Send to printer »

GEN News Highlights : Jan 26, 2007

FDA Recommends Licensure of Sanofi Pasteur’s Pediatric Combination Vaccine

If approved, Pentacel would be the first pediatric combination vaccine in the U.S. to immunize against diphtheria, tetanus, pertussis, polio, and haemophilus influenzae type b.

Sanofi pasteur reports that the FDA found that the company's pentavalent combination vaccine for use in pediatric patients that reduces the number of shots required is both safe and efficacious. Pentacel® vaccine protects against diphtheria, tetanus, pertussis, polio, and haemophilus influenzae type b (Hib).

According to the company, the Advisory Committee on Immunization Practices states that up to 23 injections are needed through 18 months of age. The use of Pentacel vaccine could reduce that number to 16.

Pentacel vaccine is licensed for pediatric use in nine countries, including Canada, where it has been used universally in infants and young children since 1998, says sanofi pasteur. Over 12.5 million doses of Pentacel vaccine have been distributed in Canada.

The company states that Pentacel vaccine is the first DTaP-based combination vaccine candidate for use in infants in the U.S. that includes both polio and Hib vaccine components. The diphtheria, tetanus, and pertussis components in Pentacel vaccine are based on the formulation in DAPTACEL®—diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP vaccine)—which sanofi pasteur introduced in the U.S. in 2002.