By Peter C. Gøtzsche and Maryanne Demasi
We have published the full review here.
Abstract
BACKGROUND: Serious and severe harms of the COVID-19 vaccines have been downplayed or deliberately excluded by the study sponsors in high impact medical journals.
METHODS: Systematic review of papers with data on serious adverse events (SAEs) associated with a COVID-19 vaccine.
RESULTS: 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, myasthenic 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 studies of booster doses after a full vaccination and in a study of vaccination of previously infected people.
CONCLUSIONS: Further randomised trials are needed. Authorities have recommended population-wide COVID-19 vaccination and booster doses. They do not consider that the balance between benefits and harms becomes negative in low-risk groups such as children and people who have already recovered from COVID-19 infection.