The Food and Drug Administration (FDA) has approved an expanded indication for Gardasil 9® (human papillomavirus 9-valent vaccine [HPV], recombinant; Merck) to include the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 in patients aged 9 to 45 years. 

The effectiveness of Gardasil 9 against oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, was based on the effectiveness of Gardasil and Gardasil 9 to prevent anogenital disease caused by HPV types covered by the vaccine. Continued approval of this indication may be contingent upon ongoing confirmatory trial results.

Gardasil 9 is also indicated for use:

  • In females aged 9 to 45 years for the prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, 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.
  • In males aged 9 to 45 years for the prevention of anal 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.

Patients who receive the vaccine should still undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers when clinically indicated.


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Gardasil 9 is supplied as a suspension for intramuscular administration in 0.5mL single-dose vials and prefilled syringes.

For more information visit merck.com.

This article originally appeared on MPR