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Issue Number 13                                         July 30, 1998

CONTENTS OF THIS ISSUE

1. New DTaP vaccine licensed by FDA
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(1)
July 29, 1998
NEW DTaP VACCINE LICENSED BY FDA

On July 29, 1998, FDA approved a product license application (PLA) for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP). The trade name of this vaccine is Certiva. The vaccine is indicated for the active immunization of persons 6 weeks to 7 years of age (prior to the seventh birthday).

Certiva was evaluated in a randomized, double-blind placebo controlled NICHD sponsored trial conducted in Sweden.*  Certiva contains one pertussis antigen-inactivated pertussis toxin (PT).

Manufacturing of Certiva: The D and T bulk concentrates for use in further manufacturing are produced by Statens Seruminstitut, Copenhagen, Denmark. The aP antigen is manufactured by North American Vaccine, Inc., of Beltsville, Maryland. DTaP is formulated at the Beltsville facility, and is filled and labeled at Abbott Laboratories in McPherson, Kansas.

Please see the package insert for additional information.

*Trollfors B, et al.: A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995 Oct 19;333(16):1045-50.

 

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This page was updated on July 31, 1998