On January 27, 1999, the Food and Drug Administration initiated a voluntary recall of Tripedia(TM) 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(TM) met potency specifications before release. Previously tested lots of Tripedia(TM) 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(TM) 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(TM) 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(TM) lot number 0916490 received (Table_1).

* Use of trade names and commercial sources is for identification only and does not imply endorsement by CDC or the U.S. Department of Health and Human Services.

** Travelers may be at substantial risk for exposure to toxigenic strains of C. diphtheriae, especially with prolonged travel, extensive contact with children, or exposure to poor hygiene. Countries comprise the following: Africa -- Algeria, Egypt, and sub-Saharan Africa; Americas -- Brazil, Dominican Republic, Ecuador, and Haiti; Asia/Oceania -- Afghanistan, Bangladesh, Cambodia, China, India, Indonesia, Iran, Iraq, Laos, Mongolia, Myanmar, Nepal, Pakistan, Philippines, Syria, Thailand, Turkey, Vietnam, and Yemen; and Europe -- Albania and all countries of the former Soviet Union.

TABLE 1. Recommendations for children who travel to areas where the risk for
diphtheria is high* and who received Tripedia(TM) diphtheria and tetanus toxoids and
acellular pertussis vaccine (DTaP) lot number 0916490+
=======================================================================================================
            Total doses received
              of any diphtheria         No. doses of
              toxoid-containing     Tripedia(TM) from lot
Age (mos)          vaccine               no. 0916490       Recommendation&
-----------------------------------------------------------------------------------------------
2-11                 1-2                     1-2           Complete primary series with DTaP@
                      3                       1            Administer fourth dose of DTaP at
                                                            age 15-18 mos
                      3                      2-3           Administer supplemental dose of DT,
                                                            followed by fourth dose of DTaP at
                                                            age 15-18 mos
-----------------------------------------------------------------------------------------------
>=12                  3                       1            Administer fourth dose of DTaP at
                                                            age 15-18 mos
                      3                      2-3           Administer supplemental dose of DT
                                                            if <6 months have elapsed since
                                                            third dose of DTaP, followed by
                                                            fourth dose of DTaP at age
                                                            15-18 mos
                                                           OR
                                                           Administer fourth dose of DTaP as
                                                            early as age 12 mos if >=6 months
                                                            have elapsed since third dose of
                                                            DTaP
                      4                      1-3           Administer fifth dose of DTaP at age
                                                            4 to 6 yrs
                      5                       1            Administer routine tetanus and
                                                            diphtheria toxoids (for adolescent
                                                            and adult use) boosters
-----------------------------------------------------------------------------------------------
* Travelers may be at substantial risk for exposure to toxigenic strains of Corynebacterium
  diphtheriae, especially with prolonged travel, extensive contact with children, or exposure to
  poor hygiene conditions. Countries comprise the following: Africa--Algeria, Egypt, and sub-Saharan
  Africa; Americas--Brazil, Dominican Republic, Ecuador, and Haiti; Asia/Oceania--
  Afghanistan, Bangladesh, Cambodia, China, India, Indonesia, Iran, Iraq, Laos, Mongolia,
  Myanmar, Nepal, Pakistan, Philippines, Syria, Thailand, Turkey, Vietnam, and Yemen; and
  Europe--Albania and all countries of the former Soviet Union.
+ Manufactured by Pasteur Mórieux Connaught USA. Use of trade names and commercial
  sources is for identification only and does not imply endorsement by CDC or the U.S. Depart-
  ment of Health and Human Services.
& The minimum interval is 4 weeks between a dose of diphtheria and tetanus toxoids (for
  pediatric use) (DT) and any other dose of diphtheria toxoid-containing vaccine. The minimum
  interval is 6 months between the third dose of DTaP (including doses of Tripedia(TM) lot number
  0916490) and the fourth dose of DTaP.
@ If time is sufficient before travel, children who received two doses of Tripedia(TM) lot number
  0916490 should receive their third dose of DTaP (as early as 4 weeks after the previous dose
  of DTaP) and a supplemental dose of DT (as early as 4 weeks after the third dose of DTaP).
=======================================================================================================

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