In response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several new pharmaceutical agents have been administered to billions of people worldwide, including the young and healthy at little risk from the virus. Considerable leeway has been afforded in terms of the pre-clinical and clinical testing of these agents, despite an entirely novel mechanism of action and concerning biodistribution characteristics.
… In the non-elderly population the “number needed to treat” to prevent a single death runs into the thousands. Re-analysis of randomised controlled trials using the messenger ribonucleic acid (mRNA) technology suggests a greater risk of serious adverse events from the vaccines than being hospitalised from COVID-19. Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascular safety. Mirroring a potential signal from the Pfizer Phase 3 trial, a significant rise in cardiac arrest calls to ambulances in England was seen in 2021, with similar data emerging from Israel in the 16–39-year-old age group.
… It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally. A pause and reappraisal of global vaccination policies for COVID-19 is long overdue.