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

By MSV On Aug 11, 2021

Three new conditions reported by a small number of people after vaccination with COVID-19 shots from Pfizer and Moderna are being studied to assess if they may be possible side-effects, Europe’s drugs regulator said in a Reuters report.

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 https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-spikevax-previously-covid-19-vaccine-moderna-11-august-2021_en.pdf by the safety committee of the European Medicines Agency (EMA), according to the regulator https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-11-august-2021_en.pdf.

Pfizer, by far the biggest supplier of COVID-19 vaccines to the EU, 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 .

Last month, the EMA found a possible link https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-lists-heart-condition-possible-side-effect-mrna-vaccines-2021-07-09 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.

It disclosed the new assessments as part of routine updates to the safety section of all authorized vaccines’ database and added menstrual disorders as a condition it was studying for vaccines, including those from AstraZeneca and J&J , after the EMA’s update https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-lists-heart-condition-possible-side-effect-mrna-vaccines-2021-07-09 last week.