The NIH and Moderna have rigged the clinical trial of their COVID-19 vaccine, mRNA-1273, to avoid capturing adverse reactions that occur more than 28 days after injecting this experimental vaccine. ICAN’s legal team has filed an emergency petition to stop this unethical conduct.
ICAN previously filed a petition to the FDA demanding that this clinical trial include a placebo. The clinical trial for this vaccine was then delayed and when its design was finally issued, it included a placebo. But it appears that NIH and Moderna have decided to play a different game to avoid capturing safety issues that could prevent licensure of their mRNA-1273 vaccine.
Their trick is to only capture adverse reactions that occur more than 28 days after injection if the participant withdraws from the clinical trial. This is nonsensical, since there is little for a participant to withdraw from after getting two doses during the first 28 days of the clinical trial. Once a participant has received both doses, if anything, a participant would have an incentive to remain part of the follow-up check-ups to address any adverse effects.
There could be many autoimmune, neurological and chronic health disorders which have a major impact on the quality of life that this experimental vaccine could cause. All of which may only arise more than 28 days after the injection. But yet, as long as the participant does not withdraw from the clinical trial, these will nonsensically be ignored as if they did not occur. This is unethical and renders vacuous any claim of safety for this product based on this trial.
Given that efficiency in this trial will be tracked for two years, the only reason to not track safety for this same duration is to avoid detecting safety issues that would prevent licensure.
ICAN’s legal team has therefore filed a citizen petition and an emergency stay petition demanding that the clinical trial design for this vaccine be updated to require that all adverse reactions for the entire period of the clinical trial be tracked. These petitions also demand that the number of participants in this trial be increased and that they be tested before and after injection for any T-cells to SARS-CoV-2. ICAN intends to take further legal action if its rational and sensible requests are not met.
