Louis Z. Cooper

Addressing the vaccine confidence gap.

Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK (H J Larson PhD); Department of Paediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA (Prof L Z Cooper MD); National Institute for Health and Welfare (THL), Helsinki, Finland (J Eskola MD); Department of Paediatrics, Duke University, Durham, NC, USA (Prof S L Katz MD); Government Aff airs and Policy, Johnson & Johnson, New Brunswick, NJ, USA; (S Ratzan MD); and Journal New Decade of Vaccines 5Vaccines--often lauded as one of the greatest public health interventions--are losing public confidence. Some vaccine experts have referred to this decline in confidence as a crisis. We discuss some of the characteristics of the changing global environment that are contributing to increased public questioning of vaccines, and outline some of the specific determinants of public trust. Public decision making related to vaccine acceptance is neither driven by scientific nor economic evidence alone, but is also driven by a mix of psychological, sociocultural, and political factors, all of which need to be understood and taken into account by policy and other decision makers. Public trust in vaccines is highly variable and building trust depends on understanding perceptions of vaccines and vaccine risks, historical experiences, religious or political affiliations, and socioeconomic status. Although provision of accurate, scientifically based evidence on the risk-benefit ratios of vaccines is crucial, it is not enough to redress the gap between current levels of public confidence in vaccines and levels of trust needed to ensure adequate and sustained vaccine coverage. We call for more research not just on individual determinants of public trust, but on what mix of factors are most likely to sustain public trust. The vaccine community demands rigorous evidence on vaccine efficacy and safety and technical and operational feasibility when introducing a new vaccine, but has been negligent in demanding equally rigorous research to understand the psychological, social, and political factors that affect public trust in vaccines.

Protecting Public Trust in Immunization

Public trust in the safety and efficacy of vaccines is one key to the remarkable success of immunization programs within the United States and globally. Allegations of harm from vaccination have raised parental, political, and clinical anxiety to a level that now threatens the ability of children to receive timely, full immunization. Multiple factors have contributed to current concerns, including the interdependent issues of an evolving communications environment and shortfalls in structure and resources that constrain research on immunization safety (immunization-safety science). Prompt attention by public health leadership to spreading concern about the safety of immunization is essential for protecting deserved public trust in immunization.

The pediatrician and disaster preparedness

For decades, emergency planning for natural disasters, public health emergencies, workplace accidents, and other calamities has been the responsibility of government agencies on all levels and certain nongovernment organizations such as the American Red Cross. In the case of terrorism, however, entirely new approaches to emergency planning are under development for a variety of reasons. Terrorism preparedness is a highly specific component of general emergency preparedness. In addition to the unique pediatric issues involved in general emergency preparedness, terrorism preparedness must consider several additional issues, including the unique vulnerabilities of children to various agents as well as the limited availability of age- and weight-appropriate antidotes and treatments. Although children may respond more rapidly to therapeutic intervention, they are at the same time more susceptible to various agents and conditions and more likely to deteriorate if they are not monitored carefully. This article is designed to provide an overview of key issues for the pediatrician with respect to disaster, terrorism, and public health emergency preparedness. It is not intended to be a complete compendium of didactic content but rather offers an approach to what pediatricians need to know and how pediatricians must lend their expertise to enhance preparedness in every community. To become fully and optimally prepared, pediatricians need to become familiar with these key areas of emergency preparedness: unique aspects of children related to terrorism and other disasters; terrorism preparedness; mental health vulnerabilities and development of resiliency; managing family concerns about terrorism and disaster preparedness; office-based preparedness; hospital preparedness; community, government, and public health preparedness; and advocating for children and families in preparedness planning.

Preparing for elimination of congenital Rubella syndrome (CRS): summary of a workshop on CRS elimination in the United States.

The goal of eliminating indigenous rubella and congenital rubella syndrome (CRS) in the United States in the near future is now within reach, because rubella incidence has been sustained at record-low levels since the mid-1990s. Effective prevention strategies to eliminate CRS and rubella require improvement in the surveillance of CRS and congenital rubella infection (CRI). The purpose of the workshop was to review rubella and CRS epidemiology, as well as current clinical, diagnostic, and laboratory practices, to determine whether new strategies are needed to achieve and document CRS elimination. Workshop participants agreed that surveillance for CRS must be strengthened, particularly through augmented laboratory capabilities, and the case definition for CRS must be revised to reflect the current scientific information available. Further studies of methods are needed to identify high-risk populations and geographic areas for rubella and CRS and to enhance identification of infants with CRS.

Neonatal rubella in a breast-fed infant after postpartum maternal infection

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Characterization of the Risks of Adverse Outcomes Following Rubella Infection in Pregnancy

Although most infections with the rubella virus result in relatively minor sequelae, rubella infection in early pregnancy may lead to severe adverse outcomes for the fetus. First recognized in 1941, congenital rubella syndrome (CRS) can manifest with a diverse range of symptoms, including congenital cataracts, glaucoma, and cardiac defects, as well as hearing and intellectual disability. The gestational age of the fetus at the time of the maternal rubella infection impacts the probability and severity of outcomes, with infection in early pregnancy increasing the risks of spontaneous termination (miscarriage), fetal death (stillbirth), birth defects, and reduced survival for live-born infants. Rubella vaccination continues to change the epidemiology of rubella and CRS globally, but no models currently exist to evaluate the economic benefits of rubella management. This systematic review provides an overall assessment of the weight of the evidence for the outcomes associated with rubella infections in the first 20 weeks of pregnancy. We identified, evaluated, and graded 31 studies (all from developed countries) that reported on the pregnancy outcomes of at least 30 maternal rubella infections. We used the available evidence to estimate the increased risks of spontaneous termination, fetal death, infant death, and CRS as a function of the timing of rubella infection in pregnancy and decisions about induced termination. These data support the characterization of the disability-adjusted life years for outcomes associated with rubella infection in pregnancy. We find significant impacts associated with maternal rubella infections in early pregnancy, which economic analyses will miss if they only focus on live births of CRS cases. Our estimates of fetal loss from increased induced terminations due to maternal rubella infections provide context that may help to explain the relatively low numbers of observed CRS cases per year despite potentially large burdens of disease. Our comprehensive review of the weight of the evidence of all pregnancy outcomes demonstrates the importance of including all outcomes in models that characterize rubella-related disease burdens and costs.

Global Vaccination Recommendations and Thimerosal

* Abbreviations: UNEP — : United Nations Environmental Programme WHO — : World Health Organization Vaccines remain one of the most effective ways to prevent infectious disease and deaths globally.1 Universal childhood immunization provides herd immunity against many infectious agents and is a policy that has achieved dramatic reductions in common childhood illnesses. Thimerosal, which contains ethyl mercury, has been used as a preservative in vaccines to prevent contamination of multidose vials from bacteria and fungi since the 1930s.2 Although there are clear neurotoxic effects of methyl mercury absorption, ethyl mercury has not been associated with those consequences. Nevertheless, before data were available on risks of thimerosal in vaccines, in 1999 the American Academy of Pediatrics and the US Public Health Service recommended moving toward removing thimerosal use in preservatives as a precautionary measure.3 Thus, thimerosal as … Address correspondence to Walter A. Orenstein, MD, 1462 Clifton Rd, Suite 446, Atlanta, GA 30322. E-mail: worenst{at}emory.edu

Systematic Review of the Manifestations of Congenital Rubella Syndrome in Infants and Characterization of Disability‐Adjusted Life Years (DALYs)

Congenital rubella syndrome (CRS) continues to cause disability among unvaccinated populations in countries with no or insufficient rubella vaccine coverage to prevent transmission. We systematically reviewed the literature on birth outcomes associated with CRS to estimate the duration, severity, and frequency of combinations of morbidities. We searched PubMed, the Science Citation Index, and references from relevant articles for studies in English with primary data on the frequency of CRS manifestations for ≥20 cases and identified 65 studies representing 66 study populations that met our inclusion criteria. We abstracted available data on CRS cases with one or more hearing, heart, and/or eye defect following maternal rubella infection during the period of 0-20 weeks since the last menstrual period. We assessed the quality and weight of the available evidence using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Most of the evidence originates from studies in developed countries of cohorts of infants identified with CRS in the 1960s and 1970s, prior to the development of standardized definitions for CRS and widespread use of vaccine. We developed estimates of undiscounted disability-adjusted life years (DALYs) lost per CRS case for countries of different income levels. The estimates ranged from approximately 19 to 39 for high-income countries assuming optimal treatment and from approximately 29 to 39 DALYs lost per CRS case in low- and lower- middle-income countries assuming minimal treatment, with the lower bound based on 2010 general global burden of disease disability weights and the upper bound based on 1990 age-specific and treatment-specific global burden of disease disability weights. Policymakers and analysts should appreciate the significant burden of disability caused by CRS as they evaluate opportunities to manage rubella.

Ban on Thimerosal in Draft Treaty on Mercury: Why the AAP's Position in 2012 Is So Important

* Abbreviations: AAP — : American Academy of Pediatrics FDA — : Food and Drug Administration TCV — : thimerosal-containing vaccine USPHS — : US Public Health Service A draft treaty under consideration by the United Nations Environmental Program has been prepared to greatly reduce global health hazards from environmental mercury.1 In response to the draft treaty, the World Health Organization urges removal of a provision in the treaty that calls for a ban on thimerosal (which contains ethyl mercury) in vaccines, a position recently endorsed by the American Academy of Pediatrics (AAP) and the US Public Health Service (USPHS). Removal of the ban on thimerosal-containing vaccines (TCVs) represents a significant reversal of the position expressed in an AAP/USPHS joint statement in 1999 that called for elimination of mercury in vaccines and the subsequent actions taken in the United States.2 Understanding the circumstances that led 14 years ago to the 1999 statement and the knowledge accumulated in these subsequent years can reinforce the importance of the 2012 AAP/USPHS position. AAP representatives and other members of national pediatric societies within the International Pediatric Association advocating for deletion of the provision banning TCVs need to know why the elimination of thimerosal was initially called for in 1999 but is no longer indicated. This commentary … Correspondence to Louis Z. Cooper, MD, 80 Central Park W, Apt 11F, New York, NY 10023. E-mail: lzcooper{at}verizon.net

Current Lessons from 20th Century Serosurveillance Data on Rubella

Received 3 May 2001; electronically published 20 September 2001. Reprints or correspondence: Dr. Louis Z. Cooper (Lzcooper @compuserve.com). Clinical Infectious Diseases 2001; 33:1287 2001 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2001/3308-0002