Connect
To Top

    FDA Approves Gardasil 9 HPV Vaccine

    Gardasil HPV VaccineToday the Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). The new HPV vaccine provides protection against five more strains than the previous Gardasil.

    Human papillomavirus (HPV) is a virus that affects the skin and the moist membranes of the body such as the cervix, anus, mouth, and throat. Although most HPV infections clear without any harmful effects, the virus also causes genital warts and cancers of the cervix, vagina, vulva, anus, penis, and throat.

    In addition to HPV types 6, 11, 16, and 18, Gardasil 9 also provides protection against types 31, 33, 45, 52, and 58. The five new types covered account for roughly one in five cases of cervical cancer.

    Gardasil 9 provides protection against the following diseases in females between the ages of 9 and 26:

    • 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

    The newly approved HPV vaccine also provides protection against the following diseases in males between the ages of 9 and 15:

    • 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

    Comments Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research:

    “Vaccination is a critical public health measure for lowering the risk of most cervical, genital, and anal cancers caused by HPV. The approval of Gardasil 9 provides broader protection against HPV-related cancers.”

    Like the original Gardasil, Gardasil 9 will be administered as three separate shots over six months with the initial dose followed by additional shots given two and six months later. The HPV vaccine provides maximum protection when given prior to infection with the HPV types covered by the vaccine.

    In a randomized, controlled clinical study of 14,000 females between the ages of 16 and 26, Gardasil 9 proved as effective as the original Gardasil in preventing diseases caused by the four shared HPV types and 97 percent effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types. Gardasil 9 also demonstrated effectiveness of 78 percent in preventing anal cancer. Another study of approximately 1,200 males and 2,800 females between the ages of 9 and 15 yielded similar results.

    The safety of Gardasil 9 was evaluated in approximately 13,000 males and females, with injection site pain, swelling, redness, and headaches as the most commonly reported adverse reactions.

    References

    FDA approves Gardasil 9 for Prevention of Certain Cancers Caused by Five Additional Types of HPV: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm
    Just-Approved Gardasil 9 Packs More HPV/Cancer Protection: http://www.medscape.com/viewarticle/836354

    Image Credits

    Gardasil HPV Vaccine: http://commons.wikimedia.org/wiki/File:Gardasil_vaccine_and_box.jpg

    More in News