HPV Vaccine Seeks Approval for Ages 27 to 45
Gardasil 9 protects both women and men from certain HPV cancers
The U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL 9 Human Papillomavirus 9-valent Vaccine.
This means Merck, the manufacturer of Gardasil 9, is seeking FDA approval for an expanded age indication for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomaviruses (HPV) types covered by the vaccine.
The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018.
“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” said Dr. Alain Luxembourg, director, clinical research, Merck Research Laboratories.
Currently, GARDASIL 9 is indicated in the U.S. in females 9 through 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.
Additionally, GARDASIL 9 is also indicated in males 9 through 26 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.
In the United States, 79 million persons are estimated to be infected with some type of HPV, with approximately half of new infections occurring before age 24 years.
According to the Centers for Disease Control and Prevention (CDC), while most HPV infections are asymptomatic and pass on their own within a few years, HPV types 16 and 18 are the cause of 66% of cervical cancers in the United States, while HPV 6 and HPV 11 cause about 90% of all genital warts.
HPV vaccines are offered in most pharmacies and physician offices in the USA.
To easily schedule an HPV vaccination appointment, please visit this page.
Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.