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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#501

Earlier quoted context omitted.

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?

It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early. Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines. edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge.…

A great point. The same people decrying a vaccine that has been safely administered to nearly a billion people at this point and extensively studied will be the first ones to try all sorts of untested homeopathic and "alternative" nonsense.

Re: FDA Approves First Covid-19 Vaccine

#502

Earlier quoted context omitted.

I'm already triple vaxxed (booster), but there are plenty of aspects to this that help drive people's fear: - Phase 3 trials for Pfizer not complete until May 2023: ( https://clinicaltrials.gov/ct2/show/NCT04368728 ) - Control group(s) were given vaccines after 14 days: ( https://www.npr.org/sections/health-shots/2021/02/19/9691430... ) - Pfizer generates 1.9bn in revenue off of 100m doses, just in the USA alone, cre…

> Control group(s) were given vaccines after 14 days I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else. Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups? What the hell!…

Once you have evidence the treatment works, it becomes unethical to not offer it to the control group. This happens in a lot of medical trials.

In this specific situation, they would have been condemning through a choice to not treat, a fraction of the control group to die.

Re: FDA Approves First Covid-19 Vaccine

#503

Earlier quoted context omitted.

No vaccine has ever had a long term effect that isn't visible soon after it is administered. Vaccines are one and done and eliminate quickly from the body, unlike other medications, which can be administered daily or weekly for years and can accumulate in organs. https://www.uab.edu/reporter/resources/be-healthy/item/9544-... "This is particularly true of the mRNA vaccines. mRNA degrades incredibly rapidly. You would…

How about the cases of narcolepsy that were caused by the swine-flu vaccine Pandremix? As far as I understand it took around 2 years before it was officially stated that the vaccine was/is the cause for these cases. Until 2015 the numbers grew even higher because of the delay between vaccination and the first symptoms. I wouldn't really call that "soon after it is administered". And the same is also true for covid's…

I expect those side effects were actually seen within the first few months after being administered. It merely took that long for the company producing it to officially acknowledge it, because they are terrible.

You could argue that the same could be happening with COVID vaccines, but I think that is unlikely given the unprecedented level of worldwide scrutiny on these.

Re: FDA Approves First Covid-19 Vaccine

#504
post #462

Earlier quoted context omitted.

No.

https://www.forbes.com/sites/roberthart/2021/07/23/pfizer-sh...

From your own article where it repeatedly emphasizes that the Pfizer vaccine is no way outdated:

> The vaccine still provides very high levels of protection against hospitalization (92%) and severe illness (91%) caused by the Delta variant, the ministry said.

..

> 91%. That’s how effective the Pfizer vaccine is at preventing serious illness and hospitalization caused by the Delta variant after two doses, according to the Israeli study. This is only slightly lower than against other variants. As this is the primary purpose of a vaccine, it is still highly successful, though it does mean it will likely not be sufficient to stop outbreaks on its own.

In any case, there's clear evidence that immunity waned in people given two doses too close together 8 months ago and that a third dose basically regains full efficacy.

Re: FDA Approves First Covid-19 Vaccine

#505

Earlier quoted context omitted.

> it might not be the true one or the sufficient one. Unless you’re dealing with an extraordinary individual or the issue is relatively trivial then you won’t be told sufficient reasons. A lot of what motivates us is deep down and dumb and we rarely want to admit it even if we’re aware of it which is even rarer. I find that examining reasons to change my own mind is much more fruitful because it’s harder to lie to my…

For me it's the fact that I'm making the decision based on emotional factors. I don't trust big pharma and I don't trust the vaccines. Should be reason enough. There is plenty of things we don't trust in life, so we don't use those things.

> I don't trust big pharma and I don't trust the vaccines. Should be reason enough.

This is a good example of what I was talking about. You don’t trust big pharma? Most people who say that will still pop some ibuprofen etc when they get a headache so really they do trust big pharma when it suits them. The real reason is deeper down.

Re: FDA Approves First Covid-19 Vaccine

#506
post #273

Earlier quoted context omitted.

Here's the deal: you don't have to take the vaccine, but promise to stay away from people, and not burden hospitals when you get covid. It's not your personal choice when it can harm other people (e.g. immunocompromised people who can't get the vaccine themselves, other people who need ICU beds).

Let's apply that logic to everything, then, and see how it works out. You're fat or obese and have health outcomes stemming from those choices? Enjoy your heart attack, fatty. You get injured doing something "non-essential?" Your mountain bike accident sounds like your problem. You're a smoker and get lung cancer? Sorry, no treatment is available for you. You don't get to dictate the health choices of others. And if…

Those aren't equivalent.

Preventing obesity is *very* hard, or we wouldn't have obese people. Who actually WANTS to be obese?

Preventing your ICU trip due to covid is as easy as driving to the pharmacy once or twice and spending 20minutes there.

It's easier than grocery shopping.

Re: FDA Approves First Covid-19 Vaccine

#507
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.

The vaccines were unfortunately politicized from the outset, from the first mention that they were in development. It's a shame that neither politicians nor the media felt it a good idea to keep the best interests of the people in the forefront, rather than their own. So, it's hard to blame the populous for developing a deep sense of distrust around it.

Re: FDA Approves First Covid-19 Vaccine

#508

People don’t want to take the vaccine because others are trying to force them to. They would say “it’s not FDA approved!” not as the core of their hesitancy, but because they were trying to be appeal to pro-vax peoples decision making framework. I don’t think we should be able to require them to. To many of you here: imagine the Trump admin trying to require you to take the vaccine in November of last year. Cities wo…

> the weird, Orwellian ways that the government talks about it, has turned me against the booster. You desperately need to take a step back and look at yourself and how you evaluate things. You decided to go against the booster because of your feelings, not because of science. You want government decisions to be guided by science, and yet you are very clearly anti-science with your decision making. > To many of you h…

> because of your feelings, not because of science.

For the unaware, there are multitudes of highly acclaimed scientists and academics around the world from top institutions including Nobel prize winners that are advising caution against the vaccine. You don't just get to choose which "science" you listen to. These voices are massively censored so the public doesn't really get to hear both sides of the argument. The whole "don't talk bad about the vaccine lest `vaccine hesitancy`" is evil and plain anti-science.

Re: FDA Approves First Covid-19 Vaccine

#509

Earlier quoted context omitted.

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?

Without claiming any knowledge of this particular case, the FDA has processes for accelerating approval for medication for which mass efficacy testing can only be done in the long-term, but testing for adverse side-effects is already complete. The recent approval of Alzheimer's medication[0] is one example of that. From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alt…

You mean this one?

https://news.ycombinator.com/item?id=27472107

https://news.ycombinator.com/item?id=27469092

https://news.ycombinator.com/item?id=27468756

Re: FDA Approves First Covid-19 Vaccine

#510
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.

You could pivot to many things, for example this FDA approved drug that was later retracted: https://www.fda.gov/drugs/postmarket-drug-safety-information... Or point out that the 737 MAX had approval from another federal agency. We simple can't be sure, it is personal risk management. Requiring the vaccine is silly because vaccinated people can still spread it (especially Delta), perhaps even spread it more since the…

Your personal risk management is at odds with my childs safety. Not everyone is able to be vaccinated at the moment.

"In addition, a growing body of evidence suggests that mRNA COVID-19 vaccines also reduce asymptomatic infection and transmission."

https://www.cdc.gov/coronavirus/2019-ncov/science/science-br...

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