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news.The FDA has accepted a biologics licensing application from Sanofi Pasteur for Pentacel, the company's pediatric combination vaccine candidate that targets diphtheria, tetanus, pertussis, polio, and haemophilus influenzae type b.
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Pentacel vaccine is the first DTaP-based combination vaccine candidate for use in infants in the US that includes both polio and Hib vaccine components.
The vaccine is already licensed for pediatric use in nine countries, including Canada, where it has been used universally in infants and young children since 1998.
The diphtheria, tetanus, and pertussis components in Pentacel vaccine are based on the formulation in Daptacel, which was introduced by Sanofi Pasteur in the US in 2002.
In clinical trials, Pentacel vaccine was administered as a four-dose series at 2, 4, 6 and 15-18 months of age, concomitantly with other recommended childhood vaccines.
“Pentacel vaccine could be easily integrated into the recommended childhood vaccination schedule,” said Dr Steven Black, co-director, Kaiser Permanente Pediatric Vaccine Study Center. “In addition, this combination vaccine has the potential to protect against five diseases in a single injection.”