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Executive Summary

LEDERLE's ACEL-IMUNE ACELLULAR PERTUSSIS DTP VACCINE: MID- JANUARY availability to physicians and health care providers predicted by Lederle Labs following the Dec. 17 FDA approval of the acellular pertussis component of Lederle-Praxis' combination diphtheria, tetanus and pertussis (DTP) vaccine for booster use. Lederle said it began taking orders immediately upon approval, with shipments set to begin during the new year. Most of Lederle's vaccine sales are direct to physicians, although the company does use some distributers, Lederle said. Acel-Imune is approved for use as the fourth and fifth dose of the five-dose DTP series. The fourth dose is for children of approximately 18 months, although approved labeling adds that "the administration of Acel-Imune may be considered for children as young as 15 months of age when it is expected that the child will not return at 18 months . . . although studies in this age group have not been completed." The fifth dose is supposed to be received before a child's seventh birthday. Acel-Imune will be priced at $ 155.60 for a 10-dose (5 ml) vial sold directly to physicians, Lederle said. The company noted that $ 45.60 per vial will go to the federal vaccine compensation fund. A product license application was filed in June 1990 for the whooping cough vaccine. FDA's Vaccines & Related Biological Products Advisory Committee recommended approval for booster use of the vaccine in January ("The Pink Sheet" Feb. 4, p. 9). The pertussis portion of the vaccine is licensed by Lederle from Takeda, which has marketed the vaccine in Japan since 1981. Over 16 mil. doses have been shipped in that country, Lederle said. The company added that vaccines like Acel-Immune, which contain four components of the pertussis organism, have the largest market share in Japan, compared to two-component, three- component, five-component and whole-cell vaccines. In a press release announcing the approval, FDA noted that the availability of whole-cell pertussis vaccines have reduced cases of whooping cough (pertussis) from a rate of 120,000 per year in 1950 to about 3,500 per year, and deaths have declined from 1,100 to about 10. The whole-cell vaccine, however "has caused more complaints of sore arms, fever and, occasionally, more severe effects than most other childhood vaccines," HHS Assistant Secretary for Health James Mason, MD, said. Because Acel-Imune contains part of the pertussis organism rather than the whole organism and has shown reduced side effects, "this vaccine may be very useful in getting more children protected," Mason added. The FDA press release notes that Mason, HHS Secretary Sullivan, and Surgeon General Antonia Novello have been traveling the country to encourage programs to address underimmunization. The Administration has set a goal of full immunization for 90% of children by the age of two. Approved labeling includes clinical-trial safety data from 911 children who received Acel-Imune as the fourth or fifth dose of the DTP series. The most common side effect was tenderness at the injection site (26%), followed by fever (19%) and "fretfulness" (17%). Total clinical data on the use of Acel-Imune in 2,041 children found 16 cases of reactions judged to contraindicate further doses, including one possible seizure for which "a cause and effect relationship . . . has not been established," labeling says. Acel-Imune "causes fewer local reactions such as pain, tenderness, redness, induration, and less of an increase in injection site temperature than the whole-cell DTP vaccine currently manufactured by Lederle. Acel-Imune also causes less fever, drowsiness, fretfulness and acetaminophen use than the current Lederle vaccine," the company said. Lederle is currently studying the use of Acel-Imune for the two-, four-, and six-month doses. The company has a Phase III trial ongoing in Germany, although enrollment is not completed. Connaught's acellular pertussis vaccine, supplied from Japan by Biken, was recommended for approval for the same indication as Lederle's by FDA's Vaccines & Related Biological Products Advisory Committee on Nov. 12 ("The Pink Sheet" Nov. 18, p. 18).

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