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From the Centers for Disease Control and Prevention
April 4, 2001

Update on the Supply of Tetanus and Diphtheria Toxoids and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine

JAMA. 2001;285(13):1698. doi:10.1001/jama.285.13.1698

MMWR. 2001;50:189-190

During the last quarter of 2000, the U.S. Public Health Service learned of a shortage of tetanus and diphtheria toxoids (Td) and tetanus toxoid (TT) resulting from decreased production of these vaccines by the two U.S. manufacturers. Previously published recommendations outlined priorities for use of the limited supply of Td and TT.1 The shortage was expected to be resolved by early 2001; however, on January 10, 2001, Wyeth Lederle (Pearl River, New York)* announced it had stopped production of tetanus toxoid–containing products. Although a small amount of Td is produced by the University of Massachusetts for local distribution, Aventis Pasteur (Swiftwater, Pennsylvania) is now the sole nationwide distributor of Td and TT. Aventis Pasteur is shipping limited quantities of vaccine to assure a wide distribution of available doses.

In accordance with previous recommendations, priority will be given to clinics and hospitals that treat acute wounds; continuing to prioritize Td and TT use will be necessary until supplies are restored.1 Clinics and hospitals in need of vaccine for wound care should call Aventis Pasteur, telephone (800) 822-2463. Aventis Pasteur is increasing the amount of Td production. However, because of the long production time required, the shortage is not expected to be resolved for 12-18 months.

In addition to Wyeth Lederle discontinuing production of its tetanus and diphtheria toxoids and acellular pertussis vaccine (DTaP; ACEL-IMUNE®), Baxter Hyland Immuno Vaccines (formerly North American Vaccine, Inc.) (Baltimore, Maryland) is not producing its DTaP vaccine (Certiva™). Aventis Pasteur and Glaxo SmithKline (Philadelphia, Pennsylvania), producers of Tripedia® and Infanrix™, respectively, are the remaining suppliers of DTaP. On March 7, 2001, the Food and Drug Administration approved a newly formulated version of Tripedia® in one-dose vials without preservative and with only a trace amount of thimerosal. Approval of this vaccine should improve the supply of DTaP.

DTaP vaccine is recommended as a five-dose series: three doses given to infants at ages 2, 4, and 6 months, followed by two booster doses at age 15-18 months and at age 4-6 years.2 Some vaccine providers may have difficulties obtaining sufficient supplies of DTaP to vaccinate all children in their practices. If providers have insufficient quantities of DTaP, priorities should be given to vaccinating infants with the initial three DTaP doses and, if necessary, to defer the fourth DTaP dose. However, children should be vaccinated with all other recommended vaccines according to the Childhood Immunization Schedule.3† When adequate DTaP supplies are available, providers should recall for vaccination all children who did not receive the fourth dose of DTaP. If supplies are sufficient, children aged 4-6 years should be vaccinated in accordance with existing ACIP recommendations to assure immunity to pertussis, diphtheria, and tetanus during the elementary school years. CDC is evaluating the situation, and more guidance will be provided should substantial supply problems occur.

*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.
†Children traveling to a country where the risk for diphtheria is high should be vaccinated according to the Childhood Immunization Schedule. 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. High-risk countries include 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.
CDC, Shortage of tetanus and diphtheria toxoids. MMWR. 2000;491029- 30
Advisory Committee on Immunization Practices, Pertussis vaccination: use of acellular pertussis vaccine among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 1997;46 ((RR-7)) 1- 25
CDC, Recommended childhood immunization schedule—United States, 2001. MMWR Morb Mortal Wkly Rep. 2001;507- 1019