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FDA Approves First Covid-19 Vaccine

585 pointsby PaulAnundaover 3 years ago

25 comments

dangover 3 years ago
To read all the 1000+ comments in this thread you need to click More at the bottom or on links like this:<p><a href="https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=28275509&amp;p=2" rel="nofollow">https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=28275509&amp;p=2</a><p><a href="https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=28275509&amp;p=3" rel="nofollow">https:&#x2F;&#x2F;news.ycombinator.com&#x2F;item?id=28275509&amp;p=3</a><p>(Comments like this will eventually go away. Sorry for the annoyance.)
matt_sover 3 years ago
An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0].<p>Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs.<p>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.<p>[0] <a href="https:&#x2F;&#x2F;healthtalk.unchealthcare.org&#x2F;whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval&#x2F;" rel="nofollow">https:&#x2F;&#x2F;healthtalk.unchealthcare.org&#x2F;whats-the-difference-be...</a>
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vvilliamperezover 3 years ago
Like someone else mentioned, I think the core issue is &quot;Should the government have the right to mandate medical procedures?&quot; In my mind, I&#x27;m vaccinated, so what does it matter to me if others are not?
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wingineerover 3 years ago
Does this have any effect on the exemption from liability for this drug or is that still in effect until 2024? I haven&#x27;t seen any language on this.
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hartatorover 3 years ago
Interesting that most comments focus on the social aspect of this instead of deciphering the science behind that approval.
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appleflaxenover 3 years ago
Any physician may prescribe any FDA-approved medication outside the scope of the label if it&#x27;s indicated in their medical judgment.<p>That means that it may be prescribed to individuals &lt;18 in some circumstances, and that it&#x27;s legal to do so (explicit emergency authorization notwithstanding).
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throwawayboiseover 3 years ago
Does this end the waiver of liability that was granted under the EUA?
thepasswordisover 3 years ago
People don’t want to take the vaccine because others are trying to force them to.<p>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.<p>I don’t think we should be able to require them to.<p>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.<p>And honestly: I was one of the first to take it, but the desire to almost <i>force</i> me to take a booster, and the weird, Orwellian ways that the government talks about it, has turned me against the booster.<p>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.<p>Anybody who has ever lived under an HOA will recognize this.
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ibejoebover 3 years ago
Now do Covaxin.<p>Seriously: what&#x27;s the hold-up? Why is the US still blocking this vaccine?
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yaloginover 3 years ago
The approval is specifically for 12 and over. Any word&#x2F;guesses on when it would be available for the rest?
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teerayover 3 years ago
So does this mean Moderna and J&amp;J can’t be administered now since there is an approved vaccine?
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kristjanssonover 3 years ago
All of these comments following the pattern &quot;I&#x27;m vaccinated but [insert vaccine hesitancy content here]&quot; sound quite a lot like the &quot;I&#x27;m a democrat but [insert pro-trump content]&quot; comments that abounded in the last cycle.<p>I don&#x27;t know what to make of it. Is this a rhetorical strategy that really works? A tic of people experiencing cognitive dissonance?
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joefifeover 3 years ago
A large number of those objecting to the vaccine have serious needle phobia and don&#x27;t wish to admit this publicly.<p>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.<p>There are alternative delivery methods being tested, such as by Pharmajet.<p>I suspect that when needle phobia is addressed in a less hostile light, you may find an increase in uptake.
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rpowersover 3 years ago
Great. When can my younger kid get it?
b0tzzzzzzmanover 3 years ago
Hacker news is turning into Reddit style comments section.<p>Can we talk about natural immunity and the path forward?
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queuebertover 3 years ago
&quot;Comirnaty&quot;?<p>What does that even mean?<p>Do marketing people just play Flappy Bird all day?
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umviover 3 years ago
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&#x27;s all the in-fighting and social discord.
2OEH8eoCRo0over 3 years ago
Do you hear that? It&#x27;s the sound of millions of goalposts being moved.
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zabatuvajdkaover 3 years ago
Whoever named it Comirnaty needs to stop taking Hydroxychloroquine.
acdhaover 3 years ago
I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics&#x2F;greed”.<p>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.
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eganistover 3 years ago
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.<p>So with that in mind, I&#x27;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&#x27;t already this morning) based on the news? Guessing a few probably had their policies and news pre-written in anticipation.
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menduza23over 3 years ago
Often people use the argument that this vaccine was really rushed and there could potentially be side effects to such a rushed vaccine.<p>There is one example of this actually happening. Have a look at what happened with the pandermix vaccine:<p>narcolepsy.org.uk&#x2F;blog&#x2F;important-ruling-pandemrix-case<p><a href="https:&#x2F;&#x2F;www.theguardian.com&#x2F;world&#x2F;2019&#x2F;nov&#x2F;20&#x2F;swine-flu-vaccine-case-settled-but-hopes-for-legal-precedent-dashed" rel="nofollow">https:&#x2F;&#x2F;www.theguardian.com&#x2F;world&#x2F;2019&#x2F;nov&#x2F;20&#x2F;swine-flu-vacc...</a>
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megousover 3 years ago
There are people with long term issues starting right after vaccination. Not safety issues, which everyone and their dog studies, just multi-month constant pain that will not kill you but just disables you from your normal life for months, that is not solvable by regular NSAIDs, as usual, and that you&#x27;ll get no compensation for from anyone.<p>I&#x27;m just interested in how common this is after vaccination, and perhaps when may this end, so I again spent a few hours yesterday to try to find some significant (N &gt; 5000, preferably more) independent prospective studies of &quot;mild&quot; side effects like these of this vaccine.<p>So much vaccination going on, so why not just give every 5th person vaccinated in some large center a link and a code to enter observed side effects after 1 day, 3 days, week, and a month, and then maybe 3 months after into some website. Maybe ask for a phone number and call them to ask, if they don&#x27;t fill the form in time. Even such a stupid study design would satisfy me.<p>No such thing on google scholar.<p>There are barely any studies that track side effects over time. It&#x27;s almost all just binary X,Y,Z side effects after vaccine - yes&#x2F;no. All studies I could find are &lt; 1000 people or in that range.<p>The small amount of studies that actually tracked side effects <i>over time</i>, just track for 7 days and end with 4% people still having side effects after a week. One Czech study I found tracked side effects for a month! With 2% having still issues after a month. Well, good! No, not really, N&lt;1000 again, and a biased survey style study.<p>Also the fucking irony of search returning about 5-10x more so called &quot;hesitancy&quot; studies per a side effect survey, despite me not search for it.<p>I&#x27;m fully vaccinated, and there&#x27;s no shortage of studies about efficacy, so no problem there. But people that proclaim how well the side effects are studied, because of how many millions of people were already vaccinated just sound ridiculous to me now. Where are all the actual studies?<p>From what can be found it just seems that very little fuck is given about serious study of so called &quot;mild&quot; side effects, and some guidance given on how to mitigate them, based on results.<p>(&quot;no compensation for from anyone&quot; is because my country actually passed a law that allows for compensation for covid vaccine gone wrong; but with no proof of some statistical relationship, this was just another bullshit anti-hesitancy stunt from the government, and will be of no real help to the affected)
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balb0aover 3 years ago
From ones body perspective. What is the reason to take vaccine risk if you are healthy &lt;~50&#x2F;have no disease that complicate covid recovery?<p>From societal perspective, why would you do it if you can transmit it in the same amount as if you are not vaccinated?<p>Doesn&#x27;t makes sense to me, but well..<p>I do think that it&#x27;s a good thing for people that have disease that can complicate covid recovery and older generations.
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throwawaay_3424over 3 years ago
I don&#x27;t get why people are so afraid of the VaaS model (vaccine as a service). If we already buy all our entertainment on a monthly basis, then I don&#x27;t see an issue in mandating quarterly or biannual immune system boosters to protect against the virus. Vaccine passports are a different issue. I would probably sign up for VaaS, but governments could use mandates aggressively, and it&#x27;s not far off to imagine how people end up in concentration camps from there. As Plato put it, democracy ends in tyranny, so this is to be expected&#x2F;embraced