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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The seminal study regarding DTP vaccine and mortality found that children receiving this product during the first six months of life died at 10 times the rate when compared to unvaccinated children. This confirmed what nearly a dozen other prior studies had showed – DTP increases mortality.
On December 5, 2017, ICAN sent this shocking study to UNICEF with a demand that it stop purchasing, distributing and pushing this vaccine into babies in dozens of developing countries around the globe. ICAN demanded that UNICEF join all the developed nations of the world in ceasing to use this dangerous product. UNICEF responded to ICAN’s demand on February 6, 2018, but it refused to comply. That refusal continued despite ICAN’s follow-up demands over the next year.
In the face of UNICEF’s intransigence, ICAN on July 29, 2020, through its attorneys, submitted a formal complaint to the International Criminal Court for crimes against humanity against the UNICEF officials involved in injecting and killing babies with the DTP vaccine.
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This past week ICAN’s public broadcast, the HighWire with Del Bigtree, was removed from YouTube and numerous HighWire videos and articles were removed from Facebook and Twitter. These social media platforms are the equivalent of the sidewalks of the past where Americans enjoyed the liberty of free speech. The censorship by these companies, at the behest of the government, cannot stand. ICAN intends to bring a lawsuit against these social media giants to shine a light on their illegal and unamerican conduct.
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