Major severe acute respiratory coronavirus-2 (SARS-CoV-2) vaccine-associated adverse effects; benefits outweigh the risks.

ABSTRACT

INTRODUCTION: Since its emergence, there have been huge efforts to design vaccines against coronavirus disease 2019 (COVID-19) to inhibit its interpersonal spread. Global vaccine development is the most promising cost-effective method for overcoming the epidemic. However, following reports of post-vaccination thromboembolic adverse effects, there have been raising concerns about the safety profile of the COVID-19 vaccine. AREAS COVERED We aimed to review the recent Food and Drug Administration (FDA)-approved vaccines and identify the organ-based major complications of COVID-19 vaccines based on reliable published studies. To find high-quality and large-scale observational, clinical trial, and cohort studies, PubMED, Scholar, Embase, and Web of Science were searched using keywords COVID-19, SARS-CoV-2, vaccine, Pfizer (BNT162b2), Johnson and Johnson (Ad26.COV2), Moderna (mRNA-1273), Oxford AstraZeneca (ChAdOx1nCoV19), Coronavac (Sinovac), BBIBP-CorV (Sinopharm), adverse effect, and complication. To include all relevant articles, backward searching was also done on similar article citations. Case reports, studies including less than 10 participants, and biased articles were excluded. EXPERT OPINION Based on data from high-quality and population-based studies, major adverse effects are divided into four major organ-specific groups, including cardiovascular, neurologic, hematologic, and immune-allergic side effects. The incidence of most of these side effects is not different between vaccinated and normal populations, and currently, the benefits of vaccination against COVID-19 are greater than the mortality and morbidity risks of COVID-19 infection. However, further studies, specifically systematic review and meta-analysis, are still indicated to investigate further unknown side effects of these vaccines and the existence of causality between the vaccine and reported adverse events.