Merck affirms position regarding alternate dosing regimens for Gardasil 9

Merck (MRK) affirmed its position regarding alternate dosing regimens for Gardasil 9 for the prevention of certain HPV-related cancers and diseases. “HPV vaccination has an established legacy of substantial public health impact using the currently licensed regimens, including documented reductions in certain HPV-related cervical cancers at a population level… Merck maintains that until there are sufficient data to enable the U.S. Food and Drug Administration and European Commission to license an alternate dosing regimen for GARDASIL 9, the Centers for Disease Control and Prevention recommendation should remain consistent with the approved product labeling. The 2- and 3-dose regimens currently described in the U.S. and European Union product labeling were evaluated in large clinical studies that met regulatory agency standards and were extensively evaluated through the regulatory approval process. The FDA approved GARDASIL in 2006 and GARDASIL 9 in 2014. The vaccines have over 18-years and 10-years of real-world experience respectively. As is routinely done prior to starting clinical trials, Merck sought guidance from the FDA regarding its proposed single dose trial designs to ensure they would serve as an acceptable basis for a future change to the approved dosing regimens in the label… This feedback from the FDA was highlighted in a letter shared with the CDC’s Advisory Committee on Immunization Practices… GARDASIL, Merck’s four-valent HPV Vaccine, is not marketed in the United States,” the company stated.