ICAN demands the use of inert placebo control in COVID-19 vaccine trials

After a petition from ICAN to the FDA demanding the use of an inert placebo control in the COVID-19 vaccine safety trials, the FDA on 30th June issued emergency guidelines to the industry ensuring all safety trials use a placebo control.

The petition was sparked because AstraZeneca’s safety trials did not use a placebo, but a meningococcal vaccine (Menveo) [1], so 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.

On July 17, 2020, ICAN sued the FDA in federal court demanding the entire clinical trial report for Menveo, just in case the agency was considering permitting this vaccine as a control in the AstraZeneca trial to be conducted in the United States. [1]

“On July 20, 2020, ICAN also filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding, among other things, that it also require that these clinical trials track all adverse events during the entire duration of the trial – not just for a limited time period.”

“Not long thereafter, in mid-September, in a highly unusual move, the full clinical trial protocols for the COVID-19 vaccines for which ICAN filed its petitions were released to the public.” [1]