On June 17, 2020 Aaron Siri’s law firm on behalf of ICAN sent a Citizen Petition to the FDA demanding “that all Phase II and III COVID-19 vaccine trials include a placebo control group, that the placebo should be a saline injection without anything added, and that the placebo control group be at least equivalent in size to the experimental group”. [1]
Two days later on June 19, 2020 the FDA updated their “development and licensure” Guidelines for Industry
The petition also requested:
“All systemic adverse reactions, adverse events, serious adverse events, medically-attended adverse events, new onset medical conditions, and any other health issue arising or exacerbated post-vaccination shall be documented for each subject post-vaccination for a period of at least twelve months for adults, thirty-six months for children and teenagers, and sixty months for infants and toddlers.”
The FDA failed this as the placebo arm was unblined on Dec 14, 2020 for Pfizer/BioNTech and January 14, 2021 for Moderna so no long term safety signals will ever be determined “causative”. [1]