# AstraZeneca approval in the US **URL:** \ **Category:** The Quarantine Zone\ **Tags:** covid-quarantine\ **Created:** [March 15, 2021, 4:30am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911 "2021-03-15T04:30:21Z")\ **Posts on this page:** 20\ **Page:** 6
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 20, 2021, 3:27pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/101 "2021-03-20T15:27:05Z")
> [@Magiver](#): > > In a worldwide supply and demand situation it doesn’t have to go directly to Europe to benefit them. It only has to go into the total vaccines available to free up supply in Europe. I’m pretty dumfounded that you don’t get this. When a pause in the rollout, even for a week, leaves millions unvaccinated, the release of vaccines elsewhere in the world for future use, when everyone is short, does absolutely nothing to help plug the gap _right now_. I re-iterate, the pause in Europe left appx 2.5 million people unvaccinated. That is an opportunity for infection and death that can’t now be avoided and cannot be repaired. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 3:59pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/102 "2021-03-20T15:59:53Z")
> [@Novelty\_Bobble](#): > > Do you accept that the pause in roll-out has so far cost far more lives than it has saved? I accept the need for the pause and how it was handled. i’m really not sure what you don’t understand about this? You talk of the cost of lives and ignore public safety and confidence. [From Science site:](https://www.sciencemag.org/news/2021/03/european-countries-resume-use-astrazenecas-covid-19-vaccine-hoping-pause-has-not-dented) Some researchers have fretted that the pause, which dominated headlines across the continent this week, may further erode confidence in the AstraZeneca vaccine—which surveys suggest was already viewed as inferior to Pfizer’s and Moderna’s messenger RNA vaccines—or in COVID-19 vaccines in general. But the opposite may well be the case, says Stephan Lewandowsky, a risk communication expert at the University of Bristol. “You’ve got to keep the public on board,” Lewandowsky says. “And if the public is risk-averse, as it is in Europe … it may have been the right decision to stop, examine this carefully and then say, ‘The evidence, when considered transnationally, clearly indicates it is safe to go forward.’” ---
**Author:** ![Treppenwitz](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/treppenwitz/32/3445_2.png) [@Treppenwitz](https://boards.straightdope.com/u/Treppenwitz)\ **Post date:** [March 20, 2021, 4:27pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/103 "2021-03-20T16:27:38Z")
> [@RitterSport](#): > > > [@Magiver](#): > > > > But ask yourself why we didn’t just use the approval of a group of European countries for our own. > > Because the FDA never does that? - And it’s hard to imagine a circumstance in which they could. ( 21 U.S. Code § 360bbb–3) > (c) Criteria for issuance of [emergency use] authorization > The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)), the Secretary concludes— > (1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition; > (2) that, **based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available** , it is reasonable to believe that… My Bold. That is to say, the FDA is obliged to perform an assessment of available data itself. The data is clearly available, as it was the basis of European authorisations. j ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 4:56pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/104 "2021-03-20T16:56:20Z")
> [@Novelty\_Bobble](#): > > I re-iterate, the pause in Europe left appx 2.5 million people unvaccinated. That is an opportunity for infection and death that can’t now be avoided and cannot be repaired. Yes, you’ve stated your position. The medical organizations in 20 countries disagree with you. I don’t know what to say without sounding snarky. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 4:59pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/105 "2021-03-20T16:59:11Z")
> [@Treppenwitz](#): > > My Bold. That is to say, the FDA is obliged to perform an assessment of available data itself. The data is clearly available, as it was the basis of European authorisations. Yes, exactly. And 20 other countries did the same thing in the approval and investigation of the Oxford vaccine. ---
**Author:** ![Treppenwitz](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/treppenwitz/32/3445_2.png) [@Treppenwitz](https://boards.straightdope.com/u/Treppenwitz)\ **Post date:** [March 20, 2021, 5:20pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/106 "2021-03-20T17:20:11Z")
I asked myself, as you suggested, and I was able to find an answer to the question. It was the answer I expected. j ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 20, 2021, 5:22pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/107 "2021-03-20T17:22:53Z")
> [@Magiver](#): > > I accept the need for the pause and how it was handled. i’m really not sure what you don’t understand about this? It isn’t a question of understanding. You are just choosing to answer a question that I haven’t asked. Your prerogative of course but _why_ will you not answer it? > [@Magiver](#): > > You talk of the cost of lives and ignore public safety and confidence. No, you ignore the cost of lives to the point where you won’t even acknowledge those lost due to unnecessary pauses to the vaccination program. Public safety is best served by vaccinating everyone as fast as possible. That is the judgement of every single authority that has looked at that. Confidence remains to be seen doesn’t it? you’ve found an opinion that bends one way, I can cite you plenty of others that see it differently. In the very same article you quote > Others are not so sure. “At least in the short term, there have been some negative effects of this whole series of events on general vaccine acceptance with regards to COVID,” says Michael Bang Petersen, a political scientist at Aarhus University in Denmark, > > In a [preprint posted today](https://psyarxiv.com/uh4y6), Petersen reported the Danish decision caused vaccine confidence to drop by about 11% in Denmark itself and also to a lesser degree in other countries, and it decreased a little more when those countries themselves suspended vaccination. ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 20, 2021, 5:32pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/108 "2021-03-20T17:32:41Z")
> [@Magiver](#): > > Yes, you’ve stated your position. The medical organizations in 20 countries disagree with you. I don’t know what to say without sounding snarky. And it is perfectly possible for those organisations to take bone-headed decisions that cost unnecessary lives. Which I think they clearly have. The pause has saved zero lives and cost, conservatively, hundreds. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 5:37pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/109 "2021-03-20T17:37:20Z")
> [@Novelty\_Bobble](#): > > No, you ignore the cost of lives to the point where you won’t even acknowledge those lost due to unnecessary pauses to the vaccination program. Again, I don’t know what to say. 20 countries disagree with you and I’ve spelled out why. They had to verify there weren’t issue(s) with the vaccine. You will just have to live with the fact that they didn’t consult your clairvoyant medical knowledge in the investigation. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 5:41pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/110 "2021-03-20T17:41:58Z")
> [@Novelty\_Bobble](#): > > The pause has saved zero lives and cost, conservatively, hundreds. That’s a Monday night quarterback statement. You had no way of knowing if there were production issues that contaminated the vaccine. ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 20, 2021, 6:24pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/111 "2021-03-20T18:24:10Z")
> [@Magiver](#): > > That’s a Monday night quarterback statement. You had no way of knowing if there were production issues that contaminated the vaccine. nonsense, utter nonsense. The fact that lives will be lost is a matter of fact. Any _potential_ contamination that caused the adverse effect was, if it was a fact at all, was occuring at a rate that was far outweighed by the deaths caused by not vaccinating that extra 2.5 million. That was clear, from the outset by the collation of the adverse effects that was being undertaken. No second guessing needed, no hindsight used. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 6:45pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/112 "2021-03-20T18:45:26Z")
> [@Novelty\_Bobble](#): > > Any _potential_ contamination that caused the adverse effect was, if it was a fact at all, was occuring at a rate that was far outweighed by the deaths caused by not vaccinating that extra 2.5 million. That was clear, from the outset by the collation of the adverse effects that was being undertaken. > No second guessing needed, no hindsight used. You have absolutely no way of knowing this and therefore no way of weighing the options except after the fact. This is why 20 countries disagree with you. ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 20, 2021, 7:02pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/113 "2021-03-20T19:02:42Z")
> [@Magiver](#): > > You have absolutely no way of knowing this The data gives you the rate of occurence. That’s how the evaluation of risk/benefit is done. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 20, 2021, 11:35pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/114 "2021-03-20T23:35:10Z")
> [@Novelty\_Bobble](#): > > The data gives you the rate of occurence. That’s how the evaluation of risk/benefit is done. The research showed a relationship to a rare form of blood clots as well as establishing there wasn’t an issue with contaminated batches or faulty processing. So it comes down to your guess before the fact vs research and the combined medical expertise of 20 separate countries.making a decision based on that research. ---
**Author:** ![FigNorton](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/fignorton/32/5619_2.png) [@FigNorton](https://boards.straightdope.com/u/FigNorton)\ **Post date:** [March 21, 2021, 12:21am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/115 "2021-03-21T00:21:47Z")
> [@Magiver](#): > > The research showed a relationship to a rare form of blood clots as well as establishing there wasn’t an issue with contaminated batches or faulty processing. I think the important point here is, no it didn’t. These rare blood clots showed up amongst vaccinated people at a rate not dissimilar to historical rates. This is something that could have been investigated pretty quickly via email and database searches. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 21, 2021, 1:04am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/116 "2021-03-21T01:04:58Z")
> [@FigNorton](#): > > I think the important point here is, no it didn’t. I already cited that it did in post 90. ---
**Author:** ![FigNorton](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/fignorton/32/5619_2.png) [@FigNorton](https://boards.straightdope.com/u/FigNorton)\ **Post date:** [March 21, 2021, 1:14am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/117 "2021-03-21T01:14:20Z")
As far as I see, post 90 cites that experts have a hypothetical way the vaccine might cause clots. It is not proof that the vaccine caused the blood clots and it doesn’t counter the statistics. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 21, 2021, 3:10am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/118 "2021-03-21T03:10:27Z")
The conclusion linking the vaccine to CVST was reached independently by 2 different groups. ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 21, 2021, 8:32am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/119 "2021-03-21T08:32:11Z")
> [@Magiver](#): > > The research showed a relationship to a rare form of blood clots as well as establishing there wasn’t an issue with contaminated batches or faulty processing. > > So it comes down to your guess before the fact vs research and the combined medical expertise of 20 separate countries.making a decision based on that research. Again, though I doubt you will ever concede it, That was being done anyway. You speak as though anyone is arguing that adverse events should not be investigating. It did not require, and the numbers did not warrant, a complete shutdown of the vaccine use whilst that necessary investigation was carried out. The investigation was _not_ wrong and did _not_ cost lives. The pause in use _was_ wrong and _has_ cost lives EVEN IF THE CLOTTING EVENTS END UP BEING PROVED TO BE LINKED TO A VACCINE because the rates being seen are not at a level that ouweighs the benefit provided by the drug and never have been and the countries pausing did not have a plausibly safer vaccine to switch to. I’ve said this in many ways, the figures are there for you to do the calculation yourself and they haven’t changed. You seem comfortable with a course of action that kills more people. I’m not. ---
**Author:** ![Novelty\_Bobble](https://avatars.discourse-cdn.com/v4/letter/n/a3d4f5/32.png) [@Novelty\_Bobble](https://boards.straightdope.com/u/Novelty_Bobble)\ **Post date:** [March 21, 2021, 9:14am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/120 "2021-03-21T09:14:56Z")
Perhaps a hypothetical might help tease out your thinking and appreciation of risk/benefit. And this is a hypothetical that is completely plausible with figures that are comparable in ratio and scale to the Europe situation. Imagine in the USA that a tiny subset of the population receiving the two main vaccines show unusual reactions and in some rare cases, die. Over the course of the vaccinations administered so far it amounts to perhaps 5 extra deaths per week. There is circumstantial evidence that it may be linked to the vaccines. There is an option to pause the use of vaccines for a week but there are not enough alternatives to keep up the pace and as a result of that, 10 million people will go unprotected during that week. You are in the hot seat, what do you recommend? a) anaylse and assess the cases, come to a conclusion and act, continue vaccinating in the meantime - _possible_ loss of life - 5 b) Pause the vaccine use as well as doing (a) _definite_ best case loss of life - -100+ So the figures are pretty stark. On one hand you may _possibly_ prevent 5 extra deaths. On the other you will _definitely_ cost 100 extra deaths. You may have another course of action in mind but none is without cost and you can’t avoid taking a decision to continue or pause. How would you approach the above calculus? On what grounds do you justify taking any course of action? I’m happy to explain my thinking. I’d do (a) and I justify it by it saving more people and we still come out of it with a better understanding of what is going on. Care to share your thinking? [Previous page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=5) [Next page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=7)