I keep reading people saying they aren't approved by the FDA yet. Yet I've read some sites saying that they do meet FDA requirements? Is there a definitive answer on this?

Thanks for the clarification.

amercer said:

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Pfizer is going to submit for full approval shortly, and they will get it.

Not sure why a rubber stamp makes any difference to people after the vaccine has already been put in a couple hundred million arms.

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Agreed

That'll show him!

amercer said:

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I don't think you are an ass, but you are incorrect on the how and the why of clinical approvals by the FDA

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Either the FDA approval process is important in ensuring the efficacy and safety of a vaccine, and there is inherent risk in taking a vaccine that was not subjected to that process, or the FDA approval process is essentially an unnecessarily long, bureaucratic nightmare that increases deaths for no good reason.

Given the fact that these vaccines did not go through that process, and given the fact that they are new and, relatively speaking, untested, the number of arms into which they have been shot over the last 3-4 months offers absolutely zero assurance that they will not come with long-term, unintended consequences. Hence, the process and its importance is wholly unaffected by the number of people who have been given the vaccine. When all of this is combined with the fact that I can gain a great deal of the benefit of the vaccine with none of the risk through others lining up to take it, I have concluded that it is most prudent for me not to take it at this time.

[Be respectful to others here. -Staff]

amercer said:

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Some of you are missing the point. The FDA doesn't require long term (years) safety data on any vaccine for approval. Vaccines are out of your system in a week, so that's really how long you have to look for problems. What vaccines do need is a lot of that short term data. Because they go into healthy people you do need to carefully asses the risk benefit ratio, but that's not something that requires long term follow up. The reason most vaccines take so long to get approved is that the development process is very expensive, and they aren't super profitable. So vaccine companies are generally really cautious in development for business reasons, not safety ones.

So the real world evidence from the current vaccines is 100 times more than what any vaccine would need for approval.

So in this particular case the FDA will absolutely rubber stamp the approval from Modena or Pfizer whenever they ask for it. Not because any corners are being cut, but because the amount of data they have is vastly more than required.

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So we can expect that the vaccines will be summarily approved once submitted for approval, then?

Yep

Time will tell.

Should know pretty soon

https://www.fiercepharma.com/pharma/pfizer-biontech-eye-official-covid-19-vaccine-nod-as-efficacy-stands-strong-including

It's like Kevin McAllister asking if the american dental association approved his stolen toothbrush

Snow Monkey Ambassador said:

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amercer said:

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I don't think you are an ass, but you are incorrect on the how and the why of clinical approvals by the FDA

---

Either the FDA approval process is important in ensuring the efficacy and safety of a vaccine, and there is inherent risk in taking a vaccine that was not subjected to that process, or the FDA approval process is essentially an unnecessarily long, bureaucratic nightmare that increases deaths for no good reason.

Given the fact that these vaccines did not go through that process, and given the fact that they are new and, relatively speaking, untested, the number of arms into which they have been shot over the last 3-4 months offers absolutely zero assurance that they will not come with long-term, unintended consequences. Hence, the process and its importance is wholly unaffected by the number of people who have been given the vaccine. When all of this is combined with the fact that I can gain a great deal of the benefit of the vaccine with none of the risk through others lining up to take it, I have concluded that it is most prudent for me not to take it at this time.

[Be respectful to others here. -Staff]

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amercer said:

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Some of you are missing the point. The FDA doesn't require long term (years) safety data on any vaccine for approval. Vaccines are out of your system in a week, so that's really how long you have to look for problems. What vaccines do need is a lot of that short term data. Because they go into healthy people you do need to carefully asses the risk benefit ratio, but that's not something that requires long term follow up. The reason most vaccines take so long to get developed is that the development process is very expensive, and they aren't super profitable. Also you are usually at the mercy of whatever disease you are dealing with. Novavax nearly went out of business in 2019 because a really weak flu season had ruined the statistics on their phIII vaccine trial. So vaccine companies are generally really cautious in development for business reasons, not safety ones.

So the real world evidence from the current vaccines is 100 times more than what any vaccine would need for approval.

So in this particular case the FDA will absolutely rubber stamp the approval from Modena or Pfizer whenever they ask for it. Not because any corners are being cut, but because the amount of data they have is vastly more than required.

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This x 1000! I will also add (although, it is sort of implicitly stated above), most drugs, vaccines, and new treatments are for a relatively small population of patients. Meaning, the testing process takes a long time because there aren't (relatively speaking) that many people who NEED it.

This vaccine was very different in that literally every adult can be affected by the virus. So, as statues above, they have been able to collect what would be many years worth of data in a much shorter period of time.

This vaccine has gone through the same three rigorous phases of approval as every other new vaccine or treatment or drug.

Phase 4 is "official" FDA approval.

Phase 5 is "long-term" studies. As stated above "long-term" (whatever the heck that even means) studies aren't required for approval. That's what happens AFTER approval.

cavscout96 said:

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Snow Monkey Ambassador said:

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amercer said:

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I don't think you are an ass, but you are incorrect on the how and the why of clinical approvals by the FDA

---

Either the FDA approval process is important in ensuring the efficacy and safety of a vaccine, and there is inherent risk in taking a vaccine that was not subjected to that process, or the FDA approval process is essentially an unnecessarily long, bureaucratic nightmare that increases deaths for no good reason.

Given the fact that these vaccines did not go through that process, and given the fact that they are new and, relatively speaking, untested, the number of arms into which they have been shot over the last 3-4 months offers absolutely zero assurance that they will not come with long-term, unintended consequences. Hence, the process and its importance is wholly unaffected by the number of people who have been given the vaccine. When all of this is combined with the fact that I can gain a great deal of the benefit of the vaccine with none of the risk through others lining up to take it, I have concluded that it is most prudent for me not to take it at this time.

[Be respectful to others here. -Staff]

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Re the bolded part: there are a lot of very effective vaccines that never become widely available or are only available to limited populations of people.

The SARS and MERS vaccines (which happen to be pretty similar to the Covid vaccine) never became commercially available because it was deemed they weren't necessary. That doesn't mean people don't die from SARS and MERS - it means the pharmacy companies decided not ~enough~ people die to make it worth their while to make the vaccine available.

For a long time, the HPV vaccine was pretty much only available to people age 26 and younger. Insurance companies didn't want to pay for it for people older than 26 because "statistics" indicated people over that age have most likely already been exposed to the virus. Most people aren't going to pay OOP for the vaccine.

The FDA recently expanded approval for people aged 9-45. This doesn't mean the FDA has all of a sudden deemed it "safe" for people over age 26 - they've just decided there is value in vaccinating people over that age (and it may have taken some extra time to collect the data across the wider range of ages).

Similar situation for the shingles vaccine. Shingles predominantly affects older people. It's only been since 2011 that the minimum age to get the vaccine was reduced to from 60 to 50.

It doesn't mean someone under 50 can't get shingles or that the vaccine does something different in people under age 50. It just means the initial studies targeted a specific population that is more at risk to suffer from shingles.

And, again, insurance companies don't want to pay for an expensive vaccine for populations that are low risk. Having the FDA say a vaccine is only "approved" for certain populations let's them off the hook.