FDA approves Gardasil 9 HPV vaccine

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Gardasil 9 for the prevention of certain diseases caused by nine types of human papillomavirus. 

 

Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

 

Gardasil 9 is a vaccine approved for use in females ages 9 years through 26 years and males ages 9 years through 15 years. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, as well as the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types — 31, 33, 45, 52 and 58 — which cause approximately 20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

 

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Gardasil 9 provides broader protection against HPV-related cancers. 

 

Gardasil 9 is administered as three separate shots, with the initial dose followed by additional shots given two and six months later. For all of the indications for use approved by the FDA, Gardasil 9’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.

 

Gardasil 9 is manufactured by Merck Sharp and Dohme, a subsidiary of Merck.