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U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R)
Date:6/23/2008

Pentacel(R) 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(R) 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(R) 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(R) vaccine should be based on the potential benefits and risks; if Guillain-Barre 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(R) vaccine may not protect all individuals.

Before administering Pentacel(R) vaccine, please see accompanying full Prescribing Information.

The full Prescribing Information for Pentacel(R) vaccine is available on http://www.pentacel.com and http://www.vaccineshoppe.com. More than 14 million doses of Pentacel(R) vaccine have been distributed in Canada since 1997. Pentacel(R) vaccine is expected to be available for distribution in the U.S. this summer.

Sanofi Pasteur's U.S. operations in Swiftwater, PA have long been committed to providing vaccines to prevent childhood diseases. In 1987, it licensed the first Hib conjugate vaccine. And in 1996, it was the first company to license a DTaP vaccine for use in infants (Tripedia(R)(e) vaccine). In 2005, sanofi pasteur continued its tradition of innovation b
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SOURCE Sanofi Pasteur
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