Peter C. Gøtzsche and Maryanne Demasi

We included 18 systematic reviews, 14 randomised trials, and 34 other studies with a control group. Most studies were of poor quality. A systematic review of regulatory data on the two pivotal trials of the mRNA vaccines found significantly more SAEs of special interest with the vaccines compared to placebo, and the excess risk was considerably larger than the benefit, the risk of hospitalisation. The adenovirus vector vaccines increased the risk of venous thrombosis and thrombocytopenia, and the mRNA-based vaccines increased the risk of myocarditis, with a mortality of about 1-2 per 200 cases. We found evidence of serious neurological harms, including Bell’s palsy. Guillain-Barré syndrome, myastheic disorder and stroke, which are likely due to an autoimmune reaction. Severe harms, i.e. those that prevent daily activities, were underreported in the randomised trials. These harms were very common in the studies of booster doses after a full vaccination and in a study of vaccination of previously infected people.