Fact Check-Data collected by vaxcontrolgroup.com could not be used for control trial, health body says | By Reuters Fact Check | Reuters.com

Social media users have encouraged immunisation sceptics to register for an alleged scientific study called the “Vaccine Control Group”. However, a UK health body said data collected through the platform could not be used in an official trial to compare vaccinated and unvaccinated people.

The website, which uses the domain “vaxcontrolgroup.com”, describes itself as many things: a control group, a scientific study, a community cooperative and a global community (vaxcontrolgroup.com/).

Participants can join the study for free but are encouraged to become an “Associate of the VaxControlGroup Cooperative Ltd” (here), buy merchandise and give donations. Those who enrol are also promised a digital ID card that states the person must not be vaccinated against SARS-CoV-2.

Several participants shared their ID card on social media (here , here , here , here) and cited the website as an example of “good science” (here).

The main principle of the “Vaccine Control Group” is to encourage people who have not been vaccinated against COVID-19 to register and record their health status over the next 30 years. Organisers say the data will “be made available for comparison” against vaccinated individuals (vaxcontrolgroup.com/about.html).

The website’s name and description could give the impression that it is part of a randomised controlled trial, a study involving an experimental group and a control group to test a specific drug. For instance, one popular post described the website as “the planets [sic] largest clinical trial” (here).

Clinical trials aim to determine how effective a new medicine is by randomly assigning one group to test the treatment and the other to take a placebo or have no drug at all. The outcomes are measured at specific times and any differences between the groups are assessed statistically (here).

However, health bodies do not recognise the “Vaccine Control Group” website as a control group to test COVID-19 vaccines.

Clinical trials of new medicines are regulated by government agencies called the Medicines and Healthcare products Regulatory Agency (MHRA here) and the Health Research Authority (HRA here).

Reuters showed “vaxcontrolgroup.com“ to the MHRA and asked whether it recognised the website as a real clinical trial or control group. A spokesperson responded: “The MHRA reviews and authorises clinical trials before a clinical trial of a new medicine can begin. However, collecting health data from the public does not need to be approved by the MHRA.”

The representative said the agency monitors the safety of approved COVID-19 vaccines themselves through the Yellow Card scheme, where recipients report any suspected adverse reactions to immunisation. Reports summarising the data are publicly available here.

The HRA protects the interest of patients in health research and is responsible for research ethics committees across Britain.

When shown the ‘Vaccine Control Group’ by Reuters, the HRA said in an email: “vaxcontrolgroup.com allows people to provide data about themselves and create an ID card, and the site says that anonymous data will be provided to independent researchers.

“Without more information about any proposed research we can’t comment on the science, though this collection of data could not be used for a randomised controlled trial to compare vaccinated and non-vaccinated individuals.” A spokesperson added that organisations do not need approval from the HRA to collect health data from the public.

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