Comments by Brian Shilhavy
Editor, Health Impact News
FDA Commissioner Stephen Hahn, who already has the blood of tens of thousands of Americans on his hands because of his refusal to issue an approval for the outpatient use of hydroxychloroquine according to the Association of American Physicians and Surgeons, now is saying publicly that the FDA will consider issuing a fast-track approval for the many COVID vaccines still being developed, even if they have not completed Phase 3 trials.
Writing for FiercePharma, Eric Sagonowsky reports:
With multiple COVID-19 vaccines racing ahead in late-stage testing, FDA commissioner Stephen Hahn said his agency doesn’t necessarily need those trials to wrap up before clearing them for use.
In an interview with the Financial Times, Hahn said that the FDA would consider an approval application based on preliminary data from a phase 3 trial.
The FDA has received a lot of criticism lately for developing public health policy based on politics, and many fear that the rush to get a new COVID vaccine in place is being fueled by politics, to have one before the November 3rd elections.
Hahn denies this, but the public isn’t buying it. From FiercePharma:
But the agency won’t buckle to political pressure, Hahn maintained. Such reviews and decisions could come right around the U.S. election, but the FDA will “stick to our core principles,” Hahn said.
That commitment comes as most Americans believe politics, not science, is driving the FDA’s coronavirus vaccine review process, according to a new Stat and Harris Poll survey. Large majorities of Republicans and Democrats said they think science is taking a back seat to politics.
It is hard to believe that science is driving the market push for a new COVID vaccine when there isn’t even a reliable test for Sars-Cov-2 yet, as all the 100+ COVID tests currently in the market have also been fast-tracked by the FDA.
How many people will be seriously harmed, perhaps for life, or even killed by an untested new vaccine that is supposedly going to protect people from a virus that is obviously no more dangerous than the seasonal influenza, and has never been isolated in a laboratory?
See our COVID Testing Information page which is part of the Health Impact News COVID Information Center which is designed to give you quick access to facts that can be easily shared with others.
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