PETITION TO FDA REGARDING COVID-19 VACCINES

After ICAN filed a formal petition with the FDA to require a placebo control group in all COVID-19 vaccine clinical trials, the FDA adopted this request in an emergency guidance to industry.  
On May 22, 2020, the FDA approved a Phase II/III clinical trial for one of the potential COVID-19 vaccines with a meningococcal vaccine as the control (instead of a placebo). After reviewing this approval, ICAN filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control.
Nine days after ICAN filed its 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. The FDA also required that, as requested by ICAN, the size of the placebo group must at least match the size of the vaccine group. The result has been that the Phase II/III clinical trials for COVID-19 vaccines approved by the FDA since June 30, 2020 have included a placebo control group.
ICAN, however, is not done fighting to assure that these clinical trials are properly conducted. On July 20, 2020, ICAN filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding 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. It also demanded that adverse events be tracked for at least 1 year for adults, 3 years for children, and 6 years for toddlers and infants.
If these additional demands are not met, ICAN has reserved the right to take the FDA to court to enforce these demands.
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