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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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).

7. 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).

8. 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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