Evaluation of the safety profile of COVID-19 vaccines: a rapid review

Abstract

Background The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. Methods English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. Results A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Conclusions Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.

Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

“…However, in the current study, the incidences of headache and myalgia had no differences between the high, moderate dose and low dose, or between the first and second vaccination doses. No significant correlation between the dose and adverse events occurrence was found, consistent with the previous literature about COVID-19 vaccines [ 43 , 46 ]. Different vaccines have varied doses.…”

Reported COVID-19 vaccines side effects among Jordanian population: a cross sectional study

“…27 This is also consistent with the findings of Wu et al (2021) recent review of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines. 35 Gastrointestinal symptoms, particularly nausea, were reported in 23.% of those who received AstraZeneca vaccine with lower proportions observed with the administration of Pfizer vaccine in two cross sectional studies (15.94% and 13.0%) and one randomized trial with the administration of Sinopharm vaccine (1%). [27][28][29]33 This trend was also observed in our study, though with higher proportions observed for AstraZeneca and Sinopharm vaccines and lower proportions with Pfizer vaccine.…”

“…27 In general, consistent with our findings, rates of local and systemic reactions were significantly lower among inactivated vaccines including Sinopharm vaccine compared to Pfizer and AstraZeneca vaccines as observed in Wu et al (2021) review. 35 Notably, localized lymphadenopathy was reported in two cross-sectional studies that included healthcare workers who were given Pfizer vaccine. 29,33 However, lower proportions were observed in our study perhaps due to lower health literacy among Jordanian population that might be affecting the ability to recognize lymphadenopathy symptoms compared to that expected from health care workers in the aforementioned studies.…”

A Retrospective Cross-Sectional Study Assessing Self-Reported Adverse Events following Immunization (AEFI) of the COVID-19 Vaccine in Bangladesh

“…We prepared a survey questionnaire after a careful review of COVID-19 data and surveillance from the Centers for Disease Control and Prevention (CDC) [22]. An extensive literature review on the associated side-effects of COVID-19 vaccines [8][9][10] and group discussion was integrated to finalize the questionnaire. Ethical approval was obtained from the human ethical review committee of the State University of Bangladesh to conduct the study (approval number: 2021-03-25/SUB/H-ERC/0005).…”

“…"Short length of the vaccine development process", "insufficient evidence to prove the efficacy of the vaccines", "safety evaluation of vaccines in the development process", and "potential side-effects recorded" were some of the most prevalent causes behind this [9]. Furthermore, when a global mass vaccination campaign was rolled out, certain severe and uncommon adverse events following immunization (AEFI) were observed [10].…”