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FDA approves Quadracel as DTaP, IPV vaccine
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Sanofi Pasteur announced today that the FDA has approved Quadracel, a DTaP and inactivated poliovirus vaccine, for use among children aged 4 through 6 years.
The approval is based on data from a multicenter, randomized, controlled phase 3 study that compared safety and efficacy of Quadracel vs. Daptacel (DTaP, Sanofi Pasteur) and Ipol (IPV, Sanofi Pasteur). Study participants had been previously vaccinated with DTaP or Pentacel (DTaP-IPV-Hib, Sanofi Pasteur). Results indicated Quadracel had similar immunogenicity and safety as Daptacel and Ipol vaccines.
Quadracel can be administered to children aged 4 through 6 years as a fifth dose in the DTaP vaccine series or as a fourth or fifth dose in the IPV vaccine series, according to a company press release.
“The FDA approval of Quadracel vaccine provides health care providers with a new combination vaccine, potentially reducing the number of vaccine injections children aged 4 through 6 would need,” David P. Greenberg, MD, vice president of U.S. scientific and medical affairs at Sanofi Pasteur, said in the release. “Our goal is to help remove barriers to timely immunization, and we think this combination vaccine could help ensure children are getting vaccinated in line with current recommendations.” – by Amanda Oldt