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FDA OKs expanded indication for Gardasil 9

BY Sandra Levy

The Food and Drug Administration has approved the expanded the use of Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), to include women and men aged 27 years old through 45 years old. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck Sharp & Dohme, a subsidiary of Merck.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” FDA’s Center for Biologics Evaluation and Research director Peter Marks said in a statement. “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% of these cancers, or 31,200 cases every year, from ever developing.”

According to the Centers for Disease Control and Prevention, roughly 14 million Americans annually become infected with HPV. Roughly 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses.

Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, 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 an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 years old through 26 years old.

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.

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