In late 2020, the airways became saturated with triumphant reporting of Pfizer and Moderna’s “95% effective” COVID-19 vaccines. Millions rolled up their sleeves with the belief that reaching herd immunity would end the pandemic. But by June 2021, the pandemic endgame story had gone off script. Highly vaccinated countries like Israel were experiencing a new wave of […]
The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline. The Need for Speed Since the enactment of […]
Phase III controlled trials are considered the ‘gold standard’ for assessing vaccine efficacy and safety in humans. These are the trials upon which authorities have assured the public that COVID-19 vaccines are “safe and effective.” The benefits of the vaccines in reducing disease severity and hospitalizations are well-known, but what do we know about the adverse events?Data on adverse events is vital for effective decision-making by regulators, policy makers, doctors, and patients.