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12-18-2021, 05:52 AM #1
Former FDA Officials Expose Biden Admin’s Sidelining Of “Vax Experts”
Former FDA Officials Expose Biden Admin’s Sidelining Of “Vax Experts”
By Jacob Palmieri - December 17, 2021
The Biden Administration’s goal is to push the COVID vaccine on Americans at all costs.
Two former FDA officials exposed how the Biden administration is shutting down dissent regarding the COVID vaccine.
The Biden administration is accused of making “three important decisions on vaccines without consulting independent panels of experts.”
Vinay Prasad, MD MPH
@VPrasadMDMPH
FDA vaccine deputy director who resigned over WH pressure on boosters is writing op eds critical of pushing boosters for teens without Ad Com. WH is acting seriously reckless. If the last administration did this, all experts would be outraged.
Perspective | The Biden administration has been sidelining vaccine experts
The FDA, for example, approved booster shots for 16- and 17-year-olds without convening a key advisory panel.
washingtonpost.com
7:35 PM · Dec 16, 2021
From The Washington Post:
The U.S. government, over the past few weeks, has made three important decisions on vaccines without consulting independent panels of experts. On Nov. 19, the Food and Drug Administration authorized boosters for all adults — regardless of their job or any underlying health conditions. On Nov. 29, the Centers for Disease Control and Prevention announced that everyone 18 and above should get a booster shot, a revision of previous guidance that strongly recommended boosters only for those 50 and older. Then, on Dec. 9, the FDA authorized booster shots (of Pfizer) for 16- and 17-year-olds, moving the age of eligibility down from 18.
Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote. That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.
One of us is the former deputy director of the FDA’s Office of Vaccines Research and Review; the other is a former acting chief scientist at the FDA. We believe that much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question.
…
In each of the recent decisions we’ve mentioned, at least some experts would probably have voiced opposition (based on earlier scientific debates and votes the two committees had taken, which supported different conclusions). That these experts were not given a chance to make their cases could hurt the credibility of these agencies. (In a poll published in May, conducted by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health, some 75 percent of American adults said they trusted the FDA a great deal or somewhat, with 24 percent saying they felt not much trust or none. The rest of the respondents refused to answer or had no opinion.)
This area of research is fast-moving, and much changed between the most recent meetings of the expert committees (on the booster question) and the FDA’s decision to authorize boosters for 16- and 17-year-olds — notably the emergence of the omicron variant. Still, the lack of involvement of the FDA’s expert panel on that question was striking, and observers noticed. Helen Branswell, a senior writer for the health and science publication STAT News, tweeted that the FDA had “authorized Pfizer booster shots for 16- & 17-years olds, without asking its vax expert panel for advice.” She added, “This approach sidesteps what would likely have been lengthy discussion about myocarditis” — an uncommon side effect of the mRNA vaccines, which had drawn careful study in earlier steps of the approval process.Trust the science has quickly become shutdown dissenters.
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