FDA Approves Children's DTaP-IPV Vaccine

The FDA today approved a vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis for children aged 4 to 6 years.

Quadracel combines the diphtheria and tetanus toxoids and acellular pertussis adsorbed vaccine (DTaP) and the inactivated poliovirus vaccine (IPV).

Quadrecel’s approval was based on the results of a phase 3 study, which demonstrated that Quadracel has a similar safety and immunogenicity profile as the DTaP vaccine and IPV when administered separately.

Side effects may include pain, redness, and swelling at the injection site, as well as muscle pain, fatigue, and headache. Patients also face a small risk of allergic reaction, according to Sanofi Pasteur, Quadracel’s manufacturer.

David P. Greenberg, MD, vice president of US Scientific and Medical Affairs at Sanofi Pasteur noted in a press release that Quadracel could reduce the number of vaccinations that children aged 4 to 6 need to receive.

“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,” Dr. Greenberg said.