by Robert W Malone MD, MS at Malone News
A new paper came out on April 6, 2025 in the British Journal of Clinical Pharmacology titled “EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding” with some startling new information regarding COVID-19 vaccination in infants.
To begin, the paper discusses the EudraVigilance system, which serves as the European Union’s centralized system for managing and analyzing information on suspected adverse reactions to medicines. Operated by the European Medicines Agency (EMA), it plays a critical role in pharmacovigilance, ensuring the safety of medicines authorized or being studied in clinical trials within the European Economic Area (EEA).
EudraVigilance facilitates the electronic submission and exchange of Individual Case Safety Reports (ICSRs), documenting suspected adverse drug reactions (ADRs). The case reports are submitted by national regulatory authorities, marketing authorization holders, healthcare professionals, patients, and clinical trial sponsors. You can think of it as somewhat like the CDC VAERS system, and it has similar problems.