The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety.
Journal
Vaccine
Journal Volume
39
Journal Issue
19
Start Page
2712-2718
ISSN
1873-2518
Date Issued
2021-05-06
Author(s)
Black, Steven B
Law, Barbara
Chen, Robert T
Dekker, Cornelia L
Sturkenboom, Miriam
Gurwith, Marc
Poland, Greg
Abstract
Beginning in December of 2019, a novel coronavirus, SARS-CoV-2, emerged in China and is now a global pandemic with extensive morbidity and mortality. With the emergence of this threat, an unprecedented effort to develop vaccines against this virus began. As vaccines are now being introduced globally, we face the prospect of millions of people being vaccinated with multiple types of vaccines many of which use new vaccine platforms. Since medical events happen without vaccines, it will be important to know at what rate events occur in the background so that when adverse events are identified one has a frame of reference with which to compare the rates of these events so as to make an initial assessment as to whether there is a potential safety concern or not. Background rates vary over time, by geography, by sex, socioeconomic status and by age group. Here we describe two key steps for post-introduction safety evaluation of COVID-19 vaccines: Defining a dynamic list of Adverse Events of Special Interest (AESI) and establishing background rates for these AESI. We use multiple examples to illustrate use of rates and caveats for their use. In addition we discuss tools available from the Brighton Collaboration that facilitate case evaluation and understanding of AESI.
Subjects
Background rates
COVID-19 vaccines
Vaccine safety
Publisher
Elsevier
Type
journal article