In a pair of safety updates released Wednesday, the European Medicines Agency (EMA) said its safety panel is investigating whether three new conditions reported by a "small number" of people may be linked to their having received mRNA-based coronavirus vaccines. According to the EMA, more than 330 million doses of Pfizer and partner BioNTech's Comirnaty were administered in the EU as of July 29, as well as just over 43.5 million doses of Moderna's Spikevax.
Specifically, the agency's Pharmacovigilance Risk Assessment Committee (PRAC) is looking into whether erythema multiforme may be a side effect of Comirnaty and Spikevax after some cases were reported to its EudraVigilance adverse event database following vaccination. PRAC is also investigating possible links with glomerulonephritis and nephrotic syndrome, based on cases reported after vaccination in the medical literature, including instances where people experienced relapse of pre-existing kidney conditions.
The agency did not specify how many cases of the new conditions were recorded, but said it had requested more data and analyses from the companies to help PRAC assess any potential relation between them. The EMA also did not make any recommendations to change the labelling of the vaccines.
Last month, the EMA concluded that myocarditis and pericarditis can occur in "very rare" instances following immunisation with mRNA-based COVID-19 vaccines, with PRAC recommending that those conditions be added as new side effects in their product information sheets.
Comirnaty and Spikevax are currently the only two mRNA-based vaccines authorised in the EU to prevent COVID-19. The two other coronavirus vaccines that have been greenlighted for use in the region are AstraZeneca's Vaxzevria and Johnson & Johnson's Ad26.COV2.S. Earlier this year, both of those viral vector-based vaccines were linked to rare, but serious cases of blood clots characterised by low platelets.
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