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FDA approves new Aventis Pasteur vaccine for diphtheria, tetanus, pertussis.(Brief Article)
2002 JUN 19 - (NewsRx.com & NewsRx.net) -- Aventis Pasteur said today that it received U.S. Food and Drug Administration (FDA) licensure to market Daptacel, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP).
Daptacel has been approved for the first four consecutive doses of the recommended childhood immunization series against diphtheria, tetanus, and pertussis. Aventis Pasteur will be pursuing licensure for a fifth dose indication. Daptacel demonstrated a high level of protection against pertussis disease in a randomized, double-blind, placebo controlled trial sponsored by the National Institute of Health and published in the New England Journal of Medicine.
Daptacel is a thimerosal-free formulation that is highly effective (84.9%) in the prevention of pertussis disease, which can lead to complications, hospitalizations, and death.
As a result of two DTaP vaccine manufacturers recently exiting the market, the U.S. is experiencing a shortage of DTaP vaccine. To help meet the ...
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Source: HighBeam Research, FDA approves new Aventis Pasteur vaccine for diphtheria, tetanus,...