| Previous issues index | Issue Number 13
July 30, 1998 CONTENTS OF THIS ISSUE 1. New DTaP vaccine licensed by FDA -------------------------------------------------------- (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. |
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