May 31, 2021
Continuing in our discussion on COVID vaccination and our children, the World Health Organization (WHO) defines an adverse drug reaction as "any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function."
The US Food and Drug Administration (FDA) categorizes an adverse event as “any undesirable experience associated with the use of a medical product in a patient.”
The US Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS), Europe’s EudraVigilance system and the UK’s Yellow Card Reporting System, are among the world’s major tracking systems for suspected adverse events associated with medicines and medical devices.
All platforms point out that a reported adverse event does not necessarily mean the event was caused by the medicine or substance used, but the systems are key mechanisms that enable regulators and officials to track trends, and be quickly alerted to potential problems.
EudraVigilance advises, “Before a medicine is marketed, information on its safety and efficacy is based on use of the medicine in clinical trials. However, clinical trials may not be able to detect all side effects, as they involve limited numbers of patients.
“Also, some side effects may take a long time to develop, and only occur after the clinical trial is finished. Often (but not always), people taking part in clinical trials are healthy or do not have other diseases or do not normally take other medicines. This is not the situation when the medicine is used in real life.
“Continuous monitoring after the clinical trial is therefore essential, to maintain a comprehensive safety and effectiveness profile of the medicine.”
As of May 29, 198,678 cases of adverse reactions to the Pfizer vaccine were reported to EudraVigilance, the majority of which were reported by healthcare professionals.
The adverse reactions run the gamut of categories including disorders of the cardiac, vascular, respiratory, thoracic, reproductive, immune and nervous systems, as well as disorders of the blood and lymphatic systems.
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