Vaccination Programmes With Gardasil® Could Cost-effectively Prevent Up To 91% Of Vaccine Virus Type Related Cervical Cancer

Compared with current practice, vaccinating 70% of young girls before
the age of 12 with Gardasil® could reduce the incidence of cervical cancer due to human
papillomavirus types 16 and 18 in the entire population by 78%. Thanks to the prevention of
other human papillomavirus diseases, that start before cervical cancer and go beyond the cervix,
vaccination with Gardasil® is also expected to provide early and additional benefit compared to
the prevention of cervical cancer alone. 78% of precancerous cervical lesions (CIN*2/3) and 83%
of genital warts due to human papillomavirus types 6, 11, 16, 18 for example, could also be
prevented through vaccination with Gardasil®. Including males in the vaccination programme
would further increase effectiveness, indirectly reducing the incidence of cervical cancer,
precancerous cervical lesions (CIN**2/3), and genital warts due to human papillomavirus types 6,
11, 16, 18 by 91%, 91%, and 97%, respectively.


Combined with current screening and human papillomavirus disease treatment practice,
vaccination with Gardasil® would be cost-effective compared to other commonly accepted
healthcare programmes such as screening alone or measures to prevent heart disease.


Temporary vaccination of 50% of 12- to 24-year old girls and women with Gardasil® (catch-up
programme) would further accelerate disease reduction significantly whilst remaining cost-
effective. With a catch-up programme, vaccination against the four virus types 6, 11, 16 and 18
would be approximately twice as cost-effective as vaccination against the virus types 16 and 18
alone. With a catch-up programme, benefit from vaccination would become evident from as early
as five years after initiation of the programme.


These results come from an assessment of the epidemiologic consequences and cost-
effectiveness of different vaccination strategies with Gardasil® in a setting of organised cervical
cancer screening in the United States using a transmission dynamic model. Each vaccination
strategy was assessed over a planning horizon of 100 years. The assessment did not include
protection from additional human papillomavirus diseases that start before cervical cancer and
go beyond the cervix such as potentially precancerous cervical lesions (CIN 1), vulvar cancer
and precancerous vulvar lesions. It focussed on the four virus types (6, 11, 16, 18) directly
targeted by Gardasil® and did not include potential cross protection against additional virus types
not directly targeted by the vaccine. The results have been published in the January 2007
edition of the Emerging Infectious Diseases journal of the US Centers of Disease Control
(Elbasha E.H. et al., Volume 13, Number 1, January 2007 -
www.cdc/ncidod/EID/13/1/28.htm).















Gardasil® is the only licensed vaccine for cervical cancer and other human papillomavirus
diseases before cervical cancer and beyond the cervix. Gardasil® has been filed in 120 countries
and approved in 50 countries (all under accelerated review timelines), including the European
Union, the United States, Canada and Australia. The four virus types (6,11,16,18) tathe vaccine cause the vast majority of genital human papillomavirus diseases.


In June 2006, just three weeks after approval of Gardasil® in the US, the US health authorities
recommended the routine vaccination of 11- and 12- year-old females and the catch-up
vaccination of females aged 13 to 26 who have not previously been vaccinated and that 9- and
10- year-old females can be vaccinated at the discretion of their physicians. In the meantime,
health insurers covering approximately 94% of privately insured lives in the US have decided to
reimburse Gardasil®. In November, the authorities added Gardasil® to their Vaccines for Children
(VFC) contract for girls and women aged 9 to 18.


Just four months after gaining a license in the European Union, Gardasil® is now available in 15
European countries***. As of 1 January 2007 vaccination is recommended in Austria for girls and
boys aged 9 to 15 years as well as for women, preferably before the start of sexual activity. In
Germany and France, decisions are anticipated soon. In Germany, three large statutory health
insurance funds, which together cover almost half of the German population, have announced
immediate and full reimbursement of human papillomavirus vaccination for females even before
any recommendations by the authorities have been published. The French health authorities
have announced a decision upon reimbursement by the national social security system for the
first trimester of 2007. Three large private health insurance funds have announced immediate
partial reimbursement of human papillomavirus vaccination also even before any
recommendations by the authorities have been published. Accelerated discussions are under
way in most European countries to integrate human papillomavirus vaccination in each country's
recommendation and reimbursement programme. Assessments of vaccination strategies in
Europe are under way with results expected to be published in the near future.



* Cervical Intraepithelial Neoplasia

** Cervical Intraepithelial Neoplasia

*** Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, the Netherlands, Norway, Portugal,
Sweden, Switzerland and the United Kingdom. Italy will follow during the first quarter and Spain during the second quarter 2007.


Sanofi Pasteur MSD is the only European company dedicated exclusively to vaccines


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