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HPV Vaccine Approval Expanded Through Age 45

In a step crucial to preventing the occurrence of both the human papillomavirus (HPV) and HPV-related cancers, the United States Food and Drug Administration (FDA) has expanded the approval of the 9-valent human papillomavirus (9vHPV) vaccine (Gardasil®9, Merck and Co.) for men and women between the ages of 27 and 45.

The human papillomavirus infects approximately 14 million Americans each year. It is also a well-documented cause of a number of cancers, including cervical carcinoma and oropharyngeal, anal, vulvar, penile, and vaginal squamous cell carcinomas. "The Centers for Disease Control and Prevention 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," commented Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.

In 2014, the 9vHPV vaccine, which is effective against 9 different varieties of HPV, was FDA approved for use in children and young adults of both genders, aged 9 through 26 years. It replaced the quadrivalent HPV (4vHPV) vaccine (Gardasil®, Merck and Co.), which is effective against only 4 HPV strains and is no longer available in the United States. The 9vHPV vaccine is 1 of 3 vaccines currently used for routine vaccinations of preadolescent youth.

A study involving the 4vHPV vaccine in women aged 27 to 45 has been considered in the approval of the 9vHPV vaccine for women of the same age group because both drugs are manufactured similarly and cover 4 of the same HPV strains. In approximately 3,200 women followed for an average of 3.5 years, 4vHPV was 88% effective in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer associated with HPV strains covered by the vaccine. The FDA approval of the 9vHPV vaccine in women aged 27 to 45 is based on data from this study and new data from its long-term follow-up. Approval of the 9vHPV vaccine in men aged 27 to 45 is based on efficacy of the 4vHPV vaccine in women, using data from the same study mentioned above, as well as data on the 4vHPV vaccine in young men, aged 16 to 26, and immunogenicity data from a clinical trial of 150 men aged 27 to 45.

Safety of the 9vHPV vaccine was evaluated in approximately 13,000 individuals, with the most common adverse reactions being injection site pain, swelling, redness, and headaches.

Dr. Marks emphasized the importance of increasing the vaccine's availability: "Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range."

For More Information

Clinicaltrials.gov (2017). A study to evaluate the safety, immune response, and efficacy of Gardasil (V501, qHPV) in mid-adult women (V501-019). NLM identifier: NCT00090220.

Clinicaltrials.gov (2018). Study of Gardasil in mid-adult males (MAM). NLM identifier: NCT01432574. 

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