Merck's HPV Vaccine Gardasil 9 Receives CDC Advisory Committee Recommendation for Expanded Use in Adults Aged 27–45

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MSD recently announced that the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) has voted to recommend Gardasil for individuals aged 27–45 years who are inadequately vaccinated, based on shared clinical decision-making.^®9 (Gardasil 9, 9-valent) for human papillomavirus (HPV) vaccination. In addition, the ACIP voted to expand routine and catch-up vaccination recommendations for males under 26 years of age who have been inadequately vaccinated. Currently, the CDC recommends routine HPV vaccination for both males and females aged 11–12 years, with vaccination starting as early as age 9.

If approved by the CDC, the recommended indications for Gardasil 9 will be expanded to include females and males aged 13–26 years who have not previously been vaccinated; for adults aged 27–45 years, the decision to vaccinate will be made jointly by the individual and their healthcare provider. Detailed information on the ACIP recommendations for Gardasil 9 is available on the CDC website. These interim recommendations have been reviewed by the CDC Director and the Department of Health and Human Services, and the final recommendations will be officially published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

In the United States, Gardasil 9 is indicated for females aged 9 to 45 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by seven high-risk HPV types (16, 18, 31, 33, 45, 52, and 58); for the prevention of precancerous or dysplastic lesions caused by nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58); and for the prevention of genital warts caused by two low-risk HPV types (6 and 11). Gardasil 9 is also indicated for males aged 9 to 45 years for the prevention of anal cancer caused by seven high-risk HPV types (16, 18, 31, 33, 45, 52, and 58); for the prevention of precancerous or dysplastic lesions caused by nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58); and for the prevention of genital warts caused by two low-risk HPV types (6 and 11).

Gardasil 9 is contraindicated in individuals with hypersensitivity, including those who have had severe allergic reactions to yeast or after previous administration of Gardasil 9 or Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine].

In the United States, nearly half of new HPV infections occur in adults aged 25 years or older. Based on the latest incidence data released in 2015, approximately 23,000 Americans are diagnosed each year with HPV-related cervical, vaginal, vulvar, and anal cancers. The nine HPV types covered by Gardasil 9 are responsible for the majority of HPV-related cancers and other diseases in males. Although adults may have already been exposed to some of the HPV types included in the vaccine, Gardasil 9 may help prevent certain cancers and diseases caused by any of the nine HPV types to which they have not yet been exposed.

Dr. Richard M. Haupt, Vice President and Head of Global Medical Affairs for Vaccines and Infectious Diseases at MSD, stated: “With a history spanning more than 100 years in vaccines, MSD is passionate about impacting public health by delivering our broad portfolio of vaccines to people around the world. We appreciate the ongoing efforts of the ACIP and CDC to address the significant burden of HPV-related cancers by continuously evaluating vaccination recommendations based on comprehensive scientific evidence.”

References:

CDC Advisory Committee on Immunization Practices (ACIP) Votes to Provisionally Recommend Shared Clinical Decision-Making for Vaccination of Adults Ages 27-45 with GARDASIL?9 & Harmonization of Catch-up Vaccination for Males and Females Through Age 26