TUESDAY, SEPTEMBER 27, 2016

FDA approves Quadracel DTaP-IPV vaccine

The U.S. Food and Drug Administration (FDA) recently approved Sanofi Pasteur's Quadracel DTaP-IPV (Diphtehria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus) for use in children between 4 and 6 years old.

The immunization is meant to protect the children from poliomyelitis, pertussis, diphtheria and tetanus.

The FDA approved Quadracel following positive results from a pivotal multi center, controlled and randomized Phase II study. The study, which tested the immunogenicity and safety of Quadracel compared to other vaccines, showed that Quadracel produces  immune results similar to the other vaccines.

Health official from the U.S. Centers for Disease Control and Prevention have recommended that physicians administer the fifth dose of the DtaP vaccine and the fourth dose of the IPV vaccine to children ages 4 to 6. Physicians can use the new Quadracel vaccine as the fifth DTaP dose and the fourth IPV dose.

"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," Dr. David P. Greenberg, vice president for U.S. Scientific and Medical Affairs at Sanofi Pasteur, said. "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."

Organizations in this story

Sanofi Pasteur Discovery Drive Swiftwater, PA 18370

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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