During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.
The PRAC concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis (AIH).
AIH is a serious chronic inflammatory condition in which the immune system attacks and damages the liver. Signs and symptoms of autoimmune hepatitis vary from person to person and may include yellowing of the skin (jaundice), build-up of fluid in the legs (oedema) or belly (ascites) and gastrointestinal symptoms.
The committee’s assessment is based on data from the medical literature, cases of AIH spontaneously reported in the EudraVigilance database and further data and analyses provided by the marketing authorisation holders.
The PRAC concluded that the available evidence does not currently warrant an update to the product information of the vaccines.
EMA will continue to closely monitor any new reports of the condition and take appropriate measures if necessary.
Les vaccins mRNA contre la COVID-19 Comirnaty et Spikevax sont disponibles en Belgique.
More information is available on the EMA website.