The Food and Drug Administration (FDA) has approved a supplemental application of the Gardasil 9 human papillomavirus (HPV) vaccine for men and women up to the age of 45. Gardasil 9 prevents certain cancers and diseases including oropharyngeal cancers caused by the nine HPV types covered by the vaccine.
“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’s Center for Biologics Evaluation and Research.
“The Centers for Disease Control and Prevention (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% of these cancers, of 31,200 cases every year, from ever developing,” Marks said.
According to the CDC, about 14 million Americans become infected with HPV each year. About 10% of men and 3.6% of women have oral HPV, which is more common among older populations. HPV is thought to cause 70% of oropharyngeal cancers in the United States.
Further, the CDC says, about 3,400 new cases of HPV-associated oropharyngeal cancers are diagnosed in women and about 14,800 are diagnosed in men each year in the United States. These numbers are based on specific areas of the oropharynx and do not include cancers in all areas of the head and neck or oral cavity.
It usually takes years after being infected with HPV for cancer to develop. The CDC says that it is unclear if having HPV alone is enough to cause oropharyngeal cancers or if other factors such as tobacco use interact with HPV to cause these cancers.
The safety of Gardasil 9 was evaluated in about 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches. The FDA granted the Gardasil 9 application priority review status, facilitating and expediting its review.