The FDA has approved an additional application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) to include women and men aged 27 through 45 years. The vaccine helps prevent infections from certain HPV-related cancers and diseases that are caused by nine types of HPV.
According to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, the CDC states that being vaccinated with Gardasil 9, before infection, could prevent more than 90 percent of these cancers (31,200 cases each year) from ever developing. The FDA granted the Gardasil 9 application priority review status.
Of the 14 million Americans who become infected with HPV annually, some 4,000 women die from cervical cancer caused by certain HPV viruses. HPV viruses are also associated with various other cancers that aﬀect both men and women.
Gardasil, approved by the FDA in 2006 for the prevention of cancers and diseases caused by four HPV types, is no longer distributed in the U.S. Gardasil 9, which was approved in 2014 and can be used in males and females aged 9 through 26 years, covers a total of nine types of HPV, including the four covered by its forerunner. The most commonly reported adverse reactions to Gardasil 9 include injection-site pain, swelling, redness, and headaches.
In a study involving 3,200 women aged 27 through 45 years, who were followed for approximately 3.5 years, Gardasil was 88 % eﬀective in preventing a combination of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The approval of Gardasil 9 in women of this age range is based on the study’s results as well as new data arising from long-term follow-up.
The eﬀectiveness of the vaccine in men of the same age is inferred from the data described above, as well as data from Gardasil in younger men (16–26 years of age) and immunogenicity data from a clinical trial involving 150 men aged 27 through 45 years, who received a 3-dose regimen of Gardasil over 6 months.