Food and Drug Administration Approval
of Use of Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine
The Immunization Practices Advisory Committee (ACIP) and the
Committee on Infectious Diseases, American Academy of Pediatrics,
recommend that children routinely receive a series of five doses of
vaccine against diphtheria, tetanus, and pertussis before 7 years
of age (1,2). The Food and Drug Administration has approved a
diphtheria and tetanus toxoids and acellular pertussis vaccine
(DTaP) prepared by Lederle Laboratories (Pearl River, New York) and
distributed as ACEL-IMUNETM *. This vaccine is licensed only for
use
as the fourth and fifth doses for children who have previously been
vaccinated against diphtheria, tetanus, and pertussis with three
doses of whole-cell diphtheria and tetanus toxoids and pertussis
vaccine (DTP) and is not licensed for the initial three-dose series
in infants and children; whole-cell DTP should continue to be used
for these initial doses. Whole-cell DTP continues to be an
acceptable alternative for the fourth and fifth doses. DTaP is not
licensed for use in children less than 15 months of age or after
the seventh birthday. The fourth dose should be given at least 6
months after the third dose of whole-cell DTP and is usually
administered to children 15-18 months of age (1,2). A dose of DTaP
may be given as the fifth dose in the series for children aged 4-6
years who have received either all four prior doses as whole-cell
vaccine or three doses of whole-cell DTP plus one dose of DTaP;
this fifth dose should be given before the child enters
kindergarten or elementary school. The fifth dose in the
vaccination series is not necessary if the fourth dose was given on
or after the fourth birthday (1,2).
The following evidence supports the use of ACEL-IMUNETM after
the initial three-dose series of whole-cell DTP vaccine in infants:
The immunogenicity of the antigens comprising ACEL-IMUNETM when
used for the fourth and fifth doses is comparable to that of
whole-cell DTP vaccine (3).
Although not evaluated in a prospective study in which
clinicians and investigators were blinded with respect to the
vaccination status of the study subjects, the effectiveness against
clinical pertussis disease of a DTaP vaccine manufactured and used
in Japan (which contained a pertussis vaccine component identical
to that in ACEL-IMUNETM) has been demonstrated in children greater
than or equal to 2 years of age (4).
The rates of local reactions, fever, and other common systemic
symptoms following receipt of ACEL-IMUNETM inoculations are lower
than those following whole-cell DTP vaccination (3).
A statement from ACIP will be published as an MMWR Recommendations
and Reports (5).
Reported by: Center for Biologics Evaluation and Research, Food and
Drug Administration. National Center for Prevention Svcs, CDC.
References
ACIP. Diphtheria, tetanus, and pertussis: recommendations for
vaccine use and other preventive measures--recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no.
RR-10).
American Academy of Pediatrics. Report of the Committee on
Infectious Diseases. Elk Grove Village, Illinois: American Academy
of Pediatrics, Committee on Infectious Diseases, 1991.
Blumberg DA, Mink CM, Cherry JD, et al. Comparison of an
acellular pertussis-component diphtheria-tetanus-pertussis (DTP)
vaccine with a whole-cell pertussis-component DTP vaccine in 17- to
24-month-old children, with measurement of 69-kilodalton outer
membrane protein antibody. J Pediatr 1990;117:46-51.
Mortimer EA, Kimura M, Cherry JD, et al. Protective efficacy of
the Takeda acellular pertussis vaccine combined with diphtheria and
tetanus toxoids following household exposure of Japanese children.
Am J Dis Child 1990;144:899-904.
ACIP. Pertussis vaccination: acellular pertussis vaccine for
reinforcing and booster use--supplementary Immunization Practices
Advisory Committee (ACIP) statement. MMWR (in press).
Use of trade names is for identification only and does not imply
endorsement by the Public Health Service or the U.S. Department of
Health and Human Services.
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