EMA publishes the second safety update for the COVID-19 vaccines Comirnaty and Moderna. The latest safety data for these vaccines are in line with the known-benefit-risk profile. Diarrhoea and vomiting after Comirnaty vaccination have been identified as new undesirable effects. No new undesirable effects have been identified for COVID-19 Vaccine Moderna.

The safety updates provide the outcomes of the assessment carried out by EMA’s safety Committee (Pharmacovigilance Risk Assessment Committee [PRAC]) based on all new safety data, including suspected adverse effects with fatal outcome and severe allergic reactions.

The PRAC concluded that the benefit-risk balance of Comirnaty and COVID-19 Vaccine Moderna remains unchanged. Adverse Drug Reactions Reports continue to be closely monitored.

The safety updates are available on EMA web site and accessible through the box "Related links".