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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#271
post #237

Earlier quoted context omitted.

Something similar to the Rubella vaccine that took about four years to be licensed. https://en.m.wikipedia.org/wiki/Rubella_vaccine

My problem with this "we just have to wait N units of time" approach is: what do we do instead meanwhile? What's the alternative?

That's the hard part, I'm all for giving the vaccine to all who wants it.

And at the same time not forcing everyone to take the vaccine.

As an example Denmark will reach about 75% vaccinated without any mandates, though a Corona passport will be in effect until October 2021.

That is one of the better ways of handling it in my opinion.

Re: FDA Approves First Covid-19 Vaccine

#272
post #60

Earlier quoted context omitted.

Exactly like governments are moving goalposts with their measures: one lockdown... second one... wait no, a third one is necessary; herd immunity will be reached at 70% vaccination + infected, ah no actually only vaccinated count and it's 90%... did I say 99%? No, it will be 100%! Meanwhile in Japan: people living freely their lives with no lockdowns, no forced vaccination, no vaccine pass. Another model is possible…

> herd immunity will be reached at 70% vaccination + infected, ah no actually only vaccinated count and it's 90%... did I say 99%? No, it will be 100%! 70% is enough for the original Covid. Covid moved the goalposts to Delta which needs different numbers. This is not experts moving the goalposts, this is Covid changing on us - as was always expected to happen and why experts said we don't know what % is required unti…

It was 84% for the original covid. Anything lower was a lie.

Re: FDA Approves First Covid-19 Vaccine

#273

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…

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).

Re: FDA Approves First Covid-19 Vaccine

#274
post #250

Earlier quoted context omitted.

Again with this argument. This particular decision with their bodies is harming others. Getting really drunk and driving home is also a decision about your body. So is smoking inside restaurants. Those have been illegal for a while. For those of us who got the vaccine, we’re still having to take precautions because of the delta variant spikes, largely from people who didn’t get a vaccine. Where is our choice?

> Getting really drunk and driving home is also a decision about your body. So is smoking inside restaurants. Smelly analogy is smelly. You're talking about the difference between very specific behaviors being prohibited versus blacklisting half of the population from participating in society with vaccine mandates (many of whom are black, by the way). It's not even close to a valid comparison. I get the sense that th…

> Why? Apparently my government isn't capable of providing useful guidance to keep me safe. We keep hearing about masks, but the mandate got dropped and there was never any talk about mandating the clearly superior KN95 or N95 masks.

> Anti-vaxxers have been consistent from the beginning that they're not getting vaccinated. You know whose position keeps changing? FDA & CDC. Whether it's how effective the vaccine is, what the side effects are, do we need to wear masks, how much social distancing is required, whether or not a booster is useful...

> You and everyone else blaming anti-vaxxers are letting the government redirect blame for its own failures.

Science adapts and adjusts based on new information.

The lack of willingness to adapt when confronted with new evidence has an unfortunate name.

Re: FDA Approves First Covid-19 Vaccine

#275
post #2

My biggest concern now is around seeing those who hedged their willingness to get the vaccine on its approval instead find a new reason not to get it. So with that in mind, I'm much more keen on seeing how employers will decide on vaccination mandates now that at least one vaccine is fully approved. Any news yet on whether any more employers are likely implementing mandates (if they haven't already this morning) base…

I’m surprised we haven’t seen more from health insurers - unless they’re gambling on being able to get out of paying for any long term care costs for COVID complications by claiming ‘preexisting condition’ or ‘government said they’d pay for COVID treatment’ they should surely be interested in incentivizing group plan holders (ie employers) to have vaccination programs. When having a vaccination mandate policy shows u…

On the contrary with the insurance profits capped at a percentage it is beneficial for them for the services to be as expensive as possible and patients to have as many as possible claims.

They can just pass on the cost onto the consumer and raise their profits.

Re: FDA Approves First Covid-19 Vaccine

#276

Earlier quoted context omitted.

I recent came across a technique for having a more substantial discussion and it was to ask: "Well, what would it take for you to change your mind?" Not that this is a silver bullet that automatically leads to peace and harmony, but it's a step in the right direction.

Why does this technique change anything? You are still assuming the supposed superior position, since you imply that the stance of your discussion partner is wrong and needs to be changed. Dont you see how patronising this is?

In any debate outside of clubs you assume you're right and the other person is wrong - otherwise you'd change your mind.

What the question your parent poses can do is get to the root of the objection your conversation partner has. "What would make you change your mind" forces the conversation in the direction of uncovering the true source of the disagreement. It helps to avoid talking about "symptoms" or issues that you might find important but are not important to your partner. It helps avoid talking past each other. It helps identify what issues are important to the other person.

Re: FDA Approves First Covid-19 Vaccine

#277

Earlier quoted context omitted.

Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…? Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.

Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.

You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved).

Said another way, what was the extra steps that needed to happen between EUA & full approval?

Re: FDA Approves First Covid-19 Vaccine

#278

Earlier quoted context omitted.

Again with this argument. This particular decision with their bodies is harming others. Getting really drunk and driving home is also a decision about your body. So is smoking inside restaurants. Those have been illegal for a while. For those of us who got the vaccine, we’re still having to take precautions because of the delta variant spikes, largely from people who didn’t get a vaccine. Where is our choice?

> we’re still having to take precautions because of the delta variant spikes, largely from people who didn’t get a vaccine That's because the manufacturers lied about efficacy in the first place. The whole theory for these mRNA vaccines was that by targeting the 'spike' protein, the vaccine would be resistant to mutant strains because that protein is what binds to the ACE2 receptors and allows infection. If that prot…

> You choice was to fund therapeutics that cure the disease, or try to enforce mandates. You chose wrong, now you live with the choice.

You do know that there's a ton of investment going into curing Covid, right? But you can't just "magic" a cure out of thin air.

Re: FDA Approves First Covid-19 Vaccine

#279

Often people use the argument that this vaccine was really rushed and there could potentially be side effects to such a rushed vaccine. There is one example of this actually happening. Have a look at what happened with the pandermix vaccine: narcolepsy.org.uk/blog/important-ruling-pandemrix-case https://www.theguardian.com/world/2019/nov/20/swine-flu-vacc...

It is my understanding that simply waiting for a longer time would not have helped. This side effect did not come much later after the vaccination, but only in very rare cases, which is why it took some time to notice it. Considering how many people we vaccinated with the Covid vaccines, we should have seen (and have seen, with myocarditis, trombosis) such rare side effects. Plus, it is likely that the disease itself would have a similar effect on patients, because it is an interaction of the immune system with the nervous system. The vaccine itself is cleared from the body within weeks, after all, so it's not like medicine that is taken over a long period of time and can build up.

So what you need is not longer trials, but trials with more people. Which is what is done in so called phase 4 trials after approval.

Re: FDA Approves First Covid-19 Vaccine

#280
post #266
post #163

Earlier quoted context omitted.

This is also about what’s coming out of their bodies and going into others’.

Making it illegal to harm someone by transmitting a disease to them, and all of the logistical problems with proving it, makes more sense than mandating the covid vaccine.

Triple health insurance premiums for people who refuse to vaccinate, like car insurance companies do when you get caught driving drunk. We can keep our precious "bodily autonomy" while still making sure reckless behavior is costly.
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