Merck announced that Health Canada has approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age for the prevention of infection caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 and the following diseases associated with the HPV types included in the vaccine: Oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.1 This market authorization has been issued with conditions pending the results of trials to verify its clinical benefit.
"Head and neck cancers can be extremely debilitating for survivors. Although curative treatment of HPV induced oropharyngeal cancer is usually successful, the treatment and cancer itself can cause significant morbidities, dysfunction, and lowered patient qualities of life moving forward. A vaccine that can actually help prevent certain HPV-related head and neck cancers is an important scientific advancement," said Dr. Peter Spafford, College of Medicine Division of Otolaryngology – Head and Neck Surgery, Department of Surgery, University of Saskatchewan.
"No screening program exists for HPV-related oropharyngeal cancers. This approval represents the first clinical tool to help prevent oropharyngeal and head and neck cancer caused by HPV infection in men and women," said Dr. Vivien Brown, Past President of the Federation of Medical Women of Canada (FMWC) and co-founder of HPV Prevention Week in Canada.
It is estimated that 75% of sexually active Canadians will have an HPV infection at some point if not immunized2 and that more than 550,000 Canadians become infected with HPV each year.3 While most infected people clear the virus, those who do not can develop HPV-related cancers and precancers, or genital warts. Many people who have HPV may not show any signs or symptoms, which means they can infect others without knowing it.4
According to the Public Health Agency of Canada, about 25% to 35% of mouth and throat cancers are related to oral HPV infection and in 2012, the incidence rate of HPV-associated oropharyngeal cancer was more than 4.5 times higher in males and females. The proportion of tonsillar cancers in Canada in which HPV has been detected increased from 25% (1993–1999) to 62% (2006–2011).5
"Scheduling regular dentist check-ups can allow your dental professional to detect signs of head and neck cancers including oropharyngeal cancers at their earliest stage. Canadians should speak to their dental professional about a thorough evaluation, as there is currently no screening program that exists for head and neck cancers," said Dr. Cheryl Cable, Maxillofacial Prosthodontist, President of Canadian Association of Women Dentists, Lead of the Alberta Head and Neck Cancer Dental Leadership Team, and Associate Professor of the University of Alberta.
"Today's expanded approval for GARDASIL®9 is a key milestone in the prevention of HPV-related oropharyngeal and other head and neck cancers. It is a clear testament to Merck Canada's mission of saving and improving the lives of Canadians," said Marwan Akar, President and Managing Director of Merck Canada.
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