CHMP recommends approval of Gardasil 9 for nine types of HPV- Sanofi Pasteur MSD

The European Committee for Medicinal Products for Human Use granted a positive opinion for Gardasil 9, from Sanofi Pasteur MSD, the first nine-valent HPV vaccine. The opinion recommends marketing authorization for active immunization of females and males from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types and genital warts (Condyloma acuminata) caused by specific HPV types. Gardasil 9 includes the greatest number of HPV types in any available HPV vaccine. Seven high-risk HPV types, HPV 16, 18, 31, 33, 45, 52 and 58, cause approximately 90 percent of cervical cancer cases and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. The two remaining types, HPV 6 and 11, cause 90 percent of genital wart cases.

The CHMP opinion was granted following review of the results from a comprehensive clinical program that began in 2007 and included seven trials that evaluated more than 15,000 individuals in more than 11 countries. The pivotal study recently published in the New England Journal of Medicine showed that Gardasil 9 was 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 16- through 26-year-old girls and women. In addition, the vaccine was shown to elicit antibody responses in females aged 9-26 years against HPV types 6, 11, 16 & 18 that were non-inferior to Gardasil, the leading HPV vaccine, thereby bridging the efficacy of Gardasil to Gardasil 9.

Gardasil 9 is administered as three separate shots, with the initial dose followed by additional shots given two and six months later. For all of the indications for use approved by the FDA, Gardasil 9’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.