> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck’s Gardasil 9 Expanded Indication
- URL: https://www.fdaweb.com/mercks-gardasil-9-expanded-indication/
- Published: 2020-06-15T12:00:00.000Z
- Updated: 2026-09-14T16:18:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147004

FDA has approved Merck’s Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) for preventing oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58\. The accelerated-approval indication was based on effectiveness data showing prevention of HPV-related anogenital disease. Continued approval will require a confirmatory trial, which the company says is currently underway.  
  
Gardasil 9 is a vaccine indicated in females for preventing cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV. It is also indicated in males for preventing anal, oropharyngeal and other head and neck cancers caused by HPV.