Welcome!

News Feed Item

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

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 MSD
Sylvia Martin-Jarrand
Tel: +33-4-37-28-40-55
Mob: +33-6-33-46-1365
[email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"Storpool does only block-level storage so we do one thing extremely well. The growth in data is what drives the move to software-defined technologies in general and software-defined storage," explained Boyan Ivanov, CEO and co-founder at StorPool, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, provided some practical insights on what, how and why when implementing "software-defined" in the datacent...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.
The need for greater agility and scalability necessitated the digital transformation in the form of following equation: monolithic to microservices to serverless architecture (FaaS). To keep up with the cut-throat competition, the organisations need to update their technology stack to make software development their differentiating factor. Thus microservices architecture emerged as a potential method to provide development teams with greater flexibility and other advantages, such as the abili...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.