* Skin rash, two kidney disorders being studied by EMA
* Requested more data from Pfizer, Moderna
* Has not recommended label changes
(Adds detail throughout)
By Pushkala Aripaka
Aug 11 (Reuters) - 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 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 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.
The success of the mRNA technology used by the two vaccines
has been a turning point https://www.reuters.com/article/us-health-coronavirus-mrna-idUSKBN2B713D
for the pandemic and the scientific community, but some rare
side-effects are being studied as more people are inoculated
globally.
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 on the new cases.
Just over 43.5 million doses of Moderna's vaccine, Spikevax,
have been administered in the European Economic Area (EEA) as of
July 29, the EMA said, compared to more than 330 million doses
of the Pfizer shot, Comirnaty, which was developed with
Germany's BioNTech.
Last month, the EMA found a possible link between very rare
heart inflammation and the mRNA vaccines https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-lists-heart-condition-possible-side-effect-mrna-vaccines-2021-07-09.
However, the European regulator and the World Health
Organization have stressed that benefits from these vaccines
outweigh any risks posed by them.
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 to study any potential
relation between them.
The EMA did not make any recommendations to change 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 another condition it was studying
for all vaccines, including those from AstraZeneca and
J&J, after the EMA's update last week https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-advises-updating-jj-shot-label-with-new-disorders-2021-08-06.
(Reporting by Pushkala Aripaka in Bengaluru
Editing by Shounak Dasgupta and Mark Potter)