Notice to Readers
FDA Approval of a Second Acellular Pertussis Vaccine for Use Among
Infants and Young Children
On December 30, 1996, the Food and Drug Administration (FDA)
licensed Wyeth-Lederle Vaccines and Pediatrics to distribute a
combined diphtheria and tetanus toxoids and acellular pertussis
vaccine (DTaP) (ACEL-IMUNE{Registered} *) ** for all five doses of
the diphtheria, tetanus, and pertussis vaccination series
administered to infants and children aged 6 weeks-6 years (before
the seventh birthday). Since December 1991, ACEL-IMUNE{Registered}
has been licensed for use as the fourth and fifth doses of the
vaccination series among children aged 15 months-6 years who
previously received three or four doses of diphtheria and tetanus
toxoids combined with whole-cell pertussis vaccine (DTP).
ACEL-IMUNE{Registered} is the second acellular pertussis-containing
vaccine to be licensed for use in infants in the United States (1).
The Advisory Committee on Immunization Practices (ACIP);
Committee on Infectious Diseases, American Academy of Pediatrics;
and American Academy of Family Physicians recommend that children
routinely receive a series of five doses of vaccine against
diphtheria, tetanus, and pertussis before age 7 years (2-5). The
first four doses should be administered at ages 2, 4, 6, and 15-18
months and the fifth dose at age 4-6 years.
The following evidence supports the use of
ACEL-IMUNE{Registered} for the diphtheria, tetanus, and pertussis
vaccination series:
The rates of local reactions, fever, and other common systemic
symptoms following receipt of ACEL-IMUNE{Registered} inoculations
were lower than those following whole-cell pertussis vaccination
(administered as DTP) for doses one through four in controlled
clinical studies. The rates of these reactions following the fifth
dose of ACEL-IMUNE{Registered} were no greater than the rates
described for historical controls who received a fifth dose of DTP
after four previous doses of DTP (6, package insert).
Efficacy of ACEL-IMUNE{Registered} was assessed in a prospective
study in Erlangen, Germany. Infants were randomly assigned to
groups that were administered either ACEL-IMUNE{Registered} or DTP
(distributed by Wyeth-Lederle Vaccines and Pediatrics) at mean ages
3, 5, 7, and 17 months. A third group of infants (not selected
randomly) received DT at ages 3, 5, and 17 months. In this trial,
pertussis was defined as cough illness lasting �21 days with at
least one pertussis-associated symptom (paroxysms, whoop, or
post-tussive vomiting) confirmed by culture, serology, or
epidemiologic link to a culture-positive household contact. The
adjusted vaccine efficacy after three doses and before receipt of
the fourth dose was 73% (95% confidence interval {CI}=51%-86%) for
ACEL-IMUNE{Registered} and 83% (95% CI=65%-92%) for DTP. The
adjusted efficacy after four doses of ACEL-IMUNE{Registered} was
85% (95% CI=76%-90%). Adjusted efficacy of four doses of DTP was
94% (95% CI=89%-97%). Considering all observation time, (i.e.,
including after the third dose until the fourth dose {approximately
40% of follow-up time} and after the fourth dose until the end of
the study {approximately 60% of follow-up time}), the adjusted
efficacy estimated for ACEL-IMUNE{Registered} was 81% (95%
CI=73%-87%)
compared with 91% for DTP (95% CI=85%-95%) (package insert).
Because of the reduced frequency of adverse reactions and high
efficacy, the ACIP recommends DTaP (either ACEL-IMUNE{Registered}
or Tripedia{Registered} {Connaught Laboratories, Inc., Swiftwater,
Pennsylvania}) for all doses of the routine diphtheria, tetanus,
and pertussis vaccination series (1). DTaP also is recommended for
all remaining doses in the schedule for children who have started
the vaccination series with one, two, three, or four doses of DTP.
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.
Whenever feasible, the same DTaP vaccine should be used
throughout the entire vaccination series. No data exist on the
safety, immunogenicity, or efficacy of different DTaP vaccines when
administered interchangeably in the primary or booster vaccination
of a child. However, if the vaccine provider does not know or have
available the type of DTaP vaccine the child to be vaccinated had
previously received, any of the licensed DTaP vaccines may be used
to complete the vaccination series. ACIP is developing
recommendations for use of DTaP among infants.
References
CDC. Food and Drug Administration approval of an acellular
pertussis vaccine for the initial four doses of the diphtheria,
tetanus, and pertussis vaccination series. MMWR 1996;45:676-7.
CDC. 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. Pertussis. In: Peter G, ed. 1994
Red book: report of the Committee on Infectious Diseases. 23rd
ed.
Elk Grove Village, Illinois: American Academy of Pediatrics,
Committee on Infectious Diseases, 1994:355-67.
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).
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).
Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13
acellular pertussis vaccines: adverse reactions. Pediatrics
1995;96(suppl):557-66.
* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Adsorbed, ACEL-IMUNE{Registered}, manufactured by Lederle
Laboratories and distributed by Wyeth-Lederle Vaccines and
Pediatrics (Pearl River, New York). The acellular pertussis vaccine
component is produced by Takeda Chemical Industries, Ltd. (Osaka,
Japan), and is combined with diphtheria and tetanus toxoids
manufactured by Lederle Laboratories.
** 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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