The Food and Drug Administration has approved a new version of the Gardasil vaccine that protects against five more human papillomavirus types that cause about 20% of cervical cancers, the agency announced on Dec. 10.
The new vaccine, which is called Gardasil 9, “has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers,” according to the statement.
Gardasil 9 is approved for use in females aged 9 through 26 years and in males aged 9 through 15 years 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. It is administered in three separate intramuscular injections, on a 0, 2-, and 6-month schedule.
HPV types 31, 33, 45, 52 and 58 were not included in the initial Gardasil vaccine approved in 2006. Another HPV vaccine, Cervarix, was approved in 2009 and protects against HPV types 16 and 18.
Approval of Gardasil 9 was based on a randomized, controlled study in about 14,000 females aged 16-26 years, who tested negative for the HPV types in the vaccine and were given the Gardasil or Gardasil 9 vaccine; safety was evaluated in about 13,000 males and females, according to the FDA.
In the study, 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),” the FDA statement said. “In addition, Gardasil 9 is as effective as Gardasil for 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.” Injection site pain, swelling, redness, and headaches were among the most common adverse events associated with the vaccine, the statement said.
Studies of about 4,000 males and females aged 9-15 years found that antibody responses to Gardasil 9 were similar to the responses seen in females aged 16-26 years. “The vaccine is expected to have similar effectiveness when used in this younger age group,” according to the FDA.
Adverse events associated with vaccines should be reported to the Vaccine Adverse Event Reporting System.The label for Gardasil 9 is available at the FDA.