Merck & Co. Inc. (MRK) announced Monday that Health Canada has approved an expanded indication of GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of oropharyngeal and other head and neck cancers in individuals 9 through 45 years of age.
The company noted that GARDASIL 9 has been approved for the prevention of infection caused by the Human Papillomavirus or 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.
GARDASIL9 is the first vaccine in Canada approved for the prevention of HPV-Related Oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
The market authorization has been issued with conditions pending the results of trials to verify its clinical benefit.
The approval is based on the effectiveness of GARDASIL and GARDASIL9 to prevent persistent infection and anogenital disease caused by HPV types covered by the vaccine.
The company noted that the oropharyngeal and other head and neck cancer indication for GARDASIL9 has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit.
It is estimated that 75 percent of sexually active Canadians will have an HPV infection at some point if not immunized and that more than 550,000 Canadians become infected with HPV each year.
According to the Public Health Agency of Canada, about 25 percent to 35 percent of mouth and throat cancers are related to oral HPV infection. In 2012, the incidence rate of HPV-associated oropharyngeal cancer was more than 4.5 times higher in males and females.
Vivien Brown, Past President of the Federation of Medical Women of Canada or FMWC and co-founder of HPV Prevention Week in Canada, said, “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.”
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