Anticipating Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine Testing, Licensure, and Recommendations for Use

• Type of Material: Article
• Authors: Kathryn M. Edwards, Vanderbilt University; Walter Orenstein, Emory University
• Language: English
• Date: 2020-09-01
• Publisher: Mosby-Elsevier
• Publication Version: Final Published Version
• Copyright Statement: © 2020 Elsevier Inc. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jpeds.2020.06.048
• Title of Journal or Parent Work: Journal of Pediatrics
• Volume: 224
• Start Page: 124
• End Page: 128
• Grant/Funding Information: None declared
• Keywords: Pediatrics; United States; Life Sciences & Biomedicine; Science & Technology; Immunization
• Research Categories: Health Sciences, Immunology; Health Sciences, Epidemiology; Health Sciences, Public Health; Health Sciences, Medicine and Surgery

Abstract

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China and its rapid spread throughout the world, inflicting enormous morbidity and mortality, clearly highlights the need for safe and effective vaccines.1 Many countries and pharmaceutical companies are moving rapidly to design and test such vaccines; the World Health Organization has listed more than 120 candidates in various stages of development.2 As we quickly embark on the pursuit of vaccines to prevent coronavirus disease 2019 (COVID-19), many are concerned that the rapidity with which these studies are being conducted will mean that vaccine safety will be sacrificed. However, over the past several decades, existing procedures to test and license vaccines, to regulate their production and purity, and advisory bodies to guide their use have been established and refined and are well prepared to ensure safe and effective vaccines. In this brief review, we will outline these processes from our perspectives. Both of us have been working in the vaccine field for 4 decades; we provide reassurance that the process is well established and designed to provide safe and effective vaccines.