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US FDA licenses Sanofi Pasteur's new pediatric combination vaccine, pentacel
Date:6/23/2008

Swiftwater, PA - Lyon, France - June 23, 2008 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Pentacel®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel® vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel® vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday).

Pentacel® vaccine is the first and only four-dose diphtheria, tetanus, and acellular pertussis (DTaP)-based combination vaccine for use in infants and young children in the U.S. that includes both poliovirus and Hib antigens.

Pentacel® vaccine is approved for administration as a four-dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. According to the current Recommended Childhood Immunization Schedule of the U.S. Centers for Disease Control and Prevention (CDC), up to 23 injections are needed by the time a child reaches 18 months of age with single-entity vaccines. The use of Pentacel® vaccine could reduce that number of shots by seven.

"Pentacel® vaccine will help simplify the immunization schedule by reducing the number of injections infants and young children will receive in their first two years of life," said Wayne Pisano, President and Chief Executive Officer, sanofi pasteur. Pentacel® vaccine has been used in Canada for a decade and is licensed in seven other countries. "We are pleased that the U.S. FDA has now taken this important step, to make the convenience of Pentacel® vaccine available to health-care providers and parents in the U.S.," Pisano added.

"The FDA approval of Pentacel® vaccine is great new
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Contact: Len Lavenda
len.lavenda@sanofipasteur.com
570-839-4446
Publicis Consultants | PR
Source:Eurekalert

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