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NEW PEDIATRIC COMBINATION VACCINE APPROVED

The Food and Drug Administration (FDA) today announced the approval of a new combination vaccine that protects infants against diphtheria, tetanus, pertussis (whooping cough), polio, and disease due to the Hepatitis B virus. The vaccine will be marketed as Pediarix™ by SmithKline Beecham Pharmaceuticals.

Pediarix™ is the only vaccine marketed in the U.S. that contains DTaP (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), Hepatitis B Vaccine (Recombinant], and Inactivated Poliovirus Vaccine (IPV) for administration as one intramuscular injection. The specific DTaP (Infanrix) and Hepatitis B (Engerix-B) components used in Pediarix were previously licensed in the U.S.

DTaP vaccine, Hepatitis B vaccine and IPV are all currently available in the U.S. as separate vaccines. A Hepatitis B (recombinant) and Haemophilus influenza type b combination vaccine is also available in the U.S.

Pediarix™ is recommended for administration as a 3-dose primary series to infants at approximately 2, 4, and 6 months of age. When DTaP, Hepatitis B and IPV vaccines are administered separately, in the same time frame, infants receive 9 injections. Pediarix™ should not be administered to infants before the age of 6 weeks, and therefore is not indicated for infants born to mothers who are infected with Hepatitis B or whose Hepatitis B status is unknown. Such infants should receive Hepatitis B Vaccine shortly after birth and complete their immunization according to a particular schedule.

In a trial with the administration of the vaccine at 2, 4, and 6 months of age, Pediarix™-induced immune responses were generally similar to those induced by separately administered licensed vaccines. The most frequently reported adverse reactions to Pediarix™ were local injection site reactions (pain, redness, swelling), fever, and fussiness. In clinical studies, fever occurred more frequently after administration of Pediarix™ than separately administered licensed vaccines.

Inoculations have played a critical role in protecting individuals from potentially deadly diseases. In addition, vaccines safeguard the public from infectious diseases, proportionately decreasing the risk of disease spreading as vaccination rates increase. Children's caregivers should consult with their healthcare providers for more information on vaccine protection.

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