EMA's PRAC reports on latest reviews of COVID-19 vaccines

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty, the vaccine developed amd marketed by Germany’s BioNTech (Nasdaq: BNTX) and US pharma giant Pfizer (NYSE: PFE).

The case occurred in a 17-year old male in Denmark who has since fully recovered. Some cases of MIS were also reported in the EEA following vaccination with other COVID-19 vaccines, the PRAC noted following ins August 3-Septmber 2 meetings.

MIS is a serious inflammatory condition affecting many parts of the body and symptoms can include tiredness, persistent severe fever, diarrhoea, vomiting, stomach pain, headache, chest pain and difficulty breathing. MIS has previously been reported following COVID-19 disease. The Danish patient, however, had no history of COVID-19.