Sanofi Pasteur’s Gardasil® 9 HPV vaccine has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The CHMP’s positive opinion is granted for a 2-dose schedule in adolescent boys and girls aged 9 – 14 years.
Gardasil® 9 Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed) is indicated for active immunisation of individuals from the age of 9 years against cervical, vulvar, vaginal and anal cancers causally related to vaccine HPV types and genital warts causally related to specific HPV types.
The vaccine was originally approved in the EU in June 2015 with a three-dose schedule for all age groups. The positive opinion was adopted on 26 February 2016.
The EU application is based on the results of a clinical trial performed in around 1200 girls and boys aged 9 to 14 years old and 300 young women aged 16 to 26 years old. This was the age group in which the efficacy of the vaccine was demonstrated.
The CHMP’s positive opinion for the 2-dose schedule will now be reviewed by the European Commission, which has the authority to approve medicines for the EU.
Dr Ned Powell, who leads HPV Research at Cardiff University Medical School, said: “Approval…is great news, both for young women and for the NHS, and will increase the number of young women who are protected against a range of HPV-associated diseases.”