EU Recommends Approval of Gardasil 9 Vaccine

The European Medicines Agency (EMA) has recommended approval for the new Gardasil 9 vaccine, which offers protection against diseases caused by nine types of human papillomavirus (HPV).

The earlier version of the vaccine offered protection against HPV types 6, 11, 16, and 18, and this new version of Gardasil covers these four as well as five others ― HPV types 31, 33, 45, 52, and 58. These latter five are responsible for approximately 1 in 5 cases of cervical cancer.

Nearly 100% of cervical cancers, 90% of anal cancers, 70% of vaginal cancers, and 15% of vulvar cancers are caused by HPV, and persistent infection with certain types of HPV has also been linked to malignancies of the mouth and throat, the EMA comments.

The vaccine is indicated for girls and young women aged 9 through 26 years to prevent 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; and other types of dysplastic lesions of the cervix, vulva, vagina, and anus caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The indication also extends to boys aged 9 through 15 years for anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by types 6 and 11; and anal intraepithelial neoplasia grades 1, 2, and 3 caused by types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The EMA recommendation is based primarily on four studies that looked at the efficacy of Gardasil 9 in protecting against disease caused by HPV types 31, 33, 45, 52, and 58. These studies also assessed whether Gardasil 9 continued to protect against HPV types 6, 11, 16, 18 compared with Gardasil.

One study included 14,000 young women aged 16 through 26 years who tested negative for vaccine HPV types at baseline. Findings showed that 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), and had efficacy similar to that of Gardasil against types 6, 11, 16, and 18, as determined on the basis of similar antibody responses.

The EMA notes that the safety of Gardasil 9 was evaluated in more than 23,000 people who participated in seven clinical trials. This assessment also took into account experience from the use of Gardasil, which has been authorized for use in the European Union since 2006.

The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.

Already Approved in US

The vaccine received approval late last year from the US Food and Drug Administration for marketing in the United States. In addition, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices has just published its recommendations for vaccination with Gardasil 9. The recommendations for administration are the same as for other HPV vaccines currently on the market.

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