PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis
April 22, 2022
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.
Source: FAMHP
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.