ICAN Calls for COVID-19 vaccine safety trials to last as long as the clinical trials

Few people are aware that the safety arms of vaccine clinical trials typically last a few days or weeks, rarely for a few months, and that long term safety studies are never done before the products are brought to market. That makes all who accept a vaccine subjects of Phase 4 “aftermarket” clinical trials.  Once a product is on the market, inadequate surveillance, captured oversight agencies prevent, and indemnity coverage prevent the true breadth and depth of vaccine risks from being discovered.

Few people know that COVID-19 vaccines were placed under the Public Readiness and Emergency Preparedness Act shielding their makers, those who administer them, and those who mandate them, from liability for injuries and deaths.

Few people know that control groups are never given true inert placebos, and are instead given other vaccines (usually those with the highest immediate adverse reactions) or adjuvants, muddying the data, and making the safety data meaningless.

Few people are aware that the companies that stand to profit are allowed to determine what is a vaccine reaction and what is a “coincidence.”

Few people know that the FDA bases licensing decisions on the data given to them by the drug companies, without any independent verification.

Now, for the first time in history, vaccine development is under a global spotlight, and the people are waking up to the glaring problems.

Also for the first time in history, there is a nonprofit organization with the background and legal team ready to take on the FDA and the system to push for scientific integrity in the clinical trial process. That organization is the Informed Consent Action Network (ICAN).

ICAN earlier petitioned the FDA to require valid inert saline placebo trials, and the FDA complied. ICAN followed up, requesting the FDA require safety monitoring to last at least as long as the clinical trial. Currently, Moderna’s Phase III clinical trial design monitors adverse reactions to their vaccine candidate for just 28 days following injection. To read the full legal filing, click on the image below.

 

 

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