Notice to Readers: Update on the Supply of Tetanus and Diphtheria
Toxoids and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
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.
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