FDA To Review Lederle's DTaP-Hib
The US Food and Drug Administration has accepted for reviewWyeth-Lederle Vaccines and Pediatrics' Product License Application for the use of its DTaP-Hib vaccine (diphtheria, tetanus, whooping cough and Hemophilus influenzae type b), in children aged 12 to 18 months.
The vaccine, which will be marketed as Tetracel, combines two of Wyeth-Lederle's currently-marketed vaccines, Acel-Imune (diphtheria and tetanus toxoids and acellular pertussis adsorbed vaccine), and HibTiter (Hemophilus influenzae type b conjugate vaccine).
"Vaccinations Halved" The acellular pertussis component is manufactured by Takeda Chemical Industries of Japan, and offers a lower reactogenicity than is seen with whole-cell DTP vaccine, adds Wyeth-Lederle. The company says that the combination of the four different components will halve the number of vaccinations that a child needs to have.
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