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CONNAUGHT COMBINATION DTP/INACTIVATED POLIO VACCINE

Executive Summary

CONNAUGHT COMBINATION DTP/INACTIVATED POLIO VACCINE is presently in clinicals, the company disclosed at a conference on policy options for re-evaluating polio vaccines held by the Institute of Medicine. The company said at the Jan. 22 conference that it expects to have results completed by "the third quarter of this year." Connaught presented the information after a question was raised about whether there was a combined DTP/polio product in the pipeline. Connaught received approval for its enhanced-potency IPV vaccine on Nov. 20 ("The Pink Sheet" Dec. 21, 1987, T&G-1). Institut Merieux has an IPV vaccine in clinicals. Lederle Technical Operations Director Frank Cano, PhD, said that Lederle has a long-term objective to develop a combination acellular pertussis DTP/IPV vaccine. "We do see that [on] the horizon. Right now we're working on an inactivated polio program using the Sabin strains for that," he said. The acellular pertussis DTP vaccine is currently in clinicals and "we would hope to have that licensed shortly, within two years," Cano said. The Institut Merieux is understood to have begun human studies in France with an acellular pertussis DTP/polio combination. The institute has filed an IND with FDA for its acellular pertussis vaccine. Institut Merieux is also studying a combination Haemophilus B conjugate/DTP/polio vaccine. The Institute of Medicine held the conference to provide a forum for discussing policy options for the U.S. poliomyelitis vaccine immunization program. Committee members, speakers, and attendees assessed the benefits and risks of the continued use of the oral polio virus vaccine (OPV), compared to the use of inactivated polio virus vaccine. The National Childhood Vaccination Act of 1986 requires the development of informational materials including the risk and benefits of vaccines and information on filing compensation claims. France's polio vaccine immunization policy was presented at the conference as a possible alternative to the U.S. program. In France, both OPV and IPV vaccines are equally available. The vaccine of choice is determined by both the patient's family and the physician. The physician informs the family of the risks and benefits of both vaccines. OPV is reportedly used for one third of the immunizations, and IPV is used two thirds of the time. From issues discussed at the conference, IOM's Committee on Evaluation of Poliomyelitis Vaccines will develop recommendations for the Public Health Service's Advisory Committee on Immunization Practices (ACIP). IOM's report is expected to be available for review by ACIP at its May meeting.
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