An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0].
Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs.
In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval.
This flow chart is not quite accurate, or at least is misleading. There is more to a distinction between EUA and full FDA approval than where manufacturing happens. The FDA's own website[0] says:
> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.
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.
Like someone else mentioned, I think the core issue is "Should the government have the right to mandate medical procedures?"
In my mind, I'm vaccinated, so what does it matter to me if others are not?
Really? Because if others are the pandemic will end and mutations won’t happen and if you need to go to the hospital it won’t be over booked. And a myriad of other reasons.
Unrelated to approval status. We handle vaccine injury compensation via a special court and system funded by a tax on vaccine doses so manufacturers don't nope out and threaten the production of vaccines entirely.
The switch from experimental to full approval is mostly about repeatable and certified manufacturing and logistics. There is no new science in this approval.
The most interesting science is not public and probably never be. What, if any, internal debate was occurred at the FDA, their pre-approval questions for manufacturers, and their responses, ect.
Without this, all we really have to go on is the public information that was release a year ago.
Any physician may prescribe any FDA-approved medication outside the scope of the label if it's indicated in their medical judgment.
That means that it may be prescribed to individuals <18 in some circumstances, and that it's legal to do so (explicit emergency authorization notwithstanding).
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 would have burned over it.
And honestly: I was one of the first to take it, but the desire to almost force me to take a booster, and the weird, Orwellian ways that the government talks about it, has turned me against the booster.
It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do.
Anybody who has ever lived under an HOA will recognize this.
>Anybody who has ever lived under an HOA will recognize this.
My HOA telling me to take Christmas decorations down in January doesn't really equate to the government trying to keep me and my community alive and out of the hospital. Don't like the HOA covenants? Move. Don't want the vaccine? Stay away from places that will now be allowed to require vaccination.
we don't require anyone to take the vaccine, and we will never require anyone to take the vaccine. What we should and will do is restrict what someone who is not vaccinated can do to limit the harm they will cause to others. No one is going to bang down your door and force a vaccine into your arm, but if you do not want to get vaccinated you will need to change your life because you will be restricted from participating in many things where you are a danger to others.
The FDA asked for information on the stage 3 clinical trails (which is a normal thing to get) and instead of providing it they decided to go for full approval.
Which is really strange. Unclear why they would do that.
Nobody knows when under 12 will get an EUA: they need more data before they can apply. Rumor is they will have the data soon and so the EUA will happen by the end of September. This is just a rumor: it seems likely, but could be wishful thinking.
All of these comments following the pattern "I'm vaccinated but [insert vaccine hesitancy content here]" sound quite a lot like the "I'm a democrat but [insert pro-trump content]" comments that abounded in the last cycle.
I don't know what to make of it. Is this a rhetorical strategy that really works? A tic of people experiencing cognitive dissonance?
A large number of those objecting to the vaccine have serious needle phobia and don't wish to admit this publicly.
The most common presentation is mild anxiety, but in more serious instances, a needle phobic person may pass out or be genuinely convinced they are having a cardiac arrest.
There are alternative delivery methods being tested, such as by Pharmajet.
I suspect that when needle phobia is addressed in a less hostile light, you may find an increase in uptake.
Can you point to any papers demonstrating natural immunity? I ask as my virologist friend, working on covid-related projects, says to me that it hasn't been shown to be plausible. Which, intuitively, makes sense because of (1) the positive effects vaccines have on reducing severity of the disease and (2) the cycle of variants we see and its path forward.
Yes, the whole argument of vaccines, lockdowns, masks are moot when you consider that the default position should have always been - if you're scared of the virus, stay home. If the virus was that dangerous, we would not need a global marketing campaign to tell us to how to be safe. The last 2 years defies all logic and common sense.
Community + mRNA, if I'm remembering right. Marketing is a joke for these ones. Every government agency on earth is doing the marketing for them for free.
Honestly, one of my life goals is to somehow tap into creating a plausibly excusable place for companies to dump their marketing dollars, I feel like that's one of the secrets to an easy life.
The real question is whether covid or all the in-fighting around politicization of covid is doing more harm to society. I almost think it's all the in-fighting and social discord.
[+] [-] dang|4 years ago|reply
https://news.ycombinator.com/item?id=28275509&p=2
https://news.ycombinator.com/item?id=28275509&p=3
(Comments like this will eventually go away. Sorry for the annoyance.)
[+] [-] matt_s|4 years ago|reply
Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs.
In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval.
[0] https://healthtalk.unchealthcare.org/whats-the-difference-be...
[+] [-] colinmorelli|4 years ago|reply
> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.
[0] https://www.fda.gov/consumers/consumer-updates/understanding...
[+] [-] ericcholis|4 years ago|reply
[+] [-] vlovich123|4 years ago|reply
Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.
[+] [-] vvilliamperez|4 years ago|reply
[+] [-] eddieroger|4 years ago|reply
[+] [-] a_imho|4 years ago|reply
https://twitter.com/ksorbs/status/1417538663018344448
Remember to get vaccinated or a vaccinated person might get sick from the virus that they were vaccinated against because you’re not vaccinated.
I'm really interested a rebuttal to this.
[+] [-] barfingclouds|4 years ago|reply
[+] [-] wingineer|4 years ago|reply
[+] [-] ceejayoz|4 years ago|reply
https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...
[+] [-] hartator|4 years ago|reply
[+] [-] bart_spoon|4 years ago|reply
[+] [-] nl|4 years ago|reply
[+] [-] s1artibartfast|4 years ago|reply
Without this, all we really have to go on is the public information that was release a year ago.
[+] [-] linuxftw|4 years ago|reply
[deleted]
[+] [-] appleflaxen|4 years ago|reply
That means that it may be prescribed to individuals <18 in some circumstances, and that it's legal to do so (explicit emergency authorization notwithstanding).
[+] [-] xiphias2|4 years ago|reply
[+] [-] throwawayboise|4 years ago|reply
[+] [-] thepasswordis|4 years ago|reply
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 would have burned over it.
And honestly: I was one of the first to take it, but the desire to almost force me to take a booster, and the weird, Orwellian ways that the government talks about it, has turned me against the booster.
It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do.
Anybody who has ever lived under an HOA will recognize this.
[+] [-] learc83|4 years ago|reply
Public schools, colleges, and the military have been requiring vaccines for decades.
>It ends up feeling less like the decisions are guided by science and more like they’re guided by petty tyrants wanting to control what others do.
This sounds like a result of reading about what health care and government officials are saying instead of actually reading what they are saying.
[+] [-] eddieroger|4 years ago|reply
My HOA telling me to take Christmas decorations down in January doesn't really equate to the government trying to keep me and my community alive and out of the hospital. Don't like the HOA covenants? Move. Don't want the vaccine? Stay away from places that will now be allowed to require vaccination.
[+] [-] 0xB31B1B|4 years ago|reply
[+] [-] ibejoeb|4 years ago|reply
Seriously: what's the hold-up? Why is the US still blocking this vaccine?
[+] [-] ceejayoz|4 years ago|reply
Other countries are entirely free to approve it for their citizens.
[+] [-] nl|4 years ago|reply
Which is really strange. Unclear why they would do that.
https://www.hindustantimes.com/india-news/why-was-bharat-bio...
[+] [-] giantg2|4 years ago|reply
[+] [-] yalogin|4 years ago|reply
[+] [-] bluGill|4 years ago|reply
Nobody knows when under 12 will get an EUA: they need more data before they can apply. Rumor is they will have the data soon and so the EUA will happen by the end of September. This is just a rumor: it seems likely, but could be wishful thinking.
[+] [-] eli|4 years ago|reply
[+] [-] rpowers|4 years ago|reply
[+] [-] xdennis|4 years ago|reply
[+] [-] teeray|4 years ago|reply
[+] [-] jasongill|4 years ago|reply
[+] [-] kristjansson|4 years ago|reply
I don't know what to make of it. Is this a rhetorical strategy that really works? A tic of people experiencing cognitive dissonance?
[+] [-] joefife|4 years ago|reply
The most common presentation is mild anxiety, but in more serious instances, a needle phobic person may pass out or be genuinely convinced they are having a cardiac arrest.
There are alternative delivery methods being tested, such as by Pharmajet.
I suspect that when needle phobia is addressed in a less hostile light, you may find an increase in uptake.
[+] [-] the_doctah|4 years ago|reply
[+] [-] rpowers|4 years ago|reply
[+] [-] b0tzzzzzzman|4 years ago|reply
Can we talk about natural immunity and the path forward?
[+] [-] Qub3d|4 years ago|reply
> Please don't post comments saying that HN is turning into Reddit. It's a semi-noob illusion, as old as the hills.
[+] [-] hall0ween|4 years ago|reply
[+] [-] president|4 years ago|reply
[+] [-] unknown|4 years ago|reply
[deleted]
[+] [-] queuebert|4 years ago|reply
What does that even mean?
Do marketing people just play Flappy Bird all day?
[+] [-] thehappypm|4 years ago|reply
[+] [-] TameAntelope|4 years ago|reply
Honestly, one of my life goals is to somehow tap into creating a plausibly excusable place for companies to dump their marketing dollars, I feel like that's one of the secrets to an easy life.
[+] [-] umvi|4 years ago|reply
[+] [-] 2OEH8eoCRo0|4 years ago|reply
[+] [-] zabatuvajdka|4 years ago|reply