Abstract

On July 8, 2003, the U.S. Food and Drug Administration (FDA) approved the use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (INFANRIX®, SmithKline Beecham Biologicals, Rixensart, Belgium) as a fifth dose for children aged 4--6 years after 4 previous doses of INFANRIX®. INFANRIX® had been previously approved for the first 4 doses in the DTaP vaccination series. Sufficient data are now available to establish the frequency of adverse events after a fifth dose of INFANRIX® at age 4--6 years in children who have received 4 previous doses of INFANRIX® (1).

Recommendation Americas United States of America Diphtheria