A Facebook user has falsely claimed that every person who has received a COVID-19 vaccine has unwittingly become part of an ongoing clinical trial.
The post, which has nearly 100 likes, reads: “Every single person taking one of the CONvid Wack Zines is taking part in clinical trial unknowingly.” (here). It also includes the link and screenshot of a Business Insider news article about residents of a slum in India who say they didn’t 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 unwitting trial participation (here), it is not true to say “every single person” getting a COVID-19 vaccine is part of a trial themselves. The shots being rolled out in the UK and US were approved after regulators evaluated evidence from a number of large clinical studies.
In the UK, coronavirus vaccines were approved using an Emergency Use Authorisation dossier, which allows for temporary drug approvals in emergency situations. As Oxford University’s Vaccine Knowledge Project explains: “Regulation 174 of the Human Medicine Regulations 2012 enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic. This regulation is an EU provision introduced in national law that allows for the authorisation of a medicine in response to a public health need.
“Instead of going through the centralised licensing route of the European Medicines Agency, which was the normal route until the end of the Brexit transition period, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccine based on public health need.” (here)
The MHRA approved the Pfizer/BioNTech vaccine on Dec. 2, 2020 (here), Oxford/AstraZeneca’s vaccine on Dec. 30, 2020 (here) and Moderna’s on Jan. 8, 2021 (here)
The US has a similar process of Emergency Use Authorization (EUA) to facilitate the use of medicines and vaccines during 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 about the vaccine’s benefits and potential risks (here).
Ultimately, the claim likely stems from misinformation shared elsewhere which equates “estimated study completion dates” for vaccines to the end dates of clinical trials. For Pfizer, this estimated date is Jan. 31, 2023 (here), while Moderna is Oct. 27, 2022 (here). However, these dates do not mean clinical trials are ongoing, rather they reference continued safety monitoring after the vaccine has been approved and rolled out, which is standard practice within the industry.
The process of how vaccines are tested, licensed and monitored is explained 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 has also written fact checks addressing this issue (here and here).
VERDICT
False. People taking clinically-approved vaccines are not unknowingly participating in clinical trials.
This article was produced by the Reuters Fact Check team. Read more about our work to fact-check social media posts here .
Our Standards: The Thomson Reuters Trust Principles.