Sanofi Pasteur Announces FDA Has Expanded Age Indication of Adacel® Tdap Vaccine to Include Persons 10 Years of Age

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Approval reinforces the safety profile of Adacel as an active booster immunization for the prevention of tetanus, diphtheria, and pertussis

April 1, 2014

Sanofi Pasteur, the vaccines division of Sanofi, 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 Pertussis
Pertussis, also known as whooping cough, is a highly contagious and often serious disease, especially in young children.2,3In adolescents and adults, it often presents as a severe and episodic cough that may last for weeks and even months.4Pertussis 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.5Pertussis 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

Indication
Adacel 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 Information
Side 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.

For more information about Adacel vaccine, please see the full Prescribing Information available atwww.sanofipasteur.us or www.vaccineshoppe.com.

About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris(EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us.

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