Protecting the Community Through Child Vaccination.

The direct impact of vaccines on children is well described, but the major public health impact of indirect protection provided to the community by vaccines is underappreciated. Community protection occurs when vaccinated persons block the chain of transmission, protecting undervaccinated or unvaccinated susceptible community members by preventing exposure and limiting the spread of the pathogen through the community. Substantial declines in disease incidence have occurred shortly after implementing new childhood vaccines, including declines among vaccine-ineligible children, adolescents, and adults. Protection of susceptible community members depends on maintaining high vaccination rates. Improved recognition of community protection will strengthen childhood vaccination strategies that will protect our communities into the future.

2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea.

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.

2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea.

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.

History and evolution of the advisory committee on immunization practices--United States, 1964-2014.

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).

Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices.

The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in immunization and related fields, selected by the Secretary of the U.S. Department of Health and Human Services, to provide advice and guidance on control of vaccine-preventable diseases. In its role as a federal advisory committee, the ACIP develops written recommendations, subject to approval of the Director of the Centers for Disease Control and Prevention, for administration of U.S. Food and Drug Administration-licensed vaccines to children, adolescents, and adults in the U.S. civilian population. On the basis of careful review of available scientific data, including disease morbidity and mortality in the general U.S. population and in specific risk groups, vaccine safety and efficacy, cost-effectiveness, and related factors, the ACIP recommends vaccines and age for vaccine administration, number of doses and dosing interval, and precautions and contraindications. The ACIP works closely with several liaison organizations, including the American College of Physicians, to develop immunization recommendations that are harmonized among key professional medical organizations in the United States. This report includes a description of the member composition of the ACIP, the degree to which Committee members are screened for conflicts of interest, the workgroups that gather information before full Committee consideration, and the process and types of evidence used to formulate recommendations.

Principles of Vaccine Licensure, Approval, and Recommendations for Use.

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.

Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America.

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 > or = 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.

Associations between childhood vaccination status and medical practice characteristics among white, black, and Hispanic children.

BACKGROUND: The purpose of the study was to identify and understand associations between characteristics of medical practices where immunization services are delivered and vaccination status among white, black, and Hispanic children aged less than 19 months. METHODS: Eighty pediatric and family physicians participated in a physician-patient encounters survey that included 684 children aged less than 19 months who received at least 1 vaccination during a randomly selected week in 2003. RESULTS: According to physicians' responses to survey questions, white children who used large medical practices, and black and Hispanic children who used practices, all enrolled in the Vaccine for Children (VFC) program, were more likely to receive vaccines at the recommended age, but Hispanic children who used large Medicaid practices were less likely to receive them at the recommended age. White children who used medical practices that had a large minority patient population were more likely to have completely missed whole series of vaccines. CONCLUSION: Medical practice characteristics varied in importance as determinants of childhood vaccination among white, black, and Hispanic children. Understanding how type of medical practice and other medical practice characteristics may impact the receipt of timely preventive health services is vital to improving health care access in underserved populations.

Licensure, Approval, and Uptake of Vaccines in the United States.

Immunization is one of the most effective public and private preventive health interventions, resulting in significant reductions in vaccine-preventable diseases and in substantial cost savings to the US healthcare system. Vaccine licensure, development of recommendations for use, and implementation of those recommendations leading to uptake, community protection, and effect on disease burden represent a complex system that requires collaboration in the areas of basic science, public health, vaccine delivery, outcome monitoring, and public perception. The Advisory Committee on Immunization Practices (ACIP) sets standards for immunization delivery for both public and private vaccine providers, and state immunization programs can use these ACIP recommendations to develop school immunization requirements.

Discrepancies Between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on Immunization Practices Recommendations: Provider Knowledge and Attitudes.

PURPOSE: In the United States, the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) is responsible for licensure of vaccines. The Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee that provides guidance to the Centers for Disease Control and Prevention (CDC) on use of vaccines. Discrepancies between FDA licensure indications and ACIP/CDC vaccine recommendations exist, challenging health care providers. The objectives of this study were: (1) to categorize differences between FDA vaccine licensure indications and ACIP/CDC vaccine recommendations for vaccines; and (2) to assess knowledge, attitudes, and practices of pediatricians, family physicians, and obstetrician-gynecologists regarding their understanding of differences. METHODS: Information was extracted from FDAvaccine package inserts, and corresponding information was collected for ACIP/CDC vaccine recommendations (2000-2014) for vaccines in the childhood and adult immunization schedules. Surveys regarding knowledge of discrepancies were distributed electronically to members of the Georgia chapters of the American Academy of Pediatrics (GA-AAP) and the American Academy of Family Physicians (GA-AAFP), and the national American College of Obstetricians and Gynecologists (ACOG) in 2014. FINDINGS: Differences were identified in 20 instances: differences in age group indications were identified in 6, in dosing administration schedules in 4, and in immunocompromised hosts and pregnant women in 10. We received 145 (8.5%) responses from GA-AAP, 237 (9.5%) from GA-AAFP, and 869 (1.5%) from national ACOG members. A total of 105 (72%) GA-AAP respondents reported that they follow AAP recommendations and 168 (71%) GA-AAFP respondents follow ACIP recommendations. GA-AAP and GA-AAFP respondents generally were not aware of data the FDA considers for vaccine licensure or data that pharmaceutical company representatives are permitted to discuss. Respondents remain current with vaccine recommendations through review of materials from professional organizations, the CDC, and package inserts; Continuing Medical Education; and information from pharmaceutical representatives. A total of 780 (90%) ACOG respondents had no concerns regarding routinely recommended reduced diphtheria toxoid and acellular pertussis vaccines (n = 730 [84%]) and influenza during pregnancy vaccines (n = 852 [98%]) to pregnant patients. However, these findings must be interpreted within the context of a low overall ACOG survey response rate. IMPLICATIONS: Education regarding existence of and reasons for discrepancies between FDA licensure of and ACIP/CDC recommendations for vaccines and reasons for these differences could optimize immunization delivery.

Understanding FDA-Approved Labeling and CDC Recommendations for Use of Vaccines.

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.

General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report is a revision of General Recommendations on Immunization and updates the 2002 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices and the American Academy of Family Physicians. MMWR 2002;51[No. RR-2]). This report is intended to serve as a general reference on vaccines and immunization. The principal changes include 1) expansion of the discussion of vaccination spacing and timing; 2) an increased emphasis on the importance of injection technique/age/body mass in determining appropriate needle length; 3) expansion of the discussion of storage and handling of vaccines, with a table defining the appropriate storage temperature range for inactivated and live vaccines; 4) expansion of the discussion of altered immunocompetence, including new recommendations about use of live-attenuated vaccines with therapeutic monoclonal antibodies; and 5) minor changes to the recommendations about vaccination during pregnancy and vaccination of internationally adopted children, in accordance with new ACIP vaccine-specific recommendations for use of inactivated influenza vaccine and hepatitis B vaccine. The most recent ACIP recommendations for each specific vaccine should be consulted for comprehensive discussion. This report, ACIP recommendations for each vaccine, and other information about vaccination can be accessed at CDC's National Center for Immunization and Respiratory Diseases (proposed) (formerly known as the National Immunization Program) website at http//:www.cdc.gov/nip.

FDA licensure of and ACIP recommendations for vaccines.

Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.

Policy making for vaccine use as a driver of vaccine innovation and development in the developed world.

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.

Parent attitudes toward immunizations and healthcare providers the role of information.

BACKGROUND: Lack of information has been associated with patient anxiety or concern in a number of healthcare areas. OBJECTIVES: (1) Identify the proportion of parents who agreed, were neutral, and disagreed that they had access to enough information to make a decision about immunizing their child; (2) examine how parents who agreed and disagreed differed with respect to sociodemographic characteristics, and their attitudes about immunizations, their child's healthcare provider, immunization requirements/exemptions, and immunization policymakers; and (3) identify if differences exist in specific immunization concerns. METHODS: A sample of parents with at least one child aged < or =6 years (n=642) was analyzed using data from the HealthStyles survey conducted during July and August 2003. Odds ratios and the Mantel-Haenszel chi-square test were used for analysis. RESULTS: Response rate for HealthStyles was 69% (4035/5845). The largest proportion of parents agreed they had access to enough information (67%) compared to parents who were neutral (20%) or who disagreed (13%). Compared to parents who agreed, parents who disagreed were more likely to be less confident in the safety of childhood vaccines (odds ratio [OR]=5.4, 95% confidence interval [CI]=3.3-8.9), and to disagree that their child's main healthcare provider is easy to talk to (OR=10.3, 95% CI=3.7-28.1). There was a significant linear trend in the percentage of parents expressing immunization concerns among those who agreed, were neutral, and who disagreed they had access to enough information (p<0.05; df=1). CONCLUSIONS: While most parents agreed that they had access to enough immunization information, approximately a third did not. Perceived lack of information was associated with negative attitudes about immunizations and toward healthcare providers. Basic information about the benefits and risks of vaccines presented by a trusted provider could go a long way toward maintaining and/or improving confidence in the immunization process.

A millennium update on pediatric diarrheal illness in the developing world.

More than one billion diarrhea episodes occur every year among children younger than 5 years of age in socioeconomically developing countries causing 2 to 2.5 million deaths. More than twenty viral, bacterial, and parasitic enteropathogens are currently associated with acute diarrhea. Rotavirus and diarrheagenic Escherichia coli are the most common pathogens responsible for acute diarrhea episodes in children; Shigella spp., Salmonella spp, Campylobacter jejuni/coli, Vibrio cholerae, Aeromonas spp, and Plesiomonas spp. occur more commonly in poorer areas and infections caused by protozoa and helminthes occur mainly in areas where environmental sanitation is significantly deteriorated. Initial clinical assessment of a child with diarrhea should focus on obtaining an accurate evaluation of hydration and nutritional status. Assessment of stool characteristics (e.g., liquid non-bloody stools vs. dysenteric or bloody stools) is a key feature in determining potential pathogens causing an acute diarrhea episode. Diagnostic guidelines are discussed in the article. The major therapeutic intervention for all individuals with diarrhea consists of fluid and electrolyte therapy. When antimicrobial therapy is appropriate, selection of a specific agent should be made based upon susceptibility patterns of the pathogen or information on local susceptibility patterns. Current guidelines for administering appropriate antimicrobial treatment are provided in the article. Preventive measures include careful personal hygiene, especially promotion of hand washing. Immunizations currently or soon to be available for Salmonella serotype Typhi, cholera prevention, and rotavirus are discussed.

Immunizations in the United States: a rite of passage.

Today, vaccination is a cornerstone of pediatric preventive health care and a rite of passage for nearly all of the approximately 11,000 infants born daily in the United States. This article reviews the US immunization program with an emphasis on its role in ensuring that vaccines are effective, safe, and available and highlights several new vaccines and recommendations that will affect the health of children and adolescents and the practice of pediatric medicine in future decades.

Timeliness of childhood vaccinations in the United States: days undervaccinated and number of vaccines delayed.

CONTEXT: Only 18% of children in the United States receive all vaccinations at the recommended times or acceptably early. OBJECTIVE: To determine the extent of delay of vaccination during the first 24 months of life. DESIGN, SETTING, AND PARTICIPANTS: The 2003 National Immunization Survey was conducted by random-digit dialing of households and mailings to vaccination providers to estimate vaccination coverage rates for US children aged 19 to 35 months. Data for this study were limited to 14,810 children aged 24 to 35 months. MAIN OUTCOME MEASURES: Cumulative days undervaccinated during the first 24 months of life for each of 6 vaccines (diphtheria and tetanus toxoids and acellular pertussis; poliovirus; measles, mumps, and rubella; Haemophilus influenzae type b; hepatitis B; and varicella) and all vaccines combined, number of late vaccines, and risk factors for severe delay of vaccination. RESULTS: Children were undervaccinated a mean of 172 days (median, 126 days) for all vaccines combined during their first 24 months of life. Approximately 34% were undervaccinated for less than 1 month and 29% for 1 to 6 months, while 37% were undervaccinated for more than 6 months. Vaccine-specific undervaccination of more than 6 months ranged from 9% for poliovirus vaccine to 21% for Haemophilus influenzae type b vaccine. An estimated 25% of children had delays in receipt of 4 or more of the 6 vaccines. Approximately 21% of children were severely delayed (undervaccinated for more than 6 months and for > or vaccines). Factors associated with severe delay included having a mother who was unmarried or who did not have a college degree, living in a household with 2 or more children, being non-Hispanic black, having 2 or more vaccination providers, and using public vaccination provider(s). CONCLUSIONS: More than 1 in 3 children were undervaccinated for more than 6 months during their first 24 months of life and 1 in 4 children were delayed for at least 4 vaccines. Standard measures of vaccination coverage mask substantial shortfalls in ensuring that recommendations are followed regarding age at vaccination throughout the first 24 months of life.

Lessons learned from making and implementing vaccine recommendations in the U.S.

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.

Lessons Learned From Making and Implementing Vaccine Recommendations in the U.S.

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.