ICAN demands FDA mandate inert placebo controls in COVID-19 vaccine clinical trials

Upon finding out AstraZeneca COVID-19 Vaccine clinical trials were not using a placebo control, but a neningococcal vaccine (Menveo) as a “control”, the Informed Consent Action Network (ICAN) a non-profit organisation, petitioned the FDA to mandate inert placebo control groups in US COVID-19 vaccine clinical trials, as well as track the safety for the long-term in properly sized trial groups. [1, 2]

Nine days after ICAN filed its initial petition, on June 30, 2020, the FDA changed course and issued emergency guidance to industry that all COVID-19 clinical trials must use a placebo control.

Later ICAN sued the FDA to supply the safety studies on the Menveo vaccine, in case they intended to approve it as an active control for US EUA products.

Many don’t realise using another vaccine for the “control” group to assess “vaccine safety”, is a common and accepted practice.

They don’t use inert placebo controls.  This is why post marketing surveillance is so important, but the authorities have failed in their duty.