A Facebook user falsely claimed that every person who received a COVID-19 vaccine unknowingly became part of an ongoing clinical trial.
The report, which has nearly 100 preferences, reads: “Every person taking one of the CONvid Wack Zines unknowingly participates in the clinical study.” (here). It also includes the link and screenshot of a Business Insider news article about residents of a slum in India who say they do not know they were part of a trial for the country’s Covaxin COVID vaccine (here, here) .
While it is true that residents of the Indian slum told reporters of the illegal participation in the trial (here), it is not true to say that “every person” who gets a COVID-19 vaccine is himself a part of a trial. The shots rolled out in the UK and US were approved after regulators reviewed evidence from a number of major clinical studies.
In the UK, coronavirus vaccines have been approved using an emergency authorization dossier, which allows for temporary authorization of drugs in emergencies. As the Vaccine Knowledge Project of the University of Oxford explains: “Regulation 174 of the Human Medicine Regulations 2012 allows for rapid temporary approvals to address important health issues such as a pandemic. This regulation is an EU provision introduced into national law, which allows the admission of a medicine in response to a public health need.
“Instead of following the centralized licensing route of the European Medicines Agency, which was the normal route until the end of the Brexit transition period, the Regulatory Agency of Medicines and Healthcare Products (MHRA) approved the vaccine on the basis of the need for public health. ” (here)
The MHRA approved the Pfizer / BioNTech vaccine on 2 December 2020 (here), the Oxford / AstraZeneca vaccine on 30 December 2020 (here) and Moderna on 8 January 2021 (here)
The US has a similar process of authorization for emergency use (EUA) to facilitate the use of medicines and vaccines in public health emergencies, such as the COVID-19 pandemic. Manufacturers submit EUAs to the Food and Drug Administration (FDA), which then evaluates the scientific evidence from clinical trials on the benefits and potential risks of the vaccine (here).
Ultimately, the claim probably stems from incorrect information shared elsewhere, which equates “estimated study completion dates” for vaccines to the end dates of clinical trials. For Pfizer, this estimated date is January 31, 2023 (here), while Moderna is October 27, 2022 (here). However, these dates do not mean that clinical trials are underway, but refer to ongoing safety monitoring after the vaccine has been approved and rolled out, which is standard in the industry.
The process of testing, licensing and monitoring vaccines is outlined by Oxford University’s Vaccine Knowledge Project (here), the European Medicines Agency (bit.ly/2YLLros) and the US Centers for Disease Control and Prevention (CDC) (here ). Reuters also wrote fact checks that address this issue (here and here).
VERDICT
Untrue. People taking clinically approved vaccines do not unknowingly participate in clinical trials.
This article was produced by the Reuters Fact Check team. Read more about our work to actually check social media posts.