Are Adverse Events in COVID-19 Vaccine Trials Under-Reported?
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.
COVID-19 Vaccine Trial Volunteer in India Develops Encephalopathy and Sues
A 40-year old business consultant in India, who volunteered to be a participant in clinical trials of the experimental COVID-19 vaccine (Covishield) created by AstraZeneca and Oxford University is suing Serum Institute of India (SII), which is producing the vaccine in India, for 50 million rupees ($680,000) after he developed acute encephalopathy (brain dysfunction) within […]
AstraZeneca Halts, Resumes COVID-19 Vaccine Trial After Serious Neurological Event
News update, Sept. 15, 2020—U.S. regulators paused AstraZeneca’s vaccine trial in the U.S. while the National Institutes of Health (NIH) launches an investigation of its own into a serious side effect in an unnamed patient in Britain. “The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader […]
