exposed to all the types of the virus covered by the vaccine. That means GARDASIL could still help guard women against HPV types to which they haven't been exposed.
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GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. GARDASIL is for girls and young women ages 9 to 26.
GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts. GARDASIL will not protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL is given as 3 injections over 6 months.
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. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity. Only a doctor or health care professional can decide if GARDASIL is right for you or your daughter.
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.
This site is intended only for residents of the United States, its territories, and Puerto Rico.
GARDASIL is a registered trademark of Merck & Co., Inc.
20950185(7)-08/09-GRD