2) Basically FDA had inserted a vaccine minimum efficacy standards that would have almost certainly guaranteed that no vaccine could be authorized before the election on Nov. 3... but now Trump WH has own OVERRULED & BLOCKED it. Thereby Trump HHS can now approve on its whim!
3) And the FDA proposed (now killed) vaccine efficacy standards were already super lenient and low bar to begin with (basically easier than a layup to get over). And now Trump WH has even killed that minimum standard for the vaccine.
4) Technically the power grab last month was for the ultimate approval of the vaccine. Though this ‘approval guideline’ veto is very close to that veto power. It’s another political power move that Trump WH is using to ensure vaccine moves through before election.
5) “The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.”
6) “Mr. Meadows raised a series of concerns. He questioned the need for 2 months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was ***overly influenced by his agency’s career scientists***
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