HIGHLIGHTS: August 11, 2021
- 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.
Erythema multiforme, a form of allergic skin reaction; glomerulonephritis or kidney inflammation; and nephrotic syndrome, a renal disorder characterized 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).
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
Vaccine-associated kidney diseases: Pubmed Article
Most vaccines are safe to administer and cause only minor side effects. Although very rare, various glomerular diseases and acute kidney injuries have been reported following immunization with certain vaccines including influenza, pneumococcal, and hepatitis B vaccines. This review summarizes these rare renal complications that have been published in the literature. Physicians and other healthcare providers administrating vaccines should be aware of these very rare but possible renal side effects.
Source: REUTERS, PUBMED