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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#641

Post by collias »

azinman2 wrote: post #605
collias wrote: post #576

Earlier quoted context omitted.

It definitely hasn’t been clear “for a while now” that the vaccine is safe. They do seem to be effective, though. It really depends on what your definition of “safe” is. The vaccines have stated side effects, some of which can severe. The side effects are relatively rare, but non-zero. The other component is time. We’ve proven that the vaccine is mostly safe…for at least a year out. After that, we have no data. You d…

Getting Covid is not safe, like at all, so it’s so bizarre to me that anyone would look at the safety profile of a vaccine in a vacuum. Any medication has rare side effects. Tylenol has rare side effects that can be severe. Covid has direct effects that are common and severe. Cigarettes and asbestos are not vaccines and are thus evaluated totally differently (and at a totally different point in time). In past vaccine…

I never claimed getting covid was safe, only that we don’t have long-term data on the vaccines.

Re: things like Tylenol, the difference is we have a ton of long term data on that, and the interactions with things like alcohol or other drugs are well known.

The fact that the FDA made a point to say that the vaccine was studied for eight whole weeks is worrisome, for something that most of the population will be forced or at least coerced into taking.

Re: FDA Approves First Covid-19 Vaccine

#642

Post by rootusrootus »

thehappypm wrote: post #321
orangegreen wrote: post #308

Earlier quoted context omitted.

It's not really about you. It's about preventing other, more vulnerable people from getting sick. Living in a society means giving up some of your freedoms in exchange for security, and getting vaccinated as a way to help other people should be part of that exchange.

I don't agree with this, in general. We shouldn't give up our freedoms. "Those who would give up essential Liberty, to purchase a little temporary Safety, deserve neither Liberty nor Safety." (Benjamin Franklin) We should be motivated by a desire to help one another, and resist when freedoms are removed. That being said, if businesses want to exercise their freedoms to make life more difficult for the unvaccinated, s…

Well, Ben meant literally purchasing, not figuratively, since that quote likes to be given out of context. The vaccine is free.

Re: FDA Approves First Covid-19 Vaccine

#643

Post by spiderice »

bmarquez wrote: post #604
spiderice wrote: post #575

Earlier quoted context omitted.

Agreed. It's some variation of an "appeal to authority" logical fallacy (there may be a different logical fallacy that fits better), where the truthfulness of what you say is somehow thought to be influenced by whether or not you've had the vaccine. Even though those 2 things are completely unrelated.

Unfortunately, if he fails to say that he risks getting downvoted, flagged, or labeled as a conspiracy theorist. This is not limited to the medical field, I was once downvoted on an HN comment until I edited it to state that I wasn't supporting Trump, because people were reading it that way.

> until I edited it to state that I wasn't supporting Trump

It's funny you mentioned this because my original comment was something along the lines of:

"""

2016-2020: "I hate Trump, but..."

2021: "I got the vaccine, but..."

"""

But I erased that and wrote my comment above because I thought it had a lower chance of being downvoted.

Re: FDA Approves First Covid-19 Vaccine

#644

Post by niij »

dabeeeenster wrote: post #531
thepasswordis wrote: post #200

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…

HOA? Why do HNers habitually use obscure acronyms?! So frustrating!

It's not obscure. HOA means Home Owners Association, Google "HOA definition" for more information.

From a cursory search ~25% of Americans are a part of one.

Re: FDA Approves First Covid-19 Vaccine

#645

Post by handoflixue »

criticaltinker wrote: post #596
DangerousPie wrote: post #485

Earlier quoted context omitted.

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…

> the Pfizer vaccine works and is safe Yes the vaccine has been proven to be safe for most adults in the short-term. But blanket statements like this over-simplify the reality of the situation. People need to be aware that for certain sub-populations (eg pediatrics & pregnant women), there is insufficient scientific evidence - in terms of clinical trials and longitudinal studies - to conclude that the benefits of vac…

Just to be clear, by the standard you're proposing there's also no scientific evidence that posting on Hacker News is safe. There is no scientific evidence that the internet is safe. There is no scientific evidence that wearing a mask is safe.

There is, of course, an INCREDIBLE amount of EVIDENCE for all of these things being safe (including the vaccine). There has simply never been a 100% complete full evaluation of safety to the rigorous standards of an academic paper.

But it's really important to understand that we know TONS of things without having that rigor, and we don't hold the vast majority of our life to that standard.

Heck, we outright know that driving IS dangerous, ridiculously so compared to taking a vaccine, but we still allow that.

Re: FDA Approves First Covid-19 Vaccine

#646

Post by snarf21 »

acdha wrote: 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.

This won't help at all. The narrative will indeed move from unapproved to rushed. This is just like a run of the mill FB post: ain't nobody convincing nobody of nothing! The FDA screwed up and should have just announced it was fully approved back in December, torpedoes be damned.

Re: FDA Approves First Covid-19 Vaccine

#647

Post by 3l3c7r1c »

neither_color wrote: post #570
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…

>I'm already triple vaxxed (booster), May I ask why? I've had two shots without much hesitation but this whole booster thing came out of nowhere and gives me "fool me twice" vibes. I understand getting a flu shot every year to target new strains but this would be the exact same shot as 8 months ago.

Body takes repeat threat way more seriously. That's the reason second dose of vaccine mRNA creates about 10x more antibodies. Almost all kids vaccine require a second or even 3 shots with months of gap in between to create stronger immunity. (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolesc...)

If you keep a tab on the news you might have seen antibody level from covid vaccines drops significantly over time. Actually same is true for people already have covid; natural protection wanes off within few months.

Re: FDA Approves First Covid-19 Vaccine

#648

Post by OJFord »

giarc wrote: post #601
albatross13 wrote: post #479

Earlier quoted context omitted.

I think it is, when you read Pfizer's contract and fact0r in things like "Governments have to pay, regardless of whether or not the shipment arrives: on time, damaged, or at all". I suggest you browse their leaked contract: https://www.documentcloud.org/documents/20616251-albanian-pf... Pfizer has also been strong arming small, Latin American countries, to the tune of trying to get military assets as "collateral" ( h…

>Governments have to pay, regardless of whether or not the shipment arrives: on time, damaged, or at all Wouldn't this be standard language in any contract? If I buy a widget and they ship it to me, if it gets damaged in transit, or lost in transit I still have to pay the producer, I then go after the delivery company (and/or their insurance) for compensation.

I've never handled such things for a business, but I'd assume it'd be the same as in my personal life - that's the seller's problem?

If something arrives (late, if I care) damaged, or not at all, from Amazon or whatever, I tell them and they refund me or ship a replacement.

Re: FDA Approves First Covid-19 Vaccine

#649

Post by breck »

jpollock wrote: post #502
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!…

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.

From the December FDA report: "The expected duration of study participation is approximately 25 months".

At the time they dissolved the control group, the fatality rate in control and placebo were the same. By their very own data they did not have a strong case that they would be "condemning...a fraction of the control group to die.". One would have to make a leap. A plausible leap, but a leap nonetheless.

Let's assume though that the fatality rate across the population for COVID was 1%, a very high number, to be conservative. So in that case you'd expect ~150 preventable fatalities in the control group. We now have ~that many fatalities, in a single state (Massachusetts), from COVID-19, in people who were "fully vaccinated".

You can do the math and extrapolate that there are now orders of magnitude more deaths from "breakthrough infections" than might have been in the placebo control group. If we had known that the efficacy of these vaccines was going to fall significantly, might some of those deaths have been prevented? I think there's an argument to be made there.

Now we have statisticians scrambling over themselves with complex methods to figure out what the hell is going on, when we could have had the gold standard which would be quite simple to interpret, if we had kept those control groups.

Now some argue it would have been completely impractical to maintain that control group amidst a mass vax campaign (I think we should have tried, regardless). I think there's room to debate that. But in that case I think we need a vast upgrade to our data infra, because giving up the placebo control group was a huge loss (for truth and science, at least).

Re: FDA Approves First Covid-19 Vaccine

#650

Post by nanis »

leesalminen wrote: post #594
collias wrote: post #576

Earlier quoted context omitted.

It definitely hasn’t been clear “for a while now” that the vaccine is safe. They do seem to be effective, though. It really depends on what your definition of “safe” is. The vaccines have stated side effects, some of which can severe. The side effects are relatively rare, but non-zero. The other component is time. We’ve proven that the vaccine is mostly safe…for at least a year out. After that, we have no data. You d…

Don’t forget Vioxx!

> Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.

> Five years after Vioxx's launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide.

[1]: https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and...

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