Gardasil 9 vaccine for HPV approved for use in the EU-Sanofi Pasteur MSD

Sanofi Pasteur MSD announced that the European Commission has granted marketing authorization for Gardasil 9. Gardasil 9 is a 9-valent HPV vaccine for active immunization of females and males from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina or anus and also against genital warts (Condyloma acuminata) caused by the HPV types covered by the vaccine. The approval of Gardasil 9 follows the positive opinion of the European Committee for Medicinal Products for Human Use (CHMP) granted on March 27th 2015.

The marketing authorization is supported by a comprehensive clinical program initiated in 2007; seven trials evaluated more than 15,000 individuals across 30 countries. Gardasil 9 was shown to be 97% effective in preventing high-grade lesions of the cervix, vagina and vulva caused by the 5 additional oncogenic HPV types (31, 33, 45, 52, 58). In addition, the vaccine was shown to elicit antibody responses against HPV types 6, 11, 16 & 18 that were non-inferior to Gardasil , the leading HPV vaccine.