MedicineEuropean Medicines Agency, evaluates Pfizer vaccine's new adverse events

European Medicines Agency, evaluates Pfizer vaccine’s new adverse events

From erythema multiforme to some kidney problems, the European Medicines Agency (Ema) is studying the new reports to understand if COVID-19 vaccines have potential side effects. In addition to what was already communicated at the end of the last meeting of the Prac Pharmacovigilance Committee, a further update published on Wednesday 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 injection.

For example, for the Comirnaty, the vaccine from Pfizer / BioNTech, reports of erythema multiforme are evaluated. The Pharmacovigilance Risk Assessment Committee (PRAC) has started an analysis on a form of hypersensitivity (allergic) reaction with characteristics of 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 and See.

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