June 19, 2020 the FDA published the “Guidance for Industry” document for the “Development and Licensure of Vaccines to Prevent COVID-19“. [1]

This follows the March 25, 2020 notice in the Federal Register (85 FR 16949) titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019”.[1]

The FDA determined that given the declared COVID-19 public health emergency that it was neither “feasible or appropriate” for any prior public comment into the COVID-19 vaccine guidence document.  They note that comment will be accepted in accordance with the Agency’s good guidance practices, but that the FDA intended the recommendations, to be adjusted accordingly, but continue to apply “outside the context of the current public health emergency”.

This Guidence document allowed for multiple, brand new technology products, to enter a regulatory system, for which there was/is NO recognised, or established, regulatory pathway.  So, under the guise of an emergency, new technology such as mRNA/LNP, DNA vectors, slipped into a “vaccine” regulatory pathway, at “warp speed”, under emergency use authorisation (EUA).

For ALL this to be legally justified, there HAD to be NO alternative treatment available

In their Jun 19, 2020 release, before any COVID-19 vaccine had ever been registered they FDA future proof the guidance document to eliminate an inert, true “placebo” group and replace it with a “vaccine control”.

If the availability of a COVID-19 vaccine proven to be safe and effective precludes ethical inclusion of a placebo control group, that vaccine could serve as the control treatment in a study designed to evaluate efficacy with non-inferiority hypothesis testing.

and

[I]n the event that a safe and effective vaccine becomes available [even if it is your own]..break the blind and offer vaccine to placebo recipients. [Which would eliminate all possible long-term safety information, the purpose for the study in the first place]

Oxford/AstraZenaca‘s COVID-19 vaccine, which wasn’t trialled in the US, used meningococcal vaccine as the control group – and the regulators accepted this!