Nervous and muscular adverse events after covid‐19 vaccination: A systematic review and meta‐analysis of clinical trials
Nervous and muscular adverse events after covid‐19 vaccination: A systematic review and meta‐analysis of clinical trials
Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID‐19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID‐19 vaccination. Methods: A systematic review and meta‐analysis of clinical trials on the incidences of NMAEs after COVID‐19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Li-brary, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical var-iables were analyzed using Pearson’s chi‐square test. The pooled odds ratio (OR) with the corre-sponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Re-sults: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open‐label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia com-prised a considerable measure, although life‐threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID‐19 vaccination program.
Adverse events, COVID‐19, Muscular system, Nervous system, Vaccine
Chen, Jiaxin
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Cai, Yuangui
fb8155a6-358e-481e-8900-ae62da60294b
Chen, Yicong
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Williams, Anthony P.
973ff46f-46f1-4d7c-b27d-0f53221e4c44
Gao, Yifang
9f5b72d2-2aa2-40bc-9797-32212be1a5e2
Zeng, Jinsheng
0e722a63-cef4-42ea-aa42-04ff0672a2dc
23 August 2021
Chen, Jiaxin
4b265cff-343f-4e55-a9e4-bfe4d335d4f2
Cai, Yuangui
fb8155a6-358e-481e-8900-ae62da60294b
Chen, Yicong
8af41ca7-e39a-4cbc-a904-62566c6af7d9
Williams, Anthony P.
973ff46f-46f1-4d7c-b27d-0f53221e4c44
Gao, Yifang
9f5b72d2-2aa2-40bc-9797-32212be1a5e2
Zeng, Jinsheng
0e722a63-cef4-42ea-aa42-04ff0672a2dc
Chen, Jiaxin, Cai, Yuangui, Chen, Yicong, Williams, Anthony P., Gao, Yifang and Zeng, Jinsheng
(2021)
Nervous and muscular adverse events after covid‐19 vaccination: A systematic review and meta‐analysis of clinical trials.
Vaccines, 9 (8), [939].
(doi:10.3390/vaccines9080939).
Abstract
Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID‐19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID‐19 vaccination. Methods: A systematic review and meta‐analysis of clinical trials on the incidences of NMAEs after COVID‐19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Li-brary, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical var-iables were analyzed using Pearson’s chi‐square test. The pooled odds ratio (OR) with the corre-sponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Re-sults: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open‐label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia com-prised a considerable measure, although life‐threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID‐19 vaccination program.
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vaccines-09-00939 (1)
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Accepted/In Press date: 19 August 2021
Published date: 23 August 2021
Additional Information:
Funding Information:
We express our gratitude to the Guangdong Provincial Key Laboratory of Diagnosis and Treatment of Major Neurological Diseases (2020B1212060017), Guangdong Provincial Clinical Research Center for Neurological Diseases (2020B1111170002), Southern China International Cooperation Base for Early Intervention and Functional Rehabilitation of Neurological Diseases (2020A0505020004), Guangzhou Clinical Research and Translational Center for Major Neurological Diseases (201604020010), Guangdong Provincial Engineering Center for Major Neurological Disease Treatment, Guangdong Provincial Translational Medicine Innovation Platform for Diagnosis and Treatment of Major Neurological Disease.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
Keywords:
Adverse events, COVID‐19, Muscular system, Nervous system, Vaccine
Identifiers
Local EPrints ID: 452136
URI: http://eprints.soton.ac.uk/id/eprint/452136
ISSN: 2076-393X
PURE UUID: b242c5bd-bac8-465e-961c-b75b4bf27922
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Date deposited: 25 Nov 2021 17:56
Last modified: 17 Mar 2024 12:52
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Contributors
Author:
Jiaxin Chen
Author:
Yuangui Cai
Author:
Yicong Chen
Author:
Yifang Gao
Author:
Jinsheng Zeng
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