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Executive Summary

PASTEUR MERIEUX's ActHIB TO BE MARKETED BY SMITHKLINE BEECHAM following the March 31 approval of the Haemophilus b conjugate vaccine. ActHIB is the fourth vaccine against Haemophilus influenzae type b approved in the U.S., following Connaught's ProHIBIT, Merck's PedvaxHIB and Lederle's HibTITER. ActHIB is indicated for immunization of infants and children from two months to five years of age. Under a June 1992 agreement, Pasteur Merieux will supply SmithKline Beecham with ActHIB until the U.S. firm is able to manufacture the vaccine itself. The Clinton Administration's consolidated vaccine purchasing proposal announced April 1 may delay that process. In response to the administration announcement, SmithKline Beecham President of North American Operations J.P. Garnier said that the company is "freezing" the process of choosing a site for a new $10 mil. pediatric vaccine facility until the details of the program are clear (see related story, p. 14). The approval of ActHIB came one day after FDA's clearance of Lederle's Tetramune, a combination Haemophilus b conjugate and diphtheria-tetanus toxoids-pertussis vaccine (see preceding T&G). Both of the vaccines were recommended for approval by FDA's Vaccines and Related Biologics Advisory Committee at its Oct. 28 meeting ("The Pink Sheet" Nov. 2, 1992, p. 12). At that meeting, the advisory committee rejected a Pasteur Merieux proposal that ActHIB labeling direct physicians to reconstitute the Haemophilus b vaccine with Connaught DTP vaccine. ActHIB labeling states that the vaccine has been routinely administered concomitantly with DTP and other vaccines, but does not advise the physician to reconstitute the vaccines together. Labeling notes that "interference with the antibody response to the pertussis component has been suggested with a DTP vaccine unlicensed in the U.S." The reference is to a study reported in the Journal of the American Medical Association that found lower pertussis agglutinin titers in Chilean children immunized with ActHIB and Pasteur's DTP vaccine compared to DTP alone.

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