Evidence map›Paper›PMID 37788935›Full record

ArticleNeurology2023

Risk of Guillain-Barré Syndrome Following COVID-19 Vaccines: A Nationwide Self-Controlled Case Series Study.

Stéphane Le Vu, Marion Bertrand, Jérémie Botton, Marie-Joelle Jabagi, Jérôme Drouin, Laura Semenzato, Alain Weill, Rosemary Dray-Spira, Mahmoud Zureik

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Stéphane Le VuFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France. stephane.le-vu@ansm.sante.fr.ORCID 0000-0002-1303-8281
Marion BertrandFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Jérémie BottonFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Marie-Joelle JabagiFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Jérôme DrouinFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Laura SemenzatoFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Alain WeillFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.ORCID 0000-0001-8687-9092
Rosemary Dray-SpiraFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Mahmoud ZureikFrom the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.ORCID 0000-0002-8393-4217
Conservatoire National des Arts et Métiers · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesGuillain-Barré syndrome (GBS) has been inconsistently associated with some coronavirus disease 2019 (COVID-19) vaccines. We aimed to quantify the risk of GBS according to the type of COVID-19 vaccine in a large population.

methodsUsing the French National Health Data System linked to the COVID-19 vaccine database, we analyzed all individuals aged 12 years or older admitted for GBS from December 27, 2020, to May 20, 2022. We estimated the relative incidence (RI) of GBS within 1-42 days after vaccination up to the first booster dose compared with baseline periods using a self-controlled case series design. We then derived the number of cases attributable to the vaccination. Analyses were adjusted for the period and stratified by age group, sex, and for the presence of severe acute respiratory syndrome coronavirus 2 or common acute infections.

resultsOf 58,530,770 people aged 12 years or older, 88.8% received at least 1 COVID-19 vaccine dose and 2,229 were hospitalized for GBS during the study period. Patients had a median age of 57 years, and 60% were male patients. The RI of GBS between 1-42 days was 2.5 (95% CI 1.8-3.6) for the first dose of ChAdOx1-S and 2.4 (95% CI 1.2-5.0) for the unique dose of Ad26.COV2.S vaccine. We estimated 6.5 attributable GBS cases per million persons having received a first dose of ChAdOx1-S and 5.7 cases per million for the Ad26.COV2.S vaccine. Except for the age group of 12-49 years after the second dose of the messenger RNA (mRNA)-1273 vaccine (RI 2.6, 95% CI 1.2-5.5), none of the RI estimates were found significantly increased for the mRNA vaccines. DISCUSSION: In summary, we found increased risks of GBS after the first administration of ChAdOx1-S and Ad26.COV2.S vaccines. In this comprehensive assessment at the French population level, there was no statistically significant increase in the risk of GBS after the administration of mRNA vaccines. This is reassuring in the context of the ongoing and future use of mRNA-based booster vaccination.

Indexed as

COVID-19Guillain-Barre SyndromeInfluenza, HumanInfluenza VaccinesAd26COVS1AdolescentAdultChAdOx1 nCoV-19ChildCOVID-19 VaccinesFemaleHumansMaleMiddle AgedmRNA VaccinesRNA, MessengerAd26COVS1ChAdOx1 nCoV-19COVID-19 VaccinesInfluenza VaccinesmRNA VaccinesRNA, Messenger

Identifiers

PMID37788935
PMCPMC10663040
OpenAlexW4387299026

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.