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 fever

Dengue fever has increasing epidemiological importance due to global socio-climatic changes. The viral disease, which primarily affects children, occurs mostly in tropical and sub-tropical areas, and is spreading to new parts of the globe every year. Dengue fever is a threat to almost half of the world’s population in more than 100 tropical and subtropical countries and territories, and kills an average of 21,000 people each year. It is also one of the leading causes of fever among travelers.

Transmitted by mosquito bites, it causes severe flu-like symptoms, which can lead to fatal hemorrhagic fever.

Sanofi Pasteur is studying the efficacy of its new Dengue vaccine which would be expected in 2015.

Multiple approaches have been tested to develop a vaccine covering the dengue’s four viral serotypes in order to prevent this disease and its severe complications (hemorrhagic fever). Results of a Phase II clinical trial in adults in the United States demonstrated proof of concept of the lead vaccine candidate that is based on the ChimeriVax™ technology. Sanofi Pasteur works with the WHO and the Pediatric Dengue Vaccine Initiative, a program of the International Vaccine Institute funded by the Gates Foundation to make dengue a vaccine preventable disease and to accelerate vaccine introduction in pediatric populations where the disease is endemic through disease burden evaluation, vaccine advocacy and vaccine access. Sanofi Pasteur’s dengue vaccine research program includes ongoing clinical studies (adults and children) in endemic regions such as Asia and Latin America.

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.

Clostridium difficile is a major public health concern in North America and Europe. It is the leading cause in hospitals of infectious diarrhea in adults, particularly the elderly. The epidemiology of C. difficile associated disease (CDAD) has been increasing at an alarming rate since 2003, driven primarily by the emergence of a treatment resistant, highly virulent strain CD027. There is currently no vaccine available.

Sanofi Pasteur’s candidate vaccine against Clostridium difficile is a toxoid-based vaccine. A Phase II study is under way. While the target indication for the vaccine is prevention, this trial — with recently infected patients — aims to provide early proof-of-concept of a vaccine approach for the prevention of recurring infection.

Staphylococcus aureus.

Staph infections, including Methicillin-Resistant Staphylococcus aureus (MRSA), occur most frequently among persons in hospitals and healthcare facilities (such as nursing homes and dialysis centers) who have weakened immune systems. MRSA are responsible for several difficult-to-treat infections in humans because these bacteria are resistant to a large group of antibiotics, including penicillins. MRSA is now endemic in many hospitals, being one of the leading causes of nosocomial pneumonia and surgical site infection and the second leading cause of nosocomial blood stream infections.

On December 2009, Sanofi Pasteur entered into and exclusive, world-wide licensing agreement with a biotech company to develop and commercialize a prophylactic vaccine against Staphylococcus, including Methicillin-Resistant Staphylococcus aureus or MRSA.

Pseudomonas aeruginosa.

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.

On January 2010, Sanofi Pasteur announced an agreement with a biotech company for the development of an antibody fragment to both treat and prevent Pseudomonas aeruginosa infections.

Tuberculosis

More than 2 billion people, equal to one-third of the world’s population, are infected with TB bacilli, the microbes that cause TB. 1 in 10 people infected with TB bacilli will become sick with active TB in their lifetime; people with HIV are at much greater risk. The vast majority of TB deaths –approximately two million people each year- are in the developing world.

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 infected more than 60 million men, women and children and AIDS has cost the lives of nearly 20 million adults and children. Despite the intense international response to the HIV/AIDS pandemic, HIV continues to spread, causing more than 14,000 new infections every day, 95% of these are in the developing world. Today AIDS is the leading cause of death in Africa, and the fourth worldwide.

Sanofi Pasteur is taking part in the global effort to develop an HIV vaccine. In the nearly 20 years since Sanofi Pasteur's HIV vaccine development program was established, the Company has collaborated with a number of leading governmental agencies and pharmaceutical companies. These collaborations have led to major advances in research, clinical study design and implementation.

A 6-year collaborative HIV vaccine trial in Thailand, completed in 2009, has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. This is the first concrete evidence, since the discovery of the HIV virus in 1983, that a vaccine against HIV is potentially feasible.

Sanofi Pasteur will continue its long-standing commitment to HIV vaccine research and development efforts by partnering with academia, governments, non-governmental organizations, and other vaccine companies to progress the science, so that one day we will be able to provide access to HIV vaccines to people who need them.

New and improved 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.