Issue Number 20
September 10, 1998
CONTENTS OF THIS ISSUE
1. FEDERAL ANNOUNCEMENT: DTaP/HIB COMBINED VACCINES SHOULD NOT BE USED FOR THE PRIMARY
August 12, 1998
FEDERAL ANNOUNCEMENT: DTaP/HIB COMBINED VACCINES SHOULD NOT BE USED FOR THE PRIMARY SERIES
On August 12, the U.S. Public Health Service and the Food and Drug Administration issued a
joint statement regarding the unlicensed use of DTaP/Hib combined vaccines during the
primary series (first 3 doses). The full statement, including information on what to do in
the event that misuse has occurred, follows:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-l448
AUGUST 12 1998
To date, the only licensed combination vaccine containing Haemophilus influenzae type b
(Hib) conjugate vaccine and diphtheria and tetanus toxoid and acellular pertussis (DTaP)
vaccine is for use in toddlers (age 15-18 months of age). We have become aware that in
certain clinical settings, licensed Hib conjugate vaccines and DTaP vaccines are being
combined for administration as a single injection in infants 2,4, and 6 months of age.
These vaccines (DTaP/Hib) have not been licensed for combination use in the primary
immunization series in infants. Clinical studies in infants conducted under
Investigational New Drug Applications (INDs) have demonstrated that using some combination
products may induce a suboptimal immune response to the Hib component. Therefore,
only products licensed and labeled for use in the primary immunization series should be
used in infants.
The following is consistent with the currently approved labeling for Haemophilus
influenzae type b (Hib) conjugatevaccines:
For the immunization of children less than 15 months of age: Any licensed Hib conjugate
vaccine may be given concurrently in separate sites with DTaP or Diphtheria and Tetanus
Toxoids and Whole Cell Pertussis Vaccine (DTP) vaccine, according to the package insert.
Alternatively, any of the licensed combination products containing DTP and Hib conjugate
vaccine may be used. Please note that ACIP has a stated preference for products containing
an acellular pertussis component.
For the immunization of children 15 months of age or older: Any licensed Hib conjugate
vaccine may be given concurrently in separate sites with DTaP or DTP vaccine.
Alternatively, any of the licensed combination products containing DTP and Hib or TriHIBit
[ActHIB (Hib conjugate vaccine) reconstituted with Tripedia (DTaP)] may be used. Please
note that ACIP has a stated preference for products containing an acellular pertussis
In the event that an infant has received an unlicensed DTaP/Hib combination product,
please contact the Immunization Hotline at the Centers for Disease Control and Prevention
(l-800-232-2522 for English and l-800-232-0233 for Espanol) as to further immunization
actions which may be required.
M. Carolyn Hardegree, M.D.
Office of Vaccines
Research and Review
Center for Biologics Evaluation and Research
Walter A. Orenstein, M.D.
Assistant Surgeon General
National Immunization Program
Centers for Disease Control and Prevention