A newer whooping cough vaccine intended to reduce side effects is safer for babies than previous versions, according to a Food and Drug Administration study.
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The study, published in this month's Pediatrics journal, involved 5, 770 cases of babies given a whooping cough vaccine between January 1995 and June 1998.
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It did specify that limited side effects from the company's whooping cough vaccine could lead to regulatory approval in the U . S . and Denmark.
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North American Vaccine's new whooping cough vaccine is safe and effective for infants and older children, the company told a Food and Drug Administration advisory panel.
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SmithKline Beecham Plc's biologicals unit today became the third company to win approval to market a new, safer whooping cough vaccine for infants in the U . S.
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The department was particularly concerned about the effect of using whooping cough vaccine to accelerate the protective qualities of anthrax vaccine, which normally takes months to become effective.
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Connaught Laboratories is poised to bring a new, safer whooping cough vaccine to the American market for infants, while several companies are battling to beat it to the punch.
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Three new whooping cough vaccines have been shown to be more effective and to have fewer side effects than current vaccines in large clinical trials conducted in Italy and Sweden.
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The group also lauded the availability of new, safer whooping cough vaccines made by companies such as SmithKline Beecham Plc, Rhone-Poulenc SA and American Home Products Corp .'s Lederle Laboratories.
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The ministry concerns centered around plans to use the whooping cough vaccine, pertussis, as an accelerator with anthrax vaccine to dramatically shorten the eight months the anthrax vaccines usually takes to work.
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