The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety.
Vaccine
; 39(19): 2712-2718, 2021 05 06.
Article
in English
| MEDLINE | ID: covidwho-1118713
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Vaccine
Year:
2021
Document Type:
Article
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