# 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:** 5
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 19, 2021, 6:26pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/81 "2021-03-19T18:26:48Z")
> [@eschrodinger](#): > > Making a _diagnosis_ may take probabilities into account, but ultimately is about the individual and their symptoms, exposures, risks, test results, etc. You say that as if you have no idea how many people have had or are vulnerable to life threatening blood clots. They’re not interested in statistics. They’re interested in a medical review of the vaccinated people who got blood clots. i guarangodammte you the people in this category don’t want a statistical review. They want a bonafide medical review of the cases involved. It’s not rocket science. It’s an extension of the vetting process that generated approval of the vaccine. Countries like Italy have a low percentage of people vaccinated. It’s important that the issue is properly dealt with so there is public confidence going forward. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 19, 2021, 6:52pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/82 "2021-03-19T18:52:43Z")
> [@Novelty\_Bobble](#): > > This is why it is fine to be ultra-cautious when you have luxury of doing so but I just don’t think we are in that situation now. > > The best we can hope or is that this is an isolated political reaction and that confidence hasn’t been dented too much and they will let the science prevail in future. From what I’ve read the clotting issue is highly unusual in it’s nature. If this is the result of a bad batch or a bad process then it needs to be vetted. Just because people need it doesn’t mean it’s safe. I think it’s important to understand that the vaccine is not a monolithic object that is spit out in one chunk in perfect uniformity. I get your position that it’s holding things up but that doesn’t mean there isn’t a problem. ---
**Author:** ![puzzlegal](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/puzzlegal/32/3827_2.png) [@puzzlegal](https://boards.straightdope.com/u/puzzlegal)\ **Post date:** [March 19, 2021, 7:07pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/83 "2021-03-19T19:07:38Z")
> [@Magiver](#): > > i guarangodammte you the people in this category don’t want a statistical review. They want a bonafide medical review of the cases involved. Er, if that medical review doesn’t lean heavily on statistics, it’s a flawed process. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 19, 2021, 7:17pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/84 "2021-03-19T19:17:28Z")
> [@puzzlegal](#): > > Er, if that medical review doesn’t lean heavily on statistics, it’s a flawed process. I disagree. Again, if I’m reading this correctly it’s an unusual form of clotting that is the issue. It’s not expected. You can’t just lump every example of blood clots into a pot and crunch numbers. Delaying a vaccine is not what any country wants to do. We’re still weeks away from approving that vaccine. In your opinion, should we bypass our certification process and just accept other countries? Heck, we just gave 20 million of that vaccine to Canada and Mexico, we could have used it in the US. ---
**Author:** ![puzzlegal](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/puzzlegal/32/3827_2.png) [@puzzlegal](https://boards.straightdope.com/u/puzzlegal)\ **Post date:** [March 19, 2021, 7:55pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/85 "2021-03-19T19:55:19Z")
It’s certainly worth investigating. That doesn’t mean it’s worth halting the use the of the vaccine, when doing so has known risks. Also: > **[Significant](https://xkcd.com/882/)** > > 'So, uh, we did the green study again and got no link. It was probably a--' 'RESEARCH CONFLICTED ON GREEN JELLY BEAN/ACNE LINK; MORE STUDY RECOMMENDED!' As I’ve said elsewhere, I have concerns about the efficacy of the Oxford-AstroZeneca vaccine, and I’m hoping I can score one of the other ones. But I’m not worried about the risk of blood clots. Also, my understanding is that the hold-up in the US is that AstroZeneca hasn’t yet asked the FDA for approval. I don’t know why 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 19, 2021, 8:40pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/86 "2021-03-19T20:40:08Z")
> [@Magiver](#): > > From what I’ve read the clotting issue is highly unusual in it’s nature. If this is the result of a bad batch or a bad process then it needs to be vetted. Just because people need it doesn’t mean it’s safe. > > I think it’s important to understand that the vaccine is not a monolithic object that is spit out in one chunk in perfect uniformity. > > I get your position that it’s holding things up but that doesn’t mean there isn’t a problem. I confess I haven’t a clue what you are actually suggesting now. Are you saying that the adverse events should be investigated? Because if so, I agree, everyone in this thead agrees, the manufacturers agree, the regulatory bodies agree. That _is_ the process! Or are you also saying that the roll-out should be stopped for all serious and unusual adverse events that can be temporally linked to the jab? Because if so you are definitely advocating a course of action that will kill far more than it saves. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 19, 2021, 9:36pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/87 "2021-03-19T21:36:08Z")
> [@Novelty\_Bobble](#): > > Are you saying that the adverse events should be investigated? Because if so, I agree, everyone in this thead agrees, the manufacturers agree, the regulatory bodies agree. That _is_ the process! > > Or are you also saying that the roll-out should be stopped for all serious and unusual adverse events that can be temporally linked to the jab? Because if so you are definitely advocating a course of action that will kill far more than it saves. OK, the US approval was a bit of a side bar. I think they should be asking questions. But ask yourself why we didn’t just use the approval of a group of European countries for our own. Again, that was a sidebar I didn’t present well. I’ve read too many stories without bookmarking them. If I remember correctly, the UK isn’t seeing the same odd clotting issues that other countries have seen. If that’s correct, then they need to focus on why that is true. Makes me worry about contamination or bad processing. ---
**Author:** ![RitterSport](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/rittersport/32/6326_2.png) [@RitterSport](https://boards.straightdope.com/u/RitterSport)\ **Post date:** [March 19, 2021, 10:10pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/88 "2021-03-19T22:10:01Z")
> [@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? Because Astra Zeneca wasn’t ready to ask the FDA for approval? > [@Magiver](#): > > If I remember correctly, the UK isn’t seeing the same odd clotting issues that other countries have seen. If that’s correct, then they need to focus on why that is true. Here you’re positing that the UK hasn’t seem the clotting, also calling it “odd clotting”, and then saying, “if that’s correct…” People in this thread have posted facts backed by cites and you’re posting hypotheticals. If you’re concerned and have cites that can be found, maybe go find them and present and explain them. Otherwise, I’m not sure why anyone would take you seriously here. ---
**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 19, 2021, 10:12pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/89 "2021-03-19T22:12:01Z")
> [@Magiver](#): > > I’ve read too many stories without bookmarking them. If I remember correctly, the UK isn’t seeing the same odd clotting issues that other countries have seen. If that’s correct, then they need to focus on why that is true. Makes me worry about contamination or bad processing. That’s not true. The numbers the UK are seeing are in line with what is being seen elsewhere. That’s why the authorities in Europe have judged that there is nothing to be concerned about. There is nothing to suggest contamination and nothing to suggest bad processing. The ultra-rare, very serious adverse events remain just that, very rare. And with so few it becomes very difficult to discern any real pattern or draw any firm conclusions. Certainly none firm enough that would warrant stopping the use of the vaccine. And you didn’t address my question. Do you think the use of the AZ vaccine should be paused? ---
**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, 2:15am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/90 "2021-03-20T02:15:48Z")
[quote=“Novelty\_Bobble, post:89, topic:937911”] The ultra-rare, very serious adverse events remain just that, very rare. And with so few it becomes very difficult to discern any real pattern or draw any firm conclusions. Certainly none firm enough that would warrant stopping the use of the vaccine. > [@Novelty\_Bobble](#): > > And you didn’t address my question. Do you think the use of the AZ vaccine should be paused? BERLIN—Scientists in Europe said they had identified a mechanism that could lead the AstraZeneca PLC vaccine to cause potentially deadly blood clots in rare instances as well as a possible treatment for it. Two teams of medical researchers in Norway and Germany have independently found that the vaccine could trigger an autoimmune reaction causing blood to clot in the brain, which would offer an explanation for isolated incidents across Europe in recent weeks. > [@Novelty\_Bobble](#): > > The ultra-rare, very serious adverse events remain just that, very rare. And with so few it becomes very difficult to discern any real pattern or draw any firm conclusions. Certainly none firm enough that would warrant stopping the use of the vaccine. [Wall Street Journal.](https://www.wsj.com/articles/scientists-say-they-found-cause-of-blood-clotting-linked-to-astrazeneca-vaccine-11616169108) BERLIN—Scientists in Europe said they had identified a mechanism that could lead the AstraZeneca PLC vaccine to cause potentially deadly blood clots in rare instances as well as a possible treatment for it. Two teams of medical researchers in Norway and Germany have independently found that the vaccine could trigger an autoimmune reaction causing blood to clot in the brain, which would offer an explanation for isolated incidents across Europe in recent weeks. > [@Novelty\_Bobble](#): > > And you didn’t address my question. Do you think the use of the AZ vaccine should be paused? I think they should have paused it until they understood what is going on. It appears from this article they understand why it’s causing cerebral venous sinus thrombosis as well as how to treat it. From the same site: The issue affected a tiny portion of those who had received the shot, however, and after investigating, the [European drugs regulator ruled](https://www.wsj.com/articles/astrazenecas-covid-19-vaccine-is-cleared-by-europe-after-blood-clot-concerns-11616083845?mod=article_inline) that the benefits outweighed the potential risks of the vaccine, and recommended vaccinations resume. Some countries, such as Germany, France and Italy, resumed vaccinations with AstraZeneca’s shot on Friday, with an added warning that it could be linked to blood clotting. The French healthcare authority, which recorded three cases of CVST connected to the vaccine, advised the government on Friday to only administer the shot to people older than 55. ---
**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, 2:42am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/91 "2021-03-20T02:42:44Z")
> [@Novelty\_Bobble](#): > > That’s not true. The numbers the UK are seeing are in line with what is being seen elsewhere It took awhile to dig through previous searches but I found what I was referring to: [Science link:](https://www.sciencemag.org/news/2021/03/it-s-very-special-picture-why-vaccine-safety-experts-put-brakes-astrazeneca-s-covid-19) The United Kingdom, which has administered the AstraZeneca vaccine to more than 10 million people, has so far not reported similar clusters of unusual clotting or bleeding disorders. So given the odd nature of the type of blood clot I think they did their due diligence to establish it’s relationship with the vaccine, how to treat it, and who to give it to. Resuming use of the vaccine will not eliminate further research and it provides information on who should get it. ---
**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, 7:34am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/92 "2021-03-20T07:34:44Z")
> [@Magiver](#): > > I think they should have paused it until they understood what is going on. Then be prepared to defend thousands of extra people dying, Do you accept that the pause in roll-out has so far cost far more lives than it has saved? ---
**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, 7:56am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/93 "2021-03-20T07:56:44Z")
> [@Novelty\_Bobble](#): > > Then be prepared to defend thousands of extra people dying, > > Do you accept that the pause in roll-out has so far cost far more lives than it has saved? - There is more than one vaccine available. - There is already a substantial number of the truly vulnerable vaccinated - It was necessary to determine there wasn’t anything wrong with the vaccine or a batch of the vaccine.just as any other drug would dictate. - Finding the causal issue between the vaccine and blood clots as well as a treatment regiment for it provides the vetting needed for public confidence. - the United States released 20 million doses from it’s reserve into the market. ---
**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, 8:24am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/94 "2021-03-20T08:24:00Z")
> [@Magiver](#): > > There is more than one vaccine available. but in the countries where the AZ vaccine was paused there were not enough vaccines of the alternatives and a switch was not possible. Did you see the figures I gave above which show how many people have now not been given protection because of this pause? > [@Magiver](#): > > There is already a substantial number of the truly vulnerable vaccinated No, in Europe there is not, they are nowhere near vaccinating all the vulnerable and they are right on the cusp of another surge as we speak. > [@Magiver](#): > > It was necessary to determine there wasn’t anything wrong with the vaccine or a batch of the vaccine.just as any other drug would dictate. which didn’t require a pause > [@Magiver](#): > > Finding the causal issue between the vaccine and blood clots as well as a treatment regiment for it provides the vetting needed for public confidence. which a) didn’t need a pause and b) does not guarantee increased public confidence > [@Magiver](#): > > the United States released 20 million doses from it’s reserve into the market. Who did they release it to? When did they become available at point of use? You cannot move any extra doses into position in time to take up the slack. Even a week delay costs hundreds of lives. I ask again as you didn’t answer directly. > [@Novelty\_Bobble](#): > > Do you accept that the pause in roll-out has so far cost far more lives than it has saved? ---
**Author:** ![puzzlegal](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/puzzlegal/32/3827_2.png) [@puzzlegal](https://boards.straightdope.com/u/puzzlegal)\ **Post date:** [March 20, 2021, 10:42am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/95 "2021-03-20T10:42:30Z")
> [@Novelty\_Bobble](#): > > Who did they release it to? When did they become available at point of use? You cannot move any extra doses into position in time to take up the slack. Even a week delay costs hundreds of lives. Our neighbors, Canada and Mexico. > **[US plans to send 4m AstraZeneca vaccine doses to Mexico and Canada](https://www.ft.com/content/64eace92-e98a-48ff-ab90-5269917970c4)** > > Deal would mark its first shipments of Covid-19 jabs to other countries Since it hasn’t been approved yet, here, and is just sitting in freezers, and it has been approved there, and they have way less vaccine than they need, it makes sense to send it to them. ---
**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, 12:49pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/96 "2021-03-20T12:49:05Z")
> [@puzzlegal](#): > > Our neighbors, Canada and Mexico. > > [https://www.ft.com/content/64eace92-e98a-48ff-ab90-5269917970c4](https://www.ft.com/content/64eace92-e98a-48ff-ab90-5269917970c4) > > Since it hasn’t been approved yet, here, and is just sitting in freezers, and it has been approved there, and they have way less vaccine than they need, it makes sense to send it to them. Exactly, so it is irrelevant to the issue of pausing the vaccine roll-out in Europe. ---
**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, 3:05pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/97 "2021-03-20T15:05:02Z")
> [@Novelty\_Bobble](#): > > > [@Magiver](#): > > > > It was necessary to determine there wasn’t anything wrong with the vaccine or a batch of the vaccine.just as any other drug would dictate. > > which didn’t require a pause Since there is no way of knowing there was contamination or a flaw in the process . I don’t see how you can say this other than in hindsight. > [@Novelty\_Bobble](#): > > I ask again as you didn’t answer directly. I answered you in detail. I agree with how it was handled and provided my reasoning. ---
**Author:** ![Gorsnak](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/gorsnak/32/7587_2.png) [@Gorsnak](https://boards.straightdope.com/u/Gorsnak)\ **Post date:** [March 20, 2021, 3:09pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/98 "2021-03-20T15:09:33Z")
> [@Magiver](#): > > - the United States released 20 million doses from it’s reserve into the market. The announcement yesterday was that 4 million doses were being released. Where did you get 20 million? Also, use of past tense is incorrect here. No doses have actually been released yet. And just to top things off, all the doses being released are the Oxford/AstraZeneca 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, 3:14pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/99 "2021-03-20T15:14:38Z")
> [@Magiver](#): > > Since there is no way of knowing there was contamination or a flaw in the process . I don’t see how you can say this other than in hindsight. How would a pause have had any bearing on the outcome of the investigations that were already happening? > [@Magiver](#): > > I answered you in detail. I agree with how it was handled and provided my reasoning. No, you haven’t. It was a very specific yes or no question to find out very specifically if you appreciate the impact of the pause that was put in place. I’ll ask again. > [@Novelty\_Bobble](#): > > Do you accept that the pause in roll-out has so far cost far more lives than it has saved? Knowing where you stand on that question would be very informative. ---
**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, 3:18pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/100 "2021-03-20T15:18:17Z")
> [@Novelty\_Bobble](#): > > Exactly, so it is irrelevant to the issue of pausing the vaccine roll-out in Europe. 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. It’s interesting to note that the UK has greatly outstripped Europe in vaccinations by a considerable amount. You can see the benefit of BREXIT in their ability to escape the bureaucracy.of the Union. [Previous page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=4) [Next page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=6)