FDA Expands Gardasil to Include Adults Up to Age 45

Megan Brooks

October 05, 2018

The US Food and Drug Administration (FDA) has approved a supplemental application for Merck's 9-valent human papillomavirus vaccine (Gardasil 9) to include women and men aged 27 through 45 years.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.

"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, or 31,200 cases every year, from ever developing," Marks noted.

The CDC estimates that every year about 14 million Americans become infected with HPV. About 12,000 women are diagnosed with cervical cancer and about 4000 women die from cervical cancer caused by certain HPV viruses. HPV is also associated with several other forms of cancer affecting men and women.

Gardasil, which was first approved by the FDA in 2006 to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18, is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil as well as five additional types (31, 33, 45, 52, and 58). Gardasil 9 was first approved for use in males and females aged 9 through 26 years.

According to the FDA, in a study in roughly 3200 women aged between 27 and 45 years followed for an average of 3.5 years, Gardasil was 88% effective in preventing the combined endpoint 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 FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study," the FDA said.

"Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months," the agency said.

The safety of Gardasil 9 was evaluated in a total of 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, a program that facilitates and expedites the review of medical products that address a serious or life-threatening condition.

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