Dataset Information

Transverse Myelitis Following SARS-CoV-2 Vaccination: A Pharmacoepidemiological Study in the World Health Organization's Database.

ABSTRACT:

Background

Transverse myelitis (TM) has recently been associated by health authorities with Ad26.COV2.S (Janssen/Johnson & Johnson), one of the 5 US Food and Drug Administration (FDA) or European Medicines Agency (EMA) labeled severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) vaccines. It is unknown whether a similar association exists for the other FDA or EMA labeled SARS-CoV-2 vaccines (BNT162b2 [Pfizer/BioNTech], mRNA-1273 [Moderna], ChAdOx1nCov-19 [Oxford-AstraZeneca], and NVX-CoV2373 [Novavax]). This study aimed to evaluate the association between SARS-CoV-2 vaccine class and TM.

Methods

This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from VigiBase, the World Health Organization's pharmacovigilance database. We first conducted a disproportionality analysis with the information component (IC) using the reports of TM that occurred within 28 days following exposure to the FDA or EMA labeled SARS-CoV-2 vaccines, from December 1, 2020 (first adverse event related to a SARS-CoV-2 vaccine) to March 27, 2022. Second, we analyzed the clinical features of SARS-CoV-2 vaccine-associated TM cases reported in VigiBase.

Results

TM was significantly associated both with the messenger ribonucleic acid (mRNA)-based (n = 364; IC₀₂₅ = 0.62) and vector-based (n = 136; IC₀₂₅ = 0.52) SARS-CoV-2 vaccines that are authorized by the FDA or the EMA.

Conclusions

Findings from this observational, cross-sectional pharmacovigilance study showed that mRNA-based and vector-based FDA/EMA labeled SARS-CoV-2 vaccines can be associated with TM. However, because TM remains a rare event, with a previously reported rate of 0.28 cases per 1 million vaccine doses, the risk-benefit ratio in favor of vaccination against SARS-CoV-2 virus remains unchallenged. Rather, this study suggests that clinicians should consider the diagnosis of TM in patients presenting with early signs of spinal cord dysfunction after SARS-CoV-2 vaccination. ANN NEUROL 2022;92:1080-1089.

SUBMITTER: Nguyen S

PROVIDER: S-EPMC9538824 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Transverse Myelitis Following SARS-CoV-2 Vaccination: A Pharmacoepidemiological Study in the World Health Organization's Database.

Nguyen Sophie S Bastien Etienne E Chretien Basile B Sassier Marion M Defer Gilles G Nehme Ahmad A Lelong-Boulouard Véronique V Alexandre Joachim J Fedrizzi Sophie S Morice Pierre-Marie PM

Annals of neurology 20220923 6

<h4>Background</h4>Transverse myelitis (TM) has recently been associated by health authorities with Ad26.COV2.S (Janssen/Johnson & Johnson), one of the 5 US Food and Drug Administration (FDA) or European Medicines Agency (EMA) labeled severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) vaccines. It is unknown whether a similar association exists for the other FDA or EMA labeled SARS-CoV-2 vaccines (BNT162b2 [Pfizer/BioNTech], mRNA-1273 [Moderna], ChAdOx1nCov-19 [Oxford-AstraZeneca], and ...[more]

PMID: 36054163

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Project description:PurposeTo assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DesignA retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).ParticipantsPatients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.MethodsA descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.Main outcome measuresThe estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.ResultsA total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).ConclusionsThe low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.

Dataset Information

Transverse Myelitis Following SARS-CoV-2 Vaccination: A Pharmacoepidemiological Study in the World Health Organization's Database.

Background

Methods

Results

Conclusions

Publications

Transverse Myelitis Following SARS-CoV-2 Vaccination: A Pharmacoepidemiological Study in the World Health Organization's Database.

Similar Datasets

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