Vaccines are subject to licensure in the United States by the Food and Drug Administration (FDA) following studies that address safety and efficacy. FDA approved Gardasil in 2006 for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11.
Just last week, the FDA approved Gardasil 9 which adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers. The vaccine is approved for use in females 9-26 years old and males 9-15 years old. The vaccine is administrated in three separate shots spaced two and six months apart.
In a randomized, controlled, clinical study, the new vaccine demonstrated the same efficacy as Gardasil showing the vaccine was 97 percent effective in protecting against cervical, vulvar, and vaginal cancers. With the 5 additional strains of HPV protection, the new vaccine is considered to be 78 percent effective in preventing anal cancer.
Do you want to know more about HPV? This 3-minute video provides 10 basic facts about the virus.
I would like to ask Merck, the manufacturer, is there is a booster shot for my daughter who had the vaccine years ago and wants the additional protection?