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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#651

Post by all2 »

DangerousPie wrote: post #490
SV_BubbleTime wrote: post #461

Earlier quoted context omitted.

> 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!…

You can't force people not to get vaccinated for several years in the middle of a pandemic.

No. Quite the opposite.

It seems you can force people to get a vaccine in the middle of a pandemic. France is dealing with massive unrest [0] and are hemorrhaging medical staff [1] because they mandated vaccines for medical professionals (which doesn't make sense, the vaccine doesn't prevent a person from spreading the virus [2]).

[0] https://spectator.org/french-health-pass-riots/

[1] https://www.reuters.com/world/europe/we-have-rights-french-h...

[2] https://www.realclearpolitics.com/video/2021/08/06/cdc_direc...!

Re: FDA Approves First Covid-19 Vaccine

#652

Post by zimpenfish »

christophilus wrote: post #585
rotexo wrote: post #267

Earlier quoted context omitted.

That question might best be prefaced with “here’s what would change my mind… what about yours?” That formulation might come across as more curious and open rather than patronizing. Though I honestly don’t at all understand the mindset of people who don’t want the vaccine, so I have to admit this approach could quite easily still be offensive.

I try to ask myself this question about any important decision I make. When it comes to the vaccine, I got the first shot (Moderna) and had such a terrible week following it that my doctor was fairly convinced I probably already had COVID. Everyone I know had a much stronger reaction to the second shot than to the first, so I've opted to remain partially vaccinated. With Delta in full swing, I'm now reconsidering tha…

> Everyone I know had a much stronger reaction to the second shot than to the first

Counter-anecdata: everyone I know (in the UK[1]) had a much milder reaction to the second than the first - first one knocked most people out for a day or two; second one was half a day in the worst cases, couple of hours in the main.

[1] Which means AZ or J&J, I think, not Moderna. But it's anecdata, it's never going to be 100% helpful.

Re: FDA Approves First Covid-19 Vaccine

#653

Post by handoflixue »

xdennis wrote: post #589
michaelbuckbee wrote: post #221

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.

> Well, what would it take for you to change your mind? A lot of things, but just the top two would be enough: 1) Being able to sue. If you can sue J&J for baby powder, should be able to sue Pfizer for vaccines if anything goes wrong. 2) Falsifiability in government actions. Many rights have been taken away (some permanently) by saying "we just need to do this and then it will all be over" like "a few weeks to flatte…

> Being able to sue.

Why is suing vital? What's insufficient about the existing National Vaccine Injury Compensation Program? https://www.hrsa.gov/vaccine-compensation/index.html (I'm genuinely unfamiliar with any flaws it might have)

> Many rights have been taken away (some permanently)

What rights have been permanently removed? For that matter, what RIGHTS have been even temporarily suspended?

Re: FDA Approves First Covid-19 Vaccine

#654

Post by pgalvin »

notheretoo wrote: post #574
pgalvin wrote: post #558

Earlier quoted context omitted.

This really, really is not true. Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial. This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.

Can you prove your statement by providing an example please?

Sure.

Garasdil was approved by the FDA in 2006 and, as this press release shows [0], continued running studies into it as a condition of the approval. They conceded that full results could not be available before approval; “While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.”

From what I can gather, the Phase III study participants continued to receive follow-up checks for at least a decade.

[0]https://web.archive.org/web/20091019080918/https://www.fda.g...

Re: FDA Approves First Covid-19 Vaccine

#655

Post by XorNot »

giantg2 wrote: post #311
Pyramus wrote: post #249

Earlier quoted context omitted.

Could you explain what you mean by that? We already know Covid can cause autoimmune issues in some patients, so are you saying the effect you describe is just a subset of these, or different?

It's it's that there are known and unknown/suspected risks with both actions. We know that some vaccine recipients develop Graves disease. Some autoimmune diseases take years to develop. So we have risks on both sides, but there's not a lot of information about how common those risks are, especially for longer term effects. So all I'm saying is that the value proposition for an individual is based on the risks associ…

You are arguing "we don't know what'll happen with vaccines" as though you do know the long term risks of COVID-19. You do not - you cannot. COVID-19 has not existed for longer then about 1.5 years.

Other coronaviruses have, but mRNA vaccine technology is about 15 years old - that's how long it's been in development and studied. Long term effects are in fact, known. But if you were concerned about that, you could take J&J or Astrazeneca, both of which are based on adenovirus vector technology and has existed since the 1980s - the clotting side effect is both rare and treatable.

re: Graves disease - [1] is literally a risk of getting COVID-19.

You are engaging in some both-sideism FUD and misrepresenting the technology of vaccines while pretending a brand new novel disease is some well-understood thing.

[1] https://www.healio.com/news/endocrinology/20210519/covid19-m...

Re: FDA Approves First Covid-19 Vaccine

#656

Post by stathibus »

hannob wrote: post #584
Grim-444 wrote: post #439

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?

There is nothing unusual about any of this. A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug. What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd s…

> A drug should be approved once it is very likely causing more good than harm.

Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense.

It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for.

Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.

Re: FDA Approves First Covid-19 Vaccine

#657

Post by Izkata »

oblio wrote: post #253
acdha wrote: post #236

Earlier quoted context omitted.

There are an infinite number of things which could happen but there’s no mechanism or evidence making this likely. The vaccine doesn’t rewrite your DNA and it strengthens your normal immune response, which does none of those things.

Pluuuuuusssss... we don't know the long term impact of Covid itself. People who argue against vaccines don't seem to think enough about that aspect.

Or maybe they're just arguing for the third group: people who already were infected and recovered.

No need to double up on the unknown risks of you already have immunity.

Re: FDA Approves First Covid-19 Vaccine

#658

Post by orblivion »

DangerousPie wrote: post #485
albatross13 wrote: post #430

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…

The only reason there is fear is because people keep posting stories like these without putting them into context. It has been clear for a while now that the Pfizer vaccine works and is safe. Just because Pfizer has chosen to keep collecting data doesn't make that there is any doubt about that. This is also why control groups have been given the option to get vaccinated too. It would be highly questionable to prevent…

It seems reasonable to argue that the control group should have access to the vaccine, but it still makes them not really a control group anymore right?

Re: FDA Approves First Covid-19 Vaccine

#659

Post by handoflixue »

zimpenfish wrote: post #652
christophilus wrote: post #585

Earlier quoted context omitted.

I try to ask myself this question about any important decision I make. When it comes to the vaccine, I got the first shot (Moderna) and had such a terrible week following it that my doctor was fairly convinced I probably already had COVID. Everyone I know had a much stronger reaction to the second shot than to the first, so I've opted to remain partially vaccinated. With Delta in full swing, I'm now reconsidering tha…

> Everyone I know had a much stronger reaction to the second shot than to the first Counter-anecdata: everyone I know (in the UK[1]) had a much milder reaction to the second than the first - first one knocked most people out for a day or two; second one was half a day in the worst cases, couple of hours in the main. [1] Which means AZ or J&J, I think, not Moderna. But it's anecdata, it's never going to be 100% helpfu…

Worth noting that Moderna seems to have a much stronger and different side-effect profile, especially on the second shot. Might explain the difference you're seeing.

Re: FDA Approves First Covid-19 Vaccine

#660

Post by hhsbz »

mikeyouse wrote: post #504
hhsbz wrote: post #462

Earlier quoted context omitted.

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…

Nice, then we can all lift the lockdowns and do away with the masks. Thanks, science!!
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