Posted from: Monday, December 28, 2015 - 10:14 AM - Present

Expanded Gardasil 9 Indication Approved

December 15, 2015 – The U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 (Human Papillomavirus 9-valent vaccine, recombinant), manufactured by Merck. Gardasil 9 can now be used in males 16 through 26 years of age. The vaccine is indicated to prevent anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52 and 58, precancerous of 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 was originally approved in December 2014 to prevent certain diseases in boys 9 to 15 years of age and females 9 to 26 years of age. A treatment course of the vaccine consists of three separate intramuscular (IM) injections administered in the upper arm over a six-month period. 


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Last Updated Friday, November 15, 2019 - 10:39 AM.