MRNA COVID-19 vaccine and IgA nephropathy: Analysis of French pharmacovigilance database and literature
Fundamental and Clinical Pharmacology
; 36:135, 2022.
Article
in English
| EMBASE | ID: covidwho-1968123
ABSTRACT
Introduction:
In December 2020, mRNA COVID-19 vaccines (mCV) obtained marketing authorization for immunisation in COVID-19. A case of IgA nephropathy (IgAN) after COVID-19 mRNA vaccine was reported recently to our pharmacovigilance center (PV). The aim is to analyse cases of IgAN following mCV. Material andmethods:
We requested the cases in French PV Database with the MedDRA term (HLGT) "nephropathy" with mCV and cases summary contains "iga" AND "Nephropa%". We performed a review of the literature, (equation used "Glomerulonephritis, IGA" [Mesh]) AND "COVID-19 Vaccines" [Mesh]). Cases with non-evocative chronology, pharmaceutical industry declaration and other identified cause were excluded.Results:
Twenty cases were included and concerned 55% of women. Median aged was 39 years [13-63 years] including 2 pediatric patients [13 and 17 years]. Mean time to onset was 3.18 days [1-31d]. Concerned mCV was COMIRNATY® for 60% and SPIKEVAX® for the others. IgAN is observed after the 2nd dose for 16 cases (80%), 1st dose for 2 cases (10%), and both for 2 cases (10%). Sudden onset of macroscopic haematuria was the symptom that revealed the kidney disease for these patients and seven patients was also having acute kidney injury (35%). Among all the patient, 67% had an history of IgAN. Almost all cases resolved spontaneously except in six cases which needed corticoids or cyclophosphamide in one case. Discussion/Conclusion:
Two third of cases occurred in patient with pre-existing IgAN, vaccine could also unmask a previously undiagnosed disease [1-2], and we noted two cases of positive rechallenge. The mechanism by which mCV may be associated with IgAN flares is unclear, but suggests it is mediated by a delayed-type hypersensitivity reaction. Vaccine risk seems lower than COVID-19 kidney injury and benefit/risk ratio remains favourable for vaccination [2].
cyclophosphamide; SARS-CoV-2 vaccine; acute kidney failure; adult; adverse drug reaction; child; chronology; clinical article; conference abstract; coronavirus disease 2019; delayed hypersensitivity; disease exacerbation; drug industry; female; glomerulonephritis; hematuria; human; immunoglobulin A nephropathy; kidney disease; low drug dose; Medical Dictionary for Regulatory Activities; pediatric patient; pharmacovigilance; side effect; undiagnosed disease; vaccination
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Topics:
Vaccines
Language:
English
Journal:
Fundamental and Clinical Pharmacology
Year:
2022
Document Type:
Article
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