Kaiser Health adds some info to the mixed messages on vaccines.

http://digitaledition.pilotonline.com/infinity/article_share.aspx?guid=3d16c1e2-dd49-4a01-8fca-bd1ccd79a640
I think the important part is that testing for efficacy, as well as safety, is critical. And in our country which is rife with conspiracies and #LIBERATE views, proof that the vaccine is “gold” is important.

7 thoughts on “Kaiser Health adds some info to the mixed messages on vaccines.

  1. Why do you think testing for efficacy is necessary? Consider:

    We know from testing done so far that the vaccines are relatively safe.

    We know they produce a strong immune response comparable to recovering from the disease.

    We have already paid for the vaccine and it is available for limited distribution tight now.

    From experience with other vaccines, and from President Trump’s use of a two antibody cocktail, we know that the antibodies at the very least reduce the severity of the disease even if they don’t block it entirely.

    We know that while that vaccine sits in freezers, 20,000 mostly older Americans are dying every month.

    So, why should high risk people who are willing to take the miniscule risk the vaccine poses to stave off the very real risk of dying from the virus not be allowed to make use of the vaccine as soon as possible?

    The FDA culture is highly risk averse. No one wants to be the guy who signed off on thalidomide, but they don’t mind being the guy who delayed beta blockers and statins for a decade after they were in use in Europe.

    A rational person must always weigh the risk of both action and inaction.

    Right now, if I could get it, I would take the Russian or Chinese vaccines rather than remain unprotected 3 more months.

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    1. A pandemic is not just a few individuals, but rather a nation in crisis.

      Universal vaccination with a vaccine known to be effective in stopping the spread is critical. Especially since we have no idea how long immunity lasts, whether 2 doses is doable for 100 million people, and how to convince about 1/2 the folks that it is not some grand conspiracy to enslave the world.

      I am sure that for a decent sum you could get Putin’s prescription or Xi’s serum. Then hunker down a see what happens.

      But for control of an out-of-control pandemic that is crushing us, we need broader guarantees. If the first fails in mass usage, the second and subsequent ones will be really hard to sell.

      Plus we have gone from “it’s no worse than the flu, to 210,000 dead, back to “it’s no worse than the flu”. What kind of trust does that establish in an already divided and jaded citizenry.

      Liked by 1 person

      1. That is a non-answer.

        Why should I not be able to go to my physician and after getting informed consent not be able to get one of the vaccines right now?

        What public good is served by requiring me to risk death for 3 or more months if I am willing to accept the risks of the vaccine?

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          1. I can’t even get a supply of HCQ. The FDA has seized control of many things that should be between doctor and patient.

            But the point is that a willing patient should be able to get vaccinated at his own risk.

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      2. RE: “Universal vaccination with a vaccine known to be effective in stopping the spread is critical.”

        Thinking theoretically and idealistically that’s true. But theory and idealism are not in play with the Covid-19 vaccines.

        In practice, the issue at hand is whether the FDA should approve one of the vaccine candidates for widespread use prior to the completion of rigorous and time-consuming Phase III trials. There are good, solid reasons based on science for doing so.

        By the time of Phase III testing, both the safety and efficacy of a vaccine candidate have been established. The only thing unknown — because it hasn’t been tested — are the effects that will emerge when the vaccine is used by the target population. Phase III trials attempt to predict those effects based on expanding the number of test subjects greatly above Phase I and II levels.

        The issue is: Do we need the predictive results of Phase III trials before making the vaccine available to the population for which it is designed? After all, the risks Phase III attempts to quantify are minimal by definition, being both low occurrence and low consequence (few will have them and few will be harmed).

        Put another way, since the vaccine is already known to be safe and effective, can we not apply the Phase III protocols with the real population of vaccine users?

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