FDA Approval: Human papillomavirus vaccine (Gardasil) for Cervical Cancer

Read the label carefully: this is a vaccine, not a treatment

Gardasil is a preventive vaccine. It is given to people who do not have cancer, to stop an infection that can lead to cancer years later. It is not given to treat someone who already has cervical cancer, and the FDA license does not cover that use.

The distinction matters more here than almost anywhere else in cancer medicine, because it changes who the product is for and when it can help.

What the FDA licensed in 2006

On 8 June 2006 the FDA announced the approval of Gardasil, describing it as the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts caused by human papillomavirus types 6, 11, 16 and 18. The vaccine was licensed for females aged 9 to 26. FDA reviewed it in six months under its priority review pathway.

The current FDA listing for Gardasil, license number STN 125126, spells out the indication in more detail. It covers prevention of cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18; genital warts caused by types 6 and 11; and a list of precancerous lesions, including cervical intraepithelial neoplasia grades 1 through 3 and cervical adenocarcinoma in situ. Every one of those is something the vaccine prevents.

A later product, Gardasil 9, carries license STN 125508 and covers nine HPV types across a wider age range. NCI describes Gardasil 9 as the HPV vaccine used in the United States today.

The evidence FDA relied on

FDA's 2006 announcement describes four trials, one in the United States and three multinational, enrolling about 21,000 women aged 16 to 26. Participants received either the vaccine or a placebo.

Among women who had not already been infected, FDA reported that Gardasil was nearly 100% effective at preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by the HPV types in the vaccine.

FDA was careful about one point, and so are we. The trials did not run long enough for cervical cancer itself to appear. What was measured was prevention of the precancerous lesions that come first. FDA's reasoning was that preventing those lesions is highly likely to prevent the cancers that follow.

Two further studies measured the immune response in girls aged 9 to 15 and found it as strong as in the older group. Safety was assessed in roughly 11,000 people, with most reactions being pain or tenderness where the shot was given.

Why an infection ends up as a cancer

HPV is a family of more than 200 related viruses. NCI notes that more than 40 spread through direct sexual contact, and about a dozen of those can cause cancer.

Most infections clear on their own. A minority do not. When a high-risk type persists for years in the cells lining the cervix, it can drive those cells through a stage of abnormal change, called dysplasia, and eventually into cancer.

The type numbers explain the vaccine's design. NCI reports that HPV 16 and 18 cause about 70% of cervical cancers, and that types 31, 33, 45, 52 and 58 account for another 10% to 20%. Types 6 and 11 cause about 90% of genital warts. Gardasil 9 covers all nine.

Our explainer on HPV and cancer covers the other cancers this virus is linked to, including anal, oropharyngeal, penile, vulvar and vaginal.

What this does and doesn't change

Vaccination does not replace screening. The 2006 FDA release said so directly, and NCI repeats it: the vaccine does not cover every high-risk HPV type, so regular cervical screening stays necessary for vaccinated people. Our guide to cervical cancer screening sets out the current options.

Timing decides the benefit. FDA stated that the vaccine only works when given before infection with a given HPV type. NCI adds that vaccination in adults aged 27 to 45 offers less benefit, because more people in that group have already been exposed.

And the vaccine does nothing for an infection someone already has. NCI states plainly that it does not treat existing HPV infection or HPV-caused disease.

What to keep in perspective

• The 2006 evidence measured precancerous lesions, not cancers. NCI reports that real-world data since then have shown reduced cancer incidence, but that came later and from different studies.
• An FDA license describes an age range and a set of diseases. Whether vaccination is right for one person, and on what schedule, is a decision with a clinician. CDC, not FDA, sets the U.S. vaccination recommendations.
• Quadrivalent Gardasil and Gardasil 9 are different products with different licenses. Coverage of HPV types differs between them.

Where cervical cancer stands now

About 13,490 new cervical cancer diagnoses in the United States in 2026 and about 4,200 deaths are projected by the American Cancer Society, whose numbers SEER, NCI's cancer surveillance program, publishes. Median age at diagnosis, which NCI measures itself, is 50.

Forty-one percent of cases are caught while still confined to the cervix, where five-year relative survival is 91.8%. Thirty-seven percent have reached nearby lymph nodes, at 64.0%. Sixteen percent are found after distant spread, at 20.5%. Across all stages the figure is 68.8% for people diagnosed from 2016 through 2022.

Those are group averages from a registry, not a forecast for any individual.

If this is relevant to you, questions to ask

• Am I or my child within the age range where HPV vaccination is recommended?
• How many doses apply at this age?
• If I have already been vaccinated, what cervical screening do I still need, and how often?

Sources

• FDA News P06-77: FDA Licenses New Vaccine for Prevention of Cervical Cancer (archived)
• FDA: GARDASIL — licensed indications (STN 125126)
• FDA: GARDASIL 9 — licensed indications (STN 125508)
• NCI: Human Papillomavirus (HPV) Vaccines Fact Sheet
• NCI SEER Stat Facts: Cervical Cancer

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

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