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September 22, 2020 04:00am
By Sallie Rafie, PharmD and Whitney Russell, PharmD student
Officials with the FDA have approved a supplemental application for Merck's Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) that expands the approved use of the vaccine to include individuals aged 27 to 45 years.
Officials with the FDA have approved a supplemental application for Merck's Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) that expands the approved use of the vaccine to include individuals aged 27 to 45 years. The vaccine prevents certain cancers and diseases caused by 9 HPV types.
“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, in a prepared statement. ”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% of these cancers, or 31,200 cases every year, from ever developing.”
According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. HPV viruses also are associated with several other forms of cancer that affect men and women.
Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by 4 HPV types, is no longer distributed in the United States. In 2014,the FDA approved Gardasil 9, which covers the same 4 HPV types as Gardasil, as well as an additional 5 HPV types.Gardasil 9 was approvedfor use in males and females aged 9 to 26 years.
The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover 4 of the same HPV types. In a study in approximately 3,200women aged 27 to 45 years, followed for an average of 3.5 years, Gardasil was 88% effective in the prevention of a 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 aged 27 to 45 years is based on these results and new data on long term follow-up from this study.
Effectiveness of Gardasil 9 in men aged 27 to 45 years is inferred from the data described above in women aged 27 to 45 years, as well as efficacy data from Gardasil in younger men (aged 16 to 26 years) and immunogenicity data from a clinical trial in which 150 men, aged 27 to 45 years, received a 3-dose regimen of Gardasil over 6 months.
The safety of Gardasil 9 was evaluated in about a total of 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. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old [news release]. Silver Spring, MD; October 5, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm. Accessed October 2018.