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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

  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, Kelley 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. 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.

  5. 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).

  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 Immunization Practices Advisory Committee (ACIP). MMWR 1992;41(no. RR-15).

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