European Union Reviewing New Possible Side Effects of mRNA COVID-19 Vaccines

Experts in Europe are probing three newly reported conditions that appeared in people who received a COVID-19 vaccine built on messenger RNA, the European Union’s drug regulator said on Wednesday.

The safety panel of the European Medicines Agency (EMA) is reviewing post-vaccination cases of erythema multiforme, a skin condition that leaves people with round lesions; a type of kidney inflammation called glomerulonephritis; and nephrotic syndrome, a kidney disorder.

The cases were reported among people who received a Moderna or Pfizer-BioNTech COVID-19 vaccine. They were reported in EudraVigilance, a system the agency uses to detect possible side effects, and medical literature.

EMA officials described in documents posted to the agency’s website on Wednesday that the number of cases is small. The agency’s safety panel, formally known as the Pharmacovigilance Risk Assessment Committee, is assessing the reports and has requested information from the companies behind the jabs to support the assessment.

Pfizer and Moderna did not respond to requests for comment.

Approximately 43.5 million doses of Moderna’s shot, known as Spikevax in Europe, were administered as of July 29, the agency said. As of the same date, nearly 49,000 cases of suspected side effects were reported to EudraVigilance. Pfizer’s shot was much more widely distributed. As of July 29, about 330 million doses had been given, with nearly 255,000 cases of suspected side effects reported to EudraVigilance.

The safety panel also said it is continuing to review evidence regarding post-vaccination cases of menstrual disorders. Those cases have arisen in people who got a wider selection of the jabs, including ones from AstraZeneca and Johnson & Johnson. – READ MORE