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FDA approves Infanrix fifth dose indication

RESEARCH TRIANGLE PARK, N.C., July 8, 2003 -- GlaxoSmithKline announced that its combination vaccine Infanrix [diphtheria and tetanus toxoids and acellular pertussis adsorbed) had received approval from the 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 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, Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians.

"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 Dr. Richard Judelsohn, medical director, Erie County Department of Health, Buffalo, N.Y. "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 vaccine to protect against five diseases, eliminating up to six shots in the process. Now, physicians can confidently administer Pediarix for the first three doses of the DTaP series and finish the series with Infanrix-offering their patients a significant reduction in shots as well as the benefits of using the same brand of DTaP vaccine for all five doses.

This approval should also mean increased efficiency for physicians, since they will only need to order and manage inventory through one reliable source. Infanrix is available in a prefilled Tip- Lok syringe with peel-off labels, to help ensure accurate dosing,  easy record keeping, and time saving.

Infanrix combines diphtheria and tetanus toxoids and pertussis (whooping cough) antigens. Simultaneous immunization against these three diseases during infancy and childhood has been a routine practice in the United States since the late 1940s. Routine immunization of the DTaP vaccine at 2, 4, and 6 months of age with boosters at ages 15-18 months and 4-6 years has played a major role in markedly reducing the incidence of, and deaths from, each of these diseases.

Source: GlaxoSmithKline

Posted: July 2003