FDA News

FDA expands Gardasil 9 HPV vaccine approval to boys, young men

The FDA expanded the age indication for Gardasil 9 HPV vaccine to include boys and men aged 16 to 26 years, according to a press release from Merck, the vaccine’s manufacturer.

“The approval of Gardasil 9 for males 16 through 26 years of age is a milestone in the planned transition from Gardasil to Gardasil 9, as both products are now approved for the same populations,” the release said.

Gardasil 9 (9vHPV, Merck) protects against five additional HPV types compared with the original Gardasil. The 9-valent vaccine prevents anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, as well as precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and genital warts caused by HPV types 6 and 11.

The 9-valent HPV vaccine previously was approved for boys aged 9 to 15 years as well as girls and women aged 9 to 26 years for cervical, vulvar, vaginal and anal cancer prevention. In April, the CDC’s Advisory Committee on Immunization Practices recommended the vaccine be used as one of the three HPV vaccines for routine vaccination. The committee unanimously voted in October to approve the vaccine for the 2016 adult immunization schedule. A three-dose series of the 2-valent, 4-valent or 9-valent HPV vaccine is recommended for females aged 19 to 26 years, while a three-dose series of 4-valent and 9-valent HPV vaccine is recommended for males aged 19 to 21 years. In addition, men who have sex with men and immunocompromised men aged 26 years or younger are recommended to receive a three-dose series of the 4-valent or 9-valent HPV vaccine.

“While it is important to remember that the CDC’s ACIP recommends routine HPV vaccination at age 11 or 12, before exposure to the HPV virus, this expanded indication for GARDASIL 9 is exciting because now 16- through 26-year-old young men can get this HPV vaccine,” Anna Giuliano, PhD, clinical investigator for Gardasil 9 and director of the Center for Infection Research in Cancer at H. Lee Moffitt Cancer Center and Research Institute, said in the release. “It’s important that we collectively work to increase HPV vaccination rates to help prevent HPV-related cancers and diseases.”

Last year, the CDC reported that HPV vaccination rates were “unacceptably low” compared with other adolescent vaccines, especially in boys, according to the release. The vaccine was administered to 41.7% of boys aged 13 to 17 years, but only 21.6% of this population received the recommended three doses.

Before approval, the effectiveness of the 9-valent HPV vaccine was assessed in a noninferiority comparison of the vaccine in heterosexual boys and young men aged 16 to 26 (n = 1,106) vs. girls and young women (n = 1,101) in the same age group. Researchers found that antibody geometric mean titers (GMTs) against HPV after 7 months of vaccination in boys and young men were noninferior to anti HPV GMTs in girls and young women, according to the release. The most common adverse events in boys and young men were injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%). Most managed health care plans have already decided to cover the cost of the vaccine for this population, the release said.

The CDC estimated that approximately 14 million new genital HPV infections occur annually in the U.S., and half of infections develop in people aged 15 to 24 years, according to the release. HPV causes approximately 85% to 90% of anal cancers, 90% of genital wart, 70% to 75% of vaginal cancers, 30% of vulvar cancers, and almost all cervical cancers.

 Disclosure: Giuliano is a clinical investigator for Gardasil 9 HPV vaccine.

The FDA expanded the age indication for Gardasil 9 HPV vaccine to include boys and men aged 16 to 26 years, according to a press release from Merck, the vaccine’s manufacturer.

“The approval of Gardasil 9 for males 16 through 26 years of age is a milestone in the planned transition from Gardasil to Gardasil 9, as both products are now approved for the same populations,” the release said.

Gardasil 9 (9vHPV, Merck) protects against five additional HPV types compared with the original Gardasil. The 9-valent vaccine prevents anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, as well as precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and genital warts caused by HPV types 6 and 11.

The 9-valent HPV vaccine previously was approved for boys aged 9 to 15 years as well as girls and women aged 9 to 26 years for cervical, vulvar, vaginal and anal cancer prevention. In April, the CDC’s Advisory Committee on Immunization Practices recommended the vaccine be used as one of the three HPV vaccines for routine vaccination. The committee unanimously voted in October to approve the vaccine for the 2016 adult immunization schedule. A three-dose series of the 2-valent, 4-valent or 9-valent HPV vaccine is recommended for females aged 19 to 26 years, while a three-dose series of 4-valent and 9-valent HPV vaccine is recommended for males aged 19 to 21 years. In addition, men who have sex with men and immunocompromised men aged 26 years or younger are recommended to receive a three-dose series of the 4-valent or 9-valent HPV vaccine.

“While it is important to remember that the CDC’s ACIP recommends routine HPV vaccination at age 11 or 12, before exposure to the HPV virus, this expanded indication for GARDASIL 9 is exciting because now 16- through 26-year-old young men can get this HPV vaccine,” Anna Giuliano, PhD, clinical investigator for Gardasil 9 and director of the Center for Infection Research in Cancer at H. Lee Moffitt Cancer Center and Research Institute, said in the release. “It’s important that we collectively work to increase HPV vaccination rates to help prevent HPV-related cancers and diseases.”

Last year, the CDC reported that HPV vaccination rates were “unacceptably low” compared with other adolescent vaccines, especially in boys, according to the release. The vaccine was administered to 41.7% of boys aged 13 to 17 years, but only 21.6% of this population received the recommended three doses.

Before approval, the effectiveness of the 9-valent HPV vaccine was assessed in a noninferiority comparison of the vaccine in heterosexual boys and young men aged 16 to 26 (n = 1,106) vs. girls and young women (n = 1,101) in the same age group. Researchers found that antibody geometric mean titers (GMTs) against HPV after 7 months of vaccination in boys and young men were noninferior to anti HPV GMTs in girls and young women, according to the release. The most common adverse events in boys and young men were injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%). Most managed health care plans have already decided to cover the cost of the vaccine for this population, the release said.

The CDC estimated that approximately 14 million new genital HPV infections occur annually in the U.S., and half of infections develop in people aged 15 to 24 years, according to the release. HPV causes approximately 85% to 90% of anal cancers, 90% of genital wart, 70% to 75% of vaginal cancers, 30% of vulvar cancers, and almost all cervical cancers.

 Disclosure: Giuliano is a clinical investigator for Gardasil 9 HPV vaccine.