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.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.