European Union drug regulators said European experts are investigating three newly reported conditions that have emerged in people who have been vaccinated with COVID-19 vaccines built on messenger RNA.
The European Medicines Agency (EMA) Safety Commission is reviewing post-vaccinated cases of erythema multiforme. This is a condition of the skin that leaves people with round lesions. A type of kidney inflammation called glomerulonephritis. Nephrotic syndrome, kidney damage.
Cases were reported among people vaccinated with Moderna or Pfizer-BioNTech COVID-19 vaccines. They have been reported in EudraVigilance, a system used by agencies to detect possible side effects, and in the medical literature.
An EMA official said in a document posted on the authorities’ website Wednesday that the number of cases was low. The authorities’ safety committee, officially known as the Pharmacovigilance Risk Assessment Committee, is evaluating the report and is requesting information from the companies behind Jab to support the assessment.
Pfizer and Moderna did not respond to requests for comment.
As of July 29, officials said that about 43.5 million shots of Moderna, known in Europe as Spikevax, were administered. As of the same date, nearly 49,000 cases of suspicious side effects were reported to Eudra Vigilance. Pfizer shots were much more widely distributed. As of July 29, approximately 330 million doses were administered and nearly 255,000 suspected side effects were reported to Eudra Vigilance.
The Safety Commission also said it continues to review evidence for post-vaccination cases of menstrual disorders. These cases occurred in people who had a wide selection of jabs, including those from AstraZeneca and Johnson & Johnson.
So far, no association between vaccines and disorders has been established, according to the Commission.
The European Medicines Agency has previously identified a range of side effects that may be associated with the COVID-19 vaccine. For example, after receiving Johnson & Johnson and AstraZeneca jabs, people experienced blood clots in combination with low blood clot levels. Authorities recommend adding a warning about potential side effects to the vaccine label, and companies later added the warning.
The EMA Safety Commission also discovered last month that there may be a link between Pfizer and Moderna jabs and heart inflammation.
However, the EMA states that the benefits of vaccines continue to outweigh the risks.