Biden Administration Advises A 2nd Booster For The Public Ahead Of FDA Approval
This is real life.
Did you ever think you’d read a headline like this again? Sadly, the day has come. Specifically, this is the second time before FDA approval the Biden Administration has put unethical political pressure on health regulating agencies to approve a COVID vaccine. In this case, a 4th dose.
To begin, let’s back up to mid-September of last year. You see, before the 1st booster dose was approved for kids 12 and under and more generally for the US population, the Biden Administration made an announcement they would be offering it to those who qualified before the FDA approved it (link here). Essentially, that put unreasonable pressure on the public health agency to approve the additional dose.
Following that, a statement was made by 2 senior vaccine regulators at FDA. To be specific, Drs Gruber & Krause announced they would be leaving the agency. The reason cited, they felt there was not enough data to approve boosters for the general populace and for children under 12. Moreover, Gruber and Krause claimed such a premature announcement from the White House staff put unreasonable pressure on them to approve an extra dose.
Fast-forward to 3/25/22, the Biden Administration yet again announced their plans to offer a second booster to those 50 and up ahead of FDA approval. What could go wrong? As you see, history is repeating itself and not in a good, or pro-science way.
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Here are some things to understand before you continue reading.
First know this, historically, the FDA vaccine advisory committee and CDC have a round table meeting before approving any vaccine. In that meeting, they hash out the pros and cons of such an intervention being applied to the public. Succinctly put, ethics and health risks are weighed against benefits. All and all, such a consortium of medical minds helps direct a final FDA decision.
Next and Interestingly, this time the booster approval process will be different. It will not include the aforementioned round table meeting. The approval will simply be up to a few senior vaccine regulators at the FDA and will not be met by rigorous review of independent medical peers.
Now, let’s cover 3 main issues with the Biden Administration acting so inappropriately.
Problem number 1. Understand this. Most high ranking positions at the FDA and CDC are politically appointed by presidential administrations. As you could understand, removing outside/objective advisory committees from weighing in on vaccine approvals, coupled with politically appointed heads of public health agencies, makes for an ethical disaster. The point is, the current administration is weaponizing their political authority to leverage a medical intervention which benefits their agenda, investors, and lobbyists more than the people they serve. That is bad because the approval of any drug, health policy, or medical procedure should be based in science, not politics.
Problem number 2. New booster data against Omicron shows plummeting vaccine effectiveness within months of receiving it. In medicine we don’t simply approve things to approve them. There needs to be a significant benefit compared to risks. Unfortunately, new studies show most vaccine effectiveness dwindling down to 45% against the new Omicron BA2 variant within 3 months. With that, it could be said the benefits of such an intervention don’t necessarily outweigh the risks overall. Therefore its nonsensical to approve an additional dose for most if it does not provide a benefit.
Finally, problem number 3. There is no appropriate data to show a 3rd, let alone 4th dose being protective against severe disease and death, only minor- hospitalizations and meek symptoms transiently. Just so it’s clear, at this point, protection against severe disease and death has largely been conferred by symptomatic and asymptomatic infection from exposure to multiple variants/strains (realized or unrealized) and also dose 1&2, not boosting. That said, people should not be exposed to the higher adverse event profile of an additional COVID dose to wield away only mild symptoms of a variant acting as a common cold. Consider the evidence, a 4th dose is non-scientific and irrational. Above that, many would say it’s sophistry.
Now that it’s understood the Biden Administration is using political weight to alter the outcome of vaccine approvals, a question remains. Do you support the White House and their current behavior?
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