Dive Brief:
- The FDA on Wednesday approved Merck's Gardasil 9, which could potentially prevent about 90% of cervical, vulvar, vaginal and anal cancers, according to the agency.
- Gardasil 9 is approved for use in females between the ages of 9 and 26, and males between the ages of 9 and 15.
- The approval of Gardasil 9 increases Gardasil's protective reach to include five more HPV strains, including 31, 33, 45, 52, and 58. It also covers HPV strains 16 and 18, which were previously covered with the Gardasil vaccine, and is approved for prevention of genital warts caused by types 6 and 11.
Dive Insight:
Cancer prevention through vaccination is an ideal way to decrease the risk of certain cancers. In clinical studies, Gardasil 9 was 97% effective in preventing cervical, vulvar, and vaginal cancers caused by HPV types 31, 33, 45, 52, and 58. Efficacy determinations were based on antibody responses in 1,200 male and 2,800 female study subjects involved in a randomized, controlled trial. Safety was evaluated in approximately 13,000 males and females, with the most common adverse reactions being injection site pain, swelling, redness, and headache.
Gardasil 9, similar to previous Gardasil versions, is administered as three separate shots: The first shot, followed by the second shot two months later, and the third shot six months later.
The question, as always, is whether patients in America will actually get their shots. According to the most recent CDC data, just 57.3% of girls aged 13 to 17 receive even one dose of the vaccine. That number is even lower for boys.
