Food and Drug Administration Approval of Use of Haemophilus
influenzae Type b Conjugate Vaccine Reconstituted with
Diphtheria-Tetanus-Pertussis Vaccine for Infants and Children
Haemophilus influenzae type b (Hib) conjugate vaccines have
been recommended for use in infants since 1990, and their routine
use in infant vaccination has contributed to the substantial
decline in the incidence of Hib disease in the United States (1-3).
Vaccines against diphtheria, tetanus, and pertussis during infancy
and childhood have been administered routinely in the United States
since the late 1940s and have been associated with a more than 90%
reduction in morbidity and mortality caused by infection with these
organisms. Because of the increasing number of vaccines now
routinely recommended for infants, a high priority has been placed
on the development of combined vaccines that allow simultaneous
administration with fewer separate injections. One product
combining Hib conjugate vaccine with diphtheria and tetanus toxoids
and whole-cell pertussis vaccine had been licensed by the Food and
Drug Administration (FDA) (4).
On November 18, 1993, the FDA approved the reconstitution of
the previously licensed Hib conjugate vaccine (tetanus toxoid
conjugate) (PRP-T), with a previously licensed diphtheria and
tetanus toxoids and whole-cell pertussis vaccine (DTP), allowing
simultaneous vaccination for Hib disease, diphtheria, tetanus, and
pertussis in a single injection. PRP-T, manufactured by Pasteur
Merieux Serums and Vaccines and distributed by Connaught
Laboratories, Inc. (CLI) (Swiftwater, Pennsylvania) as ActHIBTM*,
and by SmithKline Beecham (Philadelphia) as OmniHIBTM, is now
licensed to be reconstituted with DTP manufactured by CLI. ActHIBTM
is distributed as 10 single-dose vials of lyophilized PRP-T,
packaged together with a multidose vial of CLI DTP for
reconstitution. Other licensed formulations of DTP have not been
approved by FDA for reconstitution of PRP-T vaccine and may not be
used for that purpose.
PRP-T reconstituted with CLI DTP has been licensed for use in
children aged 2 months-5 years for protection against diphtheria,
tetanus, pertussis, and Hib disease. Previously unvaccinated
younger children should receive doses of the PRP-T-CLI DTP
combination at ages 2, 4, 6, and 15-18 months. Based on comparable
antibody responses to each of the components of the vaccine, PRP-T
reconstituted with CLI DTP is expected to provide protection
against Hib disease, as well as diphtheria, tetanus, and pertussis,
equivalent to that of already licensed formulations of other DTP
and Hib conjugate vaccines.
The Advisory Committee on Immunization Practices (ACIP)
recommends that all infants receive a primary series of one of the
licensed Hib conjugate vaccines beginning at age 2 months and a
booster dose at age 12-15 months (5). The ACIP also recommends that
all infants receive a four-dose primary series of diphtheria and
tetanus toxoids and pertussis vaccine at ages 2, 4, 6, and 15
months and a booster dose at age 4-6 years (6-8).
Reported by: Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research, Food and Drug Administration.
Childhood and Respiratory Diseases Br, Div of Bacterial and Mycotic
Diseases, National Center for Infectious Diseases; National
Immunization Program, CDC.
References
Adams WG, Deaver KA, Cochi SL, et al. Decline of childhood
Haemophilus influenzae type b (Hib) disease in the Hib vaccine era.
JAMA 1993;269:221-6.
Broadhurst LE, Erickson RL, Keiley PW. Decrease in invasive
Haemophilus influenzae disease in U.S. Army children, 1984 through
1991. JAMA 1993;269:227-31.
Murphy TV, White KE, Pastor P, et al. Declining incidence of
Haemophilus influenzae type b disease since introduction of
vaccination. JAMA 1993;269:246-8.
CDC. FDA approval of use of a new Haemophilus b conjugate
vaccine and a combined diphtheria-tetanus-pertussis and Haemophilus
b conjugate vaccine for infants and children. MMWR 1993;42:296-8.
ACIP. Recommendations for use of Haemophilus b conjugate
vaccines and a combined diphtheria, tetanus, pertussis, and
Haemophilus b vaccine: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR 1993;42(no. RR-13).
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).
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).
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 on
Immunization Practices (ACIP). MMWR 1992;41(no. RR-15).
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the U.S. Department of Health and Human Services.
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