Lederle-Praxis Biologicals (Lederle) announced that anadvisory committee to the FDA voted in support of its newpediatric vaccine combination.
The combination vaccine consists of a whole-cell DTP(diphtheria, tetanus and pertussis) and a Haemiphilus bconjugate vaccine, both of which are already available fromLederle as single-entity vaccines.
According to Lederle, a subsidiary of American Cyanamid Co.,after hearing results of U.S. clinical trials of the product, theFDA committee strongly supported the concept of combinationproducts in general and this vaccine specifically, and agreedthat the data demonstrated safety, efficacy andimmunogenicity.
In studies carried out between November 1990 and July 1991involving nearly 7,000 infants, the vaccine was administered toinfants at 2, 4 and 6 months of age, and toddlers 15-18 monthsold.
Jeff Hoyak. spokesman for the Silver Spring, Md., company, saidadvantages to the two-shots-in-one approach are that doctorswill be giving fewer shots, causing the child less pain anddiscomfort.
"This marks another step in the development of a "super shot,"which will incorporate a number of the recommended pediatricvaccines," Hoyak said.
Lederle filed for a product license application (PLA) for its newvaccine with the Center for Biologics Evaluation and Research inNovember 1991.
-- Michelle Slade Associate Editor
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