Food and Drug Administration Approval
of a Second Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine
The Advisory Committee for Immunization Practices (ACIP) and
the Committee on Infectious Diseases, American Academy of
Pediatrics (AAP), recommend that children routinely receive a
series of five doses of vaccine against diphtheria, tetanus, and
pertussis before age 7 years (1,2). On December 17, 1991, the Food
and Drug Administration (FDA) approved a diphtheria and tetanus
toxoids and acellular pertussis vaccine (DTaP) prepared and
distributed by Lederle Laboratories (Pearl River, New York) as
ACEL-IMUNE\T * (3). On February 7, 1992, ACIP issued a
supplementary
statement on the use of DTaP (4), and the AAP did so on April 15
(5).
On August 21, 1992, the FDA approved licensure of a second
DTaP product, prepared and distributed as Tripedia\T by Connaught
Laboratories, Inc. (Swiftwater, Pennsylvania). As with
ACEL-IMUNE\T, Tripedia\T is licensed only for use as the fourth
and/or fifth dose(s) for children aged 15 months through 6 years
(i.e., before the seventh birthday) 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/or fifth dose(s).
The following evidence supports the use of Tripedia\T after
the initial three-dose series of whole-cell DTP in infants:
The immunogenicity of the antigens that make up Tripedia\T
when used for the fourth and fifth doses is comparable to that of
whole-cell DTP (unpublished manufacturer's data).
2. A randomized, placebo-controlled clinical efficacy trial in
Sweden in 1985-1987 demonstrated efficacy when two doses of a
pertussis vaccine similar to the formulation in Tripedia\T were
given to children starting at ages 5-11 months (an age older than
that recommended for initiating whole-cell DTP vaccination in the
United States) (6).
3. The rates of local reactions, fever, and other common
systemic symptoms following receipt of Tripedia\T inoculations when
used for the fourth and fifth doses are lower than those following
whole-cell DTP vaccination (unpublished manufacturer's data).
An updated statement from ACIP will be issued as an MMWR
Recommendations and Reports (7).
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.
CDC. Food and Drug Administration approval of use of diphtheria
and tetanus toxoids and acellular pertussis vaccine. MMWR
1991;40:881-2.
ACIP. Pertussis vaccination: acellular pertussis vaccine for
reinforcing and booster use -- supplementary ACIP statement:
recommendations of the Immunization Practices Advisory Committee
(ACIP). MMWR 1992;41(no. RR-1).
Committee on Infectious Diseases, American Academy of
Pediatrics. Acellular pertussis vaccines: recommendations for use
as the fourth and fifth doses. Pediatrics 1992;90:121-3.
Ad Hoc Group for the Study of Pertussis Vaccines.
Placebo-controlled trial of two acellular pertussis vaccines in
Sweden -- protective efficacy and adverse events. Lancet
1988;1:955-60.
ACIP. Pertussis vaccination: acellular pertussis vaccine for the
fourth and fifth doses of the DTP series -- update to supplementary
ACIP statement: recommendations of the Advisory Committee for
Immunization Practices (ACIP). MMWR 1992 (in press).
Use of trade names and commercial sources 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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