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ACELLULAR PERTUSSIS VACCINE TRIAL IN SWEDEN SCHEDULED

Executive Summary

ACELLULAR PERTUSSIS VACCINE TRIAL IN SWEDEN SCHEDULED for early 1986 and will be conducted with technical assistance and funding from the U.S. government, FDA's Bacterial Products Div. Director Carolyn Hardegree, MD, told the Vaccines and Related Biological Products Advisory Cmte. on July 29. "When it became apparent that this [Swedish] trial would go forward," Hardegree said, "the interagency group of the Public Health Service offered assistance to Swedish authorities . . . in the form of epidemiology, attempts at helping with study design, and monies." She pointed out that group has been "working very closely with the Swedish authorities over the last six months in trying to evaluate and design these particular studies." * According to Hardegree, the Swedish study will use an fha/lph acellular vaccine obtained from a Japanese supplier. Wyeth Labs has U.S. rights to an acellular pertussis vaccine, which it licensed from the Japanese firm Takeda. Noting that the Swedish protocol has not been finalized, the FDAer added: "1 think it important to comment that these children will be six months and not [the] two-, four- and six-month children that will be used in this country. In Sweden "they have felt maternal antibody levels are high in that group and they routinely use erythromycin in all children under six months if they come in contact with someone who has pertussis, and therefore efficacy evaluation would be complicated in that age group," she explained. Asked by the cmte. about the incidence of pertussis in Sweden where childhood vaccination was discontinued in 1979, Hardegree said it is estimated that during this type of trial, pertussis will occur "somewhere around 3% in the target population . . . looked at." She also pointed out that between 1981 and 1983 when Swedish authorities were evaluating the Wellcome vaccine during an epidemic, there was a 10% incidence in children under two years. Hardegree also told the cmte. that the Haemophilus influenzae b vaccine, which was licensed by FDA last April, "appears to be being used throughout the country." She noted that the adverse drug reaction reports FDA has received thus far "appear to be no different" than those which might be expected from the labeling. Hardegree added that a post marketing study has been put in place as part of the licensing agreement, but that the surveillance will "not necessarily be addressing disease incidence" in children receiving the vaccine. The vaccine was developed by Praxis Biologics and is marketed by Mead Johnson.

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