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
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...
The paradigm has shifted. A Gartner survey shows that 43% of organizations are using or plan to implement the Internet of Things in 2016. However, not just a handful of companies are still using the old-style ad-hoc trial-and-error ways, unaware of the critical barriers, paint points, traps, and hidden roadblocks. How can you become a winner? In his session at @ThingsExpo, Tony Shan will present a methodical approach to guide the holistic adoption and enablement of IoT implementations. This ov...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., will focus on real world deployments of DDoS mitigation strategies in every layer of the network. He will give an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He will also outline what we have found in our experience managing and running thousands of Linux and Unix managed service platforms and what specifically c...