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Children's Vaccines Health Center

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Gardasil Approved to Target More Cancers

FDA Expands HPV Vaccine Gardasil to Prevent Certain Cancers of the Vulva and Vagina

Gardasil vs. Vulvar, Vaginal Cancers continued...

Merck followed those participants for two extra years and found that Gardasil was highly effective at preventing precancerous vulvar and vaginal growths related to HPV types 16 and 18, which the vaccine targets.

But Gardasil only showed that benefit in women who hadn't been infected with HPV before getting Gardasil.

"To receive Gardasil's full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine," states an FDA news release.

Gardasil's label has been revised to note that current information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil doesn't protect against diseases caused by HPV types not contained in the vaccine.

No vaccine is 100% effective, and Gardasil doesn't protect against HPV infections that a woman may already have at the time of vaccination. So the FDA recommends that all women get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

The FDA notes that since Gardasil was approved, most reported adverse events haven't been serious. The most common reports have been of pain at the injection site, headache, nausea, and fever.

Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. The FDA recommends that observation period to watch for severe allergic reactions, which can occur after any immunization.

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