FDA approves Merck's HPV Vaccine

The US regulator approves Merck's human papillomavirus (HPV) Vaccine, GARDASIL9, to prevent cancers and other diseases caused by nine HPV types

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The vaccine protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58

Merck has announced that the US Food and Drug Administration (US FDA) has approved GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccine, for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11.

GARDASIL 9 is also approved for use in boys 9 to 15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11.

"With GARDASIL 9, the medical and public health community now has the potential to help prevent 90 percent of cervical cancers caused by HPV. This is an extraordinary opportunity to even further reduce the burden of HPV-related diseases and cancers in males and females," said Dr Julie Gerberding, president, Merck Vaccines.

GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine.

 

 

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