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EU looking into new possible side-effects of mRNA COVID-19 shots

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Aug 11 (Reuters) - Three new conditions reported by a small number of people after vaccination with COVID-19 shots from Pfizer (PFE.N) and Moderna (MRNA.O) are being studied to assess if they may be possible side-effects, Europe's drugs regulator said on Wednesday.

Erythema multiforme, a form of allergic skin reaction; glomerulonephritis or kidney inflammation; and nephrotic syndrome, a renal disorder characterised by heavy urinary protein losses, are being studied by the safety committee of the European Medicines Agency (EMA), according to the regulator.

Pfizer, by far the biggest supplier of COVID-19 vaccines to the European Union, and Moderna did not immediately respond to Reuters requests for comment.

Just over 43.5 million doses of Moderna's vaccine, Spikevax, have been administered in the European Economic Area as of July 29, the EMA said, compared to more than 330 million doses of the Pfizer shot, Comirnaty, developed with Germany's BioNTech (22UAy.DE).


Last month, the EMA found a possible link between very rare heart inflammation and the mRNA vaccines.

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Pfizer, Moderna COVID vaccines face new safety probe in Europe over possible link to skin condition, 2 kidney disorders​

Compared to the problems encountered by makers of adenovirus COVID-19 vaccines, it’s been a relative cakewalk for the overwhelmingly successful mRNA vaccines produced by Pfizer-BioNTech and Moderna.

But on Wednesday, Europe’s drug regulator revealed that it is investigating a possible link between mRNA vaccines and new conditions reported by a few recipients of the shots.

The European Medicines Agency is trying to determine if the mRNA shots can trigger an allergic skin reaction called erythema multiforme or two kidney disorders. It has requested additional data from Pfizer, BioNTech and Moderna.

Erythema multiforme causes round skin lesions which may also affect mucous membranes in internal body cavities. Nephrotic syndrome causes the kidneys to leak too much protein into the urine. Glomerulonephritis causes inflammation of the tiny filters in the kidneys. Symptoms of the kidney disorders are fatigue, bloody or foamy urine, and oedema, a swelling of the eyelids, feet or abdomen. Some of the patients under examination had pre-existing kidney ailments.

The EMA also is looking into menstrual side effects with all of the available adenovirus and mRNA COViD-19 vaccines.

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