Gardasil® Approved in the European Union for a 2-dose Schedule in Children Aged from 9 to 13 Years

  Gardasil® Approved in the European Union for a 2-dose Schedule in Children
                           Aged from 9 to 13 Years

  PR Newswire

  LYON, France, April 7, 2014

LYON, France, April 7, 2014 /PRNewswire/ --



 A new 2-dose regimen for Gardasil®, quadrivalent HPV vaccine, now available
                              for adolescents 

Sanofi Pasteur MSD announced today that the European Commission has granted
marketing authorization for its quadrivalent Human Papillomavirus (HPV)
vaccine, Gardasil ^® , for a 2-dose schedule at 0 and 6 months in children
aged from 9 to 13 years.

" We are delighted to be able to offer this new, 2-dose schedule. It is based
on data showing that 2 doses elicited a immune response in adolescents
comparable to that of 3 doses in young women to the four HPV types  -  6,
11, 16 and 18  -  included in Gardasil ^® ," said Dr Stephen Lockhart, Vice
President, Development of Sanofi Pasteur MSD. " These results are sustained 3
years after vaccination, which indicates that a 2 dose 0-6 month schedule of
Gardasil ^® , is able to induce high antibody levels for protection against
HPV-diseases , " concluded Dr Lockhart.

The approval of this new schedule for Gardasil ^® follows the positive opinion
from the European Medicines Agency (EMA) granted in February, based on a
Canadian study performed by Dobson et al. It demonstrates that the 2-dose 0, 6
month schedule in 9-13 year old girls elicited an immune response
comparable/non-inferior to that of 3 doses in the 16-26 year old women, the
population where quadrivalent vaccine efficacy has been shown. These results
were sustained at 36 months of follow-up. ^[ ^1* ^]

Adolescents aged 14 years and above should still receive 3 doses at 0, 2 and 6
months. For children aged 9 to 13 years, the 3-dose schedule can alternatively
be given, in accordance with national recommendations and immunisation
programmes currently in use. ^[ ^2 ^]

Gardasil ^® is the only quadrivalent HPV vaccine indicated in adolescent girls
and boys to help protect against cervical cancer, vulvar and vaginal
precancers as well as genital warts. ^[ ^1 ^]

Data recently published from a study in Australia showed the rapid impact of
Gardasil ^® on disease in the real-world setting, with a strong reduction in
high grade pre-cancerous cervical lesions in young women at population level.
^[ ^3 ^] Australian national vaccination programmes with Gardasil ^® also
resulted in the near disappearance of genital warts in Melbourne area in women
under 21 years of age. ^[ ^4 ^]

To date, more than 29 Million doses of Gardasil ^® have been distributed in
Western Europe, helping to protect futures of millions of adolescents. ^[ ^5
^]

Gardasil ^® is indicated in girls and boys from 9 years of age for the
prevention of premalignant genital lesions (cervical, vulvar and vaginal) and
cervical cancer causally related to certain oncogenic Human Papillomavirus
(HPV) types as well as genital warts (condyloma acuminata) causally related to
specific HPV types.

*the duration of protection of a 2-dose schedule has not been established 

About Gardasil ^® ^

Gardasil® 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® 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 in 2006 and manufactured by Merck, it is the most widely used HPV
vaccine worldwide with approximately 144 million doses distributed globally to
date.

About HPV 

In a study of 26 European countries, HPV types 16 and 18 were estimated to
result in around 48,000 new cancer cases every year. ^[ ^3 ^]

Genital warts are widespread in young adults, and their incidence in many
European countries is increasing. ^[ ^7 ^] ^, ^[ ^8 ^] Although genital warts
are not life-threatening, their treatment is long, painful and often
unsatisfactory, with high recurrence rates. ^[6 ^] Genital warts can also have
a significant psychosocial impact - causing feelings of anxiety, depression,
anger, shame and embarrassment. ^[ ^7 ^]

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
distribution 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- Gardasil® Summary of Product Characteristics.

3- Crowe E et al. Effectiveness of quadrivalent human papillomavirus vaccine
for the prevention of cervical abnormalities: case-control study nested within
a population based screening programme in Australia. BMJ 2014;348:g1458 doi

4- Read 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 Dec;87(7):544-7

5- SPMSD internal data. 2014

6- Hartwig S et al. Estimation of the epidemiological burden of human
papillomavirus-related cancers and non-malignant diseases in men in Europe: a
review. BMC Cancer 2012;12:30.

7- Dominiak-Felden G et al. Impact of human papillomavirus-related genital
diseases on quality of life and psychosocial wellbeing: results of an
observational, health-related quality of life study in the UK. BMC Public
Health 2013;13:1065.

8-Patel H et al. Systematic review of the incidence and prevalence of genital
warts. BMC Infect Dis 2013;13:39.

For further information please contact:

Sanofi Pasteur MSDSylvia Martin-Jarrand Tel: +33-4-37-28-40-55 Mob:
+33-6-33-46-1365 smartin-jarrand@spmsd.com
 
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