Merck announces new 10-year LTFU Gardasil data published in Pediatrics

Merck announced new, 10-year long-term follow-up LTFU data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of GARDASIL 9 or Human Papillomavirus 9-valent Vaccine, Recombinant ,at 9-15 years old. The LTFU study was conducted from 2009 through 2021 across 13 countries and five continents. “These data highlight the importance of GARDASIL 9 in prevention of certain HPV-related cancers and diseases later in life,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “HPV-related cancers and diseases are a significant public health issue. These strong study results serve as a reminder that we need to do everything we can to expand and recover vaccination rates globally to help protect all eligible people from certain HPV-related cancers.” GARDASIL 9 targets HPV types that cause approximately 80% of cervical cancers. Additionally, HPV is responsible for causing genital warts and certain types of vulvar, vaginal, and anal cancers. For most people, HPV clears on its own, but for those who don’t clear the virus it could lead to certain cancers and other diseases. As part of the primary objective of immunogenicity, data showed sustained HPV-antibody responses at 10 years after the third dose in boys and girls. Across GARDASIL 9-targeted HPV types, antibody assessments evaluated through geometric mean titers peaked at Month 7 and decreased thereafter through 126 months. The vast majority of study participants remained seropositive at the end of the study period; 99.6% to 100% of study participants were seropositive for the targeted HPV types at Month 7 based on HPV-9 competitive Luminex immunoassay, cLIA , and 81.3% to 97.7% remained seropositive at Month 126 depending on the HPV type. Based on the HPV-9 immunoglobulin G Luminex immunoassay, IgG-LIA 94.9% to 100% of participants were seropositive at Month 126.