Just-Approved Gardasil 9 Packs More HPV/Cancer Protection

Disclosures

December 10, 2014

The US Food and Drug Administration (FDA) today approved Gardasil 9, a human papillomavirus (HPV) vaccine from Merck that prevents cancers and other lesions caused by nine HPV types, five more than the original Gardasil protected against.

The earlier version of the drug covered HPV types 6, 11, 16, and 18. Gardasil 9 covers these as well as types 31, 33, 45, 52, and 58. These latter five are responsible for roughly one in five cases of cervical cancer.

Gardasil 9 is indicated in females aged nine through 26 years for the prevention of:

  • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58

  • Genital warts caused by types 6 and 11

  • Various precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58

It is also indicated in males aged nine through 15 years for:

  • Anal cancer caused by types 16, 18, 31, 33, 45, 52, and 58

  • Genital warts caused by types 6 and 11

  • Anal intraepithelial neoplasia grades 1, 2, and 3 caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

"Vaccination is a critical public health measure for lowering the risk of most cervical, genital, and anal cancers caused by HPV," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a news release. "The approval of Gardasil 9 provides broader protection against HPV-related cancers."

The agency said that Gardasil 9 will be administered as three separate shots over six months. Maximum protection is achieved if vaccination occurs before someone becomes infected with the HPV types covered by the vaccine.

The effectiveness of Gardasil 9 was studied in several clinical trials. One involved 14,000 females aged 16 through 26 years who tested negative for vaccine HPV types at the outset. Gardasil 9 was 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58). It was just as effective as Gardasil against types 6, 11, 16, and 18, based on similar antibody responses.

The FDA said Gardasil 9 also should prove to be just as effective as Gardasil for males and females aged nine through 15 years, based on clinical trials involving 4000 individuals. Their antibody responses to Gardasil 9 resembled those of females aged 16 through 26 years.

The ability of Gardasil 9 to prevent anal cancer in all these populations was based on Gardasil's effectiveness rate of 78% and antibody responses in males and females who received the new drug in clinical trials.

Injection site pain, swelling, redness, and headaches were the most commonly reported adverse reactions when the safety of Gardasil was studied in 13,000 males and females.

More information on today's decision is available on the FDA's website.

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