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Surgeon General Reports, SAMHSA TIPs, SAMHSA PEPs Put Prevention Into Practice (Static collection) Clinician's Handbook of Preventive Services, 2nd Edition. PPIP Children and AdolescentsImmunization/Prophylaxis 12. Diphtheria, Tetanus and Pertussis 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. Recommendations of Major Authorities
1. Vaccine Types Diphtheria, tetanus, acellular pertussis (DTaP)/diphtheria, tetanus, pertussis (DTP):
Combined vaccines:
Tetanus toxoid:
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): 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsThere 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.
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. 6. Special CasesIf 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. 7. Patient EducationThe 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. 8. Vaccine Storage and HandlingStore 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. Basics of Tetanus Prophylaxis1. Indications 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. 2. Dose and AdministrationThe 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. 3. Adverse ReactionsThe 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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . Acellular pertussis vaccine: Recommendations for use as the fourth and fifth doses. Pediatrics. 1992. 90: 121-123. (PubMed) American Academy of Pediatrics, Committee on Infectious Diseases. . Acellular Pertussis Vaccine: Recommendations for use as the initial series in infants and children. Pediatrics. 1997. 98(2): 282-288. American Academy of Pediatrics, Committee on Infectious Diseases. . Haemophilus influenzae type b conjugate vaccines: Recommendations for immunization with recently and previously licensed vaccines. AAP News. 1993. 9: 17-19. American Academy of Pediatrics, Committee on InfectiousDisease. . 1991 Report. Elk Grove Village, Ill: American Academy of Pediatrics; 1991. Canadian Task Force on the Periodic Health Examination. . Childhood immunizations. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 24. Centers for Disease Control and Prevention. . FDA approval of use of a new Haemophilus b conjugate vaccine and a combined diphtheria-tetanus-pertussis and Haemophilus b conjugate vaccine for infants and children. MMWR. 1993. 42: 296-298. Centers for Disease Control and Prevention. . Recommended childhood immunization scheduleUnited States, 1997. MMWR. 1997. 46: 35-40. Centers for Disease Control. . Summary of notifiable diseases, United States, 1989. MMWR. 1990. 38: 51-59. Centers for Disease Control and Prevention. . Pertussis vaccination: use of acellular pertussis vaccines among infants and young childrenrecommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1997. 46(No.RR-7): 1-25. Centers for Disease Control and Prevention. . CDC Surveillance Summaries, February 21, 1997. MMWR. 1997;46(No.SS-2). Centers for Disease Control. . Vaccine Adverse Event Reporting SystemUnited States. MMWR. 1990. 39: 730-733. Edwards KM, Karzon DT. . Pertussis vaccines. Pediatr Clin North Am. 1990. 37: 549-563. (PubMed) Farizo KM, Cochi SL, Zell ER, Brink EW, Wassilak SG, Patriarca PA. . Epidemiological features of pertussis in the United States, 1980-89. Clin Infect Dis. 1992. 14: 708-719. (PubMed) Gergen PJ, McQuillan GM, Kiely M, Ezzati-Rice TM, Sutter RW, Virella G. . A population-based serologic survey of immunity to tetanus in the United States. N Engl J Med. 1995; 332:761-766. Isselbacher KJ, Braunwald E, Wilson JD, et al. . Harrison's Principles of Internal Medicine, Companion Handbook. 13th ed. New York: MacGraw-Hill, 1995. McAuliffe JSM, Wadland WC. . Pertussis vaccination. Am Fam Physician. 1988. 37(3): 231-235. National Vaccine Advisory Committee. . Standards for Pediatric Immunization Practices. Atlanta, Ga: Centers for Disease Control and Prevention; 1993. Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 65. Tables Table 12.1. Schedule for Diphtheria, Tetanus, Pertussis Vaccination
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. Recommendations of Major AuthoritiesImmunization
1. Vaccine Types Conjugate Vaccines
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: 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsThere 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. 5. Adverse ReactionsThe 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. 6. Special CasesIf 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). 7. Patient EducationThe 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. 8. Vaccine Storage and HandlingStore 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. Basics of Rifampin Prophylaxis1. Schedule 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. 2. Dosage and AdministrationThe 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. 3. ContraindicationsDo not administer rifampin to pregnant women; consult an infectious disease specialist for alternative therapies. 4. Adverse ReactionsSide 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. Patient Resources
American Academy of Family Physicians, Commission on Public Health and Scientific Affairs. . AAFP recommendations: new Haemophilus influenzae type b immunization schedule. Am Fam Physician. 1991. 43(4): 1473-1474. Adams WG, Deaver KA, Cochi SL, et al. . Decline of childhood Haemophilus influenzae type b (Hib) disease in the Hib vaccine era. JAMA. 1993. 269: 221-226. (PubMed) American Academy of Pediatrics, Committee on Infectious Diseases. . Haemophilus influenzae type b conjugate vaccines: recommendations for immunization with recently and previously licensed vaccines. AAP News. 1993. 9: 17-19. American Academy of Pediatrics, Committee on Infectious Diseases. . 1994 Red Book: Report of the Committee on Infectious Diseases. Elk Grove Village, Ill: American Academy of Pediatrics; 1994;203-216. Canadian Task Force on the Periodic Health Examination. . Childhood immunizations. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 33. Centers for Disease Control and Prevention. . FDA approval of use of a new Haemophilus b conjugate vaccine and a combined diphtheria-tetanus-pertussis and Haemophilus b conjugate vaccine for infants and children. MMWR. 1993. 42: 296-298. Centers for Disease Control. . 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 Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(RR-1): 1-6. Centers for Disease Control and Prevention. . Recommended childhood immunization scheduleUnited States, 1997. MMWR. 1997. 46: 35-40. Centers for Disease Control and Prevention. . Recommendations for use of Haemophilus b conjugate vaccines and a combined diphtheria, tetanus, pertussis and Haemophilus b vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1993. 42(RR-13): 1-15. Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) Pomeroy SL, Holmes SJ, Dodge PR, Feigin RD. . Seizures and other neurologic sequelae of bacterial meningitis in children. N Engl J Med. 1990. 323: 1651-1657. (PubMed) Wilfert CM. . Epidemiology of Haemophilus influenzae type b infections. Pediatrics. 1990. 85(suppl 4): 631-635. US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. (2nd ed). Washington, DC: US Department of Health and Human Services; 1996: chap 65. Tables Table 13.1. Immunization Schedule for Haemophilus influenzae Type b (Hib)
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. Recommendations of Major AuthoritiesImmunization
1. Vaccine Types 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 (HeptavaxTM) is also licensed, but it is no longer produced in the United States. 2. ScheduleAccording 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsThere 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. 5. Adverse ReactionsThe 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. 6. Patient EducationThe 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. 7. Vaccine Storage and HandlingStore 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. Basics of Postexposure Prophylaxis1. Schedule 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. 2. Dose and AdministrationThe 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). 3. Contraindications/PrecautionsThe only contraindication to HBIG injection is a history of hypersensitivity to HBIG. 4. Adverse ReactionsThe 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. Patient Resources
Centers for Disease Control and Prevention. . Recommended childhood immunization schedule -- United States, 1997. MMWR. 1997. 46: 35-40. Centers for Disease Control. . Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(No. RR-13): 1-25. Centers for Disease Control. . Protection against viral hepatitis: recommendatoins of the Advisory Committee on Immunization Practices. MMWR. 1990. 39(No. RR-2): 1-26. American Academy of Pediatrics, Committee on Infectious Diseases. . 1994 Red Book: Report of the Committee on Infectious Diseases. Elk Grove Village, Ill: American Academy of Pediatrics; 1994:224-237. American Academy of Family Physicians. . Recommendations for Hepatitis B Preexposure Vaccination and Postexposure Prophylaxis. Kansas City, Mo: American Academy of Family Physicians; 1992. American Academy of Pediatrics. . Universal hepatitis B immunization. AAP News. February 1992:13-15, 22. American Medical Association. . Rationale and recommendations: infectious diseases. In: AMA Guidelines for Adolescent Preventive Services (GAPS): Recommendations and Rationale. Chicago, Ill: American Medical Association; 1994: chap 15. Canadian Task Force on the Periodic Health Examination. . Hepatitis B immunization in childhood. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 35. National Vaccine Advisory Committee. . Standards for Pediatric Immunization Practices. Atlanta, Ga: Centers for Disease Control and Prevention; 1993. Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 65. US Preventive Services Task Force. . Postexposure prophylaxis for selected infectious diseases. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 67. [Tables] Table 14.1. Groups at High Risk for Hepatitis B (HBV) Virus Infection
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. Recommendations of Major AuthoritiesNormal-Risk Children
1. Vaccine Types 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. 2. ScheduleGive 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. 3. Assessing ImmunityChildren 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. 4. Dose and AdministrationThe 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. 5. Contraindications/PrecautionsThere 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. 6. Adverse ReactionsThe 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. 7. Special casesDo 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. 8. Patient EducationThe 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. 9. Vaccine Storage and HandlingMeasles, 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. Basics of Postexposure Prophylaxis (Measles)1. Dose and Administration 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. 2. PrecautionsDo 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. 3. Adverse ReactionsLocal 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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . 1994 Red Book: Report of the Committee on Infectious Diseases. Elk Grove Village, Ill: American Academy of Pediatrics; 1994:308-322, 329-333, 406-412. Canadian Task Force on the Periodic Health Examination. . Childhood immunizations. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 33. Centers for Disease Control and Prevention. . General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994. 43(No. RR-1): 1-38. Centers for Disease Control and Prevention. . Recommended childhood immunization schedule United States, January 1995. MMWR. 1995. 43: 959-960. Centers for Disease Control. . Measles prevention. MMWR. 1989. 38(No. S-9): 1-13. Centers for Disease Control. . Mumps prevention. MMWR. 1989. 38: 388-392. Centers for Disease Control. . Rubella prevention: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1990. 39(No. RR-15): 1-13. Centers for Disease Control. . Vaccine Adverse Event Reporting System United States. MMWR. 1990. 39: 730-733. Centers for Disease Control and Prevention. . Recommended childhood immunization schedule United States, 1997. MMWR. 1997;4635-4640. View this and related citations using Greenberg MA, Birx DL. . Safe administration of mumps-measles-rubella vaccine in egg-allergic children. J Pediatr. 1988. 113: 504-506. (PubMed) Herman JJ, Radin R, Schneiderman R. . Allergic reactions to measles (rubeola) vaccine in patients hypersensitive to egg protein. J Pediatr. 1983. 102: 196-199. (PubMed) Lavi S, Zimmerman B, Koren G, Gold R. . Administration of measles, mumps, and rubella vaccine (live) to egg-allergic children. JAMA. 1990. 263: 269-271. (PubMed) National Vaccine Advisory Committee. . Standards for Pediatric Immunization Practices. Atlanta, Ga: Centers for Disease Control and Prevention; 1993. National Vaccine Advisory Committee. . The measles epidemic: the problems, barriers and recommendations. JAMA. 1991. 166(11): 1547-52. Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 65. Watson JC, Pearson JA, Markowitz LE, et al. . An evaluation of measles revaccination among school-entry-age children. Pediatrics. In press Tables Table 15.1. Contraindications and Precautions for MMR Vaccination
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. Recommendations of Major Authorities
1. Vaccine Types 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. 2. Schedulea. Primary:
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. 4. Contraindications/PrecautionsThere 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. 5. Adverse ReactionsThe 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. 6. Patient EducationThe 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. 7. Vaccine Storage and HandlingStore 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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . Poliomyelitis prevention: recommendations for use of inactivated poliovirus vaccine and live oral poliovirus vaccine. Pediatrics. 1997. 99(2): 300-305. (PubMed) Canadian Task Force on the Periodic Health Examination. . Childhood immunizations. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 33. Centers for Disease Control. . Paralytic poliomyelitis Senegal, 1986-1987: update on the N-IPV efficacy study. MMWR. 1988. 37: 257-259. Centers for Disease Control. . Vaccine Adverse Event Reporting System United States. MMWR. 1990. 39: 730-733. Centers for Disease Control and Prevention. . General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994;43 (RR-1): 24-25. 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 (ACIP). MMWR. 1997. 46(No. RR-3): 1-25. Centers for Disease Control and Prevention. . Recommended childhood immunization schedule-United States. 1997. MMWR. 1997. 46: 35-40. Kimpen JL, Ogra PL. . Poliovirus vaccines: a continuing challenge. Pediatr Clin North Am. 1990. 37(3): 627-649. (PubMed) LaForce FM. . Poliomyelitis vaccines: success and controversy. Infect Dis Clin North Am. 1990. 4: 75-83. (PubMed) National Center for Health Statistics. . Health, United States, 1995. Hyattsville, Md: Public Health Service. 1996. Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) Physician's Desk Reference. . 51st ed. Montvale, NJ: Medical Economics Co: 1997:3005-3007. Strebel PM, Sutter RW, Coohi SL, et al. . Epidemiology of poliomyelitis in the United States one decade after the last reported case of indigenous wild virus-associated disease. Clin Infect Dis. 1992. 14: 568-579. (PubMed) US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 65. Tables
17. Varicella (Including Adult Immunization) 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. Recommendations of Major AuthoritiesChildren/Adolescents
1. Vaccine Types 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. 2. ScheduleChildren 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsThere 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. 5. Adverse ReactionsThe 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. 6. Patient EducationThe 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. 7. Vaccine Storage and HandlingThe 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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . Recommendation[s] for use of live attenuated varicella vaccine. Pediatrics. 1995. 95: 791-796. (PubMed) Centers for Disease Control and Prevention. . Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1996. 45: (No. RR-11)1-36. Centers for Disease Control and Prevention. . Recommended childhood immunization schedule-United States. 1997. MMWR. 1997. 46: 35-40. Lieu T, Cochi SL, Black SB, et al. . Cost-effectiveness of a routine varicella vaccination program for US children. JAMA. 1994. 271: 375-381. (PubMed) Patel R, Kinsinger L. . Childhood immunizations: American College of Preventive Medicine Practice Policy Statement. Am J Prev Med. 1997. 13(2): 74-77. (PubMed) US Preventive Services Task Force. . Adult immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 66. US Preventive Services Task Force. . Childhood immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 65. |