FDA Issues News Release on Expanded Use of Gardasil 9

On October 5, 2018, the U.S. Food and Drug Administration (FDA) issued a news release to announce the administration’s approval of the expanded use of Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) to include women and men aged 27 through 45 years of age.  Gardasil 9, which protects against nine HPV types, was originally approved by the FDA in 2014 for use in males and females aged 9 through 26 years.

Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, stated, “Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range. 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.”

For more information, view the news release, FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. To access additional information regarding Gardasil 9 and recent updates, visit

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