Covid vaccine and autoimmune hepatitis, there are no links. This was concluded by the Prac Pharmacovigilance Committee of the European Medicines Agency EMA, in its last meeting which took place from 4 to 7 April. “The available evidence does not support a causal link between Pfizer / BioNTech’s Covid-19 Comirnaty * vaccines and Moderna’s Spikevax * and very rare cases of autoimmune hepatitis (Aih),” he says.
Aih – recalls the Ema – is a serious chronic inflammatory condition in which the immune system attacks and damages the liver. The signs and symptoms of autoimmune hepatitis vary from person to person and can include yellowing of the skin (jaundice), fluid buildup in the legs (edema) or belly (ascites), and gastrointestinal symptoms. The Prac assessment is based on data from the medical literature, on cases of Aih spontaneously reported in the EudraVigilance database and on additional data and analyzes provided by the marketing authorization holders of the two mRna vaccines. Panel experts believe that “the available evidence does not currently justify an update of the product information” of these products.
The EU regulator assures that it will continue to closely monitor any new AIH reports, and that it will take appropriate measures if necessary.
