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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#81

Interesting that most comments focus on the social aspect of this instead of deciphering the science behind that approval.

There isn't much of a difference between the science behind this approval and that of an EUA. Its largely red-tape and bureaucracy.

Re: FDA Approves First Covid-19 Vaccine

#83
post #6

I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.

> I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”.

No doubt this will be the case for some. So, you've found a logical flaw in people's stated reasons for not wanting a vaccine. How does that help anything? In these kinds of debates, the actual goals or beliefs of both sides often differ from what they say.

For example, the government being able to tell you what to do, vs. it not.

People end up locking in to trivialities like approval or some study, but they just obscure the real debate. Doing more to get the tradeoffs we are making into the open, and talk plainly about what people are being asked to do, why, and what their rights and options are, is much more valuable IMO than trying to find clever flaws in the reasoning of either side. Flaws are there, and obvious, but generally not central to anyone's core thesis, and almost certainly not going to sway anybody. They just let people score cheap shots against their opponents and pump up their own supporters.

Re: FDA Approves First Covid-19 Vaccine

#84
post #58
post #39

Earlier quoted context omitted.

The US needs it if they want people who are spooked my mRNA tech to get vaccinated. They also need it if they want a vaccine that is the mostly likely to be safe for use in children.

Astrazeneca and J&J are both non-mRNA vaccines.

AZ isn't available in the United States.

OK, fine, it's not just mRNA. It's novel tech vs. well known tech like attenuated/inactivated virus.

Beyond that, Covaxin is the only that I'm aware of that is performing well under delta.

Re: FDA Approves First Covid-19 Vaccine

#86
post #6

I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.

I think you are right. People won't change their minds about it. But the question is, should they be allowed to control what goes inside their bodies? In my opinion, the answer is a huge YES OF COURSE.

Re: FDA Approves First Covid-19 Vaccine

#87

An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0]. Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs. In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval. […

This flow chart is not quite accurate, or at least is misleading. There is more to a distinction between EUA and full FDA approval than where manufacturing happens. The FDA's own website[0] says:

> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.

[0] https://www.fda.gov/consumers/consumer-updates/understanding...

Re: FDA Approves First Covid-19 Vaccine

#88
post #26

Now do Covaxin. Seriously: what's the hold-up? Why is the US still blocking this vaccine?

The FDA asked for information on the stage 3 clinical trails (which is a normal thing to get) and instead of providing it they decided to go for full approval.

Which is really strange. Unclear why they would do that.

https://www.hindustantimes.com/india-news/why-was-bharat-bio...

Re: FDA Approves First Covid-19 Vaccine

#89
post #57
post #37

Earlier quoted context omitted.

Where exactly do you get the 1.7%? Is it computed the same way the breakthrough deaths are computed? What is the denominator in each case? I see, you are using this table[1] ... This is the case fatality rate (which is inflated depending on how many infections are never recorded). Using the numbers provided by the CDC, if we put the cases in the denominator and not the vaccinated population, we have: Hospitalized or…

Even if we had that data it wouldn't be a fair evaluation of vaccine efficacy. The elderly are the most vaccinated demographic, have the highest number of breakthrough infections, and have the highest mortality rate. There are too many confounding variables.

[deleted]

Re: FDA Approves First Covid-19 Vaccine

#90

Interesting that most comments focus on the social aspect of this instead of deciphering the science behind that approval.

That's not how the drug industry works. The companies fund and conduct their own efficacy and safety trials, the government just rubber stamps them. The FDA doesn't perform an actual science. They don't even require an impartial group to replicate the science.

The FDA doesn't do really much of anything to collect safety data. There's seemingly no reason for the agency to exist.

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