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European Medicines Agency: mRNA COVID-19 vaccine is not associated with autoimmune hepatitis
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European Medicines Agency: mRNA COVID-19 vaccine is not associated with autoimmune hepatitis.
Recently, a study on “COVID-19 vaccine may cause a rare T cell-mediated autoimmune hepatitis” published in the Journal of Hepatology, a journal in the field of liver disease concerns about adverse reactions.
The paper, which was finalized on March 31, 2022, refers to a case report in Germany of a 52-year-old man who developed a bimodal flare of acute hepatitis after 2 doses of mRNA vaccine.
In this regard, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) announced on April 8 that there is currently no evidence to support a causal relationship between the mRNA COVID-19 vaccine and autoimmune hepatitis (AIH), and no update is currently required. Product information for vaccines.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed the case at its April 2-7 meeting and subsequently released its latest minutes.
Autoimmune hepatitis (AIH) is a very rare chronic progressive liver inflammatory disease mediated by an autoimmune response, according to the PRAC meeting minutes. The PRAC came to this conclusion after reviewing literature data, AIH cases reported to the EudraVigilance database and further data provided by marketing authorisation holders.
The European Medicines Agency (EMA) said it will continue to closely monitor any new situation reports and take appropriate measures if necessary.
(source:internet, reference only)