WASHINGTON _ The FDA's Vaccines and RelatedBiological Products Advisory Committee Thursdayreviewed data from two large European clinical trialswhich showed that three new acellular pertussis vaccinesare highly effective in protecting infants against pertussisand have fewer side effects than whole cell vaccinescurrently used.
Melinda Wharton, epidemiologist with the Centers forDisease Control and Prevention in Atlanta, said theresults of the studies convinced her that "whole cellvaccines should be retired but retired with honor."
Dan Granoff, vice president, scientific affairs forEmeryville, Calif.-based Chiron Biocine, whichmanufactures the only genetic engineered version of theacellular pertussis vaccine, said his company was"actively working with the FDA to expedite approval ofthe product license application (PLA) for the vaccine."He declined to speculate when the PLA would be filedbut said the process is "moving rapidly."
The new vaccines are acellular because they contain onlythe specific parts of the pertussis bacterium thought to beimportant for immunity. Whole cell vaccines employwhole, killed pertussis organisms. Chiron Biocine usesgenetic engineering to eliminate the toxic activity of thepertussis antigen, improving its safety while retainingefficacy, according to the company.
Chiron Biocine's vaccine was involved in the landmarkItalian and Swedish studies reviewed by the FDAadvisory committee. Both trials were sponsored byNational Institutes of Health's National Institute ofAllergy and Infectious Disease and Italy's and Sweden'shealth ministries. _ Michele L. Robinson
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