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Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement updates and replaces the recommendations found in the 2012 Red Book.

The first edition of the Red Book was published in 1938. Since then, there have been numerous advances in the fields of infectious diseases and public health that have decreased morbidity and mortality of infants, children, and adolescents. Over the years, emerging pathogens and disease complexes have been described, sophisticated diagnostic techniques developed, advances in antimicrobial therapy have occurred, and immunizations have been implemented to prevent previously deadly diseases. Of the 18 diseases or organisms in the 1938 edition, 13 are now vaccine-preventable. Since inception of the Red Book, the aims of the editors have been to keep pace with these innovations and to continue to inform the medical community. These goals have made the Red Book a fundamental resource for pediatricians and other health care professionals in terms of guiding diagnosis, therapy, and prevention of infectious diseases. The list of 18 diseases or organisms originally described in the 1938 Red Book has expanded to include over 160 diseases or organisms in the 2012 edition. The pace of biomedical discovery, as well as the amount of information available and the number of methods for its delivery, will continue to accelerate in the future. Integration of information into future editions of the Red Book will ensure that practitioners continue to rely on the Red Book in its various electronic formats for clinical guidance and support.

Development of safe and effective vaccines is one the greatest medical triumphs. However, despite high immunization rates in the United States, 85% of health care providers (HCPs) will have a parent refuse a vaccine for his or her child each year. HCPs have the greatest influence on a parent's decision to vaccinate his or her child. To effectively communicate with vaccine-hesitant parents, HCPs must first understand the concerns of parents regarding immunization and understand influences that can lead to misinformation about the safety and effectiveness of vaccines. HCPs should establish an open, nonconfrontational dialogue with vaccine-hesitant parents at an early stage and provide unambiguous, easily comprehensible answers about known vaccine adverse events and provide accurate information about vaccination. Personal stories and visual images of patients and parents affected by vaccine-preventable diseases and reports of disease outbreaks serve as useful reminders of the need to maintain high immunization rates. Ongoing dialogue including provider recommendations may successfully reassure vaccine-hesitant parents that immunization is the best and safest option for their child.

Palivizumab was licensed in June 1998 by the US Food and Drug Administration for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients who are at increased risk of severe disease. Safety and efficacy have been established for infants born at or before 35 weeks' gestation with or without chronic lung disease of prematurity and for infants and children with hemodynamically significant heart disease. The American Academy of Pediatrics (AAP) published a policy statement on the use of palivizumab in November 1998 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 1998;102[5]:1211–1216) and revised it in December 2003 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1442–1446), and an AAP technical report on palivizumab was published in 2003 (Meissner HC, Long SS; American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1447–1452). On the basis of the availability of additional data regarding seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children who are at increased risk of serious RSV lower respiratory tract disease, AAP recommendations for immunoprophylaxis have been updated in an effort to ensure optimal balance of benefit and cost from this expensive intervention. This statement updates and replaces the 2003 AAP statement and the 2006 Red Book and is consistent with the 2009 Red Book recommendations.

This statement updates and replaces the 2007 American Academy of Pediatrics statement for prevention of rotavirus gastroenteritis. In February 2006, a live oral human-bovine reassortant rotavirus vaccine (RV5 [RotaTeq]) was licensed as a 3-dose series for use in infants in the United States. The American Academy of Pediatrics recommended routine use of RV5 in infants in the United States. In April 2008, a live, oral, human attenuated rotavirus vaccine (RV1 [Rotarix]) was licensed as a 2-dose series for use in infants in the United States. The American Academy of Pediatrics recommends routine immunization of infants in the United States with rotavirus vaccine. The American Academy of Pediatrics does not express a preference for either RV5 or RV1. RV5 is to be administered orally in a 3-dose series with doses administered at 2, 4, and 6 months of age; RV1 is to be administered orally in a 2-dose series with doses administered at 2 and 4 months of age. The first dose of rotavirus vaccine should be administered from 6 weeks through 14 weeks, 6 days of age. The minimum interval between doses of rotavirus vaccine is 4 weeks. All doses should be administered by 8 months, 0 days of age. Recommendations in this statement also address the maximum ages for doses, contraindications, precautions, and special situations for administration of rotavirus vaccine.

The purpose of this statement is to provide the rationale and recommendations for adolescent use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines. Despite universal immunization of children with multiple doses of pediatric diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, pertussis remains endemic with a steady increase in the number of reported cases. Two peaks in the incidence of pertussis occur in pediatric patients: infants younger than 6 months of age who are inadequately protected by the current immunization schedule and adolescents 11 through 18 years of age whose vaccine-induced immunity has waned. Significant medical and public health resources are being consumed in postexposure management of adolescent cases, contacts, and outbreaks with little beneficial effect on individuals or the epidemiology of disease. Two Tdap products were licensed in 2005 for use in people 10 through 18 years of age (Boostrix) and 11 through 64 years of age (Adacel). The American Academy of Pediatrics recommends the following: 1. Adolescents 11 to 18 years of age should receive a single dose of Tdap instead of tetanus and diphtheria toxoids (Td) vaccine for booster immunization. The preferred age for Tdap immunization is 11 to 12 years. 2. Adolescents 11 to 18 years of age who have received Td but not Tdap are encouraged to receive a single dose of Tdap. An interval of at least 5 years between Td and Tdap is suggested to reduce the risk of local and systemic reactions; however, intervals of less than 5 years can be used, particularly in settings of increased risk of acquiring pertussis, having complicated disease, or transmitting infection to vulnerable contacts. Data support acceptable safety with an interval as short as approximately 2 years. 3. Tdap and tetravalent meningococcal conjugate vaccine (MCV4 [Menactra]) should be administered during the same visit if both vaccines are indicated. If this is not feasible, MCV4 and Tdap can be administered using either sequence. When not administered simultaneously, the American Academy of Pediatrics suggests a minimum interval of 1 month between vaccines. The rationale for this strategy is to provide direct protection of immunized adolescents. With implementation of vaccine recommendations, indirect benefitalso is likely to extend to unimmunized peers and other age groups. The strategy of universal Tdap immunization at 11 to 12 years of age is cost-effective.

Background. A national shortage of heptavalent pneumococcal conjugate vaccine (PCV7) occurred from September 2001 through May 2003. In December 2001 and January 2002, the Advisory Committee on Immunization Practices and the American Academy of Pediatrics (AAP) issued PCV7-shortage recommendations, emphasizing that all health care providers decrease the number of doses for healthy children so that more children could receive some PCV7. Objectives. We assessed (1) how the PCV7 shortage affected pediatricians, (2) whether children in the public and private sectors were vaccinated differently during the shortage, (3) pediatricians' knowledge of and adherence to the Advisory Committee on Immunization Practices/AAP recommendations, (4) and what factors were associated with nonadherence to the recommendations. Methods. We conducted a cross-sectional mail survey of 2500 US physician-members of the AAP from November 2002 through March 2003; physicians providing childhood immunizations were eligible. We asked about PCV7-shortage experience, assessed recommendation adherence through clinical scenarios, and modeled potential factors associated with reported nonadherence to the recommendation to defer the fourth PCV7 dose. Results. Of 2478 surveys sent to valid addresses, 1412 (57%) completed surveys were received; 946 (67%) of these were from eligible pediatricians. Overall, 79% experienced a PCV7 shortage, 94% reported being aware of the recommendations, and 42% reported barriers to recommendation adherence. Ninety-four percent reported vaccinating 6-month-old infants with private or public insurance in the same manner. As recommended, 91% reported fully vaccinating high-risk patients. Contrary to recommendations, 49% reported sometimes or always administering the fourth PCV7 dose to healthy children 12 to 15 months old; their reasons included recurrent otitis media, childcare attendance, and parental desire. Controlling for other characteristics, pediatricians who had no PCV7 shortage in their practices were significantly more likely to report administering the fourth dose than pediatricians who had a shortage (odds ratio [OR]: 3.67; 95% confidence interval [CI]: 2.40–5.63). Other factors associated with nonadherence were being in solo private practice (OR: 2.18; 95% CI: 1.26–3.77) or being male (OR: 1.51; 95% CI: 1.08–2.12). Among pediatricians deferring PCV7, 36% reported having no system to track children for whom PCV7 was deferred. Conclusions. Many pediatricians, both with and without a PCV7 shortage, administered more PCV7 doses than recommended. Pediatricians without a shortage were less likely to limit use, which suggests that they might have focused on the perceived value of administering the full schedule to their patients in preference to broader public health goals. Providing more information to physicians on the effectiveness of a fewer-dose schedule and the risk of disease when vaccine is deferred and educating parents might increase adherence to recommendations and achieve more equitable coverage during vaccine shortages.

Objective.To examine the timeliness of vaccine administration among infants and young children in the United States. Methods. We analyzed age at receipt of vaccines among 16 211 children aged 24 to 35 months in the 2000 National Immunization Survey and examined receipt at the recommended time of each dose and selected vaccination series, as well as receipt at 4 additional time frames: acceptably early, late, never by 24 months, and too early to be considered valid. We also examined the relationship between timeliness of vaccinations and characteristics of the child, mother, and immunization provider, using multivariate logistic regression. Results. Only 9% of children received all recommended vaccines at the recommended ages. The rates varied significantly by antigen, ranging from 24% for all Haemophilus influenzae type b doses to 75% for all hepatitis B doses as recommended. Overall, 55% of children did not receive all recommended doses by 24 months of age, and 8% of children received at least 1 vaccination dose too early to be considered valid. Factors associated with not receiving all vaccines as recommended were having more children in the household, mothers younger than 30 years, use of public providers, and multiple vaccination providers. Conclusions. By 24 months of age, 9 of 10 children received at least 1 vaccine outside the recommended age ranges. High vaccination status of children at 24 months of age does not reflect the reality that many vaccinations are not given at the appropriate ages. Timeliness of vaccination is critical to prevent disease outbreaks, protect children through their first 2 years of life, and minimize the need to repeat doses.

Objective. Currently, 4 diphtheria-tetanus-acellular pertussis (DTaP) vaccines are licensed for pediatric use in the United States, and 2 are commercially available. Although a single manufacturer’s DTaP vaccine should be used for all 3 doses of the primary immunization series, some circumstances result in infants receiving DTaP vaccines from more than 1 manufacturer. The purpose of this study was to evaluate the safety and immunogenicity of a mixed sequence of 2 different DTaP vaccines.Methods. In this multicenter, observer-blinded, controlled study, 449 infants were randomized into 1 of 3 groups (1:1:1 ratio) to receive Tripedia at 2, 4, and 6 months of age (control group); Tripedia at 2 and 4 months of age and Infanrix at 6 months of age; or Tripedia at 2 months and Infanrix at 4 and 6 months of age. Other vaccines were administered concurrently as separate injections according to the recommended childhood immunization schedule. Safety was monitored closely, and standard enzyme immunoassays were used to measure antibody concentrations to each antigen of the DTaP vaccines.Results. The rates of injection-site and systemic adverse events were similar in each study group, and there were no clinically significant differences among groups after any dose. Infants in all 3 groups responded well to each antigen contained in both vaccines, with 97% to 100% seroprotection or vaccine response rates after the 3-dose primary series. Postvaccination geometric mean antibody concentrations and seroprotection or vaccine response rates to nearly all vaccine antigens were as high or higher in the mixed-sequence groups as in the control group.Conclusion. Initiating the primary immunization series with 1 or 2 doses of Tripedia and completing the 3-dose series with Infanrix is as safe and at least as immunogenic as administering Tripedia for all 3 doses.

The numbers of reported cases of meningococcal disease in 15- to 24-year-olds and outbreaks of meningococcal serogroup C disease, including outbreaks in schools and other institutions, have increased during the past decade. In response to outbreaks on college campuses, the American College Health Association has taken an increasingly proactive role in alerting college students and their parents to the risk of this disease and informing them about the availability of an effective vaccine. Recent epidemiologic studies have demonstrated an increased risk of disease in college students living in dormitories, particularly among freshmen, compared with similarly aged persons in the general population. At least 60% of these cases are potentially preventable by vaccination with the quadrivalent meningococcal A, C, Y, and W-135 polysaccharide vaccine. These findings support immunization of college students, particularly freshmen living in dormitories. Hence, college students and their parents should be informed by health care professionals at routine prematriculation visits and during college matriculation of the risk of meningococcal disease and potential benefits of immunization. Vaccine should be made available to those requesting immunization. College and university health services also should facilitate implementation of educational programs concerning meningococcal disease and availability of immunization services.

Heptavalent pneumococcal conjugate vaccine (PCV7) is recommended for universal use in children 23 months and younger, to be given concurrently with other recommended childhood vaccines at 2, 4, 6, and 12 to 15 months of age. For children 7 to 23 months old who have not received previous doses of PCV7, administration of a reduced number of doses is recommended. Two doses of PCV7 are recommended for children 24 to 59 months old at high risk of invasive pneumococcal infection—including children with functional, anatomic, or congenital asplenia; infection with human immunodeficiency virus; and other predisposing conditions—who have not been immunized previously with PCV7. Recommendations have been made for use of 23-valent pneumococcal polysaccharide (23PS) vaccine in high-risk children to expand serotype coverage. High-risk children should be given vaccines at the earliest possible opportunity. Use of antibiotic prophylaxis in children younger than 5 years with functional or anatomic asplenia, including children with sickle cell disease, continues to be recommended. Children who have not experienced invasive pneumococcal infection and have received recommended pneumococcal immunizations may discontinue prophylaxis after 5 years of age. The safety and efficacy of PCV7 and 23PS in children 24 months or older at moderate or lower risk of invasive pneumococcal infection remain under investigation. Current US Food and Drug Administration indications are for administration of PCV7 only to children younger than 24 months. Data are insufficient to recommend routine administration of PCV7 for children at moderate risk of pneumococcal invasive infection, including all children 24 to 35 months old, children 36 to 59 months old who attend out-of-home care, and children 36 to 59 months old who are of Native American (American Indian and Alaska Native) or African American descent. However, all children 24 to 59 months old, regardless of whether they are at low or moderate risk, may benefit from the administration of pneumococcal immunizations. Therefore, a single dose of PCV7 or 23PS vaccine may be given to children 24 months or older. The 23PS is an acceptable alternative to PCV7, although an enhanced immune response and probable reduction of nasopharyngeal carriage favor the use of PCV7 whenever possible.

Infection control is an integral part of pediatric practice in outpatient settings as well as in hospitals. All employees should be educated regarding the routes of transmission and techniques used to prevent transmission of infectious agents. Policies for infection control and prevention should be written, readily available, updated annually, and enforced. The Centers for Disease Control and Prevention standard precautions for hospitalized patients with modifications from the American Academy of Pediatrics are appropriate for most patient encounters. As employers, pediatricians are required by the Occupational Safety and Health Administration (OSHA) to take precautions to protect staff likely to be exposed to blood or other potentially infectious materials while on the job. Key principles of infection control include the following: hand-washing before and after every patient contact, separation of infected, contagious children from uninfected children, safe handling and disposal of needles and other sharp medical devices, appropriate use of personal protection equipment such as gloves, appropriate sterilization, disinfection and antisepsis, and judicious use of antibiotics.

There is an increasing threat that chemical and biological weapons will be used on a civilian population in an act of domestic terrorism. Casualties among adults and children could be significant in such an event. Federal, state, and local authorities have begun extensive planning to meet a chemical-biological incident by developing methods of rapid identification of potential agents and protocols for management of victims without injury to health care personnel. Because children would be disproportionately affected by a chemical or biological weapons release, pediatricians must assist in planning for a domestic chemical-biological incident. Government agencies should seek input from pediatricians and pediatric subspecialists to ensure that the situations created by multiple pediatric casualties after a chemical-biological incident are considered. This statement reviews key aspects of chemical-biological agents, the consequences of their use, the potential impact of a chemical-biological attack on children, and issues to consider in disaster planning and management for pediatric patients.

Recommendations for routine varicella vaccination were published by the American Academy of Pediatrics in May 1995, but many eligible children remain unimmunized. This update provides additional information on the varicella disease burden before the availability of varicella vaccine, potential barriers to immunization, efforts to increase the level of coverage, new safety data, and new recommendations for use of the varicella vaccine after exposure and in children with human immunodeficiency virus infections. Pediatricians are strongly encouraged to support public health officials in the development and implementation of varicella immunization requirements for child care and school entry.

Current recommendations of the American Academy of Pediatrics (AAP) for infection control practices to prevent transmission of blood-borne pathogens, including human immunodeficiency virus (HIV) in hospitals, other medical settings, schools, and child care facilities, are reviewed and explained. Hand-washing is essential, whether or not gloves are used, and gloves should be used when contact with blood or blood-containing body fluids may occur. In hospitalized children, the 1996 recommendations of the Centers for Disease Control and Prevention (CDC) should be implemented as modified in the 1997 Red Book. The generic principles of Standard Precautions in the CDC guidelines generally are applicable to children in all health care settings, schools, child care facilities, and the home. However, gloves are not required for routine changing of diapers or for wiping nasal secretions of children in most circumstances. This AAP recommendation differs from that in the CDC guidelines. Current US Public Health Service guidelines for the management of potential occupational exposures of health care workers to HIV are summarized. As previously recommended by the AAP, HIV-infected children should be admitted without restriction to child care centers and schools and allowed to participate in all activities to the extent that their health and other recommendations for management of contagious diseases permit. Because it is not required that the school be notified of HIV infection, it may be helpful if the pediatrician notify the school that he or she is operating under a policy of nondisclosure of infection with blood-borne pathogens. Thus, it is possible that the pediatrician will not report the presence of such infections on the form. Because HIV infection occurs in persons throughout the United States, these recommendations for prevention of HIV transmission should be applied universally.

Objective. To evaluate the accuracy of the cotton swab technique for identifying fungal infections of the scalp. The purpose of the study was: 1) to compare the cotton swab technique with the toothbrush method, a popular and reliable means for obtaining specimens; and 2) to ascertain if transport of a specimen, entailing variable transport duration and conditions, impairs the sensitivity and specificity of the technique. Materials and Methods. Part 1 consisted of a prospective, investigator-blinded comparison analysis. Fifty children with scalp findings suspicious for tinea capitis were cultured using both techniques: the toothbrush and cotton swab. Ninety-six culture results were obtained for analysis. The second part of the study consisted of a prospective comparison analysis of cotton swab culture results obtained from samples plated immediately after collection in the physician's office as compared with samples transported to outside laboratories for processing. Thirty-one children with presumed tinea capitis were cultured twice with the cotton swab technique; one sample was immediately plated onto fungal medium and the other sent to an outside lab, the selection of which was dictated by the patient's insurance plan. A total of 62 samples were obtained; 58 sample results were used for analysis. Results. In part 1 of the study, 60% of the 48 children analyzed had positive fungal cultures. Eighty percent of these wereTrichophyton species. There was 100% agreement in the results obtained; all patients with positive results using the toothbrush method were also positive when the cotton swab method was used. Similarly, there was complete concordance in laboratory results from the second part of the study. Fifty percent of the 28 children analyzed had positive cultures; 86% grew Trichophytonspecies. All patients who had positive cultures from those samples plated in-office also had positive results from the outside laboratory samples. Conclusions. The cotton swab technique is an easy, atraumatic, inexpensive, and reliable means to evaluate patients with suspected tinea capitis. The method remains sensitive and specific even when transport of these specimens is required and processing is thus delayed. This painless technique requires little technical expertise and can be rapidly performed with a standard cotton tip applicator. It should prove an invaluable aid to practitioners in evaluating patients with possible fungal infections of the scalp.

Virtually all children experience rotavirus (Rv) infection before school entry. In the United States and other temperate countries, Rv disease peaks in the winter and during this time is responsible for the majority of episodes of diarrhea in infants and young children.1–4 Data collected by the Centers for Disease Control and Prevention from 1979 through 1992 indicate that approximately 50 000 hospitalizations attributable to Rv occur annually in the United States, a number that approximates about 1 in 78 children being hospitalized with Rv diarrhea by 5 years of age.2,5 RotaShield (Wyeth-Lederle Vaccines and Pediatrics, Philadelphia, PA) was licensed by the Food and Drug Administration on August 31, 1998, for oral administration to infants at 2, 4, and 6 months of age. The rationale for using Rv immunization for prevention or modification of Rv disease is based on several considerations. First, the rate of illness attributable to Rv among children is comparable in industrialized and developing countries, which indicates that improved public sanitation is unlikely to decrease the incidence of disease.6,7 Second, although implementation of oral rehydration programs to prevent dehydration has improved in the United States, widespread use is inadequate to prevent significant morbidity.8–11 Third, trials of rhesus rotavirus-tetravalent (Rv) vaccine in the United States, Finland, and Venezuela show efficacy rates of approximately 80% for prevention of severe illness and 48% to 68% against Rv-induced diarrheal episodes.12–16 These results are similar to the protection observed after natural Rv infection, which also confers better protection against subsequent episodes of severe disease than against mild illness.17–19 This statement provides recommendations regarding the use of Rv vaccine in infants in the United States.