GlaxoSmithKline announced that its combination vaccine, Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], received approval from the U.S. Food and Drug Administration (FDA) to be given to infants at 2, 4 and 6 months of age for the prevention of diphtheria, tetanus, pertussis, hepatitis B, and polio. Pediarix is the first five-in-one U.S.-licensed vaccine to offer protection against five serious diseases in a three-dose vaccination series. This combination vaccine results in up to six fewer injections for infants, which may reduce infants' pain and discomfort.

"The introduction of a combination vaccine like Pediarix marks a milestone for the United States immunization program," said Joel Ward, director of the University of California, Los Angeles (UCLA) Center for Vaccine Research, Research and Education Institute at Harbor-UCLA Medical Center and principal clinical trial investigator. "Combination vaccines make it easier to comply with the implementation of a complicated immunization schedule and reduce the number of injections and office visits compared with separately administered vaccines."

Currently, children receive approximately twenty injections in the first two years of life and with the development and introduction of new vaccines, that number will continue to increase. Nine injections are presently recommended to protect the more than four million babies born in the United States each year against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio. Pediarix protects against these diseases with only three injections in the primary series, which could result in as many as 24 million fewer injections per year for infants in the United States.

"GlaxoSmithKline is proud to bring Pediarix to the United States," said Barbara Howe, vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "Pediarix is approved in many other countries. We believe this combination vaccine will not only help ease the United States immunization process for both parents and healthcare professionals, but may also reduce parent anxiety and infant pain and discomfort associated with multiple injections."