Welcome!

News Feed Item

Gardasil®: New 2-dose Schedule Granted Positive CHMP Opinion for Europe's Leading HPV Vaccine

LYON, France, February 27, 2014 /PRNewswire/ --

European Committee for Medicinal Products for Human Use evaluated positively a 2-dose schedule for Gardasil® in adolescents

Sanofi Pasteur MSD announced today that its quadrivalent HPV vaccine, Gardasil® 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],[ 3],[ 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)]

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 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[3], 385-393.
  5. Gardasil SmPC

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
SYS-CON Events announced today that Akvelon will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Akvelon is a business and technology consulting firm that specializes in applying cutting-edge technology to problems in fields as diverse as mobile technology, sports technology, finance, and healthcare.
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, will introduce two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a...
SYS-CON Events announced today that Datera will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera offers a radically new approach to data management, where innovative software makes data infrastructure invisible, elastic and able to perform at the highest level. It eliminates hardware lock-in and gives IT organizations the choice to source x86 server nodes, with business model option...
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, Cloud Expo and @ThingsExpo are two of the most important technology events of the year. Since its launch over eight years ago, Cloud Expo and @ThingsExpo have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, I provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading the...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., discussed how these tools can be leveraged to develop a lasting competitive advantage ...
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business - from apparel to energy - is being rewritten by software. From planning to development to management to security, CA creates software that fuels transformation for companies in the applic...
SYS-CON Events announced today that Elastifile will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Elastifile Cloud File System (ECFS) is software-defined data infrastructure designed for seamless and efficient management of dynamic workloads across heterogeneous environments. Elastifile provides the architecture needed to optimize your hybrid cloud environment, by facilitating efficient...
“Why didn’t testing catch this” must become “How did this make it to testing?” Traditional quality teams are the crutch and excuse keeping organizations from making the necessary investment in people, process, and technology to accelerate test automation. Just like societies that did not build waterways because the labor to keep carrying the water was so cheap, we have created disincentives to automate. In her session at @DevOpsSummit at 20th Cloud Expo, Anne Hungate, President of Daring System...
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?
Most companies are adopting or evaluating container technology - Docker in particular - to speed up application deployment, drive down cost, ease management and make application delivery more flexible overall. As with most new architectures, this dream takes a lot of work to become a reality. Even when you do get your application componentized enough and packaged properly, there are still challenges for DevOps teams to making the shift to continuous delivery and achieving that reduction in cost ...
"Cloud computing is certainly changing how people consume storage, how they use it, and what they use it for. It's also making people rethink how they architect their environment," stated Brad Winett, Senior Technologist for DDN Storage, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We provide IoT solutions. We provide the most compatible solutions for many applications. Our solutions are industry agnostic and also protocol agnostic," explained Richard Han, Head of Sales and Marketing and Engineering at Systena America, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.