The reason the phase III trial placebo groups were all given the vaccine after three months without any blinding was that maintaining blinding while also giving the placebo group the chance to get vaccinated was considered “onerous” by the companies.
J&J had a median of TWO MONTHS follow up when it amended its protocol to implement unblinding of the two phase III trials.
The FDA guidance was that at least six months if not twelve months of placebo-controlled followup.
The FDA itself said that continuing the blinded placebo control after emergency use authorization would be critical to collect the safety data needed for approval.
Meissner of Tufts/FDA said that licensure is important because they won’t get made mandatory without it, and they are currently considered “experimental.”
No one knows what happens to the vaccine components once they enter your body, and rushing passed that usually asked question is not considered a problem.
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Installment five in our series on understanding the truth about SSRIs.
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In our series on how to understand the truth about serotonin, SSRIs, SSRI side effects, and the sometimes devastating effects of SSRI withdrawal...
...we have so far established that serotonin is a primarily non-brain non-neuronal signaling chemical that is fundamentally involved in the hypoxia response, and is also the substance from which we make melatonin, our mitochondria’s guardian angel.
Installment two in our series on understanding the truth about SSRIs.
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As our story moves on from the first installment in our journey toward understanding why Prozac is a performance-enhancing drug, why people who use SSRIs often develop sexual dysfunction...
...and why people who quit SSRIs can feel electric shocks running through their head as if they were trying to exit a relationship with an abusive partner with an electrifying temper, we need to properly define what serotonin is doing to our systems of energy metabolism.