GSK Pediarix approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant), inactivated poliovirus) vaccine clears FDA Dec. 13 for administration to infants at 2, 4 and 6 months. Labeling contains a warning that "administration of Pediarix is associated with higher rates of fever relative to separately administered vaccines." GSK has Phase IV commitments for fever and seizure risk. The firm expects the Feb. 25-26 Advisory Committee on Immunization Practices to make a coverage recommendation for Pediarix. The combination vaccine is priced at slight premium to separate vaccine component