people are refusing to take the Vaccine because they don’t trust his Administration
Would’ve helped if you had acknowledged getting vaccinated you absolute pile of feces.
I dunno, I feel like this take makes the FDA look absolutely horrible. This is the worst public health crisis in a century, and you have them shrugging and saying “The rules are the rules” like the stereotypical DMV employee when you have the wrong 6 forms of ID. And to boot, they’ve already pushed this drug out to like 150 million people! They really needed to be confident that the drug was safe before they let that happen! (Which, to be clear, I believe they were completely and correctly confident about.)
The take that makes the FDA look reasonable is that they don’t really think EUA vs full approval matters for adults and they have genuine cost-benefit concerns about kids getting the vaccine before they can fully evaluate the data from the juvenile trials.
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I sort of see it as the equivalent of saying we might be facing the greatest national security threat in the country’s history, but the rules are the rules and you still have to follow things like habeas corpus rather than your DMV example.
The FDA is certifying that the vaccine meets a certain level of safety, as determined by rigorous testing and analysis of data. Asking them to change those standards is asking them to make a political decision.
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I’m like 90% sure it’s illegal unless it’s an fda approved thing, this law came after they shot a bunch of people up with massive amounts of LSD in the 60s.
It’s not though, that’s the whole point of having an emergency authorization in the first place. It’s not been given the full testing we’d normally insist on, but given the stakes and the time crunch we should still be rushing it out there.
The #1 problem is still the Fox News / Facebook disinfo campaign that’s feeding complete lies to millions of people. The people who won’t get an Emergency Authorized vaccine but will get a Fully Authorized vaccine exist only in Marty’s head. Obv that’s a bitter pill for a libertarian hot take artist, so he has to find convoluted ways to blame the FDA.
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What’s interesting that I’m just reading about now is that the justification for the emergency use authorizations is actually extremely shady. You can find the emergency declaration here. Here’s some of the preamble:
Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a, chemical, biological, radiological, or nuclear (“CBRN”) agent or agents; (2) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act [1] sufficient to affect national security or the health and security of United States citizens living abroad; (3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or (4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents.
And here’s the meat of it:
On February 4, 2020, pursuant to section 564 of the FD&C Act, I determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19.
(‘I’ here means the Secretary of HHS.) So if you put those two bits together, this is a declaration under prong (4) of section 564, which requires a public health emergency that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents. Which, um, does not seem to be true at all? I mean, is the theory that maybe COVID “may” be a bioweapon after all and that’s the foundation of the whole edifice for vaccination?
I’m completely here for this approach, but it’s hard to square with a picture of the FDA as an organization that’s just dutifully following the rules and is deathly afraid of letting “politics” interfere with their disinterested scientific process. Indeed, unless I’ve gotten something wrong here, the EUA justification seems like a lot more of a stretch than dispensing with the whole new drug application process and saying that the vaccines are generally recognized as safe and effective based on the fact that many millions of people have gotten them without significant issues. Not saying that’s a good idea, but if you think the FDA is just following the rules, you’re gonna miss what’s really going on. (And if you think the FDA should just be following the rules, you ought to be raising your eyebrows about these EUAs.) But just to reiterate, that’s not what they’re doing and it shouldn’t be.
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I read that as prong 2.
Doesn’t seem like it has to be a bioweapon for part two of that justification.
I thought about that, but the language doesn’t really track right, and there’s no reference to the required determination by the Secretary of Homeland Security. But in any case, if you dig into section 319F-2, you find this definition of a material threat:
(2) Determination of material threats
(A) Material threat
The Homeland Security Secretary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis-
(i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security.
(B) Public health impact; necessary countermeasures
The Secretary shall on an ongoing basis-
(i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and
(ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health.
So you end up in the same place.
The term “biological agents” includes naturally occurring agents. Release of biological agents can be natural, intentional, or accidental. “Biological agent” does not imply bioweapon in the technical jargon of writing legislation, even though it may heavily imply that in common, everyday language.
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bob dude come on biological agents doesn’t exclusively mean bioweapons
eta: I think you’re reading too much origin nonsense.
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It seems kind of silly that the emergency authorization would only cover bioweapons and not naturally occurring bio-threats.
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This is an unnecessary rabit hole dude
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You can definitely say this, but it’s the sort of thing you say when you’re straining to achieve a result with unpromising language, not a good interpretation of the words. No normal person would look at the phrase “chemical, biological, radiological, or nuclear agent” and say “oh, that means weapons of mass destruction, plus any infectious disease” (or maybe any living thing? Does “chemical agent” mean any substance?).
Confused by the likes on this post, as it’s liked by people who have argued vociferously exactly what Rand Paul says in the recent Paul v Fauci thing. Have we changed our minds?
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walk it back bob
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oh good grief take it to AU
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It’s the sort of thing you would say when you’re a lawyer or a judge. The opinion of a normal person does not matter.
Vaccines are still quite effective against the delta variant. We also know quite well what the riskiest activities are: those that involve being unmasked indoors with lots of other unmasked people. If you want to be extra cautious out of respect for your mom, which is entirely reasonable, but you also don’t want to be a hermit, then the things to avoid are exactly those. Wearing a mask while doing regular shopping is of little cost to you or anyone around you, and it can be an extra layer of security. If you want to eat out, pick a place with outdoor dining. I’m not sure if your mom needs so much support that it’d be unreasonable to take her along on such an outing, but covid isn’t a big risk to a vaccinated person outdoors even if they’re “high risk.” And it is still a good idea to keep an eye on the local case load. If you’re seeing a big spike, then it’s good to be more cautious.
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