News Feature | December 15, 2014

Sanofi Pasteur MSD's Gardasil 9 For HPV Approved By FDA

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has approved Sanofi Pasteur MSD’s Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) to prevent diseases caused by nine types of Human Papillomavirus (HPV).

Gardasil 9 is an updated version of the previously FDA-approved Gardasil, which originally targeted only four HPV types. Gardasil 9 covers five more HPV types than its predecessor and can potentially prevent an estimated 90 percent of cervical, vaginal, vulvar, and anal cancers. The vaccine is approved for use in females 9 through 26 years old and males 9 through 15 years old.

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

The FDA approved Gardasil 9 based on positive results from the randomized, controlled, clinical study, which showed the vaccine was 97 percent effective in protecting against cervical, vulvar, and vaginal cancers caused by the five HPV types 31, 33, 45, 52, and 58. The new vaccine demonstrated the same efficacy as Gardasil for the prevention of the other four shared HPV types (6, 11, 16, and 18) according to the similar antibody responses in the clinical study participants. The vaccine is administrated in three separate shots spaced two and six months apart.

The vaccine was also considered to be 78 percent effective in preventing anal cancer based on the low incidence of disease caused by the five additional HPV types. The joint Sanofi Pasteur and Merck venture reported in June that the European Commission approved Gardasil for the prevention of anal precancerous lesions and anal cancers causally linked to oncogenic HPV types. The EC also granted marketing authorization for two-dose Garsadil in pediatric patients aged 9 to 13 years of age.

CTV news reported that Gardasil brought in $1.83 billion in sales last year for its manufacturer, Merck.