3 Update COVID-19 list of Adverse events (Part 1 and Part 2) (SO2-D2.1)

SPEAC has completed a 4th update of the COVID-19 clinical literature covering the period from November 2020 – August 2021. The primary objectives were to review the evidence on the following outcomes: Long COVID (Part 1) Acute cardiac injury other than myocarditis/pericarditis; Maternal, foetal and neonatal outcomes; Paediatric and adult COVID-19 related complications; System-specific COVID-19 complications. For this update, the search focused on meta-analyses and reviews and excluded case reports, case series, studies, guidelines and commentaries. The system specific annexes from previous reports have been updated with the newly published meta-analyses and reviews. New annexes have been added for specific populations: adult, paediatric, pregnant/foetal/neonatal. Based on this review, SPEAC recommends that: Long COVID should not be added to the COVID-19 AESI list at the present time and continued review of the evidence on Long COVID should be a focused activity of the fifth update. Beyond myocarditis and pericarditis, for which Brighton case definitions have been completed, no new case definitions need to be created for the other acute cardiac injuries. No maternal, foetal or neonatal outcomes will be added at this time to the COVID-19 AESI list. No new AESI will be added to the COVID-19 AESI list related to COVID-19 course and complications in children or adults. No new system-specific AESIs will be added to the COVID-19 AESI list. The next update (fifth update due December 2021) will use the same methods as described for this update to focus on new evidence related to Long COVID, Pregnancy and perinatal outcomes, paediatric course and complications and system specific AESIs or those seen in adult populations. The COVID-19 AESI list, as published in the 3rd update of December 2020, remains the same. Summaries are provided in body system specific annexes to the deliverable. As well, all citations in full along with PMID links are included in a spreadsheet that has separate tabs by body system. For pregnancy there are three tabs: one with all citations including PMID links similar to other tabs; a second that provides summaries of all the meta-analyses and systematic reviews included in the 4th update; and a third tab that cross tabulates all studies referenced by any meta-analysis and/or systematic review, against the meta-analyses and systematic reviews included in the fourth update.The SPEAC Project is funded in whole by CEPI