BRIEF—FDA approves wider use of Gardasil 9

The US Food and Drug Administration on Friday approved a supplemental application for Merck & Co’s Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant), expanding the approved use of the vaccine to include women and men aged 27 through 45 years.

Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

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

“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,” he added.

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 USA. 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 nine through 26 years.