Notice to Readers
Food and Drug Administration Approval of an Acellular Pertussis
Vaccine for the Initial Four Doses of the Diphtheria, Tetanus,
and Pertussis Vaccination Series
The Advisory Committee on Immunization Practices (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 age 7 years (1,2). On July 31, 1996, the Food and Drug
Administration licensed Connaught Laboratories, Inc. * (Swiftwater,
Pennsylvania), to distribute a combined diphtheria and tetanus
toxoids and acellular pertussis vaccine (DTaP)
(Tripedia{Registered} ** ), for the initial four doses of the
diphtheria, tetanus, and pertussis vaccination series. Vaccine
doses should be administered at ages 2 months, 4 months, 6 months,
and 15-20 months, with an interval of at least 6 months between the
third and fourth doses. Available data are insufficient to evaluate
the use of Tripedia{Registered} as a fifth dose among children aged
4-6 years who have received Tripedia{Registered} for the previous
four doses. Additional information about the immunogenicity and
safety of a fifth dose following four previous doses of the same
acellular vaccine is being collected and should be available before
infants started on this new schedule are aged 4-6 years and require
a fifth dose.
Tripedia{Registered} is the first acellular pertussis vaccine
to be licensed in the United States for the first three doses of
the diphtheria, tetanus, and pertussis vaccination series.
Tripedia{Registered} may be used to complete the primary series in
infants who have received one or two doses of diphtheria and
tetanus toxoids and whole-cell pertussis vaccine (DTP). For
children who have received DTP for the first three doses of the
series, two acellular pertussis vaccines (Tripedia{Registered} and
ACEL-IMUNE{Registered} {Wyeth-Lederle Vaccines and Pediatrics
(Pearl River, New York)}) already are licensed for the fourth and
fifth doses of the series (3,4). The fifth dose of either DTaP or
DTP is not necessary if the fourth dose was administered on or
after the fourth birthday (1,2).
The following evidence supports use of Tripedia{Registered}
for the first four doses of the diphtheria, tetanus, and pertussis
vaccination series:
The rates of local reactions, fever, and other common systemic
symptoms following receipt of Tripedia{Registered} inoculations are
lower than those following whole-cell DTP vaccination for each of
the first four doses in the series (3,5; Connaught Laboratories,
Inc., unpublished data).
The protective efficacy of three doses of Tripedia{Registered}
against pertussis disease (defined as cough lasting greater than or
equal to 21 days with culture confirmation of infection with
Bordetella pertussis) when administered at approximately 3, 5, and
7 months of age was 80% (95% confidence interval {CI}=59%-90%) in
a case-control study in Germany (Connaught Laboratories, Inc.,
unpublished data). In a randomized, placebo-controlled clinical
trial in Sweden, the acellular component of this vaccine
manufactured by BIKEN, Inc., was administered as a two-dose series
to children aged 5-14 months (6). Point estimates of protective
efficacy were 69% (95% CI=47%-82%) for cases of culture-confirmed
pertussis with any cough lasting greater than or equal to 1 day and
79% (95% CI=57%-90%) for cases of culture-confirmed disease of
greater than 30 days' duration.
Because of the reduced frequency of adverse reactions and high
efficacy, the ACIP recommends DTaP for routine use as the first
four doses of the pertussis vaccination series. During the
transition period from use of whole-cell DTP to DTaP, vaccines
containing a whole-cell pertussis component continue to be an
acceptable alternative for all doses in the pertussis vaccination
series. A complete statement by the ACIP about recommendations for
use of DTaP among infants is being developed.
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. Pertussis vaccination: acellular pertussis vaccine for the
fourth and fifth doses of the DTP series -- update to the
supplementary ACIP statement. Recommendations of the Advisory
Committee on Immunization Practices. MMWR 1992;41(no. RR-15).
CDC. 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).
Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13
acellular pertussis vaccines: adverse reactions. Pediatrics
1995;96(suppl):557-66.
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.
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.
** Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine,
Adsorbed, prepared and distributed by Connaught Laboratories, Inc.
The purified acellular pertussis component is produced by
BIKEN/Tanabe Corporation (Osaka, Japan) and is combined with
diphtheria and tetanus toxoids manufactured by Connaught
Laboratories, Inc.
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