tetano
Editor, Senior Moderator
BMC Med
. 2021 Jul 28;19(1):173.
doi: 10.1186/s12916-021-02059-5.
Evaluation of the safety profile of COVID-19 vaccines: a rapid review
Qianhui Wu[SUP] 1 [/SUP], Matthew Z Dudley[SUP] 2 3 [/SUP], Xinghui Chen[SUP] 1 [/SUP], Xufang Bai[SUP] 1 [/SUP], Kaige Dong[SUP] 1 [/SUP], Tingyu Zhuang[SUP] 1 [/SUP], Daniel Salmon[SUP] 2 3 [/SUP], Hongjie Yu[SUP] 4 5 6 [/SUP]
Affiliations
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.
Keywords: Novel coronavirus diseases 2019; Review; Safety profile; Severe acute respiratory syndrome coronavirus 2; Vaccine.
. 2021 Jul 28;19(1):173.
doi: 10.1186/s12916-021-02059-5.
Evaluation of the safety profile of COVID-19 vaccines: a rapid review
Qianhui Wu[SUP] 1 [/SUP], Matthew Z Dudley[SUP] 2 3 [/SUP], Xinghui Chen[SUP] 1 [/SUP], Xufang Bai[SUP] 1 [/SUP], Kaige Dong[SUP] 1 [/SUP], Tingyu Zhuang[SUP] 1 [/SUP], Daniel Salmon[SUP] 2 3 [/SUP], Hongjie Yu[SUP] 4 5 6 [/SUP]
Affiliations
- PMID: 34315454
- DOI: 10.1186/s12916-021-02059-5
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.
Keywords: Novel coronavirus diseases 2019; Review; Safety profile; Severe acute respiratory syndrome coronavirus 2; Vaccine.