VigiAccess Covid-19 dataset

Background: The monitoring and analysis of adverse drug reactions (ADR’s) play a pivotal role in ensuring drug safety. In the context of a public health emergency of international concern (PHEIC), and the roll out of experimental COVID-19 vaccines, the need for a comprehensive database and process to scrutinize ADRs is imperative.Areas of uncertainty: We aim to provide a broader understanding of ADRs associated with COVID-19 vaccines and their implications for public health given this has received attention worldwide.Data sources: This is the first in a series of scientific reports by the World Council for Health (WCH) delving into the COVID-19 vaccine data available on VigiAccess.org, which should be a valuable resource in this context.Therapeutic Advances: For all regions worldwide during the 26-month period, there were nearly 24 million reported adverse events (AEs), of which nearly 8 million were serious (SAEs). Over one million people experienced at least one SAE ranging from a combination of debilitating and life-threatening conditions and death. A total of 58,091 people were reported to have died in the dataset.Conclusions:Global authorities on the COVID-19 pandemic such as the World Health Organization (WHO), and the Uppsala Monitoring Centre (UMC) for global pharmacovigilance, need to liaise with health providers, government authorities and the public to investigate the COVID-19 vaccine safety signals. One-off vaccine damage payments of £120,000 for victims in the UK and schemes in other countries may be insufficient.Whilst further investigation is needed to establish causation, based on the substantial numbers of deaths and SAEs associated with the COVID-19 vaccines on VigiAccess.org, the strategy of COVID-19 vaccination programmes worldwide should be reconsidered. Furthermore, these data will likely be significantly underreported given majority of cases were not self-reported and data would also be reported in other sources not captured by VigiAccess.