“Association between COVID-19 vaccination, infection, and risk of Guillain-Barre syndrome, Bell’s palsy, encephalomyelitis and transverse myelitis: a population-based cohort and self-controlled case series analysis”
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Abstract
OBJECTIVE
We aimed to study the association between COVID-19 vaccines, SARS-CoV-2 infection, and the risk of immune-mediated neurological events.
METHODS
Design
Population-based historical rate comparison study and self-controlled case series (SCCS) analysis.
Setting
Primary care records from the United Kingdom.
Participants
Individuals who received the first dose of ChAdOx1 or BNT162b2 between 8 December 2020 and 6 March 2021. A cohort with a first positive RT-PCR test for SARS-CoV-2 between 1 September 2020 and 28 February 2021 was used for comparison.
Main outcome measures
Outcomes included Guillain-Barre syndrome (GBS), Bell’s palsy, encephalomyelitis, and transverse myelitis.
Incidence rates were estimated in the 28 days post first-dose vaccine, 90 days post-COVID-19, and between 2017 to 2019 for the general population cohort for background rates. Indirectly standardised incidence ratios (SIRs) were estimated. Adjusted incidence rate ratios (IRR) were estimated from the SCCS when sufficient statistical power was reached.
Results
We included 1,868,767 ChAdOx1 and 1,661,139 BNT162b2 vaccinees; 299,311 people infected with COVID-19; and 2,290,537 from the general population. SIRs for GBS were 1.91 [95% CI: 0.86 to 4.26] after ChAdOx1, 1.29 [0.49 to 3.45] after BNT162b2, and 5.20 [1.95 to 13.85] after COVID-19. In the same cohorts, SIRs for Bell’s palsy were 1.34 [1.05 to 1.72], 1.15 [0.88 to 1.50], and 1.23 [0.80 to 1.89], and for encephalomyelitis 1.62 [0.61 to 4.31], 0.86 [0.22 to 3.46], and 11.05 [5.27 to 23.17], respectively. Transverse myelitis was too rare to analyse (n<5 in all cohorts). SCCS analysis was only conducted for Bell’s palsy due to limited statistical power. We found no association between either vaccine and Bell’s palsy, with an IRR of 1.10 [0.81 to 1.46] and 1.15 [0.87 to 1.49] for BNT162b2 and ChAdOx1, respectively.
Conclusions
We found no consistent association between either vaccine and any of the studied neuroimmune adverse events studied. Conversely, we found a 5-fold increase in risk of GBS and an 11-fold of encephalomyelitis following COVID-19.
Article activity feed
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Sasha Živković
Review 1: "Association between COVID-19 vaccination, infection, and risk of Guillain-Barre syndrome, Bell's palsy, encephalomyelitis and transverse myelitis: a population-based cohort and self-controlled case series analysis"
Reviewer: Sasha Živković (University of Pittsburgh) | 📒📒📒 ◻️◻️
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Sasha Živković
Review of "Association between COVID-19 vaccination, infection, and risk of Guillain-Barre syndrome, Bell's palsy, encephalomyelitis and transverse myelitis: a population-based cohort and self-controlled case series analysis"
Reviewer: Sasha Živković (University of Pittsburgh) | 📒📒📒 ◻️◻️
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SciScore for 10.1101/2021.09.08.21263276: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding Due to the limited number of events, we only had power to run SCCS for Bell’s Palsy (Appendix table 2).[49] Any subgroups with less than 5 people were blinded and reported as <5, following information governance requirements. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code and data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Study strengths and limitations: The main strength of our study is the population-based method with data from the UK primary care system, which …
SciScore for 10.1101/2021.09.08.21263276: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding Due to the limited number of events, we only had power to run SCCS for Bell’s Palsy (Appendix table 2).[49] Any subgroups with less than 5 people were blinded and reported as <5, following information governance requirements. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code and data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Study strengths and limitations: The main strength of our study is the population-based method with data from the UK primary care system, which have great representativeness and complete capture of vaccinations among the UK population. In addition, the use of self-controlled case series study design took the advantage of within person comparison to reduce time-fixed confounding. We also further adjusted for age and seasonality to control for time-varying confounding. Our study has limitations. As we only included primary care data, diagnoses from inpatient settings may not be captured and the absolute risk may be underestimated. However, a previous study has showed that CPRD primary care data captures immune-mediated neurological disorders like GBS accurately, even without linking hospital data.[72] Within-database comparisons are recommended when comparing observed and expected rates due to database-level heterogeneity.[43] We used CPRD Aurum and CPRD GOLD. Although both contain UK primary care data, these data come from different electronic health record clinical systems and use different medical coding. However, one study showed that the two databases generated similar estimates.[73] We used code lists and algorithms for the identification of neuro-immune events previously published as part of a study on the background rates of COVID-19 AESI.[43] Mapping to the OMOP common data model also helped maximise comparability. The short follow-up time after vaccination may have le...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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