FDA Approves Merck's HPV Vaccine, Gardasil 9

Merck (MSD) has announced that the FDA approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, for use in girls and young women aged 9–26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous 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 also approved for use in boys 9 to 15 years of age 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 contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

“With Gardasil 9, the medical and public health community now has the potential to help prevent 90% of cervical cancers caused by HPV,” said Dr Julie Gerberding, president, Merck Vaccines. “This is an extraordinary opportunity to even further reduce the burden of HPV-related diseases and cancers in males and females.”

Gardasil 9 includes the greatest number of HPV types in any available HPV vaccine. After HPV types 16 and 18, the five additional HPV types in Gardasil 9 are the most common cervical cancer-causing types worldwide. Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. These seven HPV types also cause 85–90% of HPV-related vulvar cancers, 80–85% of HPV-related vaginal cancers, and 90–95% of HPV-related anal cancers.

HPV types 6 and 11 cause approximately 90% of genital warts cases. In addition, approximately 50% of cases of low-grade cervical lesions (CIN 1) are caused by the nine HPV types included in the vaccine. Not all vulvar, vaginal, and anal cancers are caused by HPV, and Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.