The European drug agency Ema evaluates new safety reports to understand if they are potential side effects linked to the anti-Covid vaccination. In addition to what was already communicated at the end of the last meeting of the Prac Pharmacovigilance Committee, a further update published today on the website indicates that new data is being examined. The reports concern events observed after vaccination but not automatically and necessarily related to the shield injection.
For example, for the Comirnaty * vaccine (Pfizer / BioNtech), reports of erythema multiforme are evaluated. The Prac has started an analysis on this form of hypersensitivity (allergic) reaction with characteristic round skin lesions to determine if it is a side effect of the vaccine. The evaluation follows a small number of cases reported after shield injection to the EudraVigilance system.
Other reports are being investigated for glomerulonephritis (inflammation of the tiny filters in the kidneys) and nephrotic syndrome (kidney disease that leads to losing too much protein in the urine) to determine if they may be side effects of Comirnaty. At this time, it is noted, no further updates to the product information are currently recommended. Since the authorization of the Pfizer / BioNTech vaccine in the European Union (December 2020), until 29 July 2021, over 330 million doses have been administered in the EU / See.