Know the facts about our HPV vaccines

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Vaccination is an important decision you can make for yourself and your family to help protect against certain vaccine-preventable diseases. Merck has played an important part in the history of vaccines, and our commitment to help prevent diseases continues. The safety and efficacy of our medicines and vaccines is paramount to that commitment.

We know how important it is to make sure you have accurate information in order to make decisions about whether to vaccinate yourself or your family from certain HPV-related cancers and diseases. We encourage you to speak with your doctor to discuss what’s best for you and your family.

This site is dedicated to giving you the facts about GARDASIL 9 and GARDASIL,^a our HPV vaccines. We encourage you to look to trusted, independent sources of information, such as your health care provider and the Centers for Disease Control and Prevention (CDC).

You can also read the Patient Information for GARDASIL 9 here. The physician Prescribing Information is also available here.

^aGARDASIL is no longer available in the United States.

Know the Facts

Scientific evidence continues to support the safety and efficacy profile of GARDASIL 9 and GARDASIL.

The body of scientific evidence supporting the safety and efficacy profile of our HPV vaccines includes tens of thousands of people, with clinical studies in more than 29,000 individuals for GARDASIL and more than 15,000 individuals for GARDASIL 9. It also includes some studies of GARDASIL with up to 8 to 10 years of follow-up data after vaccination.

Since GARDASIL was first approved in the United States in 2006, and then with the approval of GARDASIL 9 in 2014, hundreds of millions of doses of our HPV vaccines have been distributed and administered globally.

GARDASIL and GARDASIL 9 continue to be licensed for use by health authorities around the world, including the US Food and Drug Administration (FDA).

As is done for all Merck products, even after their approval, we routinely monitor our HPV vaccines for potential adverse events and share this information with regulatory agencies, including the FDA.

GARDASIL 9 and GARDASIL have been shown to help protect against certain cancers and diseases caused by HPV.

HPV may be more common than you think. It is a sexually transmitted infection. Anyone who is sexually active and has the virus can pass it on without knowing it.

For most people, HPV clears on its own. But for those who don’t clear the virus, it could cause certain cancers later in life.

Each year from 2016 to 2020, tens of thousands of men and women were diagnosed with certain HPV-related cancers in the United States.^b

^bBased on 2016-2020 CDC data of diagnosed HPV-related cancers each year.

GARDASIL 9 can help prevent over 80% of cervical cancers caused by HPV. Additionally, in women, it can help prevent certain types of vulvar and vaginal cancers, as well as precancerous cervical, vulvar, and vaginal lesions. In men and women, it can help prevent against certain types of anal cancer, certain head and neck cancers including throat and back of mouth cancers, as well as precancerous anal lesions and genital warts.

Reports of potential adverse events including Postural Orthostatic Tachycardia Syndrome (POTS) have been carefully evaluated and monitored by Merck, the CDC, and the FDA.

Your health care provider can talk with you about POTS and how it’s been evaluated by the CDC and help answer questions you may have. You can also talk to your doctor about the overall safety profile of GARDASIL 9.

The safety of our HPV vaccines has been closely monitored by Merck, the FDA, and the CDC. The CDC continues to recommend HPV vaccination.

The CDC notes that HPV vaccination may begin at age 9 and recommends routine HPV vaccination at ages 11-12. HPV vaccination is recommended for persons through age 26 years who have not been vaccinated before, or have not completed the vaccination series.

The vaccine is recommended for adults aged 27-45 based on shared clinical decision-making.

All vaccines go through a stringent review process to evaluate safety and efficacy before approval by health authorities, and their safety is continually monitored once approved.

All vaccines go through an extensive, multistep process with the FDA to determine safety and efficacy before they are approved for use.

Merck, as well as the FDA and the CDC, closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS) once they are approved.

Information About GARDASIL 9 and GARDASIL

GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer, certain head and neck cancers, such as throat and back of mouth cancers and genital warts in both males and females.

GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] helps protect individuals ages 9 to 26 against the following diseases caused by 4 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer and genital warts in both males and females.

GARDASIL 9 and GARDASIL may not fully protect everyone, nor will they protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 and GARDASIL do not prevent all types of cervical, vulvar, vaginal, or anal cancers. GARDASIL 9 does not prevent all types of head and neck cancers. Vaccination does not remove the need for recommended screenings for these cancers, and it’s important for girls to get routine cervical cancer screenings later in life and for women to continue routine cervical cancer screenings. GARDASIL 9 and GARDASIL do not treat cancer or genital warts.

GARDASIL 9 is a shot that is usually given in the arm muscle. GARDASIL 9 may be given as 2 or 3 shots.

For persons 9 through 14 years of age, GARDASIL 9 can be given using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second shot should be given 6–12 months after the first shot. If the second shot is given less than 5 months after the first shot, a third shot should be given at least 4 months after the second shot. For the 3-dose schedule, the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.

For persons 15 through 45 years of age, GARDASIL 9 is given using a 3-dose schedule; the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.

The appropriate dosing schedule will be determined by your child’s or your health care professional.

GARDASIL was a shot that was usually given in the arm muscle. GARDASIL was given as 3 shots over 6 months.

Important Safety Information for GARDASIL 9 and GARDASIL

Anyone who is allergic to the ingredients of GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) or GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant],^c including those severely allergic to yeast, should not receive the vaccine. GARDASIL 9 was not studied in women who knew they were pregnant. GARDASIL is not recommended for pregnant women.

The side effects for GARDASIL 9 include pain, swelling, redness, itching, bruising, bleeding, and a lump where you got the shot; headache; fever; nausea; and dizziness.

The side effects for GARDASIL include pain, swelling, itching, bruising, and redness where you got the shot; headache; fever; nausea; dizziness; vomiting; and fainting.

Fainting can happen after getting GARDASIL 9 and GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask your child or you to sit or lie down for 15 minutes after your child or you get GARDASIL 9 or GARDASIL. Some people who faint might shake or become stiff.

Only a doctor or health care professional can decide if GARDASIL 9 is right for your child or you.

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.

Please read the Patient Information for GARDASIL 9, and discuss it with your doctor. The physician Prescribing Information also is available.

Please also read the Patient Information for GARDASIL, and discuss it with your doctor. The physician Prescribing Information also is available.

^cGARDASIL is no longer marketed in the United States.