Skin rash, two kidney disorders being studied by EMA
Regulator requests more data from Pfizer, Moderna
Has not recommended label changes
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.
By Pushkala Aripaka/Reuters
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. 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 authorised vaccines’ database and added menstrual disorders as a condition it was studying for vaccines, including those from AstraZeneca (AZN.L) and J&J (JNJ.N), after the EMA’s update last week.
Moderna’s shares, which have climbed more than 75% to Tuesday’s close since mid-July when it joined the S&P 500 index (.SPX), fell about 16% to $384 on Wednesday.
BioNTech’s U.S.-listed shares were down 14.4% and Pfizer nearly 4%.
Reporting by Pushkala Aripaka in Bengaluru; additional reporting by Manojna Maddipatla; Editing by Shounak Dasgupta and Mark Potter
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