Stat Monitor Repairman said:

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Are the manufacturers of the vaccines working toward full FDA approval?

What is the estimated timeline before the vaccines get full FDA approval?

Finally,

If and when the vaccines are FDA approved, will the limitation of liability provisions be lifted?

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Yes. Pfizer and I believe Moderna already applied for full approval a couple months ago.

Most expect early to mid fall. Most estimates I have seen are September or October for Pfizer.

From what I have seen all vaccines have indemnity clauses for non defective product, otherwise there would be no way for these companies to justify making a vaccine with an infinite liability. What you are asking about is not unique to these vaccines and never has been.

A few weeks ago, the pharmaceutical companies agreed to a $26 billion dollar global settlement for hydrocodone / Oxycontin and other similar FDA approved and doctor prescribed opioids.

What is the justification for extending limitation of liability beyond the FDA approval process?

Hydrocodone and Oxycontin aren't vaccines, so they aren't really relevant to this issue.

This is an interesting article explaining the history of protection for vaccine manufacturers. If you hate Newsweek, just Google it. I read several articles but thought this consolidated and explained the issue well.

Stat Monitor Repairman said:

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A few weeks ago, the pharmaceutical companies agreed to a $26 billion dollar global settlement for hydrocodone / Oxycontin and other similar FDA approved and doctor prescribed opioids.

What is the justification for extending limitation of liability beyond the FDA approval process?

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https://www.ncbi.nlm.nih.gov/books/NBK216813/

That's a good read on the subject of what is protected and why. I think, if you're discussing in good faith, you would be able to distinguish between pharmaceutical companies encouraging opiod useage without a medical reason to boost profitability (which according to the paper would expose those companies to liability of damages) and companies that ran a vaccine properly through 3 phases of trials that showed that they were both safe and effective. Feel free to look more into the trials, end points, and follow up research across CDC, FDA and company websites as well as peer reviewed research in accredited journals if you want to actually look into the details of what the data supporting that information looks like... Again, that's assuming your discussion is of genuine intrest.

The justification is pretty obvious. It would be incredibly difficult for medical companies to bring a product to market in good faith if they are permenantly exposed to an infinite liability. The consequences of not protecting manufacturers from this liability is both decreased accessibility to safe and effective vaccines (among other medical treatments) and significantly increased costs for vaccines. The result would be much worse for society than letting vaccines which have been proven both safe and effective through double blind phase 3 trials come to market. And sure these companies will make money because of these vaccines - that is what happens when you bring a product to market in high demand. There is a good reason for that demand and there is a wealth of evidence that the product has effectively met that demand.

Stat Monitor Repairman said:

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According to the article, the vaccine court has only paid out $6 million since 2005.

Will the petitioners co-morbidities be taken into account when the vaccine court determines causation?

I'm struggling with the concept that by taking a non FDA approved vaccine, you are voluntarily surrendering a legal right and a legal remedy.

I don't think the average person understands this fact.

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I think the average person doesn't understand that the difference between EUA and full approval is basically a bunch of red tape. Both require the same level of medical data.

Gordo14 said:

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Stat Monitor Repairman said:

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According to the article, the vaccine court has only paid out $6 million since 2005.

Will the petitioners co-morbidities be taken into account when the vaccine court determines causation?

I'm struggling with the concept that by taking a non FDA approved vaccine, you are voluntarily surrendering a legal right and a legal remedy.

I don't think the average person understands this fact.

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I think the average person doesn't understand that the difference between EUA and full approval is basically a bunch of red tape. Both require the same level of medical data.

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Then why dont we use EUA for every approval? How many lives are we willing to sacrifice on the alter of red tape?

Thats a fair point.

If red tape is all that stands in the way of getting FDA approval for all vaccines, then what are we waiting for?

tysker said:

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Gordo14 said:

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Stat Monitor Repairman said:

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According to the article, the vaccine court has only paid out $6 million since 2005.

Will the petitioners co-morbidities be taken into account when the vaccine court determines causation?

I'm struggling with the concept that by taking a non FDA approved vaccine, you are voluntarily surrendering a legal right and a legal remedy.

I don't think the average person understands this fact.

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I think the average person doesn't understand that the difference between EUA and full approval is basically a bunch of red tape. Both require the same level of medical data.

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Then why dont we use EUA for every approval? How many lives are we willing to sacrifice on the alter of red tape?

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Because some things are emergencies and should rightly get a shortcut through the red tape and others aren't emergencies. Getting an EUA requires that the government declare the issue the vaccine is meant for be declared an emergency, otherwise there is no path to an EUA. Full FDA approvals requires more backend controls than an EUA, for example, and getting that in line, documented, and reviewed takes more time than the trials themselves. Even then, most of the time companies want full FDA approval instead of an EUA because full FDA approval gives them the ability to market their product to the general public, EUA does not. In a pandemic, where the government covers the cost of the vaccine and the benefit is obvious, it turns out that marketing the product isn't as important as it is with a commercial drug for a non-emergency.

It's clear that you're determined to mistrust everything just because, but when the FDA gives the Pfizer vaccine full FDA approval in a month or two, I imagine you guys will be the first in line to get one, right? I mean at that point all of your good faith "concerns" about EUA vs FDA approval are gone. I mean that's clearly what you are implying in this thread.

Gordo14 said:

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tysker said:

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Gordo14 said:

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Stat Monitor Repairman said:

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According to the article, the vaccine court has only paid out $6 million since 2005.

Will the petitioners co-morbidities be taken into account when the vaccine court determines causation?

I'm struggling with the concept that by taking a non FDA approved vaccine, you are voluntarily surrendering a legal right and a legal remedy.

I don't think the average person understands this fact.

---

I think the average person doesn't understand that the difference between EUA and full approval is basically a bunch of red tape. Both require the same level of medical data.

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Then why dont we use EUA for every approval? How many lives are we willing to sacrifice on the alter of red tape?

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Because some things are emergencies and should rightly get a shortcut through the red tape and others aren't emergencies. Getting an EUA requires that the government declare the issue the vaccine is meant for be declared an emergency, otherwise there is no path to an EUA. Full FDA approvals requires more backend controls than an EUA, for example, and getting that in line, documented, and reviewed takes more time than the trials themselves. Even then, most of the time companies want full FDA approval instead of an EUA because full FDA approval gives them the ability to market their product to the general public, EUA does not. In a pandemic, where the government covers the cost of the vaccine and the benefit is obvious, it turns out that marketing the product isn't as important as it is with a commercial drug for a non-emergency.

It's clear that you're determined to mistrust everything just because, but when the FDA gives the Pfizer vaccine full FDA approval in a month or two, I imagine you guys will be the first in line to get one, right? I mean at that point all of your good faith "concerns" about EUA vs FDA approval are gone. I mean that's clearly what you are implying in this thread.

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Define obvious benefit and emergency because both can be argued for and against. Its easy to talk **** about what is or isnt an 'emergency' when its not your kid with cancer and no FDA approved options. I trust the system just fine but I'm also willing to admit we're simply trading lives and quality-adjusted life years here and frankly some of us are just more valuable to the public than others.