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.
98% of the placebo group has been vaccinated.
bmj.com/content/373/bm…
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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