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PRAC finds no causal link between Comirnaty and Spikevax mRNA COVID-19 vaccines and autoimmune hepatitis

The April 4-7, 2022 Pharmacovigilance Risk Assessment Committee (PRAC) meeting noted no link between COVID vaccines and autoimmune hepatitis (AIH).

The PRAC has 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 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 medical literature, cases of AIH spontaneously reported in the EudraVigilance database, and further data and analyses provided by the marketing authorization holders.

The PRAC concluded that the available evidence does not currently warrant an update to the product information of the vaccines.

The committee previously recommended adding small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface, and bruising) to the product information of the COVID-19 Vaccine Janssen as a possible side effect of unknown frequency, and PRAC also recommended adding a warning for flare-ups of capillary leak syndrome (CLS) to the product information for the COVID-19 vaccine Spikevax.

EMA will continue to closely monitor any new reports of the condition and take appropriate measures if necessary, says on the company’s website.


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