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Nuts who wanted hydroxychloroquine for Covid, now worry about vaccine's FDA approval.

By Curt Anderson
August 6, 2021 11:40 am
Category: Health
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It's laughable how Covid vaccine skeptics aren't taking the Covid vaccine because the vaccine "only" has an EUA (emergency use authorization) and not full FDA approval. Suddenly these people are proponents of rigorous medical testing by the government. Prior to that they were some the same nuts who were vilifying government employed doctors and the medical bureaucracy.

Along these lines, Trump signed the "Right to Try Act" giving terminally ill patients access to unapproved medications. His cultists applauded that. There’s no evidence that the law is saving “a lot of people,” as Trump claims.

My friend, a rheumatologist, was greatly bothered when Trump touted hydroxychloroquine as a Covid cure. Trump called it a "game changer". My friend's issue wasn't that HCQ was ineffective or dangerous for Covid patients. The Trump-inspired run on hydroxychloroquine caused a shortage of the drug which harmed his patients suffering from Lupus. Hydroxychloroquine is approved for Lupus patients. HCQ reduce Lupus pain and inflammation.

A year after the treatment trial launched in five cities, hydroxychloroquine had no effect in treating people with COVID-19. The results of the remote randomized, placebo-controlled trial.

(ScienceDirect)Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.



What’s the difference between full FDA approval and emergency use authorization?
(Sciencemag)It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says.

Will approval really convince more people to get vaccinated?
About 30% of unvaccinated people say they were waiting for vaccines to receive full approval, according to a survey of 1888 adults conducted in June by the Kaiser Family Foundation. But the report cautions that for many people, FDA approval is likely “a proxy for general safety concerns.” Not everyone now focused on approval may actually get a vaccine, especially if they perceive the approval process as rushed or politically motivated.

“For the people who are really dead set against getting the vaccine at this point, I don’t know that the FDA giving it full approval is going to make a huge difference,” says Krutika Kuppalli, an infectious disease doctor at the Medical University of South Carolina who says many of her patients are wary of COVID-19 shots.



Cited and related links:

  1. sciencemag.org
  2. sciencedirect.com
  3. lupus.org
  4. factcheck.org





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Comments:

  1. by islander on August 6, 2021 12:11 pm

    From my own experiences with anti-vaxxers, FDA approval is not a genuine concerne for most them, although some use it as a backup argument. A much larger percentage of the ones I know are possessed of an anti-government mindset. "Government" is the bad guy (the government is not the solution, the government is the problem) and, "no government is going to infringe on my rights and tell me what I can and can't do"...Foolish of course but it is how they think.


  2. by HatetheSwamp on August 6, 2021 12:27 pm

    No "My body my choice," for you, eh, isle!!!!?

    Why do you have to condemn people simply because they think differently than you?

    Get your vax. Wear your mask. Take responsibility for yourself and let others live by the light of their own conscience!


  3. by Curt Anderson on August 6, 2021 1:09 pm
    Using islander's drunk driver analogy, like drunk drivers, the unvaccinated wouldn't be a problem if they'd stay in their own lane. But they don't. They insist on being in public where we the vaccinated have a good but not complete protection from Covid. The fact that I have airbags and seatbelts in my car which offer good passenger protection doesn't make drunk driving acceptable. I should not have to be responsible for the risky behavior of others.


  4. by HatetheSwamp on August 6, 2021 1:31 pm

    Curt,

    We are still an effin [Friday] free people. isle's comparison is effin absurd. Vaccines are not yet effin fully approved and their effectiveness can't possibly be known this soon after they have become available.

    I admire people able to take an effin leap of blind faith and, as of this moment, all this trust in the short and long term effectiveness of COVID vaccines can possibly be is blind.

    There's, perhaps, nothing so dangerous as a person living in blind subjectivity who's convinced that they are the epitome of careful reason.


  5. by islander on August 6, 2021 2:24 pm

    ”We are still an effin [Friday] free people. isle's comparison is effin absurd. Vaccines are not yet effin fully approved and their effectiveness can't possibly be known this soon after they have become available.

    I admire people able to take an effin leap of blind faith and, as of this moment, all this trust in the short and long term effectiveness of COVID vaccines can possibly be is blind.

    There's, perhaps, nothing so dangerous as a person living in blind subjectivity who's convinced that they are the epitome of careful reason”


    Try and explain why you think the drunk driver analogy is absurd instead of just asserting that it is…

    We don’t take a leap of blind faith. We look at the empirical evidence and base our decisions on that, not on blind faith or fears for which we have no empirical evidence. We also know that virtually none of our conclusions can be made with absolute certainty (we’d have to be omniscient). In medical emergencies like this pandemic, which is killing millions of people per year (4.27 million so far), waiting for years to see any unknown adverse effects from a vaccine that works, and is saving lives as we speak, is insane. My wife was an RN working in the OR in a three state trauma center. Someone with thinking like yours could never work there. Life and death decisions must be made on the spot. We don’t always have the luxury of waiting in emergencies.

    Right now our government is NOT mandating that you be vaccinated if you don’t want to be. That's your choice. Private companies and hospitals, however, CAN legally require employees to be vaccinated if they want to work there, which is exactly as it should be.




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