Motracicletraficificker said:
fig96 said:
Motracicletraficificker said:
How long were those trials relative to the standard bedrock safety protocols by the FDA?
If you actually want to know I'll post this again. I had similar questions about EUA and asked a 25+ year veteran of the pharmaceutical testing industry and we had a great discussion about it. The short answer to your question is that all typical early phase safety testing was done, just on an accelerated timeline due to the huge number of participants and massive collaboration to eliminate the whitespace that typically occurs between phases/approvals:
Full FDA approval requires long term studies in wide populations, including blind trials which the current timeline has not yet provided for. In the case of Covid vaccines full non-clinical work was done (i.e. is this safe for humans?) before undergoing Phase 1 and 2 clinical trials for safety and efficacy. Longer term animal studies and human trials are required for full approval.
Many drugs, particularly vaccines, have received Emergency Use Authorization before going on to full approval, and EUA is still very difficult to get and highly vetted by the FDA. Companies receiving EUA have to continue with their development and testing in parallel to release. It started back in the 80s with AIDS when people were dying while waiting on the full approval of drugs that already had large amounts of clinical evidence for helping their condition.
As with any drug there will be some risk, but in the case of a vaccine like this the benefits outweigh the risks by pretty much every measure.
Thank you. How can we say this, "As with any drug there will be some risk, but in the case of a vaccine like this the benefits outweigh the risks by pretty much every measure."....without knowing this, "full FDA approval requires long term studies in wide populations" or this "Longer term animal studies and human trials are required for full approval."
A view through my lens...I see a lot of gray area of risk.
Most importantly, what is my risk of avoiding the vaccine to trust in natural immunity? Isn't natural immunity enough and hasn't naturally immunity stood the test of time more so than any vaccine?
This seems pretty self explanatory.
There is always SOME risk with any drug, people have bad allergic reactions to everything from Sudafed to morphine. But when the data overwhelmingly shows positive results (fewer and far less severe COVID cases) with minimal side effects then it's pretty safe to say that the benefit outweighs the risk.
I mentioned this earlier, but people want to act like this is some massively experimental drug that's never been tested and that's far from the case. mRNA has been studied for decades, we know what it does and now scientists have finally figured out (with a massive influx of resources) how to make them work.
Drugs can have long term negative effects when they're things we don't know about or have agents in them that are found to potentially cause harm, and that just isn't the case here.
As far a natural immunity, assuming you mean from people who already contracted COVID then I agree that's being unfairly discounted. But pandemics that wiped out millions of people are a pretty good argument in favor of vaccines.
