28 June 2019 - - The US Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices voted to recommend HPV vaccination with GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) based on shared clinical decision making for individuals 27 through 45 years of age who are not adequately vaccinated, US-based pharmaceutical company Merck (NYSE: MRK) said.
The ACIP also voted to expand routine and catch-up recommendations for males through 26 years of age who are not adequately vaccinated. The CDC currently recommends routine vaccination of females and males 11-12 years of age, and vaccination can begin at age 9.
If approved by the CDC, GARDASIL 9 recommendations would be expanded to include females and males 13-26 years of age who have not previously been vaccinated, and for adults 27-45 years of age the decision to vaccinate would be made between an individual and their healthcare provider.
Details of the ACIP recommendations for GARDASIL 9 will be available from the CDC. The provisional recommendations are reviewed by the director of the CDC and the Department of Health and Human Services and final recommendations will become official when published in the CDC's Morbidity and Mortality Weekly Report.
GARDASIL 9 is indicated for use in females aged 9-45 for the prevention of cervical, vulvar, vaginal and anal cancers 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 also indicated for use in males aged 9-45 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].
In the US, almost half of new HPV infections occur in adults 25 years of age or older. Approximately 23,000 Americans are diagnosed with cervical, vaginal, vulvar, and anal cancers associated with HPV every year, according to latest published incidence from 2015.
The nine types of HPV covered in GARDASIL 9 cause the majority of HPV-related cancers and other diseases in women and men. Even though adults may have already been exposed to some types of HPV covered by the vaccine, GARDASIL 9 may help protect against certain cancers and diseases caused by any of the nine HPV types to which someone has not yet been exposed.
The ACIP develops written recommendations for the routine administration of vaccines to children and adults. The ACIP, which consists of 15 experts in immunization and related fields, provides advice to assist the CDC and the nation in reducing the incidence of diseases that may be prevented with vaccines and to increase the safe usage of vaccines and related biological products.
The CDC reviews advice from the ACIP and publishes final recommendations in the MMWR. The Affordable Care Act generally requires coverage for all vaccines administered in accordance with final CDC recommendations. This requirement applies to all non-grandfathered commercial plans and Medicaid expansion beneficiaries.
Individuals, or their healthcare providers, should contact their health insurance plan to determine vaccine coverage and reimbursement requirements as well as adoption timeframes.