Sanofi Pasteur has received approval from US Food and Drug Administration (FDA) for its Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine.
The FDA granted approval for the vaccine for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in children between the ages of four and six.
Sanofi Pasteur US scientific and medical affairs vice-president Dr David Greenberg said: “The FDA approval of Quadracel vaccine provides healthcare providers with a new combination vaccine, potentially reducing the number of vaccine injections children aged four through six would need.
“According to Sanofi, the vaccine demonstrated similar safety and immunogenicity profiles compared to those of separately administered daptacel and IPOL vaccines.”
“Our goal is to help remove barriers to timely immunisation and we think this combination vaccine could help ensure children are getting vaccinated in line with current recommendations.”
Approval was based on data from a pivotal multicentre, randomised and controlled Phase III trial, developed to compare the safety and immunogenicity of Quadracel vaccine with daptacel (DTaP) and IPOL (IPV) vaccines in children between the ages of four and six who were previously vaccinated with daptacel or pentacel (DTaP-IPV/Hib) vaccines.
According to Sanofi, the vaccine demonstrated similar safety and immunogenicity profiles compared to those of separately administered daptacel and IPOL vaccines.
The Quadracel vaccine was approved for use in children between the ages of four and six as a fifth dose in the DTaP series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series in children who received four doses of pentacel or daptacel.
The Centers for Disease Control and Prevention (CDC) recommended children between the ages of four and six receive both their fifth dose of the diphtheria, tetanus and acellular pertussis (DTaP) vaccine series and their fourth dose of inactivated poliovirus (IPV) vaccine series for protection from life-threatening diseases.
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