EMA investigating Pfizer and Moderna vaccine side effects

pharmafile | August 12, 2021 | News story | |   

The EMA has launched an investigation into the Pfizer and Moderna vaccines after three new conditions have been reported as possible side effects by a small number of vaccinated people.

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 EMA.

So far, over 43.5 million doses of Moderna’s vaccine, Spikevax, have been administered in the European Economic Area as of July 29, compared to more than 330 million doses of the Pfizer jab.

On Wednesday the EMA watchdog disclosed that is has requested further data from the companies, stating that the assessments are part of routine updates to the safety section of all authorised vaccines’ database and added menstrual disorders as a condition it was studying for vaccines, including those from AstraZeneca and J&J.

Last month, the EMA found a possible link between very rare heart inflammation and the mRNA vaccines. However, the European regulator and the World Health Organization have stressed that benefits from these vaccines outweigh any risks.

The watchdog did not give details on Wednesday on how many cases of the new conditions were recorded, but said it had requested more data from the companies. The EMA did not recommend changes to the labelling of the vaccines.

Kat Jenkins

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