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FDA Approves Gardasil 9 for Prevention of HPV-Related Cancers
The FDA has given the green light to Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for the prevention of certain cancers caused by nine types of human papillomavirus (HPV).
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, according to the vaccine’s manufacturer (Merck Sharp & Dohme).
Gardasil 9 is a vaccine approved for use in females aged 9 through 26 years and in males aged 9 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, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five HPV types — 31, 33, 45, 52, and 58 —that 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, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.”
A randomized, controlled clinical study was conducted in the U.S. and internationally in approximately 14,000 females aged 16 through 26 years who tested negative for vaccine HPV types at the start of the study. The study participants received either Gardasil or Gardasil 9.
Gardasil 9 was determined to be 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58). In addition, Gardasil 9 was as effective as Gardasil in the prevention of diseases caused by the four shared HPV types (6, 11, 16, and 18), based on similar antibody responses in participants in clinical studies.
Because of the low incidence of anal cancer caused by the five additional HPV types, the prevention of anal cancer was based on the demonstrated 78% effectiveness rate of Gardasil and on additional antibody data from males and females who received Gardasil 9.
The effectiveness of Gardasil 9 in females and males aged 9 through 15 years was determined in studies that measured antibody responses to the vaccine in approximately 1,200 males and 2,800 females in this age group. Their antibody responses were similar to those in females 16 through 26 years of age. Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group.
Gardasil 9 is administered as three injections, with the initial dose followed by additional shots given 2 and 6 months later. For all of the indications for use approved by the FDA, the full potential of Gardasil 9 for providing an antiviral benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.
The safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.
Source: FDA; December 10, 2014.