Gardasil
® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, and 18] Recombinant Vaccine) is a vaccine that has been licensed to prevent
cervical cancer, vulvar and vaginal cancer,
genital warts, and various precancerous genital lesions caused by certain types of human papillomavirus (
HPV) in girls and women age 9 to 26. This vaccine is also approved to prevent genital warts in boys and men age 9 to 26 years of age.
Thimerosal Content and Other Concerns
Gardasil does not contain thimerosal (a mercury-containing preservative). Individuals who are concerned about exposure to thimerosal can be confident that this vaccine has no thimerosal (not even trace amounts). Some people are concerned about aluminum content of vaccines; Gardasil contains 225 mcg (0.225 mg) of aluminum per dose.
This vaccine is not made from human fetal components or animal components, as some vaccines are.
Who Makes It?
Gardasil is manufactured by Merck & Co., Inc.
How Does Gardasil Work?
Gardasil is a vaccine that protects against certain
types of HPV infections. It works by stimulating the immune system to produce antibodies to fight off the HPV virus. This virus can be sexually transmitted and can cause:
- Female genital warts
- Male genital warts
- Cervical cancer
- Various precancerous genital growths.
There are many different types of HPV virus, and Gardasil does not protect against all of them. However, it does protect against a few important HPV types (types 6, 11, 16, and 18). These four types were chosen because they cause about 70 percent of cervical cancers and 90 percent of genital warts.
Gardasil has been studied in over 20,000 women who were 16 to 26 years old. In these studies, the medication was effective in preventing
genital warts and various precancerous growths. It was more than 98 percent effective in preventing genital warts caused by
HPV types 6, 11, 16, and 18. Gardasil was more than 95 percent effective in preventing precancerous cervical growths caused by HPV types 6, 11, 16, and 18.
The effectiveness of the medication for preventing precancerous growths was studied instead of actual cancer. This is because it is easier to study precancerous growths, as they develop more quickly.
There is no evidence that Gardasil will protect against HPV types other than types 6, 11, 16, and 18. Also, it is unknown if the effects of the vaccine will "wear off" over time.
Gardasil was also studied in girls who were 9 to 15 years old. In these studies, these younger girls produced antibodies to HPV in a similar way that the women age 16 to 26 years old had done. This means that the vaccine can be expected to be just as effective in younger girls as it is in women.
Studies also show that the vaccine is about 90 percent effective for preventing genital warts in boys and men.
Some general considerations for when and how to take Gardasil include the following:
- Gardasil is an injection that your healthcare provider gives you.
- The vaccine is given as a series of three injections:
- First injection: At any time
- Second injection: Two months after the first injection
- Third injection: Six months after the first injection.
- Gardasil is injected into muscle in the upper arm or upper thigh.
- For the vaccine to work properly, you have to get all three injections. Gardasil will not work as well if you do not get all three injections.
Dosing Information
There is only one dose of Gardasil for girls and women age 9 to 26. The dose is not affected by age or weight.
As with any medicine, side effects can occur with Gardasil. However, not everyone who gets the vaccine will experience side effects. In fact, most people tolerate it well. If side effects occur, they are often minor and either require no treatment or can be easily treated by you or your healthcare provider. Serious side effects are less common.
The most common side effects include:
- Reactions at the injection site, such as:
- Pain
- Swelling
- Redness
- Itching
- Fever
- Upset stomach (nausea)
- Dizziness.
(Click Gardasil Side Effects to learn more, including potentially serious side effects you should report to your healthcare provider.)
What Should I Tell My Healthcare Provider Before Taking Gardasil?
Prior to taking Gardasil, talk with your healthcare provider if you have:
- A fever or are feeling ill
- A bleeding disorder, such as hemophilia or thrombocytopenia
- A poorly functioning immune system (such as with HIV, AIDS, or cancer)
- Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Taking anticoagulants ("blood thinners")
- Pregnant or thinking of becoming pregnant (see Gardasil and Pregnancy)
- Breastfeeding.
Also, tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What Should I Do If I Miss a Dose?
If you are late for a Gardasil injection, call your healthcare provider to schedule your next injection as soon as you remember. You do not need to "start over" with the three-injection series if you are late for an injection.
Gardasil is available in single-dose vials and single-dose, prefilled syringes.
There are currently no generic versions of Gardasil licensed for sale
(see Generic Gardasil for more information).
