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Yu-u-uk.
Well, it looks like it will more than exceed historical FDA requirements for approval under emergency use authorization.
Unfortunately, that is the case. “A team from Yale University has developed a new airborne method for delivering mRNA right to your lungs.”
“By releasing the vaccine in the air, there’s no need to inject each person individually — which is not only time-consuming but difficult if an individual objects to the shot. This isn’t the case with an airborne vaccine, which can be released into the air without consent or even the public’s knowledge.”
Hmm, where have we heard that before?
As recorded in the Federal Register:
"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
This rule is effective January 22, 2024."
@cataliesw No need to ask whether you would agree to voluntarily participate in any remaining human trials in order for the vaccine product(s) cited above to get FDA approval.