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AAFP, AAP and ACIP Release 1998 Recommended Childhood Immunization Schedule

AAFP Childhood Immunization Update

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Special Medical Reports

AAFP, AAP and ACIP Release 1998
Recommended Childhood Immunization Schedule

RICHARD KENT ZIMMERMAN, M.D., M.P.H.,

AAFP Commission on Clinical Policies and Research and AAFP Liaison with the Advisory Committee on Immunization Practices

The collaboration between the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), and the Advisory Committee on Immunization Practices (ACIP) continues with the 1998 childhood immunization schedule. The changes this year involve expansion of hepatitis B vaccine recommendations for all adolescents, expansion of the timing of the third dose of inactivated poliovirus vaccine (IPV) to as early as six months of age, and uniform recommendations for administration of the second dose of measles, mumps and rubella (MMR) vaccine at four to six years of age.

Hepatitis B Vaccine

The ACIP recently recommended that all children and adolescents 18 years of age and younger who were not previously vaccinated against hepatitis B should be vaccinated with hepatitis B vaccine. The Vaccines for Children Program was expanded, effective March 1998, to cover hepatitis B vaccine through 18 years of age. These expansions simplify current recommendations and should reduce the incidence of hepatitis B in adolescents who engage in behaviors that place them at risk for being infected.

Acellular Pertussis Vaccine

Three acellular pertussis vaccines have been licensed for use in infancy. Acellular pertussis vaccines have 25 to 50 percent fewer instances of the common adverse effects than whole-cell pertussis vaccines and fewer instances of moderate to severe adverse effects. The efficacy of the acellular pertussis vaccines generally is comparable with that of whole-cell pertussis vaccines.^1-3 Because of differences in study design, the safety and efficacy rates cannot generally be compared between trials of the various acellular pertussis vaccines. Methodologic differences exist in general design, degree of blinding, case definition, type of confirmation of pertussis disease, study population and vaccine schedule used. Diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine and Haemophilus influenzae type b (Hib) vaccine given separately cause less pain than the whole-cell DTP/Hib combination vaccines. My office has stopped using whole-cell pertussis vaccine in favor of acellular pertussis vaccine.

Haemophilus influenzae type b Vaccine

Recent studies^4-6 have shown that Hib conjugate vaccines are generally interchangeable. If PRP-OMP (PedvaxHIB) Hib vaccine is administered at two and four months of age, a dose at six months is not required. Tables are available to determine the number of doses needed if a child starts the Hib series late.⁷

Poliomyelitis Vaccine

The AAFP continues to recommend that physicians and parents jointly decide among the all oral poliovirus vaccine (OPV) schedule, the all IPV schedule and the sequential IPV/OPV schedule. This choice should take into account the potential benefits, costs and risks of each schedule. The bar on the 1998 childhood immunization schedule for the third dose of poliomyelitis vaccine has been extended down to six months of age, as it appeared in the 1996 schedule. Previously, the third dose of IPV was approved by the U.S. Food and Drug Administration beginning at 12 months of age, but a recent change allowed its use as early as six months of age. Thus, the all IPV and all OPV schedules are the same: two months, four months, six to 18 months, and four to six years. The sequential IPV/OPV schedule involves two doses of IPV (two and four months of age), followed by two doses of OPV (12 to 18 months and four to six years).

The purpose of the sequential schedule is to reduce vaccine-associated paralytic poliomyelitis, while at the same time providing eventual mucosal immunity and limiting the number of injections in the second year of life. Many children with immunodeficiency disease are diagnosed between four and 12 months of age. Thus, it's somewhat safer to delay the third dose of the sequential schedule until 12 months of age, although administration as early as six months of age is allowable. In my practice, parents differ in their choice of poliomyelitis schedules; some prefer the all OPV schedule to avoid injections and because they themselves and their older children received OPV; others prefer to avoid the small risk of vaccine-associated paralytic poliomyelitis and accept the increased number of injections that are necessary with the all IPV or sequential IPV/OPV schedules.

Measles, Mumps and Rubella Vaccine

The second dose of MMR vaccine is now recommended by the AAFP, ACIP and AAP at four to six years of age; administration at this age is feasible as other vaccines are scheduled for this same time period; furthermore, adverse effects appear to occur less often when the second dose of MMR is given at this age, compared with age 11 to 12 years.⁸ Children seven years of age or older who did not previously receive the second dose of MMR can be caught up on the vaccination at any visit. Age 11 to 12 years is a recommended time to evaluate immunization status and administer any needed vaccines.

Joint Recommendations on Related Topics

In addition to the recommended childhood immunization schedule, the ACIP, AAFP and AAP have developed joint recommendations on immunization of adolescents⁹ and, to be published soon, joint recommendations on the use of reminder and recall systems to increase vaccination rates.¹⁰ Collaboration by these groups results in uniform recommendations and may decrease the confusion that differing policies can create.

Immunization Resources

Physicians will need to make extra efforts to keep current on vaccinations and incorporate them into their practice. AAFP resources include a statement on the Recommended Childhood Immunization Schedule with additional information on poliomyelitis vaccine options, the Age Charts for Periodic Health Examination and the Vital Signs program. The Association of Teachers of Preventive Medicine has up-to-date educational materials for medical students and residents.¹¹ Useful information may be found on Web sites developed by the AAFP and the Centers for Disease Control and Prevention. The AAFP Web site address is http://www.aafp.org. The CDC Web site address is http:// www.cdc.gov/epo/MMWR/mmwr.html.

The vaccination schedule, recommendations and products available are changing rapidly. Several vaccines should be licensed in the next year. Rapid progress is being made in rotavirus and pneumococcal conjugate vaccines for children and Lyme disease vaccine for high-risk adults.

REFERENCES

1. Trollfors B, Taranger J, Lagergard T, Lind L, Sundh V, Zackrisson G, et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995;333:1045-50.
2. Schmitt HJ, von Konig CH, Neiss A, Bogaerts H, Bock HL, Schulte-Wissermann H, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996;275:37-41.
3. Gustafsson L, Hallander HO, Olin P, Reizenstein E, Storsaeter J. A controlled trial of a two-component acellualar, a five-component acellular, and a whole-cell pertussis vaccine [published erratum appears in N Engl J Med 1996;334:1207]. N Engl J Med 1996; 334:349-55.
4. Greenberg DP, Lieberman JM, Marcy SM, Wong VK, Partridge S, Chang S, et al. Enhanced antibody responses in infants given different sequences of heterogeneous Haemophilus influenzae type b conjugate vaccines. J Pediatr 1995;126:206-11.
5. Bewley KM, Schwab JG, Ballanco GA, Daum RS. Interchangeability of Haemophilus influenzae type b vaccines in the primary series: evaluation of a two-dose mixed regimen. Pediatrics 1996; 98:898-904.
6. Anderson EL, Decker MD, Englund JA, Edwards KM, Anderson P, McInnes P, et al. Interchangeability of conjugated Haemophilus influenzae type b vaccines in infants. JAMA 1995;273:849-53.
7. 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 (Morb Mortal Weekly Report) 1991;40(RR-1):1-7.
8. Davis RL, Marcuse E, Black S, Shinefield H, Givens B, Schwalbe J, et al. MMR2 immunization at 4 to 5 years and 10 to 12 years of age: A comparison of adverse clinical events after immunization in the vaccine safety datalink project. Pediatrics 1997;100:767-71.
9. Centers for Disease Control and Prevention: Immunization of adolescents. Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR (Morb Mortal Weekly Report) 1996; 45(RR-13):1-16.
10. U.S. Department of Health and Human Services. Recommendations of the ACIP, AAP, and AAFP. Use of reminder and recall by vaccination providers--programmatic strategy to increase vaccination rates. MMWR (Morb Mortal Weekly Report) (in press).
11. Zimmerman RK, Barker WH, Strikas RA, Ahwesh ER, Mieczkowski TA, Janosky JE, et al. Developing curricula to promote preventive medicine skills: The Teaching Immunization for Medical Education Project. Time Development Committee. JAMA 1997;278:705-11.

Recommended Childhood Immunization Schedule, United States--January 1998 to December 1998

Vaccine Birth 1 month 2 months 4 months 6 months 12 months 15 months 18 months 4-6 years 11-12 years 14-16 years Hepatitis B (Hep B)† Hep B-1 Hep B-2 Hep B-3 Hep B† Diphtheria, tetanus, pertussis‡ DTaP or DTP DTaP or DTP DTaP or DTP DTaP or DTP‡ DTaP or DTP Td Haemophilus influenzae type b (Hib)§ Hib Hib Hib Hib Polio || Polio || Polio Polio || Polio Measles, mumps, rubella (MMR)¶ MMR MMR¶ MMR¶ Varicella-zoster virus vaccine (Var)** Var Var**

This schedule has been approved by the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). It indicates the recommended age for routine administration of currently licensed childhood vaccines. Some combination vaccines are available and may be used whenever administration of all components of the vaccine is indicated. Providers should consult the manufacturers' package inserts for detailed recommendations.

Dark-blue bars indicate range of acceptable ages for immunization. Catch-up immunization should be done during any visit when feasible.

Light-blue bars indicate vaccines to be assessed and given if necessary during the early adolescent visit.

*--Infants born to hepatitis B surface antigen (HBsAg)-negative mothers should receive 2.5 µg of Recombivax HB or 10 µg of Engerix-B. The second dose should be administered at least one month after the first dose. The third dose should be given at least two months after the second, but not before six months of age. Infants born to HBsAg-positive mothers should receive 0.5 mL of hepatitis B immune globulin (HBIG) within 12 hours of birth, and either 5 µg of Recombivax HB or 10 µg of Engerix-B at a separate site. The second dose is recommended at one to two months of age, and the third dose at six months of age. Infants born to mothers whose HBsAg status is unknown should receive either 5 µg of Recombivax HB or 10 µg of Engerix-B within 12 hours of birth. The second dose of vaccine is recommended at one month of age, and the third dose at six months of age. Blood should be drawn at the time of delivery to determine the mother's HBsAg status; if it is positive, the infant should receive HBIG as soon as possible (no later than one week of age). The dosage and timing of subsequent vaccine doses should be based on the mother's HBsAg status; if it is positive, the infant should receive HBIG as soon as possible (no later than one week of age). The dosage and timing of subsequent vaccine doses should be based on the mother's HBsAg status.

†--Children and adolescents who have not been vaccinated against hepatitis B in infancy may begin the series during any visit. Those who have not previously received three doses of hepatitis B vaccine should initiate or complete the series during the 11- to 12-year-old visit, and unvaccinated older adolescents should be vaccinated whenever possible. The second dose should be administered at least one month after the first dose, and the third dose should be administered at least four months after the first dose and at least two months after the second dose.

‡--Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is the preferred vaccine for all doses in the vaccination series, including completion of the series in children who have received one or more doses of whole-cell diphtheria, tetanus, pertussis (DTP) vaccine. Whole-cell DTP is an acceptable alternative to DTaP. The fourth dose (DTP or DTaP) may be administered as early as 12 months of age, provided six months have elapsed since the third dose, and if the child is unlikely to return at 15 to 18 months of age. Tetanus and diphtheria toxoids (Td) is recommended at 11 to 12 years of age if at least five years have elapsed since the last dose of DTP, DTaP or DT. Subsequent routine Td boosters are recommended every 10 years.

§--Three Hib conjugate vaccines are licensed for infant use. If PRP-OMP (PedvaxHIB) is administered at two and four months of age, a dose at six months is not required.

|| --Two poliovirus vaccines are currently licensed in the United States: inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV). The following schedules are all acceptable by the ACIP, the AAP and the AAFP. Parents and providers may choose among these options: (1) Two doses of IPV, followed by two doses of OPV; (2) four doses of IPV; and (3) four doses of OPV. The ACIP recommends two doses of IPV at two and four months of age followed by two doses of OPV at 12 to 18 months and four to six years of age. IPV is the only poliovirus vaccine recommended for immunocompromised persons and their household contacts.

¶--The second dose of MMR vaccine is routinely recommended at four to six years of age but may be administered during any visit, provided at least one month has elapsed since receipt of the first dose and that both doses are administered at or after 12 months of age. Those who have not previously received the second dose should complete the schedule no later than the 11- to 12-years visit.

**--Susceptible children may receive varicella vaccine (Var) during any visit after the first birthday, and those who lack a reliable history of chickenpox should be immunized during the 11- to 12-year-old visit. Susceptible persons 13 years of age and over should receive two doses at least one month apart.

This schedule is provided by the American Academy of Family Physicians only as an assistance for physicians making clinical decisions regarding the care of their patients. As such, they cannot substitute for the individual judgment brought to each clinical situation by the patient's family physician. As with all clinical reference resources, they reflect the best understanding of the science of medicine at the time of publication, but they should be used with the clear understanding that continued research may result in new knowledge and recommendations.

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Special Medical Reports

AAFP Childhood Immunization Update

From the AAFP Commission on Clinical Policies and Research

This revised statement provides information from the American Academy of Family Physicians in addition to the Recommended Childhood Immunization Schedule--January 1998 to December 1998. The date that appears at the end of the description is the date on which the revision was approved. The AAFP recommends the following:

Selection of Polio Vaccine for Routine Immunization of Normal Children

The AAFP recommends that physicians and parents jointly decide on the most appropriate vaccine for routine immunization of their normal children against poliomyelitis. This decision should take into account the risks and benefits of each of the three recognized schedules that use oral poliovirus vaccine (OPV), inactivated poliovirus vaccine (IPV) and the combined IPV/OPV schedule.

Advantages and Disadvantages of Three Poliovirus Vaccination Options Attribute Oral poliovirus vaccine (OPV) Inactivated poliovirus vaccine (IPV) IPV/OPV Occurrence of vaccine-associated paralytic polio 8 to 9 cases per year None Estimated: 2 to 5 per year Other serious adverse events None known None known None known Systemic immunity High High High Immunity of gastrointestinal mucosa High Low High Secondary transmission of vaccine virus Yes No Some Extra injections or visits needed No Yes Yes Compliance with immunization schedule High Possibly reduced Possibly reduced Future combination vaccines Unlikely Likely Likely (IPV) Current cost Low Higher Intermediate Adapted from Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: introduction of a sequential schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR 1997;46(RR-3).

All three schedules are acceptable options for the prevention of poliomyelitis. The use of an all OPV schedule has the benefits of oral administration rather than an injection, protects 95 percent or more of recipients (probably life long) after the primary series of three doses, and induces intestinal immunity. On the negative side, use of OPV can result in rare cases of vaccine-associated paralytic polio. The overall risk of vaccine-associated paralytic polio is one case per 2.4 million total doses distributed. Among immunocompetent persons, 82 percent of cases among vaccine recipients and 65 percent of cases among contacts occur following administration of the first dose. The most current estimate of the risk for vaccine-associated paralytic polio is one case to 750,000 first doses of OPV distributed.

The use of a sequential IPV/OPV schedule theoretically reduces the risk for vaccine-associated paralytic polio by 50 percent or more. Sequential schedules differing from the one recommended for use in the United States have been used successfully in other countries. The main advantage of the sequential schedule is the reduction but not the elimination of cases of vaccine-associated paralytic polio. The use of a sequential schedule may require additional injections per infant visit depending on the combination vaccines available.

An all IPV schedule eliminates the risk of vaccine-associated paralytic polio. It involves more injections, more cost and provides low mucosal immunity. The table summarizes the advantages and disadvantages of the three polio vaccination options. (Revised July 1997)

Text adapted from the Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR 1997;46(RR-3).

This information is provided by the American Academy of Family Physicians only as an assistance for physicians making clinical decisions regarding the care of their patients. As such, they cannot substitute for the individual judgment brought to each clinical situation by the patient's family physician. As with all clinical reference resources, they reflect the best understanding of the science of medicine at the time of publication, but they should be used with the clear understanding that continued research may result in new knowledge and recommendations.

Copyright © 1998 by the American Academy of Family Physicians.
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