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
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 has been associated with a greater than
90% reduction in morbidity and mortality associated with infection
by these organisms. Because of the increasing number of vaccines
now routinely recommended for infants, a high priority is the
development of combined vaccines that allow simultaneous
administration with fewer separate injections.
The Food and Drug Administration (FDA) recently licensed two
new products for vaccinating children against these diseases: 1)
the Haemophilus b conjugate vaccine (tetanus toxoid conjugate,
ActHIB Trademark), * for vaccination against Hib disease only and
2)
a combined diphtheria and tetanus toxoids and whole-cell pertussis
vaccine (DTP) and Hib conjugate vaccine (TETRAMUNE Trademark), a
combination of vaccines formulated for use in vaccinating children
against diphtheria, tetanus, pertussis, and Hib disease.
ActHIB Trademark
On March 30, 1993, the FDA approved a new Haemophilus b
conjugate vaccine, polyribosylribitol phosphate-tetanus toxoid
conjugate (PRP-T), manufactured by Pasteur Merieux Serum et Vaccins
and distributed as ActHIB Trademark by Connaught Laboratories, Inc.
(Swiftwater, Pennsylvania). This vaccine has been licensed for use
in infants in a three-dose primary vaccination series administered
at ages 2, 4, and 6 months. Previously unvaccinated infants 7-11
months of age should receive two doses 2 months apart. Previously
unvaccinated children 12-14 months of age should receive one dose.
A booster dose administered at 15 months of age is recommended for
all children. Previously unvaccinated children 15-59 months of age
should receive a single dose and do not require a booster. More
than 90% of infants receiving a primary vaccination series of
ActHIB Trademark (consecutive doses at 2, 4, and 6 months of age)
develop a geometric mean titer of anti-Haemophilus b polysaccharide
antibody greater than 1 ug/mL (4). This response is similar to that
of infants who receive recommended series of previously licensed
Haemophilus b conjugate vaccines for which efficacy has been
demonstrated in prospective trials. Two U.S. efficacy trials of
PRP-T were terminated early because of the concomitant licensure of
other Haemophilus b conjugate vaccines for use in infants (4). In
these studies, no cases of invasive Hib disease were detected in
approximately 6000 infants vaccinated with PRP-T. These and other
studies suggest that the efficacy of PRP-T vaccine will be similar
to that of the other licensed Hib vaccines.
TETRAMUNE Trademark
On March 30, 1993, the FDA approved a combined diphtheria and
tetanus toxoids and whole-cell pertussis vaccine (DTP) and
Haemophilus b conjugate vaccine. TETRAMUNE Trademark, available
from Lederle-Praxis Biologicals (Pearl River, New York), combines
two previously licensed products, DTP (TRIIMMUNOL Registered,
manufactured by Lederle Laboratories {Pearl River, New York}) and
Haemophilus b conjugate vaccine (HibTITER Registered, manufactured
by Praxis Biologics, Inc. {Rochester, New York}).
This vaccine has been licensed for use in children aged 2
months-5 years for protection against diphtheria, tetanus,
pertussis, and Hib disease when indications for vaccination with
DTP vaccine and Haemophilus b conjugate vaccine coincide. Based on
demonstration of comparable or higher antibody responses to each of
the components of the two vaccines, TETRAMUNE Trademark is expected
to provide protection against Hib, as well as diphtheria, tetanus,
and pertussis, equivalent to that of already licensed formulations
of other DTP and Haemophilus b vaccines.
The Advisory Committee for Immunization Practices (ACIP)
recommends that all infants receive a primary series of one of the
licensed Haemophilus b conjugate vaccines beginning at 2 months of
age 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 2, 4, 6,
and 15-18 months of age, and a booster dose at 4-6 years (6-8). A
complete statement regarding recommendations for use of ActHIB
Trademark and TETRAMUNE Trademark is being developed.
Reported by: Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research, Food and Drug Administration.
Div of Immunization, National Center for Prevention Svcs;
Meningitis and Special Pathogens Br, Div of Bacterial and Mycotic
Diseases, National Center for Infectious Diseases, 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, Kelley 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.
Fritzell B, Plotkin S. Efficacy and safety of a Haemophilus
influenzae type b capsular polysaccharide-tetanus protein conjugate
vaccine. J Pediatr 1992;121:355-62.
ACIP. Haemophilus b conjugate vaccines for prevention of
Haemophilus influenzae type b disease among infants and children
two months of age and older: recommendations of the Immunization
Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-1).
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 Immunization Practices
Advisory Committee (ACIP). MMWR 1992;41(no. RR-15).
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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