NEW YORK, Jul 30 (Reuters) -- A new combined diphtheria, tetanus, and acellular pertussis (DTaP) vaccine has been approved by the US Food and Drug Administration (FDA), according to the National Institute of Child Health and Human Development (NICHD), which owns the rights to the patent on the vaccine.
The vaccine, which will be marketed under the name Certiva, contains an acellular pertussis component that is reported to have fewer side effects than older forms of the pertussis vaccine. The Certiva vaccine is indicated for immunization against diphtheria, tetanus, and pertussis (whooping cough) in infants and children who are 6 weeks to 7 years of age.
Certiva contains a pertussis toxoid that was purified and detoxified by Dr. John Robbins at the NICHD, reported the federal agency, which is licensing the product to North American Vaccine.
"The extensive studies done on this vaccine clearly show safety and protection against pertussis from a single antigen," said Dr. Duane Alexander in a statement released by the NICHD. "Its availability in the US brings to our children the benefits of this important research advance," said Alexander, the director of NICHD.
FDA licensure of the product was based on several studies, including trials on 3,450 infants in Sweden and 3,715 infants and children in the US.
"None of the infants and children who received the vaccine in the efficacy study experienced hypotonic-hyporesponsive episodes, and the rates of local reactions -- such as soreness, redness and swelling -- were quite low," said Dr. John Taranger, of the University of Goteborg, an investigator in the Swedish trial. A hypotonic-hyporesponsive episode is a rare reaction to immunization in which a child collapses and is unresponsive.
