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Diphtheria-Tetanus-Pertussis Vaccine Shortage -- United States

In the past 6 months, major changes have occurred in the pattern of manufacture and distribution of diphtheria-tetanus-pertussis* (DTP) vaccine in the United States. Now, two of the three U.S. commercial manufacturers (Wyeth and Connaught, Inc.) have stopped distribution of their products. Thus, only one manufacturer (Lederle) now markets DTP vaccine in the United States. Lederle has been increasing its production and expanding its facilities to meet current needs. Careful monitoring of supplies and production schedules previously indicated that national supplies would be adequate. However, some recent lots of Lederle DTP vaccine have failed to meet the manufacturer's requirements for release. Production and testing of this three-component vaccine is complex and requires several months. No new vaccine lots may be available until sometime in February 1985. Comparison of available stocks and the quantity of DTP vaccine now being distributed with the usual national utilization of DTP vaccine indicates that, if current use patterns continue, beginning in January 1985, supplies of DTP vaccine will be very limited, and some areas may be without DTP vaccine. This situation may continue through most of 1985.

To minimize the health impact of this shortage, two major options exist--to reduce the amount of vaccine given in a particular dose and to postpone one or more doses. Because it is impossible to predict the degree of protection conferred by partial doses, this option is not recommended (1). Consequently, consideration has been given to the possibility of postponing one or more doses of the current immunization schedule, which calls for the administration of DTP vaccine at 2, 4, 6, and 18 months of age, with a fifth dose at 4-6 years of age.

With pertussis, there is a significant risk of infection in infancy and early childhood, with 2,463 cases reported in 1983 (51% of them among infants under 1 year old). Additionally, infants are more likely to suffer complications or death from pertussis than are older children. Consequently, it is critical to continue providing protection against pertussis to infants. The first three doses of DTP vaccine provide protection against pertussis in 70%-90% of recipients and immunity to diphtheria and tetanus in over 90% of recipients (2-4). The doses given at 18 months and at 4-6 years of age enhance protection through the preschool and early school years, respectively.

Taking all these factors into account, interim postponement of the doses of DTP vaccine given at 18 months and at 4-6 years of age could achieve substantial savings in the rate of DTP vaccine use, while still protecting those at greatest risk of these diseases. To have enough vaccine to provide initial protection to all young infants until larger quantities of DTP vaccine are again available, it will be necessary to begin this approach immediately.

After consultation with members of the Immunization Practices Advisory Committee and the Committee on Infectious Diseases of the American Academy of Pediatrics, the following interim recommendations are made:

  1. Effective immediately, all health-care providers should postpone administration of the DTP vaccine doses usually given at 18 months and 4-6 years of age (fourth and fifth doses) until greater supplies are available.

  2. When adequate DTP vaccine becomes available, steps should be taken to recall all children under 7 years of age who miss these doses for remedial immunization. If these recommendations are followed by all providers of DTP

vaccine throughout this temporary vaccine shortage, immunity in infants will be maintained at the best possible levels. Public health-care providers and professional organizations throughout the United States have been notified and are being urged to follow these recommendations. Reported by U.S. Public Health Service Interagency Group to Monitor Vaccine Development, Production, and Usage.

References

  1. ACIP. Diphtheria, tetanus, and pertussis guidelines for vaccine prophylaxis and other preventive measures. MMWR 1981;30:392-96, 401-7; 1981;420.

  2. CDC. Pertussis -- United States, 1982 and 1983. MMWR 1984;33:573-5.

  3. Brown GC, Volk VK, Gottshall RY, Kendrick PL, Anderson HD. Responses of infants to DTP-P vaccine used in nine injection schedules. Public Health Rep 1964;79:585-602.

  4. Orenstein WA, Weisfeld JS, Halsey NA. Diphtheria and tetanus toxoids and pertussis vaccine, combined. In: Recent advances in immunization: a bibliographic review. Washington, D.C.: Pan American Health Organization, 1983:30-51. (Scientific publication no. 451). *Diphtheria and Tetanus Toxoids and Pertussis Vaccine, Adsorbed.



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