FDA Approves GlaxoSmithKline's (GSK) Infanrix(R) Fifth Dose Indication

RESEARCH TRIANGLE PARK, N.C., July 8 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that its combination vaccine, Infanrix(R) [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 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(TM) [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.

Fifth Dose Saves Physicians Time

The approval of the fifth dose of Infanrix(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed) also means increased efficiency for physicians, since they will only need to order and manage inventory through one reliable source. Additionally, Infanrix is available in a prefilled Tip- Lok(R) syringe, making it the first and only DTaP vaccine in the United States to be offered with this convenient and timesaving delivery system. The Infanrix prefilled Tip-Lok syringe with peel-off labels ensures accurate dosing, allows for easy record keeping, and may save doctors and nurses valuable time.

"GlaxoSmithKline is pleased to offer physicians vaccines that help simplify their practice," said Barbara Howe, M.D., vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "The approval of the fifth dose of Infanrix provides a substantial benefit for healthcare professionals, who will likely find a timesaving advantage through efficient ordering and inventory management. PEDIARIX and Infanrix are available through one reliable source."

Infanrix: The Leading DTaP Vaccine in the United States and Worldwide

Infanrix is the U.S. and worldwide leader in DTaP vaccine sales and is currently licensed in 80 countries. GlaxoSmithKline has distributed more than 29 million doses of its DTaP vaccine in the United States since its launch in 1997 and more than 43 million doses worldwide. Prior to the fifth dose approval, Infanrix was already approved by the FDA for the three-dose primary series, the booster given in the second year of life, and the completion of the five-dose DTP series for any child who has received one or more doses of whole-cell pertussis DTP vaccine. Infanrix is included in the federally funded Vaccines for Children (VFC) program, created to provide free vaccines to those children whose families could not afford them. In 2001 alone, Infanrix represented four out of five doses of all DTaP vaccines purchased by the VFC program.

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.

The ACIP, AAP and AAFP recommend the use of one brand of DTaP vaccine for all five doses of the routine childhood series of vaccination against diphtheria, tetanus and pertussis. According to the ACIP, AAP and AAFP recommendations, these five doses should be administered before 7 years of age.

Infanrix(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed] has been proven to be safe and effective. Hypersensitivity to any component of Infanrix is a contraindication. Local adverse events may occur at the site of injection and include erythema, swelling, and tenderness. Systemic adverse events may include fever, irritability, and drowsiness. As with any vaccine, vaccination with Infanrix may not protect 100% of susceptible individuals.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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