FDA approves Merck & Co.'s nine-valent version of HPV vaccine Gardasil 9

The FDA on Wednesday granted marketing authorisation to Merck & Co.'s Gardasil 9, a nine-valent version of the human papillomavirus (HPV) vaccine Gardasil, for use in females aged nine to 26 and males aged nine to 15. The vaccine covers five new HPV types, namely 31, 33, 45, 52 and 58, in addition to types 6, 11, 16 and 18 covered by the previous version of the vaccine, which was cleared by the FDA in 2006.

The approval of the therapy was supported by a clinical study of approximately 14 000 females aged 16 through 26 who tested negative for vaccine HPV types at study initiation. In the trial, patients were randomised to receive the original version of Gardasil or Gardasil 9. The FDA stated that Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by HPV types 31, 33, 45, 52 and 58 and similarly effective as Gardasil against diseases caused by the four shared HPV strains based on the similar antibody responses of study participants.

Meanwhile, the efficacy of the vaccine in children aged nine to 15 was established in a clinical trial that involved about 1200 boys and 2800 girls. According to the regulator, study results illustrated that Gardasil 9 elicited similar antibody responses in this age group as observed in females aged 16 to 26. In a safety study of 13 000 males and females, the most frequent adverse events were injection site pain, swelling, redness and headache.

Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, commented "the approval of Gardasil 9 provides broader protection against HPV-related cancers." The FDA estimated that Gardasil 9 has the potential to prevent around 90 percent of HPV-associated anal, cervical, vaginal and vulvar cancers.

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