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On January 27, 1999, the Food and Drug Administration initiated a voluntary recall of Tripedia™ diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), lot number 0916490, manufactured by Pasteur Merieux Connaught USA.* Routine post-release stability testing completed in January 1999 indicated that the potency of the diphtheria toxoid component of this lot was below specification. The potency of the tetanus and pertussis components of this lot was acceptable.
The lot was distributed during February-June 1998. All lots of Tripedia™ met potency specifications before release. Previously tested lots of Tripedia™ met diphtheria potency specifications in routine stability testing after release; stability testing of additional lots is in progress.
A primary series (three doses) of fully potent diphtheria toxoid-containing vaccine is required to reliably induce protective antibody levels. Five doses of diphtheria toxoid-containing vaccine are recommended for preschool-aged children in the United States and provide optimal protection against diphtheria.
The risk for exposure to toxigenic strains of Corynebacterium diphtheriae in the United States is low; however, diphtheria remains endemic in many countries. Additional doses of diphtheria toxoid-containing vaccine beyond those recommended in the childhood immunization schedule are associated with an increase in local reactions and should be considered only for children vaccinated with Tripedia™ lot number 0916490 who may be at increased risk for exposure to toxigenic strains of C. diphtheriae. CDC, the American Academy of Pediatrics, and the American Academy of Family Physicians have developed recommendations for children who received one or more doses of Tripedia™ lot number 0916490. The complete text of the recommendations is available on CDC's National Immunization Program World-Wide Web site, http://www.cdc.gov/nip/news/recall.htm; in summary, the recommendations are as follows:
— Children remaining in the United States until the scheduled fourth dose of DTaP or traveling to countries where the risk for diphtheria is low do not require any supplemental doses of diphtheria toxoid-containing vaccine.
— Children traveling to a country where the risk for diphtheria is high† before their scheduled fourth dose of DTaP may require a supplemental dose of DT or a dose of DTaP on an accelerated schedule; the recommendations vary based on the number of doses of Tripedia™ lot number 0916490 received.
Recall of Tripedia™ Vaccine. JAMA. 1999;281(11):982. doi:10.1001/jama.281.11.982-JWR0317-3-1