COVID-19 Vaccine: What Physicians Need to Know
Authors: Christine Laine, Deborah Cotton, Darilyn V. Moyer
Journal: Annals of Internal Medicine (2020)

Special Articles20 October 2020COVID-19 Vaccine: What Physicians Need to KnowFREEChristine Laine, MD, MPH, Deborah Cotton, MD, MPH, and Darilyn V. Moyer, MDChristine Laine, MD, MPHEditor in Chief, Annals of Internal Medicine (C.L.)Search for more papers by this author, Deborah Cotton, MD, MPHDeputy Editor, Annals of Internal Medicine (D.C.)Search for more papers by this author, and Darilyn V. Moyer, MDExecutive Vice President and Chief Executive Officer, American College of Physicians (D.V.M.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M20-6841 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Much uncertainty surrounds vaccines for coronavirus disease 2019 (COVID-19) and the course of the pandemic in general. What is certain, however, is that physicians will have an important role in the implementation of a successful immunization program once a safe and effective vaccine becomes available. Patients, health care worker colleagues, family, friends, and others will seek advice from physicians on whether to get vaccinated. We will need to discuss the benefits and risks with them. Others will tell us they will refuse vaccination, and if those individuals and the community are likely to benefit from their vaccination, we will have an opportunity to try to alleviate their hesitancy in receiving the vaccine. If the vaccine is one that can be administered in our clinical settings, we will need to structure our practices to make receipt of the vaccine as accessible and efficient as possible for our patients.Physicians must be prepared for this critical role in combatting the COVID-19 pandemic. Sound, scientific knowledge—untarnished by political views—is essential to this preparation. To help ready physicians with such knowledge, Annals of Internal Medicine and the American College of Physicians hosted the COVID-19 Vaccine Forum on 16 October 2020 to offer current, evidence-based information related to the science, approval processes, and development of clinical recommendations for vaccines. Emergency Use Authorization of COVID-19 vaccines would be the first time this process has been implemented for a vaccine in the history of the U.S. Food and Drug Administration. The implementation of Emergency Use Authorization must balance efficacy and safety with the risk for mitigating the ongoing pandemic in the nation. Given the reality of current times, the forum also addressed the political environment that threatens time-honored vaccine-related processes and fosters confusion and mistrust among clinicians and patients alike.Forum speakers included Dr. Anthony Fauci (Director, National Institute of Allergy and Infectious Diseases), Dr. H. Clifford Lane (Deputy Director for Clinical Research and Special Projects, National Institute of Allergy and Infectious Diseases), Dr. David Kessler (Former Commissioner, U.S. Food and Drug Administration), Dr. Beth Bell (Member, Advisory Committee on Immunization Practices), and Dr. Rachel Levine (Secretary, Pennsylvania Department of Health). Readers can view their presentations in the video that accompanies this article.We do not yet know results from ongoing clinical trials; whether and when one or more vaccines will be approved; whether the supply of any approved vaccine will match demand; or specific details about the allocation, distribution, and administration of any approved vaccine. However, the forum provided accurate, baseline information and highlights several questions that physicians should ask when data become available and approval ensues, including:•Did the vaccine or vaccines earn full approval or Emergency Use Authorization?•What are the characteristics of the patients who participated in the trials that led to vaccine approval or Emergency Use Authorization? Did trial participants have risks for COVID-19 similar to those of the person who is asking me for advice?•What are the clinical outcomes on which vaccine approval or Emergency Use Authorization is based?•What adverse events were observed during the clinical trials? How will postmarketing of vaccines be monitored for safety concerns?•Are the vaccine approval or Emergency Use Authorization and clinical recommendations for use limited to specific types of individuals? If so, are limits equitable and informed by scientific evidence?Answers to these questions enable us to provide well-informed counsel to those who ask about the vaccine and to decide whether to receive the vaccine ourselves. Listening to what the speakers had to say at the forum on 16 October will help you to articulate these and other questions that emerge along with the data. Comments 0 Comments Sign In to Submit A Comment Michael KoronkowskiUniversity of Illinois at Chicago20 October 2020 Valued Expert COVID Vaccine Context and Perspective ACP's Update on COVID-19 thru the expert video discussion was extremely valuable in providing context to the challenges and issues facing our public health policymakers around the vaccine from development to vaccination. Health care providers must be informed to address the needs of our at risk patients. Thank you ACP for this insightful update. Diane LevitanMultiCare Health System20 October 2020 Take a few minutes to watch- it's worth it For those having to squeeze this in between patients, Dr. Fauci’s presentation starts at 3:55, Dr. Kessler (FDA approval process) at 37:00, and Dr. Bell (ACIP clinical recommendation development) at 1:00:35. Dr. Levine (political impact) is at 1:28:24. The opinions contained on this site are my own and don't necessarily reflect my employer's or MultiCare Health System's positions, strategies, or opinions. Neil SteinHospital for Special Care30 October 2020 Vaccine administration, the problem of multiple vaccine types and brands When multiple versions of vaccines are available against a pathogen and multiple doses are recommended, data pertaining to the efficacy of administering a mixture of the different vaccines to an individual is needed. It seems likely that multiple vaccines for SARS-CoV-2 will be available. Multiple doses will probably be needed to maximize efficacy. Shortages of a specific type or band of vaccine is probable. Simply recommending the use whichever vaccine is available is insufficient. Recommending to only use the same brand of vaccine is also insufficient. How do we address the question of efficacy of administering multiple vaccine types or brands to an individual? Also, what is the data of co-administering SARS-CoV-2 vaccine with other vaccines? Laura C. HartOhio State University / Nationwide Children's Hospital18 November 2020 Worth The Time (even a Month late) I was just now able to watch this video. Even with the recent announcement of the efficacy of vaccines, I found it tremendously helpful. For anyone wondering if this video is "worth it" - even a month out, I would say the answer is yes. Thank you ACP for putting together such a thoughtful and insightful group of speakers to give the rest of us the important information we need as we take care of patients. Gaurav ChhayaShivam Medicare clinic, Ahmedabad3 February 2021 Vaccine in question.. answered soon.. SARS-COV-19 has disrupted daily lifestyle of many people. Vaccine development is welcome sign for new-normal life. After getting first shot.. I am now understanding the issue with more clarity. We now have large number of vaccine recipients.. who can provide answer about its efficacy and safety in large scale. Author, Article, and Disclosure InformationAuthors: Christine Laine, MD, MPH; Deborah Cotton, MD, MPH; Darilyn V. Moyer, MDAffiliations: Editor in Chief, Annals of Internal Medicine (C.L.)Deputy Editor, Annals of Internal Medicine (D.C.)Executive Vice President and Chief Executive Officer, American College of Physicians (D.V.M.)Disclosures: Disclosure forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-6841.Corresponding Author: Christine Laine, MD, MPH, Editor in Chief, Annals of Internal Medicine, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, claine@acponline.org.This article was published at Annals.org on 20 October 2020. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAnnals On Call - A Primer on COVID-19 Vaccines Robert M. Centor and Paul Goepfert COVID-19 Vaccine: Promoting Vaccine Acceptance Christine Laine , Deborah Cotton , and Darilyn V. Moyer COVID-19 Vaccine Distribution and Allocation: What Physicians Need to Know Christine Laine , Deborah Cotton , and Darilyn V. Moyer COVID-19 Vaccine: Practical Clinical Considerations Christine Laine , Deborah Cotton , Darilyn V. Moyer COVID-19: Evaluation and Care of Patients With Persistent Symptoms Following Acute SARS-CoV-2 Infection Christine Laine and Deborah Cotton COVID-19: Clinical and Public Health Implications of SARS-CoV-2 Immunology Christine Laine , Deborah Cotton , Darilyn V. Moyer COVID-19: Challenging Clinical Questions Christine Laine , Darilyn V. 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Moyer, MDConfidence and Receptivity for COVID-19 Vaccines: A Rapid Systematic Review 17 November 2020Volume 173, Issue 10 Page: 830 Keywords Allergy and immunology Clinical trials COVID-19 Disclosure Food and Drug Administration Health care providers Infectious diseases Patients Safety Vaccines ePublished: 20 October 2020 Issue Published: 17 November 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...