Merck & Co. Inc. affirmed its stance regarding alternative dosing regimens for GARDASIL®9, the Human Papillomavirus 9-valent Vaccine, highlighting the need for more data before considering changes to the current dosing recommendations. The FDA requires evidence showing that a single-dose regimen is as effective as the approved three-dose regimen and ensures no decrease in efficacy for HPV disease endpoints beyond cervical persistent infection. Additionally, there is currently no data supporting the efficacy of single-dose regimens in men. Until sufficient data is available, Merck believes that the CDC's recommendations should align with the approved two- and three-dose regimens, which have been extensively evaluated and have a proven public health impact.