Children and AdolescentsImmunization/Prophylaxis

Diphtheria is an acute infectious disease caused by Corynebacterium diphtheriae. It is characterized by a local inflammatory lesion, usually in the respiratory tract, and a toxic reaction that primarily affects the heart valves and peripheral nerves. Diphtheria is a rare occurrence in the United States. During the past decade, only 0 to 5 cases of diphtheria were reported each year.

Tetanus (lockjaw) is an acute and often fatal disease caused by an exotoxin produced in a wound by Clostridium tetani. Approximately 50 cases of tetanus are reported each year in the United States.

Pertussis (whooping cough) is an acute respiratory infection caused by Bordetella pertussis. Prior to the availability of a vaccine, more than 100,000 cases of pertussis were reported annually in the United States. In 1995, 5137 cases of pertussis were reported; 36% of these cases occurred in children under 1 year of age.

Diphtheria, tetanus, and pertussis are currently designated as infectious diseases notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

See chapter 52 for information on tetanus and diphtheria immunization and prophylaxis in adults.

Most major authorities, including Advisory Committee on Immunization Practices, American Academy of Family Physicians, American Academy of Pediatrics, American College of Preventive Medicine, Bright Futures, and US Preventive Services Task Force --

All children should receive immunization against diphtheria, tetanus, and pertussis: 5 doses total by their seventh birthday (3 doses of primary series at 2, 4 and 6 months of age and 2 doses of booster vaccine at 15 to 18 months and 4 to 6 years of age). All US authorities recommend that a booster dose of Td (tetanus-diphtheria toxoid for adult use) be given at 11 to 16 years of age.

Canadian Task Force on the Periodic Health Examination --

All children should receive immunization against diphtheria, tetanus, and pertussis at 2, 4, 6 and 18 months.

Diphtheria, tetanus, acellular pertussis (DTaP)/diphtheria, tetanus, pertussis (DTP):

There are two types of diphtheria, tetanus and pertussis vaccines: DTaP and whole-cell DTP. DTaP, in which the pertussis portion of the vaccine is acellular, has fewer side effects and is preferred for all five vaccinations in the series. However, during the period of transition from use of DTP to DTaP, whole-cell DTP is an acceptable alternative to DTaP. Three acellular pertussis vaccines are currently licensed for administration to infants: Tripedia, Connaught Laboratories; ACEL-IMUNE, Wyeth-Lederle Pediatric Vaccines; and Infanrix, SmithKline Beecham. Four whole-cell vaccines are currently licensed for administration to infants. They are produced by: Lederle, Connaught Laboratories, Massachusetts Public Health Biologic Laboratories, and Michigan Biologic Products.

Combined vaccines:

A combined whole-cell DTP and Haemophilus influenzae type b (DTP-HbOC) vaccine (TETRAMUNE, Lederle) has been licensed for the first four doses of the childhood vaccination series to prevent diphtheria, tetanus and pertussis, and H. influenzae type b (Hib).

The Food and Drug Administration has approved reconstituting H. influenzae type b conjugate vaccine (ActHIB, Connaught Laboratories, or OmniHIB, SmithKline Beecham) with the DTP vaccine produced by Connaught Laboratories for the first four doses of the diphtheria, tetanus and pertussis series. The DTaP vaccine Tripedia produced by Connaught Laboratories can be reconstituted with either ActHIB, Connaught Laboratories, or OmniHIB, SmithKline Beecham, and administered for the fourth dose.

Tetanus toxoid:

There are two forms of tetanus toxoid: adsorbed and fluid. Tetanus toxoid adsorbed contains aluminum, which enhances the immune response and, for this reason, is the preferred form. Tetanus toxoid fluid vaccine can be used as an alternative in cases where there is a known hypersensitivity to aluminum, which is found in the adsorbed type. Generally, the tetanus toxoid in vaccinations such as DTP, DTaP, DT, and Td are adsorbed. Check the Physician's Desk Reference for further information.

The Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics, and the American Academy of Family Physicians currently recommend the following schedule for diphtheria, tetanus, and pertussis vaccination (Table 12.1):

The recommended dose of DTaP, DTP, DTP-HbOC, DT, Td, and the single-antigen adsorbed preparations is 0.5 mL, given intramuscularly.

For infants younger than 12 months of age: The preferred site is the anterolateral thigh. Bunch the thigh muscle, using the free hand, and inject the needle (22- to 25-gauge, 7/8" to 1" in length) inferiorly at an angle to reach the muscle but avoid contact with neurovascular structures or bone. DTaP or DTP may be given simultaneously with other childhood vaccinations, but avoid giving other vaccinations in the same limb with DTaP or DTP.

For toddlers and older children: Vaccination may be given in the deltoid (if muscle mass appears adequate) using a 22- to 25-gauge needle that is 5/8" to 1-1/4" in length. DTaP or DTP may be given simultaneously with other childhood vaccinations, but avoid giving other vaccinations in the same limb with DTaP or DTP.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3 for a listing of valid contraindications. Table 12.2 lists contraindications specific to DTaP/DTP vaccination.

• Pertussis vaccine is contraindicated in children over 7 years of age.
• Because of the high diphtheria toxoid content of DT, it is not recommended for use in children over the age of 7; vaccinate children over 7 years of age with Td.

Local side effects, including redness, swelling, or pain, along with mild systemic reactions (fever less than 40.5°C [104.9°F], drowsiness, fretfulness, vomiting, or anorexia) can commonly occur. These side effects occur much less frequently with the acellular DTaP vaccine than with the DTP vaccine. Acetaminophen or ibuprofen given at the time of DTP vaccination and every 4 hours for the next 24 hours may help prevent or relieve minor side effects (eg, fever, pain).

Moderate to severe systemic events include the following: fever of 40.5°C (104.9°F) within 48 hours; persistent inconsolable crying for 3 hours or more; an unusual, high-pitched cry within 48 hours; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; and convulsions with or without fever occurring within 72 hours of vaccination. These side effects are rare following DTP vaccination and are very rare following DTaP vaccination.

Severe adverse events are very rare following DTP vaccination and are expected to be extremely rare following DTaP. These reactions include anaphylaxis (severe allergic hypersensitivity) and acute encephalopathy.

All adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording, (800)822-7967. Refer to Appendix B for details.

If pertussis vaccine is contraindicated in a child younger than age 7 years for reasons other than acute anaphylaxis, replace DTaP or DTP with DT in the immunization schedule.

If a nonimmunized child is 7 years of age or older, administer three doses of Td. Give the second dose 4 to 8 weeks after the first, and administer the third dose 6 to 12 months after the second dose.

If at least 5 years have elapsed since the last dose of DTaP, DTP, DTP-HbOC, or DT, give a booster immunization with Td at 11 to 16 years of age.

The National Childhood Vaccine Injury Act requires health care providers to provide the following information to (parents of) patients prior to administering DTP/DTaP: (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, and (3) notice of the availability of the National Vaccine Injury Compensation Program.

The US Department of Health and Human Services has developed a pamphlet for this purpose (See Patient Resources). Other patient educational materials may be used if they provide the information required by the National Childhood Vaccine Injury Act. For additional information about this requirement, contact the Training Coordinator, National Immunization Program, Centers for Disease Control and Prevention; (404)639-8226.

Store vaccine at 2 to 8°C (36 to 46°F); do not freeze. Do not use vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

Patients who may have been exposed to tetanus because of wounds may need prophylaxis via immediate passive immunization with tetanus immune globulin (TIG), active immunization with tetanus toxoid (preferably Td), or both. See Table 12.3 for guidelines on passive and active immunization according to the nature of the wound and the patient's immunization status.

The recommended dose of TIG is 250 units. This should be given intramuscularly in a different site and with a different syringe than that used for concurrent administration of DTP, DTaP, or Td.

The recommended dose of Td is 0.5 mL. This should be given intramuscularly, in a different site and with a different syringe than that used for concurrent administration of TIG.

The side effects of TIG are relatively minor (site soreness and mild temperature elevation), but a few cases of more serious side effects (anaphylaxis, angioneurotic edema, nephrotic syndrome) have been reported.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000. Internet address: http://www.aafp.org

Vaccine Information Statement -- Diphtheria, Tetanus, and Pertussis: What you need To know before your child gets the vaccines, #I1923; Tetanus and Diphtheria Vaccine: What you need to know before you or your child gets the vaccine, #I1733. US Department of Health and Human Services. This information is available from the National Immunization Program, Information/Distribution Center, MS E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225. Fax (404)639-8828. Other sources of this information are state and local health departments or the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016.

Protecting Your Child Against Diphtheria, Tetanus, and Pertussis; Immunization Protects Children. American Academy of Pediatrics, Division of Publications, 141 Northwest Point Blvd, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Parents Guide to Childhoood Immunization, #00-590. US Department of Health and Human Services. This material is available from the National Immunization Program, MS E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225. Fax (404)629-8828.

Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures, #I1413; Recommended Childhood Immunization Schedule, #I1743; Six Common Misconceptions about Vaccination and How to Respond to Them, #00-6561; Guide to Contraindications in Childhood Vaccines, #00-6562. These documents are available from the National Immunization Program, MS E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225. Fax (404)639-8828.

Immunization Protects Children. American Academy of Pediatrics, Division of Publications, 141 Northwest Point Blvd, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Immunization Action Coalition. Internet address: http://www.immunize.org

Before the introduction of Haemophilus influenzae type b (Hib) conjugate vaccines, Hib was the leading cause of bacterial meningitis in children younger than age 5 years and one of the leading causes of invasive bacterial disease (such as pneumonia, epiglottitis, septic arthritis, and cellulitis) in this age group. Even with the use of antibiotics, mortality from meningitis was approximately 5%. Among meningitis survivors, 15% to 30% had permanent neurologic sequelae. The peak incidence of Hib invasive disease occurred in children aged 6 to 12 months; 75% of all illness occurred in children younger than 24 months of age.

Risk factors for Hib invasive disease included attendance at day care centers, exposure to a family member of elementary school age, asplenia, sickle cell disease, and antibody-deficiency syndromes. In 1990, Hib conjugate vaccines were introduced and recommended as a primary series in infants. These vaccines have high efficacy (over 90%) for preventing Hib invasive disease, and since their introduction, a significant decline in the incidence of invasive disease has been documented. The efficacy of Hib vaccination in older children with chronic conditions associated with increased risk of Hib disease has not been studied. Studies suggest, however, good immunogenicity in patients with sickle cell disease, leukemia, splenectomy, and HIV infection.

Under certain circumstances, rifampin is used prophylactically to prevent the transmission of Hib (See Recommendations of Major Authorities). Rifampin prophylaxis eradicates Hib carriage in at least 95% of the contacts of persons with primary disease and reduces the risk of secondary invasive disease in exposed household contacts. The efficacy of rifampin prophylaxis in day care settings is not well defined.

H. influenzae type b (invasive disease only) is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

Advisory Committee on Immunization Practices, American Academy of Family Physicians, American Academy of Pediatrics, American College of Preventive Medicine, Bright Futures, and US Preventive Services Task Force --

Allchildren should receive a primary series of one of the conjugate vaccines licensed for infant usebeginning at 2 months of age. See below for details and schedule.

Canadian Task Force on the Periodic Health Examination --

Recommends immunization with Hib conjugate vaccine at 2, 4, 6, and 18 months of age.

Advisory Committee on Immunization Practices and American Academy of Pediatrics --

Rifampin prophylaxis is indicated for all household contacts of a person with Hib invasive disease if the household contains at least one child younger than 12 months old (regardless of immunization status). Prophylaxis is also indicated for all household contacts of a person with Hib invasive disease if the household contains children younger than 4 years of age who are not fully vaccinated against Hib disease. A household contact is defined as an individual residing with the patient, or a nonresident who spent 4 hours or more with the patient for at least 5 of the 7 days preceding the day of hospital admission of the patient. A child is considered fully immunized following (a) at least one dose of conjugate vaccine at 15 months of age or older, or (b) two doses of conjugate vaccine at 12 to 14 months of age, or (c) two or more doses of conjugate vaccine at less than 12 months of age, followed by a booster dose at 12 months of age or later.

Four types of conjugate vaccines currently are licensed for use in the United States: HbOC (HibTITER, Lederle-Praxis), PRP-OMP (PedvaxHIB, Merck, Inc.), PRP-D (ProHIBIT, Connaught Laboratories), and PRP-T (ActHIB, Connaught Laboratories and OmniHIB, Smith Kline Beecham). PRP-D is not licensed for use in primary immunization of children younger than 15 months of age; it may, however, be used as a booster dose beginning at 12 months of age. Ideally, use the same type of conjugate vaccine throughout the entire primary vaccination series. To facilitate this, note the vaccine type on the parent-held record and in the patient chart. Ifthe type of vaccine used for previous immunization is not known, ensure that the 2- to 6-month-old patient receives a total of at least three doses of conjugate vaccine. Any type of conjugate Hib vaccine can be used for booster doses.

A combined whole-cell DTP and Hib (HbOC) vaccine (TETRAMUNE, Lederle-Praxis) is licensed for use in children aged 2 months to 5 years when indications for vaccination with DTP vaccine and Hib conjugate vaccine coincide.

The Food and Drug Administration has approved reconstituting the following H. influenzae type b conjugate vaccines: ActHIB (Connaught Laboratories) or OmniHIB (Smith Kline Beecham) with DTP vaccine (Connaught Laboratories) for use in the first four doses of the DTP series. Similarly, DTaP (Tripedia, Connaught Laboratories) can be combined with either ActHIB or OmniHIB for the fourth dose in children who previously received three doses of DTP and three doses of Hib vaccine.

When both Hib and Hepatitis B vaccines are indicated, Comvax TM (Merck, Inc.), composed of the antigenic components used in PedvaxHIB (Merck, Inc.), and RECOMBIVAX HB (Merck, Inc.) can be used.

The Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians currently recommend the following schedule for H. influenzae type b (Hib) vaccination:

The recommended dose of Hib vaccines (including DTP-HbOC) is 0.5 mL, given intramuscularly.

For infants younger than 12 months of age, the preferred site is the anterolateral thigh (although the deltoid may beused if necessary). Bunch the thigh muscle, using the free hand, and direct the needle (22- to 25-gauge, 7/8" to 1" in length) inferiorly at an angle to reach the muscle but avoid contact with neurovascular structures or bone.

For toddlers and older children, vaccination may be given in the deltoid (if muscle mass appears adequate), using a 22- to 25-gauge needle that is 5/8" to 1-1/4" in length.

NOTE: Hib vaccines and Hib combination vaccines may be given simultaneously with other childhood vaccinations but must be administered at different sites.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3for a listing of valid contraindicaitons.

There are no known specific contraindications to Hib vaccination. Use in pregnant women is not recommended.

The side effects of Hib vaccination are minor and are limited to mild fever and redness and/or swelling at the injection site.

All adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording, (800)822-7967. Refer to Appendix B for details.

If the first vaccination is delayed beyond 6 months of age, the schedule for vaccination of previously unimmunized children should be followed (Table 13.2).

Hib vaccination is not recommended for healthy persons over the age of 5 years. However, one dose of Hib conjugate vaccine can be considered in persons older than 5 years who are vulnerable to Hib invasive disease (eg, persons with asplenia, sickle cell anemia, HIV infection, and leukemia).

The US Department of Health and Human Services has developed vaccine information statements about H. influenza type b vaccination (see Patient Resources). Copies of these statements must be available to patients in facilities where federally purchased vaccines are used, and their availability in other settings is encouraged.

Store vaccine at 2° to 8°C (36° to 46°F); do not freeze. Do not use vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

Begin rifampin prophylaxis as soon as possible, because most cases of secondary disease occur within the first week after occurrence of the index case. The efficacy of chemoprophylaxis is questionable if it is given 2 weeks after occurrence of the index case.

The recommended prophylactic dosage of rifampin is 20 mg/kg (maximum, 600 mg), given orally once daily for 4 days. The recommended dosage for infants younger than age 1 month is 10 mg/kg. If a child is unable to swallow capsules, prescribe a rifampin suspension or rifampin powder, which may be mixed with several teaspoons of applesauce.

Do not administer rifampin to pregnant women; consult an infectious disease specialist for alternative therapies.

Side effects of rifampin chemoprophylaxis include orange discoloration of urine and other bodily fluids, discoloration of soft contact lenses, decreased effectiveness of oral contraceptives, nausea, vomiting, diarrhea, headache, anddizziness.

All adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording, (800)822-7967. Refer to Appendix B for details.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000. Internet address: http://www.aafp.org

Vaccine Information Statement -- Haemophilus Influenzae Type B: What You Need to Know Before Your Child Gets the Vaccine, #I1905. US Department of Health and Human Services. This material is available from the National Immunization Program, Information/Distribution Center, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA 30333; (404)639-8225. Fax (404)639-8828; state and local health departments; and the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Immunization Action Coalition. Internet address: http://www.immunize.org

Immunization Protects Children. American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Parents Guide to Childhood Immunizations, #00-590. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Recommended Childhood Immunization Schedule, #I1743; Six Common Misconceptions about Vaccination and How to Respond to Them, #00-6561; Guide to Contraindications in Childhood Vaccine, #00-6562; Recommendations for Use of Haemophilus B Conjugate Vaccines and a Combined Diphtheria, Tetanus, Pertussis and Haemophilus B Vaccine, #I1706; Haemophilus b Conjugate Vaccines for Prevention of Haemophilus Influenzae Type B Disease among Infants and Children Two Months of Age and Older, #I1417. These documents are available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333; (404)639-8225, fax (404)639-8828.

Infection with hepatitis B virus (HBV) is a major health problem in the United States. About 200,000 new cases are reported annually. Every year, approximately 4000 to 5000 people die of chronic liver disease caused by HBV infection, and persons with chronic infection are also at increased risk of death from hepatocellular cancer. See Table 14.1 for a list of groups at high risk for HBV infection.

In the United States, most HBV infections are acquired during adolescence or adulthood, largely as a result of sexual contact, injection drug use, or occupational/household contact. Rates of infection are also high in certain populations, including Alaska Natives, Pacific Islanders, and immigrants from HBV-endemic areas (particularly East Asia and Africa). Efforts to control HBV infection through vaccination and education of high-risk individuals, testing of pregnant women, and vaccination of the offspring of carrier women have been only partially successful. Children of HBV-infected mothers are at high risk for developing infection during the perinatal period and the first 5 years of life. Perinatal infection leads to a 90% risk of chronic infection and a 25% risk of death from chronic liver disease as an adult. Vaccination later in life (ie, adolescence) misses this vulnerable population and requires the use of more vaccine with a subsequent higher cost per dose.

Vaccination is highly effective (up to 95%) in preventing HBV infection in susceptible patients. Because hepatitis B vaccine was developed relatively recently, its length of effectiveness is unknown; it is thought to be 10 years, but much longer-lasting immunity is likely. The combination of hepatitis B vaccination and hepatitis B immune globulin (HBIG) is 80% to 95% effective for preventing perinatal HBV infection after acute exposure.

See chapter 48 for information on hepatitis immunization and prophylaxis for adults.

Hepatitis B is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

All major authorities, including Advisory Committee on Immunization Practices, American Academy of Family Physicians (AAFP), American Academy of Pediatrics, American College of Preventive Medicine, American Medical Association, Canadian Task Force on the Periodic Health Examination (CTFPHE), and US Preventive Services Task Force --

All children should receive a complete series of hepatitis B immunizations during the first 18 months of life. Infants born to hepatitis B suface antigen (HBsAg) positive mothers should begin receiving these immunizations at birth. All adolescents should also be fully immunized. In addition, all major authorities recommend immunization of adolescents and young adults not previously immunized, particularly those at increased risk of infection. AAFP recommends offering immunization to persons aged 12 to 24 years. According to the CTFPHE, the optimal dose schedules and target populations for universal childhood immunization have not yet been determined, and vaccination of high-risk groups should continue to receive high priority. See below for details of schedule.

All major authorities

HBIG should be used as prophylaxis for nonimmunized or inadequately immunized individuals exposed to active hepatitis B infection. Prophylactic treatment may be needed in the following situations: percutaneous or mucosal exposure to HBsAg-positive blood, sexual exposure to a hepatitis B surface antigen (HBsAg) positive person, perinatal exposure of an infant to an HBsAg-positive mother, or household exposure of an infant younger than 12 months of age to a primary care-giver who has acute HBV infection. The CTFPHE indicates the prophylactic use of HBIG only in situations where there is perinatal exposure of an infant to an HBsAg positive mother.

Two licensed hepatitis B vaccines currently are produced in the United States: Engerix-B and Recombivax HB (available in three preparations for different age groups). Both vaccines are produced by recombinant DNA technology, and they may be used interchangeably at any point in the vaccination schedule, although the dosage may vary. A plasma-derived vaccine (Heptavax^TM) is also licensed, but it is no longer produced in the United States.

According to the Advisory Committee on Immunization Practices, the schedule for administering hepatitis B vaccine to infants of hepatitis B surface antigen (HBsAg) negative mothers should be flexible and integrated into the routine childhood immunization schedule. Administer the first dose between birth and 2 months of age. Give the second dose between 1 and 4 months of age and at least 1 month after delivery of the first dose. Give the third dose between 6 and 18 months of age, with a minimum of 4 months between the second and third doses. Because of possible decreased seroconversion rates, premature infants of HBsAg-negative mothers with birth weights less than 2000 g should receive the first dose at the time of hospital discharge if the infant then weighs at least 2000 g, or when routine childhood immunizations are initiated at 2 months of age.

For infants (even if premature) born to HBsAg-positive mothers, initiate immunization within 12 hours of birth. Give subsequent doses at 1 and 6 months of age. A four-dose schedule (at birth, 1, 2, and 12 months) for postexposure immunization has been licensed by Engerix-B. This schedule may slightly increase the likelihood of development of immunity, but it has not been demonstrated to offer clinical advantage over the three-dose regimens. For information on perinatal prophylaxis see Table 14.3. For information on immunization for postexposure prophylaxis, see Table 48.2.

Adolescents not immunized as infants should receive a complete series of three immunizations by 11 to 12 years of age, with the second and third doses administered at least 1 and 4 months, respectively, after the first dose.

Long-term studies of healthy adults and children indicate that immunologic memory remains intact for at least 10 years, although antibody levels may become low or undetectable. Therefore, booster doses of vaccine are not recommended for children and adults whose immune status is normal, and serologic testing to assess antibody levels is not necessary. The possible need for booster doses will be assessed as additional information becomes available.

The recommended dose of hepatitis B vaccine varies according to the vaccine type and the age of the child ( Table 14.2). Administer the vaccine as an intramuscular injection. In infants younger than 12 months of age, the preferred site is the anterolateral thigh (although, if necessary, the deltoid may be used). Bunch the thigh muscle, using the free hand, and direct the needle (22- to 25-gauge, 7/8" to 1" in length) inferiorly at an angle to reach the muscle but avoid contact with neurovascular structures or bone. In toddlers and older children, the vaccination may be given in the deltoid (if muscle mass appears adequate), using a 22- to 25-gauge needle that is 5/8" to 1-1/4" in length. Hepatitis B vaccines may be given simultaneously with other childhood vaccinations but at different sites.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3 for a listing of valid contraindications.

A history of an anaphylactic reaction to common baker's yeast is a specific contraindication to hepatitis B vaccination. The only other contraindication is a known serious adverse reaction to the vaccine. Pregnancy and lactation are not contraindications.

The side effects of hepatitis B vaccination are relatively minor in children. These include pain at the injection site (3% to 29%) and temperature higher than 38°C (100.4°F) (0.5% in infants and 1% to 6% in other children). Based on surveillance for adverse reactions in adults in the United States, a possible association between Guillain-Barré syndrome (GBS) and receipt of plasma-derived hepatitis B vaccine has been suggested; however, available data do not indicate an association between receipt of recombinant hepatitis B vaccine and GBS. Although systematic surveillance for adverse events following administration of recombinant hepatitis B vaccine to infants and children has been limited, no association has been found between vaccination and the occurrence of severe adverse events, including seizures and GBS.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The US Department of Health and Human Services has developed vaccine information statements about hepatitis B vaccination ( see Patient Resources). These statements must be available to patients in facilities where federally purchased vaccines are used, and their availability in other settings is encouraged.

Store vaccine at 2° to 8°C (36° to 46°F). Do not freeze. Do not use vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

See Table 14.3 for the recommended schedule of HBV immunoprophylaxis to prevent perinatal transmission. See Table 48.2 for the recommended schedule of HBV immunoprophylaxis for percutaneous and mucosal exposure in children and adults.

The recommended dose of HBIG for infants 12 months of age or younger is 0.5 mL. The dose for children older than 12 months of age is 0.06 mL/kg. Administer HBIG as an intramuscular injection. The recommended site is the anterolateral thigh muscle for infants and the deltoid muscle for children and adolescents. HBIG may be given at the same time as hepatitis B vaccine but must be given at a different site. The recommended dose of hepatitis B vaccine for perinatal exposure varies according to vaccine type ( Table 14.2).

The only contraindication to HBIG injection is a history of hypersensitivity to HBIG.

The main side effects of HBIG are pain and swelling at the injection site. Urticaria, angioedema, and, very rarely, anaphylaxis can occur. HIV is not known to be transmitted by HBIG injection.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000.

Vaccine Information Statement -- Hepatitis B Vaccine & Hepatitis B Immune Globulin: What you need to know before you or your child gets the vaccine, #I1906. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333, (404)639-8225, fax (404)639-8828; state and local health departments; and the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Your Baby: Protecting Your Baby Against Hepatitis B (videotape), #00-6320; Protect Your Baby With Hepatitis B Shots, #00-6550; Why Does My Baby Need Hepatitis B Vaccine?, #00-6230; Parents Guide to Childhood Immunizations, #00-590. US Department of Health and Human Services. These and other materials are available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225. fax (404)639-8828.

Recommended childhood immunization schedule, #I1743; Six common misconceptions about vaccination and how to respond to them, #00-6561; Guide to contraindications in childhood vaccines, #00-6562; Hepatitis B Virus Infection From Mother to Child: A Cycle of Tragedy (videotape), #99-4149. These documents are available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225. fax (404)639-8828.

Group	Vaccines
	Recombivax HB		Engerix-B
	mg	mL	mg	mL
Infants of HBsAg-negative mothers and children <11 years of age	2.5	0.25	10	0.5
Infants of HBsAg-positive mothers; prevention of perinatal infection	5	0.5	10	0.5
Children and adolescents 11-19 years of age	5	0.5	20	1.0
Adapted from: Advisory Committee on Immunization Practices (ACIP). Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. MMWR. 1991;40(No. RR-13):1-25.

The incidence of measles (rubeola), mumps, and rubella is now at record low levels following outbreaks that occurred in the late 1980s and early 1990s. The predominant cause of these outbreaks was failure to immunize children on time. An outbreak that occurred in the mid 1980s among school- and college-aged students was attributed to lack of vaccination and vaccine failure. Since 1989, administration of a second dose of vaccine has been recommended either in primary, middle, or junior high school to ameliorate the problem of vaccine failure.

Measles outbreaks in the United States principally affect four groups: unvaccinated preschool-aged children, persons opposed to vaccination, unvaccinated young adults, and school-aged children who receive only a single dose of measles-containing vaccine. Genetic studies of measles viruses isolated from outbreak-related cases suggest that importation of measles virus from countries with less developed measles control programs is the source of most and maybe all outbreaks of measles. The annual number of reported cases of measles was 312 in 1993, 963 in 1994, and 309 in 1995, the three lowest annual totals ever. Death, usually caused by pneumonia or encephalitis, occurs in one to two patients per every 1000 reported cases; however, no deaths have been reported since 1992.

In the early 1990s, 4264 mumps cases were reported in the United States; the number of reported cases fell steadily, to a record low of 906 cases in 1995. Orchitis occurs in up to 38% of postpubertal males with mumps. Five of every 1000 reported cases are complicated by encephalitis.

In 1995, 128 cases of rubella were reported; this is the lowest number of cases ever reported. Use of rubella vaccine has led to a significant decrease in the overall incidence of both rubella and congenital rubella syndrome (CRS), which develops in an estimated 85% of infants born to women who acquire rubella during the first trimester of pregnancy. Only six cases of CRS were reported in 1995. The most frequently occurring clinical manifestations of CRS are deafness, low birth weight, hepatomegaly, splenomegaly, ocular lesions, psychomotor retardation, congenital heart disease, and petechiae. Half of noncongenital rubella infections are subclinical, with occasional serious complications such as thrombocytopenia (1 per 3000 cases) and encephalitis (1 per 6000 cases).

See chapter 51 for information about rubella immunization of adults.

Measles, mumps, and rubella are currently designated as infectious diseases notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

All major authorities, including Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), American College of Preventive Medicine, Bright Futures, Canadian Task Force on the Periodic Health Examination (CTFPHE), and US Preventive Services Task Force (USPSTF) --

A primary measles-mumps-rubella (MMR) immunization should be given at 12 to 15 months of age. The AAFP, AAP, and ACIP recommend that the booster dose be given either at 4 to 6 years or 11 to 12 years of age, consistent with state school immunization requirements. The AAFP recommends increased attention to adolescents and young adults from congregate settings (eg, schools) who might lack a second dose. The USPSTF and CTFPHE recommend that the booster dose be given at 4 to 6 years of age. The USPSTF recommends immunization of older children who present for care so that all children have had two doses of measles or MMR vaccine by age 11 to 12 years. The AAP has recommended that colleges and other institutions require all entering students to have documentation of physician-diagnosed measles, serologic evidence of immunity, birth before 1957, or receipt of two doses of measles-containing vaccines. Students without documentation of any measles vaccination or immunity should receive a dose on entry, followed by a repeat dose 1 or more months later.

Advisory Committee on Immunization Practices and American Academy of Pediatrics --

Although MMR is recommended routinely at 12 to 15 months of age, the first vaccination should be given at 12 months of age in areas at high risk for recurrent measles transmission. A high-risk area is: a county with more than five cases among preschool-aged children during each of the last 5 years; a county with a recent outbreak among nonimmunized preschool-aged children; or a county with a large inner-city population. In order to control outbreaks of measles among preschool-aged children, the first immunization (either as monovalent measles vaccine or MMR) may be given as early as 6 months of age if cases are occurring in children younger than 1 year of age. Children immunized before 12 months of age should be revaccinated at 12 to 15 months of age and at 4 to 6 years or 11 to 12 years of age, according to state school immunization requirements.

Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics --

Exposure to measles is not a contraindication to vaccination. If live measles vaccine is given within 72 hours of measles exposure, it may provide some protection. ACIP states that use of vaccine is preferable to the use of immunoglobulin (IG) for children 12 months of age or older. The use of IG within 6 days of exposure can prevent or modify measles in susceptible individuals. IG may be particularly indicated for susceptible household contacts of measles patients, particularly contacts younger than 1 year of age, pregnant women, or immunocompromised individuals.

Measles, mumps, and rubella are live attenuated virus vaccines. They are available as single-antigen preparations and as combination preparations: measles-rubella, mumps-rubella, and measles-mumps-rubella (MMR). Unless a specific antigen is contraindicated, use MMR.

Give primary immunization at 12 to 15 months of age. Some high-risk children may benefit from receiving this immunization earlier. Revaccinate children who received MMR before their first birthdays at 12 to 15 months of age. The Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend giving a second dose either at age 4 to 6 years (before school entry) or at age 11 to 12 years (before middle school or junior high school entry). Administer doses of MMR or other measles-containing vaccines at least 1 month apart. MMR may be given simultaneously with other childhood immunizations.

Children and adolescents are considered susceptible to measles unless there is documentation of physician-diagnosed measles, serologic evidence of measles immunity, or documentation of receipt of adequate immunization. Patient or parental reports of measles illness or measles immunization are not adequate documentation.

Children and adolescents are considered susceptible to mumps unless there is documentation of physician-diagnosed mumps, laboratory evidence of immunity, or documentation of immunization with live mumps vaccine on or after the first birthday. Vaccinate childrenwhose immunization status is uncertain. Susceptibility testing of adolescents before vaccination is not necessary.

Children and adolescents are considered susceptible to rubella unless there is documentation of immunity by laboratory testing or documentation of immunization on or after the first birthday. Patient or parental reports or clinician diagnosis are not adequate evidence of immunity. See chapter 51 for more information about indications for rubella immunization in adults.

The recommended dose of MMR and the single-antigen preparations is 0.5 mL. Give the injection subcutaneously into the thigh in infants and the deltoid area in children, using a 5/8"to 3/4", 23- to 25-gauge needle.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3 for a listing of valid contraindications. See Table 15.1 for a list of contraindications specific to MMR vaccination.

The measles component may cause a transient rash in 5% of vaccinees. Fever higher than 39.4°C (103°F) develops in 5% to 15% of individuals susceptible to measles, beginning 5 to 12 days after immunization and usually lasting 1to2 days, but can persist for up to 5 days. Because of the late onset of fever, acetaminophen prophylaxis may not be practical in preventing febrile seizures.

The rubella component is associated with development of a mild rash lasting 1 to 2 days and mild pain and stiffness in the joints 1 to 2 weeks after immunization, usually lasting up to 3 days. Rarely, pain or stiffness can last for months or longer and can recur. Joint swelling (arthritis) lasting a few days to a week develops in 1% of children. Damage to joints is a very rare occurrence.

Both the rubella and mumps components can cause swollen anterior cervical, posterior auricular, or mandibular lymph nodes 1 to 2 weeks after immunization. This happens rarely with the mumps component but may affect one in seven children receiving the rubella component. Development ofencephalitis is temporally related to receipt of MMR in about one of every 1 million persons immunized.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

Do not administer MMR vaccine to patients who have received high doses of a systemically administered corticosteroid (2mg/kg or 20 mg per day of prednisone or equivalent) until at least 3 months after discontinuation of the corticosteroid.

Immune globulin-containing preparations, such as immune globulin (IG), tetanus immune globulin (TIG), hepatitis B immune globulin (HBIG), varicella zoster immune globulin (VZIG), rabies immune globulin (HRIG), and packed red blood cells, whole blood, and plasma or platelet products may interfere with the immune response to MMR vaccination. Do not administer MMR vaccine 2 weeks before or until 3 to 11 months after such preparations are given (depending on the immune globulin content). Repeat vaccination after the window of immune globulin interference has expired, or perform antibody testing to determine the patient's immunity status. See Advisory Committee on Immunization Practices (MMWR. 1994;43[RR-1]:1-38) for more detailed information regarding this issue.

The National Childhood Vaccine Injury Act requires health care providers to provide the following information to patients prior to administering MMR: (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, and (3) notice of the availability of the National Vaccine Injury Compensation Program.

The US Department of Health and Human Services has developed a pamphlet for this purpose ( see Patient Resources). Other patient educational materials may be used if they provide the information required by the National Childhood Vaccine Injury Act. For additional information about this requirement, contact the Training Coordinator, National Immunization Program, Centers for Disease Control and Prevention; (404)639-8226.

Measles, mumps, rubella, and MMR vaccines must be shipped at temperatures lower than 10°C (50°F) and stored at 2° to 8°C (36° to 46°F) or colder and must be protected from light exposure at all times. After vaccine is reconstituted, keep it refrigerated at 2° to 8°C (36° to 46°F), protect it from light, and discard any that is not used within 8 hours. Do not freeze reconstituted vaccine and the diluent. Handle all vaccine preparations according to manufacturers' instructions.

The recommended dose of IG for immunocompetent individuals is 0.25 mL/kg of body weight (maximum dose, 15 mL) given intramuscularly. The recommended dose for immunocompromised patients is 0.5 mL/kg of body weight (maximum dose, 15 mL).

Administer IG deep into a large muscle mass such as the anterolateral thigh. If the gluteal region must be used, limit injection to the ventrogluteal site or the upper outer quadrant. Divide large volumes of IG, and administer it in different sites for patient comfort. Administer no more than 5 mL in one site to an adult or large child; give smaller amounts (1 to 3 mL) to smaller children and infants.

Do not give IG to patients with severe thrombocytopenia or any coagulation disorder that would preclude IM injection. Although such instances are rare, persons with selective serum IgA deficiency can develop anti-IgA antibodies from the receipt of IG and react to a subsequent dose of IG, whole blood, or plasma with systemic symptoms. Use IG with caution in patients with a history of past allergic reactions after injections of IG.

Local pain and swelling (often mistaken for an allergic reaction) are the most common adverse effects of IG injection. Urticaria, angioedema, and (rarely) anaphylaxis may occur.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000. Internet address: http:/www.aafp.org

Vaccine Information Statement -- Measles, Mumps, and Rubella: What You Need to Know Before You or Your Child Gets the Vaccine, #I1730. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828. Other sources include state and local health departments and the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927, (800)433-9016; Internet address: http://www.aap.org

Parents Guide to Childhood Immunizations, #00-590. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Protecting Your Child Against Diphtheria, Tetanus, and Pertussis; Immunization Protects Children. American Academy of Pediatrics, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Immunization Protects Children. American Academy of Pediatrics, Division of Publications, 141 Northwest Point Blvd, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http:/www.aap.org

Rubella Prevention, #I1428; Measles Prevention, #I1418; Recommended Childhood Immunization Schedule, #I1743; Six Common Misconceptions About Vaccination and How to Respond to Them, #00-6561; Guide to Contraindications in Childhood Vaccines, #00-6562. These and other documents are available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333; (404)639-8225. Fax (404)639-8828.

In 1994, the Western Hemisphere was certified as being free of indigenous wild-type (not vaccine-related) poliovirus, the enterovirus that causes paralytic poliomyelitis. The last cases of wild, indigenously acquired poliomyelitis in the United States were reported in 1979. The current risk of exposure to wild poliovirus in the United States is very low and continues to diminish as global eradication continues. In comparison, the risk of vaccine-associated poliomyelitis (VAPP) from oral polio vaccine (OPV), for both vaccine recipients and their susceptible contacts, is greater than the risk of paralytic poliomyelitis from wild-type virus. The risk of VAPP is approximately one per 750,000 first doses of OPV administered

Between 1980 and 1994, only six imported cases and two indeterminate cases of polio occurred in the United States, while there were 125 cases of VAPP. Although the successful elimination of indigenous wild-type polio is primarily attributable to the wide use of OPV, these recent changes in the epidemiological patterns of poliomyelitis in the United States prompted a re-examination and subsequent change in many of the recommendations regarding the routine use of OPV and inactive polio vaccine (IPV) beginning in the 1997 calendar year.

Paralytic poliomyelitis is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

In 1997, the Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians (AAFP), and American Academy of Pediatrics (AAP)

changed their recommendations for routine poliovirus vaccination, and now recommend expanded use of IPV for routine poliovirus vaccination. The American College of Preventive Medicine and Bright Futures have also adopted these guidelines. The revised recommendations include three acceptable options (sequential IPV-OPV; all IPV; and all OPV), and parents and providers may choose among them. Parents and other care-givers should be informed of the poliovirus vaccines available, alternative immunization schedules, and the basis for poliovirus vaccination recommendations. The benefits and risks of the vaccines and the advantages and disadvantages of the three vaccination options, for individuals and the community, should be discussed.

Sequential: IPV at 2 and 4 months; OPV at 12 to 18 months and 4 to 6 years All-IPV: IPV at 2, 4, 12 to 18 months, and 4 to 6 years All-OPV: OPV at 2, 4, 6-18 months, and 4 to 6 years

Advisory Committee on Immunization Practices

recommends a sequential IPV-OPV schedule for greatest overall public health benefit by decreasing the incidence of VAPP while maintaining high levels of population immunity to poliovirus to prevent outbreaks should wild poliovirus be reintroduced in the United States.

American Academy of Pediatrics and American Academy of Family Physicians

recommend parent and provider choice in the selection of the vaccination schedule most suitable for the child.

Canadian Task Force on the Periodic Health Examination

recommends either IPV or OPV. The IPV vaccination schedule is at 2, 4, 6 and 18 months and 4 to 6 years. The OPV schedule is at 2, 4, and 18 months and 4 to 6 years.

US Preventive Services Task Force

acknowledged the potential benefits of incorporating IPV into the childhood immunization schedule, but has not updated its recommendations since the change in the ACIP guidelines.

Two types of trivalent vaccine are available for use in the United States: live oral poliovirus vaccine (OPV) and enhanced-potency inactivated poliovirus vaccine (IPV). Both vaccines contain antigens to poliovirus types I, II, and III and are highly effective. OPV, through its induction of intestinal immunity against poliovirus, is effective in controlling circulation of the wild virus. IPV also induces mucosal immunity, but to a lesser extent.

IPV at 2 and 4 months; OPV at 12 to 18 months and 4 to 6 years OR IPV at 2, 4, and 12 to 18 months and 4 to 6 years OR OPV at 2, 4, and 12 to 18 months and 4 to 6 years

Parents of children who are to be vaccinated should be informed of the poliovirus vaccines available, the three alternative vaccination schedules, and the basis for the vaccination recommendations. The benefits and risks of the vaccines as well as the advantages and disadvantages of the three vaccination options for individuals and for the community should be discussed (Table 16.1).

An all-OPV schedule is preferred for infants and children starting vaccination late (ie, after 6 months of age) or when accelerated protection against poliomyelitis is required. Three doses of OPV constitute a primary series and are required to assure seroconversion to all three serotypes of poliovirus. Under such circumstances, the minimum time interval between doses of OPV is 4 weeks. Administer a supplemental dose of OPV between 4 and 6 years of age. For infants and children for whom IPV is indicated and accelerated protection is needed, the minimum interval between doses of IPV is 4 weeks, although the preferred interval between the second and third dose is six months. Administer an additional dose of IPV between ages 4 and 6 years.

Routine poliovirus vaccination of adults (generally those aged 18 years and older) residing in the United States is not necessary. Immunization is recommended for certain adults who are at risk of exposure to poliovirus, including travelers, laboratory and health-care workers, and unvaccinated adults residing in households of children receiving OPV. For unvaccinated adults, primary vaccination with IPV is recommended because the risk for VAPP after receiving OPV is higher among adults than among children. Two doses of IPV should be administered at intervals of 4 to 8 weeks; a third dose should be administered 6 to 12 months after the second. If three doses of IPV cannot be administered within the recommended intervals before protection is needed, the following alternatives are recommended:

If 8 or more weeks are available, three doses of IPV should be administered at least 4 weeks apart.

If less than 8 but more than 4 weeks are available, two doses of IPV should be administered at least 4 weeks apart.

If less than 4 weeks are available, a single dose of OPV or IPV is recommended.

The remaining doses of vaccine should be administered later, at the recommended intervals, if the person remains at increased risk.

Adults who previously completed a primary series of either OPV or IPV who are at increased risk of exposure to poliovirus may be given another dose of either OPV or IPV. These adults are not at increased risk for VAPP.

OPV is supplied in a disposable pipette containing a single dose of 0.5 mL or in 10-dose vials. The vaccine should be dropped on the back of the tongue. If a substantial amount of OPV is regurgitated or spit out within 5 to 10 minutes of administration, it may be readministered. If the repeat dose is also lost, attempt readministration at the next visit.

The recommended dose of IPV is 0.5 mL, given subcutaneously or intramuscularly in the thigh of infants and in the deltoid area of older children and adults with a 5/8" to 3/4", 23- to 25-gauge needle.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3 for a listing of valid contraindications. See Table 16.2 for a list of contraindications specific to polio immunization.

Because of the increased risk for VAPP, OPV should not be administered to persons with immunodeficiency disorders or malignant diseases or to persons whose immune systems have been compromised by therapy (corticosteroids, alkylating drugs, antimetabolites or radiation) (see Adverse Reactions). Use IPV for these patients and their household contacts. Do not administer OPV to hospitalized infants until after discharge, because of the theoretical risk of poliovirus transmission in the hospital.

The risk of paralysis in recipients of OPV and their close contacts is extremely low. The rate of VAPP after the first dose of OPV is approximately one case per 750,000 doses. All adults who are not immunized or inadequately immunized against polio should be informed of the very low risk of developing paralytic poliomyelitis after a child with whom they have close contact has been immunized with the OPV vaccine. Advise them to wash their hands well after diaper changes and avoid contact with feces. Nonimmunized and partially immunized adults may be offered immunization with IPV. Because of the overriding importance of ensuring prompt and complete immunization, sequential IPV-OPV vaccination of children should begin regardless of the polio vaccination status of adult contacts.

IPV does not induce paralysis, and its side effects are minor (eg, local pain and swelling at the injection site).

Any adverse effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The National Childhood Vaccine Injury Act requires health care providers to provide the following information to patients prior to administering a polio vaccination: (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, and (3) notice of the availability of the National Vaccine Injury Compensation Program.

The US Department of Health and Human Services has developed a pamphlet for this purpose ( see Patient Resources). Other patient educational materials may be used if they provide the information required by the National Childhood Vaccine Injury Act. For additional information about this requirement, contact the Training Coordinator, National Immunization Program, Centers for Disease Control and Prevention; (404)639-8226.

Store OPV at temperatures low enough to keep it solidly frozen. Temperatures below -14°C (+7°F) may be required. Completely thaw the vaccine before use. A container of vaccine may be subjected to a maximum of 10 cycles of thawing and refreezing as long as the temperature of the vaccine does not exceed 8°C (46°F) and the total cumulative time thawed is not more than 24 hours. If the vaccine is thawed for more than 24 hours, it should not be refrozen but should be stored at 2 to 8°C (36 to 46°F) and used within 30 days. Store IPV at 2 to 8°C (36 to 46°F); do not freeze it. Do not use IPV vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000; Internet address: http://www.aafp.org.

Vaccine Information Statement -- Polio Vaccines: What You Need to Know, #I1921. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225, fax (404)639-8828; state and local health departments, or the American Academy of Pediatrics, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Immunization Protects Children. American Academy of Pediatrics, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016.Internet address: http://www.aap.org

Parents Guide to Childhood Immunizations, #00-590. US Department of Health and Human Services. This material is available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Poliomyelitis prevention: enhanced potency inactivated poliomyelitis vaccine-supplementary statement, #I1925; Recommended childhood immunization schedule, #I1743; Six common misconceptions about vaccination and how to respond to them, #00-6561; Guide to contraindications in childhood vaccines, #00-6562. These and other documents are available from the National Immunization Program, Centers for Disease Control and Prevention, M/S E-34, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Table 16.1. Advantages and Disadvantages of Three Poliovirus Vaccination Options

Table 16.2. True Contraindications and Precautions * for OPV/IPV Vaccination

Approximately 3.9 million cases of primary varicella-zoster virus (VZV) disease (chickenpox) occur annually in the United States. Chickenpox is typically a mild disease but may be severe in newborn infants, immunocompromised persons, and susceptible adults. Approximately 90 fatal cases of chickenpox are reported annually. Infants born to women who contract varicella in the first or second trimester of pregnancy may be afflicted with congenital varicella syndrome, with abnormalities in the skin, limbs, eyes, and central nervous system. In approximately 15% of chickenpox cases, subsequent reactivation in the form of zoster (shingles) occurs; shingles is particularly prevalent and severe in persons who are elderly or immunocompromised.

A varicella vaccine was licensed for use in the United States in 1995. A similar vaccine has been widely used in Japan and Korea. The varicella vaccine has been shown to be highly efficacious in children (70% to 90% effective at preventing all clinical disease, 95% effective at preventing severe disease). Clinical disease that does occur in vaccinated children tends to be less severe than that experienced by nonimmunized children. Varicella vaccine has not been as well studied in adults. Because adults tend to have a poorer immune response to the vaccine, two doses are required to achieve optimal conversion rates. Chickenpox results in considerable costs to society in the form of hospitalizations, lost days of schooling, and lost days of work. Cost-benefit analysis has indicated that routine use of varicella vaccine in children at 1 year of age would result in savings of $384 million per year in the United States.

Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians, American Academy of Pediatrics (AAP), and US Preventive Services Task Force --

Clinicians should routinely vaccinate children between the ages of 12 and 18 months. Children within this age range who have a prior history of chickenpox do not need to be immunized, although the ACIP has stated that it is acceptable to do so. Immunization is also recommended for children 19 months to 12 years of age who lack a prior history of immunization or clinical disease. Serologic testing of children before vaccination is not warranted, because most children aged 12 months to 12 years who do not have a history of chickenpox are susceptible, and the vaccine is well tolerated in seropositive persons. The AAP states that clinicians may decide to offer serologic testing to healthy adolescents who may be susceptible to VZV.

Advisory Committee on Immunization Practices (ACIP) and US Preventive Services Task Force --

Given the high prevalence of immunity in adults who have no history of chickenpox and the results of cost-effectiveness analysis, clinicians may wish to offer serologic testing for varicella susceptibility in lieu of routine immunization to history-negative adults who are likely to comply with return visits. ACIP and Centers for Disease Control and Prevention (CDC) recommend vaccination for susceptible persons aged 13 years and over who have close contact with persons at high risk for serious complications (eg, health-care workers and family contacts of immunocompromised persons). ACIP and CDC further state that vaccination should be considered for susceptible persons aged 13 years and over who: (1) live or work in environments in which transmission of VZV is likely (eg, teachers of young children, day-care workers, residents and staff in institutional settings); (2) live or work in environments in which transmission may occur (eg, college students, military personnel); (3) are women of childbearing age (if not pregnant and willing to avoid pregnancy for 1 month); and/or (4) travel internationally (especially if the traveler expects to have close personal contact with local populations).

The single vaccine available in the United States (Varivax, Merck and Co, Inc) is a live, cell-free preparation. A multiple-antigen, measles-mumps-rubella-varicella (MMR) vaccine is currently being tested.

Children should receive a single vaccination between 12 and 18 months of age. Older children, up to 12 years of age, should also receive a single vaccination at the earliest convenient date. Children and healthy adults who are immunized after age 13 years should receive two doses of varicella vaccine delivered 4 to 8 weeks apart. Do not administer varicella vaccine until at least 5 months after a patient has received any form of immune globulin or other blood product.

Varicella vaccine and other childhood vaccines may be given simultaneously but at different sites. If varicella vaccine and MMR are not given concurrently, these vaccines should be given at least 1 month apart.

Booster doses are currently not recommended. The duration of immunity provided by varicella vaccine has not been established, and research is needed to determine whether booster doses will be necessary to maintain protection throughout adulthood.

The recommended dose of varicella vaccine for children and adults is 0.5 mL. Administer the vaccine subcutaneously into the thigh of infants and the deltoid area of older children and adults using a 5/8" to 3/4", 23- to 25-gauge needle.

There are few, true contraindications to administering vaccinations. See Appendix B, Table B.3 for a listing of valid contraindicaitons.

Varicella vaccine is specifically contraindicated in persons with a history of an anaphylactic reaction to neomycin. VZV should be used with caution in any immunocompromised individual, including individuals taking steroids and recent recipients of blood or blood products (including immunoglobulin). Varicella vaccine should not be given to any pregnant women or women who intend to become pregnant within 1 month of vaccination. Individuals suffering from a severe illness should not be vaccinated until full recovery.

Advise parents to avoid administering salicylates to their children for 6 weeks following vaccination, because of the theoretical risk of developing Reye's syndrome.

The vaccine is well tolerated. Transient pain and redness at the injection site are reported by approximately 25% of vaccinees. Fewer than 10% of vaccinees report a mild maculopapular or varicelliform rash, either local or generalized. Because of the small potential for transmission of the vaccine virus, vaccinees in whom a rash develops should avoid contact with immunocompromised susceptible persons. Inadvertent administration of varicella vaccine to individuals who are immune to varicella has not resulted in an increased number of adverse reactions.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The US Department of Public Health has developed vaccine information statements about varicella vaccination ( see Patient Resources). Copies of these statements must be available to patients in facilities where federally purchased vaccines are used, and their availability in other settings is encouraged.

The lyophilized vaccine must be stored frozen at an average temperature of -15°C (8°F) or colder. Store the diluent separately at room temperature or in the refrigerator. Use the vaccine within 30 minutes of reconstitution with the supplied diluent. Discard any reconstituted vaccine that is not used within 30 minutes. Handle all vaccine preparations according to manufacturers' instructions.

Childhood Vaccines: What They Are and Why Your Child Needs Them. American Academy of Family Physicians, 8880 Ward Pkwy, Kansas City, MO 64114-2797; (800)944-0000. Internet address: http://www.aafp.org

Vaccine Information Statement -- Chickenpox Vaccine: What you need to know before you or your child gets the vaccine, #I1894. US Department of Health and Human Services. This information is available from the National Immunization Program, Information/Distribution Center, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333, (404)639-8225, Fax (404)639-8828; or the American Academy of Pediatrics, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Immunization Protects Children. American Academy of Pediatrics, PO Box 927, Elk Grove Village, IL 60009-0927; (800)433-9016. Internet address: http://www.aap.org

Parents Guide to Childhood Immunizations, #00-590; Immunization of Adults: A Call to Action, #00-6040. US Department of Health and Human Services. This material is available from the National Immunization Program, Information/Distribution Center, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Rules of Childhood Immunization. Immunization Action Coalition, 1573 Selby Ave, Suite 229, St. Paul, MN 55104; (612)647-9009. Internet address: http://www.immunize.org

Recommended Childhood Immunization Schedule, #I1743; Six Common Misconceptions About Vaccination and How to Respond to Them, #00-6561; Guide to Contraindications in Childhood Vaccines, #00-6562. These and other documents are available from the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.