Multisystem Inflammatory Syndrome Cases Confirmed Post COVID-19 Vaccination

The European Medicines Agency (EMA) safety committee (PRAC) announced today it is assessing whether there is a risk of the multisystem inflammatory syndrome (MIS) with COVID-19 vaccines.

As of August 19, 2021, MIS cases reported in children and adults from the EudraVigilance database were: Comirnaty: 5; Spikevax: 1; COVID-19 Vaccine Janssen: 1.

At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines, says the EMA.

MIS is a rare but serious inflammatory condition affecting many parts of the body. Symptoms can include tiredness, persistent severe fever, diarrhea, vomiting, stomach pain, headache, chest pain, and difficulty breathing, says the U.S. CDC.

The PRAC's announcement confirmed it would assess the available data on MIS to determine whether the condition can be caused by the vaccine and recommend whether any changes to the product information of the vaccines are needed.