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David W. Kimberlin, MD, FAAP, 2021. "Introduction", Red Book: 2021–2024 Report of the Committee on Infectious Diseases, Committee on Infectious Diseases, American Academy of Pediatrics, David W. Kimberlin, MD, FAAP, Elizabeth D. Barnett, MD, FAAP, Ruth Lynfield, MD, FAAP, Mark H. Sawyer, MD, FAAP
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The Committee on Infectious Diseases (COID) of the American Academy of Pediatrics (AAP) is responsible for developing and revising guidance from the AAP for management and control of infectious diseases in infants, children, and adolescents. Every 3 years, the COID issues the Red Book: Report of the Committee on Infectious Diseases, which contains a composite summary of current recommendations representing the policy of the AAP on various aspects of infectious diseases, including updated vaccine recommendations for the most recent US Food and Drug Administration (FDA)-licensed vaccines for infants, children, and adolescents. These recommendations represent a consensus of opinions based on consideration of the best available evidence by members of the COID, in conjunction with liaison representatives from the Centers for Disease Control and Prevention (CDC), the FDA, the National Institutes of Health, the National Vaccine Program Office, the Canadian Paediatric Society, the American Thoracic Society, the Pediatric Infectious Diseases Society, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, Red Book consultants, and scores of collaborators. This edition of the Red Book is based on information available as of February 2021. The Red Book is your own personal infectious disease consultant, on your bookshelf and ready for you 24 hours a day, 7 days a week. Arguably, it is most valuable in those circumstances in which definitive data from randomized controlled trials are lacking. It is in those situations that guidance from experts in the field is most critical, and the COID has literally hundreds of years of cumulative expertise to bring to bear on such recommendations.
Preparation of the Red Book is a team effort in the truest sense of the term. Within weeks following the publication of each Red Book edition, all Red Book chapters are sent for updates to primary reviewers who are leading national and international experts in their specific areas. For the 2021 Red Book, one third of primary reviewers were new to this process, ensuring that the most up-to-date information has been included in this new edition. Following review by the primary reviewer, each chapter is returned to the assigned Associate Editor for incorporation of the reviewer’s edits. The chapter then is disseminated to content experts at the CDC and FDA and to members of all AAP Sections, Committees, and Councils that agree to review specific chapters for their additional edits as needed, after which it again is returned to the assigned Associate Editor for harmonization and incorporation of edits as appropriate. Two designated COID reviewers then complete a final review of the chapter, and it is returned to the assigned Associate Editor for inclusion of any needed additional modifications. Chapters requiring consideration by the full committee then are debated at the “Marathon Meeting,” where the chapters are finalized. Copyediting by the Editor and Senior Medical Copy Editor, Jennifer Shaw, follows, and the book then is reviewed by the Red Book reviewers appointed by the AAP Board of Directors. In all, 1000 hands have touched the 2021 Red Book prior to its publication! That so many contributors dedicate so much time and expertise to this product is a testament to the role the Red Book plays in the care of children.
As with literally everything in the world in 2020, the SARS-CoV-2 pandemic necessitated on-the-fly modifications to the production process. The Marathon Meeting typically is held in person in March of the year prior to publication. With the rolling restrictions on travel during the spring of 2020, the Marathon Meeting initially was pushed to April and then finally changed to a virtual meeting in June 2020. This put us 3 months behind in the production cycle, at a time when pediatricians more than ever needed timely guidance with the management of infectious diseases and when the pediatric infectious diseases experts who are the members of COID were being stretched more thinly than ever before. The responses of the committee members were simply amazing, and quite honestly I have never been more proud to be in the field of pediatric infectious diseases. As a direct consequence of their commitment and that of the AAP Board of Directors reviewers, and the tireless effort of Senior Medical Copy Editor Jennifer Shaw, we were able to make up 3 months of delay to bring this edition to you on time in the midst of a once-in-a-century pandemic.
Through the deliberative and inclusive process that defines the production of the Red Book, the COID endeavors to provide current, relevant, evidence-based recommendations for the prevention and management of infectious diseases in infants, children, and adolescents. Seemingly unanswerable scientific questions, the complexity of medical practice, ongoing innovative technology, continuous new information, and inevitable differences of opinion among experts all are addressed during production of the Red Book. In some cases, other committees and experts may differ in their interpretation of data and resulting recommendations, and occasionally no single recommendation can be made because several options for management are equally acceptable. In such circumstances, the language incorporated in the chapter acknowledges these differing acceptable management options by use of the phrases “most experts recommend...” and “some experts recommend...” Both phrases indicate valid recommendations, but the first phrase signifies more agreement and support among the experts. Inevitably in clinical practice, questions arise that cannot be answered easily on the basis of currently available data. When this happens, the COID still provides guidance and information that, coupled with clinical judgment, will facilitate well-reasoned, clinically relevant decisions. Through this process of lifelong learning, the committee seeks to provide a practical guide for physicians and other health care professionals in their care of infants, children, and adolescents.
To aid physicians and other health care professionals in assimilating current changes in recommendations in the Red Book, a list of major changes between the 2018 and 2021 editions has been compiled (see Summary of Major Changes, p xxxv). However, this list only begins to cover the many in-depth changes that have occurred in each chapter and section. Throughout the Red Book, internet addresses enable rapid access to new information. In addition, new information between editions from the COID, in the form of Policy Statements, Clinical Reports, and Technical Reports, are posted on Red Book Online (www.aapredbook.org), and online chapters are modified as needed with clear indications of where changes have been made. These completed work products are a result of the continuous reassessment by the COID of its current positions across the spectrum of pediatric infectious diseases and demonstrate the dynamic process by which the committee’s deliberations always are inclusive of new data and perspectives.
Information on use of antimicrobial agents is included in the package inserts (product labels) prepared by manufacturers, including contraindications and adverse events. The Red Book does not attempt to provide this information comprehensively, because it is available readily in the Physicians’ Desk Reference (www.pdr.net) and in package inserts.
As in previous editions of the Red Book, recommended dosage schedules for antimicrobial agents are provided (see Section 4, Antimicrobial Agents and Related Therapy) and may differ from those of the manufacturer as provided in the package insert. Antimicrobial agents recommended for specific infections in the Red Book may or may not have an FDA indication for treatment of that infection. Physicians also can reference additional information in the package inserts of vaccines licensed by the FDA (which also may differ from COID and ACIP/CDC recommendations for use) and of immune globulins, as well as recommendations of other committees (see Sources of Vaccine Information, p 3), many of which are included in the Red Book.
Likewise, we strive to utilize the accurate terminology for licensure, approval, or clearance of drugs and devices by the FDA. The correct term used depends on the classification of the product (eg, drug, biological product, or device) and, for devices, whether a “premarket notification” or a “premarket application” has been submitted. Drugs are approved by the FDA, biologic products (eg, vaccines, immunoglobulin preparations) are licensed by the FDA, and vaccines are approved for use in certain populations and age groups. The FDA “clears” devices after reviewing premarket notifications, but “approves” devices after reviewing a premarket application. Whether a premarket notification or premarket application needs to be filed depends on the classification of the medical device. “Cleared” devices (also called “510 (k)” or “premarket notification” devices) can be searched at www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances. Devices@FDA (www.fda.gov/medical-devices) is more comprehensive and includes both “cleared” and “approved” tests and other devices. Where we fail in the Red Book to select the appropriate term for a given product, we apologize for any (additional) confusion this adds to this regulatory structure.
This book could not have been prepared without the dedicated professional competence of many people. The AAP staff has been outstanding in its committed work and contributions, particularly Jennifer Shaw, Senior Medical Copy Editor; Linda Rutt, Project Specialist; Jennifer Frantz, Senior Manager, who serves as the administrative director for the COID and coordinated preparation of the Red Book; Theresa Wiener, Manager of Publishing and Production Services; and all of the directors and staff of the AAP publishing and marketing groups who make the full Red Book product line possible.
Marc Fischer, MD, of the CDC, and Karen M. Farizo, MD, of the FDA, devoted time and effort in providing significant input from their organizations. Lisa Cosgrove, MD, Gary Floyd, MD, and Yasuko Fukuda, MD, served as Red Book reviewers appointed by the AAP Board of Directors, spending scores of hours reviewing the final chapters for consistency and accuracy. I am especially indebted to the Associate Editors Elizabeth D. Barnett, MD, Ruth Lynfield, MD, and Mark H. Sawyer, MD, for their expertise, tireless work, good humor, and immense contributions in their editorial and committee work. Members of the COID contributed countless hours and deserve appropriate recognition for their patience, dedication, revisions, and reviews. The COID appreciates the guidance and dedication of Yvonne A. Maldonado, MD, COID Chairperson, whose knowledge, dedication, insight, and leadership are reflected in the quality and productivity of the committee’s work. I thank my wife, Kim, for always being there and for her patience, understanding, and never-ending support as this edition of the Red Book came to fruition.
I also would like to personally thank Mark Del Monte, JD, Chief Executive Officer/Executive Vice President of the Academy, for his calm demeanor and exceptional support throughout what likely is the most stressful year that any of us have ever experienced. His steady hand on the rudder of the AAP directly results in the productivity that we have been able to achieve during these extraordinary times. All pediatricians across the country, and the patients they serve, owe him a debt of gratitude.
There are many other contributors whose professional work and commitment have been essential in the committee’s preparation of the Red Book. Please forgive any omissions I have made in expressing my gratitude. As stated in the African proverb, if you want to go fast, go alone; if you want to go far, go together. This edition of the Red Book, produced in the most unusual and difficult of times, shows just how far we can go, together.