Originally approved by the FDA in 2006, the vaccine prevents certain cancers and diseases caused by the 9 types of HPV covered by the vaccine—an expansion from its originally-approved prevention of 4 different types.
The US Food and Drug Administration (FDA) has approved the supplemental application for recombinant human papillomavirus (HPV) nine-valent vaccine (Gardasil 9).
With the expanded approval, the vaccine’s use can now include women and men aged 27-45 years old. Originally approved by the FDA in 2006, Gardasil 9 prevents certain cancers and diseases caused by the 9 types of HPV covered by the vaccine—expanded from its originally-approved prevention of 4 different types.
Gardasil 9, from Merck, Sharp & Dohme Corporation, was approved in 2014 for males and females aged 9-26 years old. According to the US Centers for Disease Control and Prevention (CDC), about 14 million people in the US are infected with HPV annually, with another 4000 women dying from cervical cancer caused by certain forms of the virus.
In considering the expanded approval of Gardasil 9, the FDA considered relevant data from the similarly-manufactured and original Gardasil. In a study involving about 3200 women aged 27-45 years old—who were followed for a mean 3.5 years—Gardasil reported 88% efficacy in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.
Along with new data on long-term follow-up analysis from this study, the FDA expansion was granted based on this study. Its efficacy in men aged 27-45 years old is inferred from the same data, plus efficacy data observing Gardasil in men aged 16-26 years old, and immunogenicity data from a clinical trial involving 150 men aged 27-45 years old receiving a three-dose regimen of the drug over 6 months.
In a 13,000-patient safety evaluation of Gardasil 9, the most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.
The expanded approval was predated by an FDA priority review grant, which facilitated and expedited its review to address the life-threatening HPV condition.
In a statement accompanying the approval, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the indication represents an “important opportunity to help prevent HPV-related diseases and cancers in a broader age range.”
“The [CDC] has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing,” Marks said.