WASHINGTON -- The FDA expanded the approval of Gardasil 9, the human papillomavirus (HPV) vaccine, to include men and women ages 27 to 45, the .
"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, in a statement.
The CDC estimates that HPV vaccination can prevent more than 90% of HPV-related cancers, which most commonly include those of the cervix and oropharynx, as well as penile, anal, vaginal, and vulvar cancers.
In all, an estimated 31,000 new HPV-related cases are diagnosed in the U.S. each year. In women, roughly 12,000 new cervical cancer cases are diagnosed each year and 4,000 die from the disease.
In Gardasil 9 for individuals ages 9 to 26. It covers nine types of HPV, including seven that can lead to cancer (16, 18, 31, 33, 45, 52, and 58).
An earlier version of the vaccine first came to market in 2006 -- marketed as Gardasil and covering four types of HPV -- for HPV prevention in girls and women ages 9 years to 26. This indication was later expanded to include boys and men in this same age group.
Questions have been raised at various times over the vaccine's safety, but most studies have found the vaccine to be safe, including a study conducted in women during early pregnancy. The FDA reports that the safety of Gardasil 9 was evaluated in roughly 13,000 individuals, with injection site pain, swelling, headaches, and redness being the most frequently reported adverse events.
The efficacy data for the new approval comes from both earlier studies with the 4-valent HPV vaccine and a study of the newer 9-valent version.
For women ages 27 to 45, the vaccine was studied in roughly 3,200 women who were followed for 3.5 years on average. The vaccine was 88% effective in preventing persistent infection; genital warts; precancerous cervical, vaginal, and vulvar lesions; and HPV-related cervical cancers (for types covered by the vaccine).
In men ages 27 to 45 years, the approval was based on both the efficacy data in women for this age group, the earlier trials in boys and younger men, and immunogenicity data from a trial of 150 men in this older age group.