FDA Approves New HPV Vaccine

The FDA has approved Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for the prevention of disease caused by 9 strains of the human papillomavirus (HPV).

The drug is approved for use by females (aged 9-26) and males (aged 9-15), has the potential to prevent 90% of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts caused by HPV types 6 and 11.
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The safety and efficacy of Gardasil 9 was evaluated in a randomized, controlled study of nearly 14,000 females (aged 16-26) who were randomly assigned to either Gardasil or Gardasil 9.

Researchers found Gardasil 9 to be 97% effective in preventing cancers caused by the 5 additional HPV strains not covered in the original Gardasil (31, 33, 45, 52, and 58), and just as effective as Gardasil at preventing diseases caused by the 4 shared types (6, 11, 16, and 18). 

Note: A second study of females and males (aged 9-15) revealed similar results as the study of older females.

Gardasil 9 is administered as 3 injections, with the second and third given at 2 and 6 months after initial injection.

Headache and pain at the injection site were the most common side effects.

—Michael Potts

Reference:

FDA. FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV [press release]. December 10, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm. Accessed December 11, 2014.