Gardasil 9 Vaccine

                                    Gardasil 9 Vaccine                                    Gardasil 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cerviral, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus ( HPV ) Types 16,18,31,33,45,52, and 58; cervical, vaginal, and anal 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 indicated in male 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV types 16,18,31,33,45,52, and 58; anal 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.                                                                                                                   The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.                                                                                                                                          Gardasil 9 dose not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head abd neck cancer as recommended by a health care provider.                                     Gardasil 9 has not been demonstrated to provide protection against disease caused by:                                                                                      HPV types not covered by the vaccine                                                                            HPV types to which a person has previously been exposed through sexual activity                                                                                                                                 Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16,18,31,33,45,52, and 58.                                                                               Gardasil 9 is not a treatment for external genital lesions; cerviral, vulvar, vaginal, anal, oropharyngeal and other head and neck cancer; or cervical intraepithelial neoplasia ( CIN ), vulvar intraepithelial neoplasia ( VIN ), vaginal intraepithelial neoplasia ( VaIN ), or anal intraepithelial neoplasia ( AIN ).                                                                                                                       Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.                                                                                                            Safety Information for GARDASIL 9                                                                   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 ].                                                                                                                      Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. syncope. sometimes associated with tonic- clonic movements and other seizure-like activity, has been reported following HPV vaccination. when syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.                                Safety and effectivenees of  GARDASIL 9 have not been established in pregnant women.                                                                                     The most common (10% ) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. the most common ( 10% ) local and systemic reactions in males were injection-site pain, swelling, and erythema.                                                                                                                    The duration of immunity of GARDASIL 9 has not been established.                                                                                                                                              Dosage and Administration for GARDASIL 9                                                GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.                                                                                     For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2- dose or 3-dose schedule, the second dose shoul be administered 6-12 months after the first dose. if the second is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. for the 3- dose schedule, GARDASIL 9 Should be administered at 0,2 months, and 6 months.                                                                                             For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0,2 months, and 6 months.