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Media Statement – Sanofi Pasteur MSD Rejects Opinion of Regional French Compensation Group in Gardasil Vaccination Claim
25 November 2013; Sanofi Pasteur MSD rejects the outcome of the Bordeaux Regional Commission for Conciliation and Compensation (CRCI) in France and strongly supports the safety profile of the HPV vaccine, Gardasil, for the prevention of cervical cancer and other HPV-related diseases.
The health and safety of patients is an absolute priority for Sanofi Pasteur MSD and the company closely monitors the efficacy and safety of all its vaccines. Over 134 million doses of Gardasil® have been distributed throughout the world since its launch in June 2006 and studies have demonstrated the safety profile of the vaccine. Furthermore, the WHO GACVS has reviewed updated information about the safety of HPV vaccines and the Committee continues to support the safety profile of these vaccines. 4
The case that has been reviewed by the French compensation body involves a young woman who claims to have developed Multiple Sclerosis (MS) following vaccination with Gardasil. The available scientific evidence does not support any causal link between HPV vaccination and the onset of multiple sclerosis nor any increased risk of developing the disease.
The opinion from the CRCI has attributed a causal effect of 50% to the vaccine, which is against the weight of scientific evidence. The CRCI decision in this case is based only on the time coincidence between the onset of the disease and the vaccination. No scientific proof of a causal link has been established and the fact that a disease appears after vaccination doesn’t mean that the vaccine has caused this disease.1,2,3 Unfortunately people do sometimes experience adverse events whether or not they have been vaccinated.
Sanofi Pasteur MSD regrets the conclusions of the CRCI which have not been based on scientific evidence and which could lower confidence in Gardasil® and HPV vaccination, exposing young women to the risk of HPV disease.
1 Siegrist et al.Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infec Dis J 2007; 26: 979-984
2 Rasmussen et al. Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: nationwide population based cohort study. BMJ 2012; 345:e5823
3 Klein et al. Rates of autoimmune diseases in Kaiser Permanents for use in vaccine adverse event safety studies. Vaccine 2010; 28:1062-1068
4 WHO GACVS Safety update on HPV Vaccines – Geneva, 13 June 2013, available at : http://www.who.int/vaccine_safety/committee/topics/hpv/130619HPV_VaccineGACVSstatement.pdf
About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.
For further information please contact:
Media Office, Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
Pivotal study of investigational 9-valent HPV vaccine demonstrates additional protection against HPV-related disease
Immunogenicity non-inferior to GARDASIL for original four HPV types
Lyon, 4 November 2013 – Sanofi Pasteur MSD reported today that Merck’s investigational 9-valent Human Papilloma Virus (HPV) vaccine, V503, prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by five additional HPV types in its pivotal Phase III efficacy study.
The study also showed that V503 generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Gardasil. The frequencies of adverse event reports were also generally comparable between V503 and Gardasil.
Merck’s investigational 9-valent HPV vaccine includes five more HPV types (31, 33, 45, 52, 58) in addition to the four original HPV types in its Gardasil vaccine (6, 11, 16, 18). The vaccine is being developed to provide protection against 9 types of the HPV virus that are known to cause HPV related cervical/genital cancers. The vaccine’s efficacy against these additional virus types is a major step in the battle against HPV-related disease.
“In the Phase III studies being presented for the first time, V503 prevented approximately 97 percent of high-grade cervical, vulvar and vaginal diseases caused by five additional HPV types,” said study investigator Elmar Joura M.D., Associate Professor of Gynecology and Obstetrics, Medical University of Vienna and Comprehensive Cancer Center, Vienna, Austria.
These data, along with results of two other Phase III studies, are being presented for the first time at the EUROGIN congress (European Research Organization on Genital Infection and Neoplasia) in Florence, Italy on Tuesday 5 November 2013.
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For further information please contact:
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between Merck, known as MSD outside the USA and Canada and Sanofi Pasteur, the vaccine division of Sanofi. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe.
Results from the pivotal Phase III efficacy study
The pivotal Phase III study evaluated the efficacy, safety and immunogenicity of V503 (n=7,099) compared to Gardasil (n=7,105) in 16-26 year old females who were not infected with the relevant HPV types at enrollment and who remained free of infection with the relevant HPV types through Month 7. All three doses of the vaccines were given within one year.
The results were as follows:
- 96.7% reduction in the combined incidence of high-grade cervical/vulvar/vaginal disease [CIN (cervical intraepithelial neoplasia) 2/3+, VIN (vulvar intraepithelial neoplasia) 2/3+, and VaIN (vaginal intraepithelial neoplasia) 2/3+] caused by HPV types 31, 33, 45, 52, 58 (1 case in the group that received V503 vs. 30 cases in the group that received Gardasil).
- 97.1% reduction in the combined incidence of cervical/vulvar/vaginal disease of any grade (all CIN, VIN, VaIN) caused by HPV types 31, 33, 45, 52, 58 (3 cases in the group that received V503 vs. 103 cases in the group that received Gardasil).
- 96.0% efficacy against six-month persistent HPV infection with HPV types 31, 33, 45, 52, 58 (35 cases in the group that received V503 vs. 810 cases in the group that received Gardasil).
Significance of non-inferiority outcome
Non-inferior immunogenicity for the four HPV types (6, 11, 16, 18) that are in V503 and in Gardasil was also a primary endpoint in this study. Because Gardasil has been shown in clinical studies to be highly effective against certain diseases caused by HPV types 6, 11, 16, and 18, few disease endpoints caused by these HPV types were expected, making it difficult to directly assess efficacy of V503 for these four types.
Therefore, antibody levels were evaluated for these four HPV types common to both vaccines. V503 generated immune responses for HPV 6, 11, 16, and 18 at Month 7 that were non-inferior to those generated by Gardasil. These results support bridging of the efficacy findings for Gardasil for HPV types 6, 11, 16, 18 to V503.
WHITEHOUSE STATION, N.J., Oct. 23, 2013 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that ZOSTAVAX® (Zoster Vaccine Live), the company’s vaccine to help prevent shingles, received the Prix Galien USA 2013 Award for Best Biotechnology Product.
“Merck is honored to have been chosen as a recipient of this prestigious award,” said
Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This achievement is a testament to the remarkable contributions of everyone at Merck who played a role in helping to bring ZOSTAVAX to market.”
The Prix Galien Award recognizes the pharmaceutical industry’s outstanding achievement in the development of new medicines. An internationally recognized award, the Prix Galien was founded in France in 1969 by French pharmacist Roland Mehl and is considered the highest accolade for pharmaceutical research and development.
This latest award for ZOSTAVAX is Merck’s sixth Prix Galien USA award in seven years. The company was previously recognized for VICTRELIS (2012), ROTATEQ (2010), ISENTRESS (2008), and JANUVIA and GARDASIL (2007). In total, around the world, Merck has won the Prix Galien more than 30 times, making Merck one of the two most-awarded companies of all time.
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Media Contact: Caroline Lappetito
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
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