FDA approves Infanrix fifth dose indication.

2003 AUG 6 - (NewsRx.com & NewsRx.net) -- GlaxoSmithKline (GSK) announced that its combination vaccine, Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed), received approval from the U.S. Food and Drug Administration (FDA) to be administered as a fifth consecutive DTaP vaccine dose for children between the ages of 4 and 6 years for the prevention of diphtheria, tetanus and pertussis (whooping cough).

With the approval of the fifth dose, healthcare professionals can now administer the same brand of DTaP vaccine for the entire five-dose DTaP series, as recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).

"The FDA approval of the fifth-dose indication of Infanrix is an important step toward ensuring that the greatest number of patients receive protection against diphtheria, tetanus and pertussis with a single DTaP brand," said Richard Judelsohn, medical director, Erie County Department of Health, Buffalo, New York. "Children can now receive consistent protection against serious diseases with the proven safety of Infanrix."

The approval of Infanrix for the administration as the fifth DTaP dose comes only months after the FDA approved GlaxoSmithKline's Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], the first and only five-in-one combination ...