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Merck OK’d for Gardasil 9 expanded age indication

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KENILWORTH, N.J. — Merck has received approval from the Food and Drug Administration for an expanded age indication for Gardasil 9, its 9-valent human papillomavirus (HPV) vaccine.

The company said the new indication allows Gardasil 9 to include use in males ages 16 to 26 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58; 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. Gardasil 9 is already approved for boys ages 9 to 15 for the prevention of those diseases.

Gardasil 9 product shot_MerckGardasil 9 is approved for use in girls and young women ages 9 to 26 for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58; precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58; and genital warts caused by HPV types 6 and 11.

Merck noted that the approval of Gardasil 9 for males ages 16 to 26is a milestone in the planned transition from Gardasil to Gardasil 9, since both products are now approved for the same populations. In the United States, plans call for a full transition from the use of Gardasil to Gardasil 9, the company said.

“This is an important approval that now aligns the indication for Gardasil 9 in males and females ages 9 through 26 to that of Gardasil, and also supports the CDC’s HPV vaccine recommendations for use in males,” stated Jacques Cholat, president of Merck Vaccines. “We are pleased that males 16 through 26 years of age will now have access to Gardasil 9, which includes the most HPV types, to help further reduce the burden of HPV-related diseases.”

Gardasil 9 includes the greatest number of HPV types in any available HPV vaccine, according to Merck. The medication adds protection against five more HPV types — 31, 33, 45, 52 and 58 — plus the four original HPV types covered by Gardasil (HPV 6, 11, 16, and 18).

Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause 90% to 95% of HPV-related anal cancers, about 90% of cervical cancers and approximately 80% of high-grade cervical lesions worldwide, the company reported. These seven HPV types also cause 90% of HPV-related vulvar cancers and 85% of HPV-related vaginal cancers. HPV types 6 and 11 cause about 90% of genital warts cases in males and females.

Aftr its February meeting, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) included Gardasil 9 in the HPV vaccination recommendations, which added it to the routine recommendations for vaccination of males and females ages 11 and 12, Merck said. The HPV vaccination series can be started at age 9. Only Gardasil 9 and Gardasil are indicated and recommended for use in males in the United States. The ACIP also recommends HPV vaccination for females ages 13 to 26 and males ages 13 to 21 who have not been vaccinated previously or who have not completed the 3-dose series.

“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,” commented Anna Giuliano, founding director of the Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla., and clinical investigator for Gardasil 9. “It’s important that we collectively work to increase HPV vaccination rates to help prevent HPV-related cancers and diseases.”

Last year, the CDC made increasing HPV vaccination rates a public health priority, Merck noted. According to the CDC, HPV vaccination rates are unacceptably low compared with rates for other adolescent vaccines, and vaccination coverage is particularly low in males. In 2014, for boys ages 13 to 17, coverage with at least one dose of HPV vaccine was just 41.7%, and receipt of the recommended three doses was 21.6%.


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