The European Medicines Agency (EMA) safety committee, the PRAC, is evaluating whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of this reaction following immunization with Pfizer of a young man. 17 year old danish
MIS is a serious inflammatory condition that affects many parts of the body and symptoms can include tiredness, persistent high fever, diarrhea, vomiting, stomach pain, headache, chest pain, and shortness of breath. Previously, MIS was reported after COVID-19 illness. The Danish patient, however, had no history of COVID-19.
MIS is rare and its incidence rate before the Covid-19 pandemic estimated in 5 European countries was around 2 to 6 cases per 100,000 per year in children and adolescents under 20 years of age and below 2 cases per 100,000 per year in adults 20 years and older.
Currently, there are no changes to the current European Union recommendations for the use of vaccines against Covid-19. At the moment, the PRAC encourages all healthcare professionals to report any cases of MIS and other adverse events in people receiving these vaccines.
The PRAC will now assess the data available in the MIS to determine if the disease may be caused by the vaccine and recommend whether changes to the vaccine product information are needed. The EMA and national authorities will provide additional updates as necessary.
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