White House objections may prevent FDA from releasing stricter guidelines it has drawn up for the emergency authorization of covid19 vaccines, the agency's No. 2 vaccine official said Monday
— something that top federal health officials, including infectious disease expert Anthony Fauci, have said is unlikely.
Guidance the FDA released in June says that vaccine developers should discuss whether to unblind a study at that point and offer a vaccine to participants who had been given a placebo. "The earlier a [vaccine] developer chooses to look at their data, and there are statistical rules for when and how to they can do this, the less likely it is they’ll have accumulated the full complement of data that we would like to see in order to make a decision to deploy a vaccine in a more widespread way," he said.
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