This report is a revision of the General Recommendations on Immunization and updates the 2006 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-15]). The report also includes revised content from previous ACIP recommendations on the following topics: adult vaccination (CDC. Update on adult immunization recommendations of the immunization practices Advisory Committee [ACIP]. MMWR 1991;40[No. RR-12]); the assessment and feedback strategy to increase vaccination rates (CDC. Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination rates-assessment and feedback of provider-based vaccination coverage information. MMWR 1996;45:219-20); linkage of vaccination services and those of the Supplemental Nutrition Program for Women, Infants, and Children (WIC program) (CDC. Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination coverage by age 2 years-linkage of vaccination and WIC services. MMWR 1996;45:217-8); adolescent immunization (CDC. Immunization of adolescents: recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR 1996;45[No. RR-13]); and combination vaccines (CDC. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP], the American Academy of Pediatrics [AAP], and the American Academy of Family Physicians [AAFP]. MMWR 1999;48[No. RR-5]). Notable revisions to the 2006 recommendations include 1) revisions to the tables of contraindications and precautions to vaccination, as well as a separate table of conditions that are commonly misperceived as contraindications and precautions; 2) reordering of the report content, with vaccine risk-benefit screening, managing adverse reactions, reporting of adverse events, and the vaccine injury compensation program presented immediately after the discussion of contraindications and precautions; 3) stricter criteria for selecting an appropriate storage unit for vaccines; 4) additional guidance for maintaining the cold chain in the event of unavoidable temperature deviations; and 5) updated revisions for vaccination of patients who have received a hematopoietic cell transplant. The most recent ACIP recommendations for each specific vaccine should be consulted for comprehensive details. This report, ACIP recommendations for each vaccine, and additional information about vaccinations are available from CDC at http://www.cdc.gov/vaccines.

The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule (Figure) to ensure that the schedule reflects current recommendations for the licensed vaccines. In October 2008, ACIP approved the Adult Immunization Schedule for 2009. No new vaccines were added to the schedule. However, several indications were added to the pneumococcal polysaccharide vaccine footnote; clarifications were made to the footnotes for human papillomavirus, varicella, and meningococcal vaccines; and schedule information was added to the hepatitis A and hepatitis B vaccine footnotes.

The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP.

Adherence to recommendations for the use of licensed vaccines ensures maximum individual and societal benefits from the national immunization program. The US Food and Drug Administration (FDA) licenses a vaccine once it determines that data submitted by the manufacturer reveal that the vaccine is safe and effective for its intended use. For each US-licensed vaccine, the FDA-approved prescribing information contains detailed information for health care providers to ensure safe and effective use. Centers for Disease Control and Prevention recommendations for the use of a licensed vaccine often are based on additional considerations, such as disease epidemiology, public acceptance, vaccine supply, and cost. Our objective in this article is to explain the reasons for the differences between FDA-approved prescribing information and Centers for Disease Control and Prevention recommendations for vaccine use.

These guidelines are intended for use by healthcare professionals who care for children and adults with suspected or confirmed infectious diarrhea. They are not intended to replace physician judgement regarding specific patients or clinical or public health situations. This document does not provide detailed recommendations on infection prevention and control aspects related to infectious diarrhea.

In the past 200years, vaccines have had unmistakable impacts on public health including declines in morbidity and mortality, most markedly in economically-developed countries. Highly engineered vaccines including vaccines for conditions other than infectious diseases are expected to dominate future vaccine development. We examine immunization vaccine policy as a driver of vaccine innovation and development. The pathways to recommendation for use of licensed vaccines in the US, UK, Canada and Australia have been similar, including: expert review of disease epidemiology, disease burden and severity; vaccine immunogenicity, efficacy and safety; programmatic feasibility; public demand; and increasingly cost-effectiveness. Other attributes particularly important in development of future vaccines are likely to include: duration of immunity for improved vaccines such as pertussis; a greater emphasis on optimizing community protection rather than direct protection only; programmatic implementation, feasibility, improvements (as in the case of development of a universal influenza vaccine); public concerns/confidence/fears related to outbreak pathogens like Ebola and Zika virus; and major societal burden for combating hard to treat diseases like HIV and antimicrobial resistant pathogens. Driving innovation and production of future vaccines faces enormous economic hurdles as available approaches, technologies and regulatory pathways become more complex. As such, cost-mitigating strategies and focused, aligned efforts (by governments, private organizations, and private-public partnerships) will likely be needed to continue to spur major advances in vaccine technologies and development.

After publication of certain vaccine recommendations made by the Advisory Committee on Immunization Practices, several unexpected events have occurred during implementation of these recommendations. These have included changes in recommendations following adverse events involved with a particular vaccine and the conferral of community protection as an offshoot of vaccination of a specific population. Vaccine shortages and hesitancy have also been proven impediments to full implementation, and vaccine recommendations have not gone unaffected by either public perception of a vaccine or by cost considerations.

The United States Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee that develops written recommendations for use of vaccines licensed by the Food and Drug Administration (FDA) for the U.S. civilian population. Vaccine development and disease outbreaks contributed to the need for a systematized, science-based, formal mechanism for establishing national immunization policy in this country. Formed in 1964, the ACIP was charged with this role. The committee has undergone significant changes in structure and operational activities during its 50-year history. The ACIP works closely with many liaison organizations to develop its immunization recommendations, which are harmonized among key professional medical societies. ACIP vaccine recommendations form two immunization schedules, which are updated annually: (1) the childhood and adolescent immunization schedule and (2) the adult immunization schedule. Today, once ACIP recommendations are adopted by the Director of the Centers for Disease Control and Prevention and the Secretary of the Department of Health and Human Services, these recommendations are published in Morbidity and Mortality Weekly Report (MMWR), become official policy, and are incorporated into the appropriate immunization schedule.

The Advisory Committee on Immunization Practices (ACIP) is chartered as a federal advisory committee to provide expert external advice to CDC and the Secretary of the U.S. Department of Health and Human Services (DHHS) on the use of vaccines in the civilian population of the United States. This report summarizes the evolution of ACIP over the 50 years since its establishment in 1964 by the Surgeon General of the U.S. Public Health Service (USPHS).

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.

Health care-associated infections in the NICU are a major clinical problem resulting in increased morbidity and mortality, prolonged length of hospital stays, and increased medical costs. Neonates are at high risk for health care-associated infections because of impaired host defense mechanisms, limited amounts of protective endogenous flora on skin and mucosal surfaces at time of birth, reduced barrier function of neonatal skin, the use of invasive procedures and devices, and frequent exposure to broad-spectrum antibiotics. This statement will review the epidemiology and diagnosis of health care-associated infections in newborn infants. (Copyright 2012 by the American Academy of Pediatrics.)

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.

The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule (Figure) to ensure that the schedule reflects current recommendations for the licensed vaccines. In October 2010, ACIP approved the Adult Immunization Schedule for 2011, which includes several changes. The notation for seasonal influenza vaccine in the figure and footnotes was changed to reflect the expanded recommendation for annual influenza vaccination for everyone 6 months of age or older, which was approved by ACIP in February 2010. In October 2010, ACIP issued a permissive recommendation for use of the tetanus, diphtheria, pertussis (Tdap) vaccine in adults aged 65 years or older; approved the recommendation that Tdap can be administered regardless of how much time has elapsed since the last tetanus and diphtheria (Td)–containing vaccine; and approved a recommendation for a 2-dose series of meningococcal vaccine in adults with certain high-risk medical conditions. The vaccines listed in the Figure have been reordered to keep all universally recommended vaccines together (for example, influenza, Td/Tdap, varicella, human papillomavirus [HPV], and zoster).

The 2010 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians. There are 3 schedules: one for children 0 through 6 years of age, one for people 7 through 18 years of age, and a catch-up immunization schedule for children and adolescents who start late or fall behind. These schedules reflect current recommendations for the use of vaccines licensed by the US Food and Drug Administration and include the following changes from last year: | Reference to the recommendations of the Advisory Committee on Immunization Practices for use of influenza A (H1N1) 2009 monovalent vaccine1 is included in a footnote. | Revaccination with meningococcal conjugate vaccine (MCV4) is recommended for children who remain at increased risk for meningococcal disease. A dose of MCV4 should be administered after 3 years in children who received the initial MCV4 dose at ages 2 through 6 years and after 5 years if the first dose was given at age 7 years or older. Additional doses of MCV4 are then given every 5 years.2 | Recommendations on use of combination vaccines have been updated (the use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines). The final dose in the inactivated poliovirus vaccine series should be administered on or after the 4th birthday and at least 6 months following the previous dose. If 4 doses are administered before age 4 years, an additional (fifth) dose should be administered at age 4 through 6 years.3 | Recommendations for use of the recently licensed bivalent human papillomavirus vaccine in females and the quadrivalent human papillomavirus vaccine in males are included. | Most of the footnotes for the individual vaccines have been revised to provide additional information and to clarify recommendations provided in the schedules.

Respiratory syncytial virus (RSV) is an RNA virus that infects human respiratory epithelial cells and causes annual outbreaks of respiratory tract disease among infants and young children, as well as recurrent infections throughout life. Annual outbreaks of RSV disease are attributable to first-time infection in susceptible infants, reinfection in children and adults with waning or incomplete immunity, and infection by viral genotypes with sufficient antigenic variation to avoid innate and acquired immunity. In industrialized countries, few infectious diseases have a greater effect on the health of young children than does lower respiratory tract disease caused by RSV. By 2 years of age, almost all children will experience an RSV infection, and ∼50% will be infected twice.1 Results from the New Vaccine Surveillance Network (a prospective, population-based surveillance program sponsored by the Centers for Disease Control and Prevention [CDC]) define the burden of RSV disease in children younger than 5 years of age.2 An estimated 2 million children require medical care because of RSV infection, and ∼57500 children younger than 5 years are hospitalized annually. The major burden of RSV disease occurs among previously healthy infants and children whose susceptibility to severe RSV illness cannot be predicted by risk factors. | Protection against RSV infection is mediated by serum antibody, secretory antibody, cytotoxic T lymphocytes, and innate immune responses. A vaccine offers the greatest promise for control of RSV disease, but vaccine development has been slowed by concerns about safety (enhancement of naturally occurring disease), the limited ability of infants to mount an immune response to RSV glycoprotein antigens, and the presence of maternal neutralizing antibody, which may attenuate an active immune response. Passive immunization with either a hyperimmune globulin or a monoclonal antibody preparation has been demonstrated in randomized, placebo-controlled trials to reduce the risk of hospitalization caused by RSV.3–7 The annual rate of hospitalization attributable to RSV infection among young infants in selected high-risk groups who do not receive immunoprophylaxis is ∼10% to 15%, which is ∼5 times higher than the hospitalization rate among infants who are not at high risk.3–7 Results from 2 randomized, placebo-controlled trials that involved 2789 infants and children with prematurity, chronic lung disease, or congenital heart disease who received palivizumab prophylaxis demonstrated a reduction in RSV hospitalization rates of between 39% and 78% in different groups.6,7

The Advisory Committee on Immunization Practices (ACIP) annually reviews the Recommended Adult Immunization Schedule (Figure) to ensure that the schedule reflects current recommendations for the licensed vaccines. In October 2009, ACIP approved the Adult Immunization Schedule for 2010, which includes several changes. A bivalent human papillomavirus vaccine (HPV2) was licensed for use in females in October 2009. The ACIP recommends vaccination of females with either HPV2 or the quadrivalent human papillomavirus vaccine (HPV4). HPV4 was licensed for use in males, and the ACIP used a permissive recommendation for use of this vaccine in males. Introductory sentences were added to the footnotes for measles, mumps, rubella, influenza, pneumococcal, hepatitis A, hepatitis B, and meningococcal vaccines. Clarifications were made to the footnotes for measles, mumps, rubella, influenza, hepatitis A, meningococcal, and Haemophilus influenzae type B (Hib) vaccines, and schedule information was added to the hepatitis B vaccine footnote.

Evidence-based guidelines for immunization of infants, children, adolescents, and adults have been prepared by an Expert Panel of the Infectious Diseases Society of America (IDSA). These updated guidelines replace the previous immunization guidelines published in 2002. These guidelines are prepared for health care professionals who care for either immunocompetent or immunocompromised people of all ages. Since 2002, the capacity to prevent more infectious diseases has increased markedly for several reasons: new vaccines have been licensed (human papillomavirus vaccine; live, attenuated influenza vaccine; meningococcal conjugate vaccine; rotavirus vaccine; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis [Tdap] vaccine; and zoster vaccine), new combination vaccines have become available (measles, mumps, rubella and varicella vaccine; tetanus, diphtheria, and pertussis and inactivated polio vaccine; and tetanus, diphtheria, and pertussis and inactivated polio/Haemophilus influenzae type b vaccine), hepatitis A vaccines are now recommended universally for young children, influenza vaccines are recommended annually for all children aged 6 months through 18 years and for adults aged 50 years, and a second dose of varicella vaccine has been added to the routine childhood and adolescent immunization schedule. Many of these changes have resulted in expansion of the adolescent and adult immunization schedules. In addition, increased emphasis has been placed on removing barriers to immunization, eliminating racial/ethnic disparities, addressing vaccine safety issues, financing recommended vaccines, and immunizing specific groups, including health care providers, immunocompromised people, pregnant women, international travelers, and internationally adopted children. This document includes 46 standards that, if followed, should lead to optimal disease prevention through vaccination in multiple population groups while maintaining high levels of safety.