Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

FDA Approves First Covid-19 Vaccine

fda.gov

Post reply on HN
Print view View original

141–150 of 1001 posts

Re: FDA Approves First Covid-19 Vaccine

#141

Post by deeg »

tohnjitor wrote: post #73
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.

FDA approval is mostly meaningless. Just this year they approved an Alzheimer's treatment which ended clinical trials early because it didn't work. https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...

"mostly meaningless" is an overstatement. The FDA oversees a lot of drug applications and gets it right a vast majority of the time. No human endeavor is perfect; if there's evidence that 20% of approvals are wrong then I'll agree that there's a problem.

Re: FDA Approves First Covid-19 Vaccine

#142

Post by PragmaticPulp »

tohnjitor wrote: post #73
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.

FDA approval is mostly meaningless. Just this year they approved an Alzheimer's treatment which ended clinical trials early because it didn't work. https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...

No, it’s not meaningless. That’s hyperbole and a misunderstanding of what’s going on.

That story was all over the headlines not because it was normal. It was in headlines, and in the front of your mind, because it was the exception that proves the rule. That’s not typical.

Regardless, the FDA approval was mostly about assessing safety of the drug in controlled trials and follow-ups. Likewise, the vaccine studies were rigorous examinations of safety and an in-depth search for warning signs that might indicate problems in small populations. The correct interpretation of this approval is to see that it has been thoroughly examined for safety in the field.

Finally, we already have mountains of evidence that the vaccine is effective. That much is not in question after administering an incredible number of doses globally and observing the outcomes. Proving efficacy was the least of the FDA’s concerns at this point.

Re: FDA Approves First Covid-19 Vaccine

#143

Post by wpasc »

tohnjitor wrote: post #73
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.

FDA approval is mostly meaningless. Just this year they approved an Alzheimer's treatment which ended clinical trials early because it didn't work. https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...

To look at that Alzheimer's approval and then conclude that FDA approval is mostly meaningless is a pretty strong statement based off of that alone. Even if you add in high profile drugs that were approved and later were shown to cause huge problems, it still doesn't make FDA approval meaningless. It's pretty hard to get a drug to be FDA approved and means quite a bit.

Re: FDA Approves First Covid-19 Vaccine

#144

Post by nl »

nanis wrote: post #52
spywaregorilla wrote: post #28

Earlier quoted context omitted.

I think you put on your tinfoil hat by mistake there buddy. None of the numbers you provided have any sort of relevance to the links you posted. Net breakthrough deaths, as far as I can tell, is not a real metric. And only 4 million people have died of covid globally to begin with...

> I think you put on your tinfoil hat by mistake there buddy. Condescension is not helpful. > Net breakthrough deaths, ..., is not a real metric. What terminology would you recommend for getting the number of people who died from Covid19 after being fully vaccinated against Covid19? >> Deaths† 1,587 (20%) >> †341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19. The numbers are from the…

Are you claiming this is good or bad?

By comparison, in some years the influenza vaccine is under 40% effective. 0.9 deaths per 1 million is amazing (especially given the likely age profile).

See https://www.webmd.com/lung/news/20200902/how-effective-is-th... for some information about the flu vaccine.

In April the vaccination rate was much lower. In a hypothetical situation where 100% of people are vaccinated, all Covid deaths will be vaccinated people.

With so small numbers if vaccinated people dying we should expect that deaths per million to jump around depending on regional outbreaks for a while.

Re: FDA Approves First Covid-19 Vaccine

#145

Post by ceejayoz »

sithlord wrote: post #111
ceejayoz wrote: post #65

Earlier quoted context omitted.

> The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/af... > Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.

I'll start by saying I am vaccinated, got it the first week immunocompromised people could: But I do not believe that this is valid at all, being that this is the very first mRNA vaccine. >By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks. I feel like what you are saying is basically like someone asking "How do we know that self driving cars will be safe on t…

This is not the first mRNA vaccine. It's the first to reach full approval, but we've been testing them in humans for a decade now. https://ec.europa.eu/research-and-innovation/en/horizon-maga...

Re: FDA Approves First Covid-19 Vaccine

#147

Post by amrcnimgrnt »

felipellrocha wrote: post #55
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.

Huge odds. People were anti-vaxxers before, and were just looking for an excuse to justify their position. Goal post moving is a thing to be expected nowadays

It wasn't an excuse. It was just the easiest way to get street preachers on a power trip to bugger off

Re: FDA Approves First Covid-19 Vaccine

#148

Post by nanis »

nanis wrote: post #119
spywaregorilla wrote: post #92

Earlier quoted context omitted.

> What terminology would you recommend for getting the number of people who died from Covid19 after being fully vaccinated against Covid19? "Breakthrough deaths" not "Net breakthrough deaths" Your post is flagged and unreadable now but I'm pretty sure you were claiming 8 million breakthrough deaths. That's obviously wrong because it's two times larger than the total number of deaths globally among all people. > Since…

> Breakthrough deaths" not "Net breakthrough deaths" That is nonsense. This is the "gross" figure reported by CDC[1]: >> Deaths† 1,587 The footnote is: >> †341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19. So the net number of deaths due to Covid19 in people with breakthrough infections is 1,587- 341. "Breakthrough deaths" would use the gross figure, and result in a breakthrough deat…

Right, now go and downvote an accurate explanation of how a baseless accusation ("you claimed eight million deaths") is wrong.

Also, just saw this:

> Net implies you are counting positives and subtracting negatives.

That is incorrect.

See https://www.google.com/search?q=define%3Anet

> 1 : free from all charges or deductions: such as. a : remaining after the deduction of all charges, outlay, or loss net earnings net worth — compare gross. b : excluding all tare net weight. 2 : excluding all nonessential considerations : basic, final the net result net effect.

Note (2): "excluding all nonessential considerations". In calculating the rate of deaths from Covid19 among those who are fully vaccinated against Covid19, the people who were infected from Covid19 but did not die from it is "nonessential consideration".

There is nothing wrong with using "net" here. Don't hang your hat on it.

If anyone is willing to think, the increasing rate is problematic, because, naturally, there is a lag between when one is vaccinated and infected. Another lag between infection and hospitalization. Another lag between hospitalization and death.

Update: CDC just updated the numbers. The rate of death from Covid19 among those fully vaccinated against Covid19 now stands at 8.6/million. Deleting previous comments about updates not being made.

> compare current deaths of vaccinated individuals vs unvaccinated individuals

That'd be a nice change from the cumulative totals everyone is using. Do you know where I can find those data?

Also, note that the people who haven't yet had their second shot or people whose second shot was less than two weeks ago are counted as "unvaccinated".

> Your math is pointless.

It would only be pointless if we didn't care about correctly estimating the risk of serious illness or hospitalization from Covid19 among the fully vaccinated.

Given the entirety of the current information, it is reasonable to believe that people who's at greatest risk for suffering seriously or die from Covid19 are going to be in that situation with or without a vaccine.

Re: FDA Approves First Covid-19 Vaccine

#149

Post by enumjorge »

peakaboo wrote: post #94
cbg0 wrote: post #13

Earlier quoted context omitted.

More likely than not, they'll just move the goalposts farther and find a different excuse for not getting it.

Even if true, so what? It's their bodies. They should be allowed to choose, just like you are.

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?

Re: FDA Approves First Covid-19 Vaccine

#150

Post by miked85 »

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.

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

Or maybe just stick with the fact that it isn't very effective. [1]

[1] https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v...

Post reply on HN