WASHINGTON _ Connaught Laboratories Inc. said it hopes theendorsement given this week by an FDA advisory committee for asecond indication for its acellular pertussis vaccine will give it acompetitive advantage over the handful of biotech firms that aredeveloping similar vaccines.
Connaught intends to build a competitive edge by emphasizing the"long history of the vaccine and the facts about its safety andefficacy," said Carlton Meschievitz, executive director of medicalaffairs for Connaught. "Over 20 million doses of this vaccine havebeen administered in Japan and its safety and efficacy have beendemonstrated in two clinical trials in two countries," he said in aninterview with BioWorld Today.
Connaught was buoyed by the news that on Monday the FDA'sVaccines and Related Biological Products Advisory Committeeunanimously recommended approval of a second indication forTripedia, a combination vaccine, in infants ages 2, 4 and 6 months.The vaccine had been on the market for older babies.
The advisory panel reviewed new data from Connaught, ofSwiftwater, Pa., from a study of German babies that showed the drugwas 80 percent effective and produced few side effects.
Several biotech firms have invested in the production of acellularversions of the pertussis vaccine which is more accepted by parentswho have associated whole cell versions with serious side effects andrarely death of the infant.
Clinical trials, including one sponsored by the National Institutes ofHealth, have shown that the acellular version is associated with fewerside effects and serious reactions, while still protecting againstdisease.
Connaught's Tripedia vaccine combines an acellular version ofpertussis with diphtheria and tetanus toxoids. Chiron Biocine, locatedin Emeryville, Calif., manufactures a genetically engineered acellularpertussis vaccine which has been compared in clinical trails to achemically detoxified acellular vaccine from SmithKline BeechamBiologicals SA, of Rixensart, Belgium.
Chiron Biocine has sought to differentiate its vaccine from theSmithKline product by citing an Italian clinical trial which showedthat the Chiron Biocine vaccine was safer and protected infantssooner than the SmithKline vaccine.
But all three vaccine show comparable efficacy rates. According todata published in Infectious Disease in Children, the efficacy rates ofConnaught, SmithKline, and Chiron Biocine vaccines ranged from 84percent to 89 percent.
The Chiron Biocine combination vaccine, which has not yet beennamed, is still in clinical trails and the company has not yet submittedits product licensing application (PLA) to the FDA for review.SmithKline, of Philadelphia, filed its PLA in November, 1995 forInfanix, a combination vaccine for acellular pertussis, tetanus anddiphtheria.
At stake is a worldwide market of hundreds of thousands of doses forinfants and toddlers. All acellular vaccine manufacturers are toutingthe merits of the acellular version of their vaccines over the wholecell vaccines which have been associated with a higher rate oflocalized reaction and some serious reactions. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.