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Biologics License Application Accepted for Pentacel Vaccine

SWIFTWATER, Pa., and LYON, France, Sept. 26 /PRNewswire-FirstCall/ -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group (EURONEXT: SAN), (NYSE:SNY) , announced today the acceptance of a Biologics Licensing Application (BLA) by the U.S. Food and Drug Administration (FDA) for PENTACEL(TM) vaccine(1), a pediatric combination vaccine candidate that targets diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b (Hib).

PENTACEL vaccine is the first DTaP-based combination vaccine candidate for use in infants in the U.S. that includes both polio and Hib vaccine components. The diphtheria, tetanus, and pertussis components in PENTACEL vaccine are based on the formulation in DAPTACEL(R)-- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine) -- which was introduced by sanofi pasteur in the U.S. in 2002. In clinical trials, PENTACEL vaccine was administered as a four-dose series -- at 2, 4, 6 and 15-18 months of age -- concomitantly with other recommended childhood vaccines.

According to the current Recommended Childhood and Adolescent Immunization Schedule from the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC), up to five separate vaccine injections may be required during well-child visits. If licensed, PENTACEL vaccine could reduce that number by two.

"PENTACEL vaccine could be easily integrated into the recommended childhood vaccination schedule," said Steven Black, MD, co-director, Kaiser Permanente Pediatric Vaccine Study Center. "In addition, this combination vaccine has the potential to protect against five diseases in a single injection."

The regulatory submission of PENTACEL vaccine is based on results of clinical studies involving more than 5,000 children in multi-center trials(2) conducted in the U.S. and Canada. PENTACEL vaccine is licensed for pediatric use in nine countries, including Canada, where it has been used universally in infants and young children since 1998.

(1) The full chemical name for PENTACEL(TM) vaccine is: (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate] - ActHIB(R) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated)
(2) Herz A, Black S, Shinefield H, Noriega F, Greenberg, D. Safety of DTaP-IPV//PRP-T (PENTACEL) administered at 2, 4, 6, and 15 to 18 months of age. Annual meeting of the Pediatric Academic Societies 2005
(3) Vitek CR, Pascual FR, Baugham AL, Murphy TV. Increase in Deaths From Pertussis From Young Infants in the United States in the 1990s. Pediar Infect DIF J.2003:22:628:634.6.
(4) Donnelly, M.J, Herold, B.C., Jenkins, S.G., Daum, R.S. Obstacles to the elimination of Haemophilus influenzae type b disease: Three illustrative cases. Pediatrics. Vol. 112, No. 6, December 2003, pp. 1465-1466

Source: sanofi pasteur; sanofi-aventis

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