FW: DTaP/HIB COMBINED VACCINES SHOULD NOT BE USED FOR PRIMARY SERIES

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August 12, 1998

FEDERAL ANNOUNCEMENT: DTaP/HIB COMBINED VACCINES SHOULD NOT BE USED FOR

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) conjugate vaccines:

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

Immunization Action Coalition & the Hepatitis B Coalition

1573 Selby Avenue

St. , MN 55104

Voice: 612-647-9009

Fax: 612-647-9131

Web: http://www.immunize.org/

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