Gardasil 9 Approved for Five Additional HPV Strains

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA has approved Gardasil 9, a recombinant vaccine that can prevent diseases caused by nine human papillomavirus strains (five more than the previously approved Gardasil). It is indicated for females aged 9 to 26 years and males aged 9 to 15 years.

Gardasil 9 can potentially prevent about 90% of anal, cervical, vulvar, and vaginal cancers (caused by HPV types 16, 18, 31, 33, 45, 52, and 58). It also prevents genital warts (caused by HPV types 6 and 11). The strains new to this vaccine are types 31, 33, 45, 52, and 58, which are responsible for 20% of cervical cancers.

The vaccine is given in three doses, with the second and third shots given 2 and 6 months, respectively, after the initial one.

Headache and pain, redness, and swelling at the injection site were the most common side effects in a study of some 13,000 females and males.