Gardasil®: New 2-dose Schedule Granted Positive CHMP Opinion for Europe's Leading HPV Vaccine
Lyon, France (ots/PRNewswire) - European Committee for Medicinal Products for Human Use evaluated positively
a 2-dose schedule for Gardasil(R) in adolescents
Sanofi Pasteur MSD announced today that its quadrivalent HPV vaccine, Gardasil(R) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of a two-dose schedule in 9 to and including 13 year old adolescent girls and boys.
"We are delighted of the CHMP's positive opinion, said Dr Benoit Soubeyrand, Director, Medical Affairs Europe for Sanofi Pasteur MSD "and we are very proud to be able to propose a simplification of the dosing regimen of this important vaccine, which may enable better vaccine coverage in adolescent girls and boys."
The European licence application is supported by the results of a study performed in Canada by Dobson et al. [(1)] It demonstrates that antibody levels 1 month after a 2 dose schedule (0,6 months) of Gardasil in 243 girls 9-13 years old are non-inferior to the ones observed 1 month after a 3-dose schedule (0, 2, 6 months) in 272 16-26 years old women, population in which efficacy has been demonstrated.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.
Gardasil is the only quadrivalent HPV vaccine, helping to protect people from cervical cancer, genital precancerous lesions and genital warts, with demonstrated protection in real-life [(2],,[4)]. It is the Europe's leading HPV vaccine with 29 million doses distributed in Western Europe and approximately 144 million doses distributed worldwide.
Gardasil is currently licensed as a 3 dose vaccination schedule at 0, 2, 6 months in both girls and boys from the age of 9 years, for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types and genital warts (condyloma acuminata) causally related to specific HPV types.[(5)]
Gardasil(R) is a quadrivalent vaccine for protection against cancer of the cervix and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata).
Data published since Gardasil(R) came on the market have confirmed the positive impact of this vaccine on the prevention of genital diseases caused by human papillomavirus types 6, 11, 16 and 18.
Launched 2006, it is the most widely used HPV vaccine worldwide with approximately 144 million doses distributed to date.
About Sanofi Pasteur MSD http://www.spmsd.com
Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the development of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck's research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.
1) Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women. JAMA 2013;309(17):1793-802. 2) Brotherton JML et al. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet 2011;377:2085-92. 3) Read TRh et al. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme. Sex Transm Infect 2011; 87: 544-547. 4) Markowitz LE et al. Reduction in Human Papillomavirus (HPV) Prevalence Among YoungWomen Following HPV Vaccine Introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. JID, 2013; 208, 385-393. 5) Gardasil SmPC
For further information please contact: Sylvia Martin-Jarrand,
Sanofi Pasteur MSD, Tel : +33-4-37-28-40-55, Mob : +33-6-33-46-1365,