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Notice to Readers Recommended Childhood Immunization Schedule -- United States, 1997

Since publication of the recommended childhood immunization schedule in July 1996 (1), the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) have made important changes in recommendations for preventing pertussis and poliomyelitis (Figure_1A) (Figure_1B). Following the licensure of two acellular pertussis vaccines for infants, the advisory groups now recommend use of acellular pertussis vaccine (Tripedia{Registered}

  • or ACEL-IMUNE{Registered} **)*** as the preferred vaccine for pertussis vaccination for infants beginning at age 2 months. To reduce the risk for vaccine-associated paralytic poliomyelitis (VAPP), recommendations for poliovirus vaccination have expanded the use of inactivated poliovirus vaccine (IPV) by providing three options for poliovirus vaccination (sequential IPV/oral poliovirus vaccine {OPV}, all IPV, or all OPV). In addition, a combination Haemophilus influenzae type b (Hib) and hepatitis B vaccine and a combination diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) and Hib vaccine have been licensed for use in certain situations. This report presents the recommended childhood immunization schedule for 1997 and explains the changes that have occurred since the last publication of the schedule. Licensure of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines for Infants

Since 1992, two DTaP vaccines, ACEL-IMUNE{Registered} and Tripedia{Registered}, have been licensed for use as the fourth and fifth doses of diphtheria and tetanus toxoids and pertussis vaccine (DTP) in children aged 15 months-6 years. In 1995, data became available about the clinical protection conferred by acellular pertussis vaccines when administered to young infants. Multiple controlled trials conducted in Europe demonstrated that, when administered to infants beginning at age 2 months, the protective efficacy of acellular pertussis vaccines was similar to the expected range for most whole-cell vaccines (70%-90%) and these vaccines were associated with fewer local reactions, fevers, and other systemic adverse events than whole-cell pertussis vaccines (2-5).

In 1996, the Food and Drug Administration (FDA) licensed two DTaP vaccines, Tripedia{Registered} (July 31) for the initial four doses and ACEL-IMUNE{Registered} (December 30) for all five doses of the DTP vaccination series. As with whole-cell DTP, the first three doses of DTaP are recommended at ages 2, 4, and 6 months. The fourth dose is recommended at age 15-18 months and the fifth dose at age 4-6 years. The fourth dose of DTaP can be administered as early as 12 months of age if at least 6 months have elapsed since receipt of the third dose and if the provider considers the child to be unlikely to return at age 15-18 months to receive this dose.

DTaP is preferred for all doses of the pertussis vaccination series, but whole-cell pertussis vaccines remain acceptable alternatives. Both Tripedia{Registered} and ACEL-IMUNE{Registered} continue to be recommended for administration of doses four and five to children who have received three doses of whole-cell DTP vaccine and are preferred for these doses. Change in Polio Vaccination Recommendations: Sequential Polio Vaccination Schedule

The elimination of wild-virus-associated polio in the Western Hemisphere (6) and the reduced threat of poliovirus importation into the United States because of rapid progress in global polio-eradication efforts have resulted in the most important change in polio vaccination policy since the introduction of OPV in 1961. Since 1980, an average of eight to nine cases of VAPP have been reported annually in the United States, and VAPP has been the only indigenous paralytic polio in this country since 1979. Although the risk for acquiring VAPP is low (about one case per 2.4 million doses distributed or one case per 750,000 children receiving their first dose of OPV), the relative benefits of OPV have diminished, and the risk for VAPP attributable to OPV is now considered less acceptable. Therefore, ACIP, AAP, and AAFP now recommend a greater reliance on IPV, with a transition policy that will increase use of IPV and decrease use of OPV during the next 3-5 years.

ACIP, AAP, and AAFP recommend three options for polio vaccination: sequential administration of IPV and OPV, all IPV, or all OPV. For overall public health benefit, ACIP recommends a sequential schedule of two doses of IPV followed by two doses of OPV for routine childhood vaccination; however, all three polio vaccination options meet acceptable standards of care. Parents should be informed of the benefits and risks associated with each schedule and should choose among them. Implementation of these recommendations should reduce the risk for VAPP and facilitate a transition to exclusive use of IPV following further progress toward global polio eradication.

The recommended schedule for sequential IPV/OPV vaccination consists of two doses of IPV administered at ages 2 and 4 months, followed by two doses of OPV, administered at age 12-18 months and at age 4-6 years. If an all IPV schedule is used, the timing of doses is the same as for the sequential schedule (i.e., 2 months, 4 months, 12-18 months, and 4-6 years of age). If an all OPV schedule is used, the first two doses are recommended at ages 2 and 4 months, the third dose at age 6-18 months, and the fourth dose at age 4-6 years. Licensure of New Combination Vaccines

Two new combination vaccines have recently been licensed. On September 27, 1996, FDA licensed one Hib conjugate vaccine (Act-HIB{Registered} ****) reconstituted with Tripedia{Registered} for the fourth dose of the DTP and Hib vaccination series. This vaccine is not licensed for the primary three-dose series; children receiving the primary series should either be vaccinated simultaneously with DTaP and Hib vaccines or with combined whole-cell DTP-Hib vaccine. *****

A combination Hib and hepatitis B vaccine (ComVax{Registered} ******) was licensed on October 2, 1996. The vaccine is routinely recommended at ages 2, 4, and 12-15 months and constitutes a complete series of Hib and hepatitis B vaccines. As with other licensed combination products, these vaccines may be used whenever administration of all vaccine components is indicated. Use of combination vaccines may reduce the number of injections required at a single visit.

Detailed recommendations about the use of vaccines are available from the manufacturers' package inserts, the 1994 Red Book (7), or the vaccine-specific ACIP statements.

References

  1. CDC. Recommended childhood immunization schedule -- United States, July-December 1996. MMWR 1996;45:635-8.

  2. Gustafsson L, Hallander HO, Olin P, Reizenstein E, Storsaeter J. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med 1996;334:349-55.

  3. Greco D, Salmaso S, Mastrantonio P, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med 1996;334:341-8.

  4. Schmitt HJ, Wirsing von Konig CH, Neiss A, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996;275:37-41.

  5. Trollfors B, Taranger J, Lagergard T, et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995;333:1045-50.

  6. CDC. Certification of poliomyelitis elimination -- the Americas, 1994. MMWR 1994;43:720-2.

  7. American Academy of Pediatrics. Active and passive immunization. In: Peter G, ed. 1994 Red book: report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, Illinois: American Academy of Pediatrics, 1994:1-67.

    • Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, prepared and distributed as Tripedia{Registered} by Connaught Laboratories, Inc. (CLI) (Swiftwater, Pennsylvania). The purified acellular pertussis vaccine component is produced by BIKEN/Tanabe Corporation (Osaka, Japan) and is combined with diphtheria and tetanus toxoids manufactured by CLI. ** Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, prepared and distributed as ACEL-IMUNE{Registered} by Lederle Laboratories, Inc. (LLI) (Pearl River, New York). The purified acellular pertussis vaccine component is produced by Takeda Chemical Industries, Ltd. (Osaka, Japan), and is combined with diphtheria and tetanus toxoids manufactured by LLI. *** Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. **** Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) is manufactured by Pasteur Merieux Serums & Vaccins S.A. (Lyon, France). ActHIB{Registered} is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)-OmniHIB{Registered} (distributed by SmithKline Beecham Pharmaceuticals {Philadelphia, Pennsylvania}) and is manufactured by Pasteur Merieux Serums & Vaccins S.A. ***** Tetramune{Registered} (DTP-HbOC) is a sterile combination of diphtheria and tetanus toxoids and pertussis vaccine adsorbed (manufactured by LLI) and a conjugate of oligosaccharides of the capsular antigen of H. influenzae type b and diphtheria CRM197 protein (manufactured by Praxis Biologics, Inc. {West Henrietta, New York}). ActHIB{Registered} may be reconstituted at the time of use with CLI DTP. Both Tetramune{Registered} and CLI DTP-ActHIB{Registered} are licensed for use in infants beginning at age 2 months. ****** The vaccine contains 7.5 ug of H. influenzae polyribosylribitol phosphate (PRP) covalently bound to an outer membrane protein (OMP) component of Neisseria meningitidis B11 and 5 ug of hepatitis B surface antigen and is manufactured by Merck, Inc. (West Point, Pennsylvania).

+------------------------------------------------------------------- ---+ |             | |             | | Erratum: Vol. 46, No. 2 | | ======================= | | SOURCE: MMWR 46(10);227 DATE: Mar 14, 1997 | |             | | In the Notice to Readers "Recommended Childhood Immunization | | Schedule -- United States, 1997," in the double asterisk footnote | | on page 39, the manufacturer of the HbOC component of Tetramune | | was incorrect. Instead of Praxis Biologics, the manufacturer | | should have been listed as Lederle Laboratories, Inc., Division | | of American Cyanamid (Pearl River, New York). | |             | +------------------------------------------------------------------- ---+
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Figure_1B

Figure_1B
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Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

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