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Sanofi Pasteur Announces FDA Has Expanded Age Indication Of AdacelA® Tdap Vaccine To Include Persons 10 Years Of Age

SWIFTWATER, Pa., April 1, 2014 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has expanded the approved age indication of Adacel ® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; Tdap) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 10 through 64 years of age.

"We are pleased the FDA has expanded the age indication for Adacel vaccine, especially in a time when we have seen increases in reports of pertussis, commonly referred to as whooping cough," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "This approval not only reinforces the safety profile of Adacel, but importantly provides an additional opportunity to vaccinate a younger age group to help prevent this highly contagious disease."

The FDA approval was based on data from a Phase IV, open label, multi-center trial to evaluate the safety and immunogenicity of a single dose of Adacel vaccine in persons 10 years of age compared with those in persons 11 years of age. Antibody responses to all of the vaccine antigens (tetanus, diphtheria, and pertussis) and rates of adverse reactions were similar in the two age groups.

To reduce pertussis morbidity in adolescents and adults and maintain the standard of care for tetanus, diphtheria, and pertussis protection, the U.S. Centers for Disease Control and Prevention recommends that persons in these age groups receive a single dose of a Tdap vaccine because immunity from early childhood vaccination wanes over time. 1

Adacel vaccine was licensed in the United States by the FDA in June 2005 to address pertussis protection for people 11 through 64 years of age. Adacel vaccine provides demonstrated immunogenicity against tetanus, diphtheria, and pertussis, and has a safety profile similar to that of tetanus-diphtheria (Td) vaccine.

About PertussisPertussis, also known as whooping cough, is a highly contagious and often serious disease, especially in young children. 2,3 In adolescents and adults, it often presents as a severe and episodic cough that may last for weeks and even months. 4 Pertussis is caused by bacteria called Bordetella pertussis, found in the nose and throat of persons with the disease; it is spread through contact with respiratory droplets generated by coughing or sneezing. 1,2

Pertussis is often undiagnosed or misdiagnosed in adults, leading to vast underreporting of the disease. 5 Estimates indicate that there may be as many as 800,000 to 3.3 million adult and adolescent cases of pertussis in the U.S. in any given year. 5 Pertussis disease can be treated with antibiotics. 6 If caught early enough, antibiotic treatment may help lessen disease severity. 6 Antibiotic therapy also helps reduce transmission and is important for disease control. 6

About Adacel Vaccine

IndicationAdacel vaccine is given as a single dose to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough).

Safety InformationSide effects to Adacel vaccine include pain, redness, and swelling at the injection site; headache, body ache or muscle weakness, and tiredness. Other side effects may occur. Tell your doctor if you have ever experienced a severe brain disorder, such as encephalopathy (altered consciousness), Guillain-Barre syndrome (severe muscle weakness), brachial neuritis (inflammation of nerves in the arms), or an Arthus-type reaction (severe, exaggerated swelling involving an injection site) after a previous dose of a tetanus toxoid- or pertussis-containing vaccine.

There is a small risk of allergic reactions (eg, anaphylaxis). Some signs of allergic reactions are hives, swelling of the throat, low blood pressure, shock, and difficulty breathing. If you begin to experience any of these signs seek treatment right away. These reactions are rare and usually occur before leaving the doctor's office. If you notice any other problems or symptoms following vaccination, please contact your health care professional promptly. Fainting can happen after getting Adacel vaccine. The tip caps of the prefilled syringes may contain natural rubber latex that may cause allergic reactions in latex-sensitive individuals. Vaccination with Adacel vaccine may not protect all people receiving the vaccine.

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