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US FDA licenses Sanofi Pasteur's new pediatric combination vaccine, pentacel

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 news for parents and pediatricians who want to reduce the stress of well-baby visits," said Tina Q. Tan, M.D., infectious disease specialist, Children's Memorial Hospital, Chicago. "Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a four-dose primary series of Pentacel® vaccine, pediatricians can reduce the number of vaccination shots while providing protection against five diseases, including pertussis."

Pentacel® vaccine is also the first five-component (pentavalent) pediatric combination vaccine in the U.S. to contain sanofi pasteur's five acellular pertussis antigens, which are also used in its DTaP vaccine for children (DAPTACEL®[a] vaccine, licensed in 2002) and its tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents (Adacel®[b] vaccine, licensed in 2005). Pertussis is commonly known as whooping cough because of the sound some patientsespecially childrenmake while gasping for air during coughing spells.

The FDA licensure of Pentacel® vaccine is based on the results of multi-center clinical studies conducted in the U.S. and Canada involving more than 5,000 children who received at least one dose of Pentacel® vaccine. The immunogenicity of Pentacel® vaccine was compared to separately administered DAPTACEL, IPOL®[c] and ActHIB®[d] vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel® vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).

In clinical studies, local and systemic reactions following administration of Pentacel® vaccine were reported at rates consistent with those of the separately administered vaccines used in each trial. The most common local and systemic adverse reactions to Pentacel® vaccine include injection site redness, swelling and tenderness; fever, fussiness and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel® vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.

The decision to give Pentacel® vaccine should be based on the potential benefits and risks; if Guillain-Barr syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel® vaccine may not protect all individuals.


Contact: Len Lavenda
Publicis Consultants | PR

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