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Vaccines for Tomorrow
The scope of Sanofi Pasteur’s Research & Development (R&D) activities is vast and complex, encompassing the entire chain of events before a new vaccine becomes available – from understanding a disease and its biological foundations, to clinical development and testing, to obtaining health authorities’ approval for marketing the new vaccine.
Globally, we have currently 14 vaccines in development or submitted for approval to meet the specific needs of different segments of the population (flu, vaccines combination, etc.) or unmet medical needs (dengue, hospital-acquired infections, etc.).
Dengue is a mosquito-borne disease caused by four types of dengue virus (1 to 4). It occurs mostly in tropical and subtropical countries and its global incidence has grown dramatically in recent decades. About half of the world's population is now at risk.
WHO currently estimates there may be 50-100 million dengue infections worldwide every year of whom 500,000—mostly children—develop dengue hemorrhagic fever (DHF), a severe form of the disease. DHF is a leading cause of hospitalization, placing tremendous pressure on strained medical resources and having a heavy economic and societal impact.
Dengue is a health priority in many countries of Latin America and Asia where epidemics occur. Many factors contribute to the spread of dengue fever, including urbanization and increased travel which facilitate the dissemination and the circulation of this disease.
As there is no specific treatment for dengue, vaccination and disease eradication are the only hopes in the fight against dengue fever. Sanofi Pasteur researchers have been working to develop a vaccine against dengue since 1992.
Additional information about dengue and the Sanofi Pasteur dengue vaccine candidate are available at http://www.dengue.info.
Hospital Acquired Infections
Hospital-acquired infections are a major concern for public health in many industrialized countries and cause significant annual costs to the healthcare systems.
Clostridium difficile infections (CDI) have become a considerable problem in North America and Europe. They are the leading cause in hospitals of infectious diarrhea in adults, particularly the elderly. The incidence of C. difficile infections has been increasing at an alarming rate for fifteen years, driven primarily by the emergence of highly virulent treatment resistant, strains. Although the number of new cases tends today to stabilize, the disease remains very severe. There is currently no vaccine available.
Sanofi Pasteur’s vaccine candidate is being developed for primary prevention of C. difficile infection. Sanofi Pasteur has chosen a well established approach for this vaccine. Toxoids have been used as the basis of a number of highly successful vaccines (against tetanus, diphtheria and pertussis).
A phase II study is under way in the US. In 2010, The U.S. Food and Drug Administration (FDA) granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The FDA’s fast-track program is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Most serious Pseudomonas aeruginosa (Pa) infections occur in hospitalized and critically or chronically ill patients - primarily affecting the respiratory system in susceptible individuals - and are a serious clinical problem due to their resistance to antibiotics.
Sanofi Pasteur has signed an agreement with a biotech company for the development of an antibody fragment to prevent Pseudomonas aeruginosa infections.
More than 2 billion people, equal to one-third of the world’s population, are infected with TB bacilli, the microbes that cause tuberculosis. People infected with TB bacteria have a lifetime risk of falling ill with TB of 10%. In 2011, 8.7 million people fell ill with TB resulting in 1.4 million deaths.
The only TB vaccine (BCG--attenuated Bacille Calmette Guérin) used in the world today was developed over 80 years ago. A TB vaccine is especially important in areas of the world where TB is highly prevalent and the chances of an infant or young child becoming exposed to an infectious case are high. Although BCG is effective in protecting infants against childhood forms of the disease, a more effective vaccine is needed for protection of adolescents and adults against pulmonary tuberculosis.
Research is focused on a vaccine against tuberculosis. By relying on a network of partnerships with public institutions and biotech companies, Sanofi Pasteur’s global research department has significantly increased its options. In 2008, Sanofi Pasteur signed a collaborative agreement with Denmark’s Statens Serum Institut to develop a new tuberculosis vaccine. Enrollment in the Phase I clinical trial was completed in 2008 and analysis of the clinical samples is ongoing.
With the global death toll from the disease the need for a new tuberculosis vaccine is particularly important.
Acquired Immunodeficiency Syndrome (AIDS)
The World Health Organization estimates that since the start of the epidemic, HIV has cost the lives of more than 25 million people. In 2011, more than 34 million people were living with HIV.
Despite the intense international response to the HIV/AIDS pandemic, HIV continues to spread, causing more than 7,000 new infections every day.
Sanofi Pasteur has been taking part in the global effort to develop an HIV vaccine for more than 20 years, in partnership with a number of leading governmental agencies and Pox-Protein-Public Private Partnership companies.
Over the years, we have developed several vaccine candidates that have been the subject of clinical studies. The Phase III, RV144 trial in Thailand − sponsored by the U.S. Military HIV Vaccine Research Program and including Sanofi Pasteur’s ALVAC-HIV® vaccine – for the first time showed that an HIV vaccine is possible.
This trial was conducted in partnership not only with the US Army, but also with Vaxgen (acquired by Global Solutions for Infectious Diseases (GSID) during the trial), the National Institutes of Health, Mahidol University, the US National Institute of Allergy and Infectious Diseases, the Ministry of Health in Thailand and the Royal Thai Army Medical Department. In-depth analysis of RV144 results showed a 60% vaccine efficacy in the first year, which fell to 31% by the end of the 6-year trial.
Based on these results, a new collaboration, called the Pox-Protein-Public Private Partnership (P5), has been established to substantiate and extend the results obtained in RV144.
The Pox-Protein-Public Private Partnership (P5) members are:
- National Institute of Allergy and Infectious Diseases of the U.S. NIH
- Bill & Melinda Gates Foundation
- HIV Vaccine Trials Network
- US Military HIV Research Program
- Sanofi Pasteur
- Novartis Vaccines and Diagnostics
To know more about the P5 click here
New and next generation vaccines for every stage of life
Infants. Globally, Sanofi Pasteur is continuing efforts toward polio eradication and preventing respiratory and meningeal infections that cause severe sequelae in infants; new pediatric combination vaccines are being developed to immunize against up to six childhood diseases simultaneously, reducing the number of injections required, increasing coverage and improving public health.
Adolescents. Sanofi Pasteur scientists are making strides in four directions: combating sexually-transmitted infections, increasing protection against the devastating effects of meningitis, and developing booster vaccines against polio and pertussis.
Adults and the Elderly. Sanofi Pasteur is developing vaccines focused on the fight against respiratory tract infections such as influenza and pneumonia.