HPV vaccine approved by FDA to treat additional strains
Gardasil 9 is given as three separate shots within six months
HealthDay News – Gardasil 9, a vaccine designed to treat five additional types of human papillomavirus (HPV) has been approved by the United States Food and Drug Administration (FDA), according to an agency news release.
The agency's approval of Gardasil 9 covers female patients aged 9 to 26 years and male patients aged 9 to 15 years. The additional types of HPV -- 31, 33, 45, 52, and 58 -- cause about 20% of cervical cancers and weren't covered by prior approvals of the vaccine.
Gardasil 9 was found 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types among 14,000 female patients aged 16 through 26 years who were enrolled in the clinical trial.
The vaccine is given as three separate shots within six months. The most common side effects reported during clinical evaluation included pain, swelling, and redness at the injection site and headache.
“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research in an agency news release.
“The approval of Gardasil 9 provides broader protection against HPV-related cancers.”