Issue Number 20                                       September 10, 1998

CONTENTS OF THIS ISSUE

1. FEDERAL ANNOUNCEMENT: DTaP/HIB COMBINED VACCINES SHOULD NOT BE USED FOR THE PRIMARY SERIES
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(1)
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

Dear Colleague:

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 component.

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.

Sincerely yours,

M. Carolyn Hardegree, M.D.
Director
Office of Vaccines
Research and Review
Center for Biologics Evaluation and Research

Walter A. Orenstein, M.D.
Assistant Surgeon General
Director
National Immunization Program
Centers for Disease Control and Prevention