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LEDERLE-PRAXIS TETRAMUNE "WILL HELP INCREASE IMMUNIZATION RATES"

Executive Summary

LEDERLE-PRAXIS TETRAMUNE "WILL HELP INCREASE IMMUNIZATION RATES" by making "vaccine administration more convenient and easier than administering multiple vaccines," Lederle maintained in announcing the March 30 approval of the four-in-one combination vaccine. Tetramune couples Lederle's Tri-Immunol diphtheria, tetanus and pertussis (DTP) vaccine with Praxis' HibTITER Haemophilus b conjugate vaccine. Tetramune is scheduled to be commercially available by early May, the company said. The vaccine will be sold in 5 ml vials. Tetramune "will allow immunization against the diseases using four injections, instead of the eight injections which are currently needed," FDA said in a March 30 press release. For previously unvaccinated children, the vaccine is recommended for administration at two, four, six and 15-18 months of age, the same schedule as the separate vaccines. An additional dose of DTP alone is recommended at about five years. "Tetramune may be substituted for DTP and HibTITER administered separately, whenever the recommended schedules for use of these two vaccines coincide," labeling states. "However, no published data are available to support the interchangeability of the Haemophilus b conjugate vaccine in Tetramune and HibTITER with other Haemophilus b conjugate vaccines for the primary series. Therefore, it is recommended that the same conjugate vaccine be used throughout the primary series, consistent with the data supporting licensure of the vaccine." In addition to increasing immunization rates, Tetramune "should result in: less trauma for infants because of fewer needle sticks; more comfort, relief for parents; simpler, faster vaccine administration process for healthcare professionals; and less medical waste because of fewer needed syringes, cotton swabs and other supplies," Lederle-Praxis maintained. "As secretary of HHS, I call this good news," HHS Secretary Shalala said. "If I were an infant about to get four fewer shots, I'd call it great news." The approval of Tetramune came two days before Shalala unveiled the Clinton Administration's childhood immunization initiative calling for consolidated vaccine purchase (see related story, p. 14). The administration has billed its vaccine plan as a means to increase immunization rates by controlling vaccine costs. The timing of the proposal, however, will have the more immediate impact of controlling prices of new combination vaccines like Tetramune that appear to be candidates for premium pricing. Lederle has not disclosed pricing of Tetramune. Tri-Immunol currently sells for $5.41 per dose while HibTITER costs $15.13 per dose, Lederle said. Both prices do not include federal vaccine excise taxes, Lederle noted, which are no longer being collected because the federal vaccine compensation fund has lapsed. In a March 31 letter to HHS Secretary Shalala, Lederle-Praxis President Ronald Saldarini said that "Lederle-Praxis undertook on a crash basis the additional clinical trials required for approval of this combination vaccine." The firm conducted a 7,000-patient trial beginning in 1989. Saldarini told an April 1 press conference that "I rather doubt we would have had [Tetramune] now had we been under the [proposed] national vaccine program" in 1989. Tetramune was recommended for approval by FDA's Vaccines and Related Biological Products Advisory Committee Oct. 28, 1992 ("The Pink Sheet" Nov. 2, 1992, p. 12). Pasteur Merieux' Haemophilus b vaccine ActHIB was recommended for approval at the same meeting and was approved March 31 (see following T&G). The Tetramune PLA was submitted in December 1991.
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