# 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:** 14
**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:** [April 4, 2021, 1:46pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/261 "2021-04-04T13:46:18Z")
> [@silverfish](#): > > It looks like you are referring to [This Document](https://www.gov.uk/government/news/mhra-response-to-irish-authorities-action-to-temporarily-suspend-the-astrazeneca-covid-19-vaccine#history). It is still there, but listed as Withdrawn. Yes, there isn’t any skullduggery going on, just an evolving picture. The advice from the WHO, MHRA and EMA is still that the benefits continue to outweigh any potential risks. ---
**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:** [April 4, 2021, 6:01pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/262 "2021-04-04T18:01:28Z")
Hmm - that appears to be it. Thing is, I had been to that page already and didn’t see it. maybe I just read “withdrawn” and stopped looking. j ---
**Author:** ![eschrodinger](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/eschrodinger/32/122_2.png) [@eschrodinger](https://boards.straightdope.com/u/eschrodinger)\ **Post date:** [April 4, 2021, 6:12pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/263 "2021-04-04T18:12:42Z")
Is this the page that mentions 30 instances of blood clots? I’m not seeing that on the linked page. Maybe I’m dense and missing it. If that’s supposed to be there, can someone point out where? ---
**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:** [April 4, 2021, 6:25pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/264 "2021-04-04T18:25:56Z")
This: > **[Coronavirus vaccine - summary of Yellow Card reporting](https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting)** is consistent with the BBC story (and other press reports); the widely reported figure of 30 (for “blood clot cases”) is here: > Our rigorous review into the UK reports of rare and specific types of blood clots is ongoing. Up to and including 24 March, we have received **22 reports of cerebral venous sinus thrombosis (CVST) and 8 reports of other thrombosis events** with low platelets, out of a total of 18.1 million doses of COVID-19 Vaccine AstraZeneca given by that date. There were no reports for the Pfizer/BioNTech vaccine. To note, the current analysis prints include data up to and including the 21 March. My bold. j ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [April 5, 2021, 4:31am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/265 "2021-04-05T04:31:55Z")
It didn’t mention that 7 of the people who got CVST died. ---
**Author:** ![eschrodinger](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/eschrodinger/32/122_2.png) [@eschrodinger](https://boards.straightdope.com/u/eschrodinger)\ **Post date:** [April 5, 2021, 5:39am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/266 "2021-04-05T05:39:29Z")
Thanks. ---
**Author:** ![PookahMacPhellimey](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/pookahmacphellimey/32/3175_2.png) [@PookahMacPhellimey](https://boards.straightdope.com/u/PookahMacPhellimey)\ **Post date:** [April 5, 2021, 7:40am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/267 "2021-04-05T07:40:38Z")
In the Netherlands, like in Germany, they are now giving it only to over 60s until at least next week. However, an article in a national newspaper\* talked to a “furious” trombosis expert who says all expert opinions were ignored, that the decision is political and not scientific and that by far the best thing to do is to continue to giving to everyone and stop terrifying people. Various colleagues in the article back this up. He also claims he is in an email group op over a 100 experts in this field and not a single one backed the idea of the pause, not even the German one who first signalled the correlation. \*I’d link it, but I think we can’t link foreign language articles. ---
**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:** [April 5, 2021, 2:36pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/268 "2021-04-05T14:36:30Z")
No, you’re right. That figure has been published by reputable news sources (eg Financial Times), but I haven’t yet found a source doc from the MHRA. 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:** [April 5, 2021, 4:31pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/269 "2021-04-05T16:31:00Z")
> [@PookahMacPhellimey](#): > > an article in a national newspaper\* talked to a “furious” **trombosis** expert who says all expert opinions were ignored, yeah but that’s experts for you, keen on blowing their own trumpet. 😁 ---
**Author:** ![Tfletch1](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/tfletch1/32/5340_2.png) [@Tfletch1](https://boards.straightdope.com/u/Tfletch1)\ **Post date:** [April 5, 2021, 5:40pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/270 "2021-04-05T17:40:12Z")
> [@Treppenwitz](#): > > Hmm. I think the technical term for this is “Oh Shit”: > > [BBC News](https://www.bbc.co.uk/news/health-56616119) > > ### [Covid: 30 blood clot cases found in AstraZeneca recipients in the UK](https://www.bbc.co.uk/news/health-56616119) > > The cases identified by the medicines regulator were out of more than 18 million doses given. > > From the article: > > > **The UK’s medicines watchdog says it has found 30 cases of rare blood clots in people who have had the Oxford-AstraZeneca Covid vaccine.** > > > > The Medicines and Healthcare products Regulatory Agency (MHRA) says the risk of having this type of clot is “very small”… > > > > …[The MHRA said] it had received 22 reports of cerebral venous sinus thrombosis (CVST) - where a blood clot forms in the brain - and eight reports of “other thrombosis events with low platelets [the cells involved in clotting]” following use of the Oxford-AstraZeneca jab, out of a total of 18.1 million doses given up to and including 24 March. > > The FT reports that there were 7 deaths. > > Why _Oh Shit_ ? Well, when your pharmacovigilance system doesn’t report 30 cases of a very rare event until weeks after people have been telling you that this is definitely happening, it’s not a good look for your competence. > > And to many people who were suspicious of the vaccination program in the first place… this is going to do nothing to persuade them that the whole truth about the vaccine is out there. I must be having a brain fart because I’m reading this very differently. The UK is reporting 22 cases of CVST out of 18 million vaccinated individuals. That is 1.2 per million. If you include the thrombocytopenia, it’s still only 1.8 per million. Germany reports 4 cases per million vaccinated individuals. Johns Hopkins states that CVST affects 5 people out of a million each year. According to these data, the AstraZeneca vaccine either has little effect or is even protective against CVST. [https://www.hopkinsmedicine.org/health/conditions-and-diseases/cerebral-venous-sinus-thrombosis](https://www.hopkinsmedicine.org/health/conditions-and-diseases/cerebral-venous-sinus-thrombosis) The risk of thrombosis in Covid-19 patients is quite high. Maybe not CVST, but definitely CVT. I gotta be missing something. ---
**Author:** ![Tfletch1](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/tfletch1/32/5340_2.png) [@Tfletch1](https://boards.straightdope.com/u/Tfletch1)\ **Post date:** [April 5, 2021, 5:41pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/271 "2021-04-05T17:41:55Z")
> [@Novelty\_Bobble](#): > > > [@PookahMacPhellimey](#): > > > > an article in a national newspaper\* talked to a “furious” **trombosis** expert who says all expert opinions were ignored, > > yeah but that’s experts for you, keen on blowing their own trumpet. Booooo! _throws tomatoes_ ---
**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:** [April 5, 2021, 5:50pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/272 "2021-04-05T17:50:53Z")
What you’re missing is that these vaccines were rushed through development (for all the right reasons) and so hit the market with relatively little known about their adverse event profiles. This means that in-market monitoring (pharmacovigilance) becomes critically important, particularly as exposure is massive. You are supposed to be able to spot alerts - particularly high profile ones that kill people. Whilst all of Europe said _Hey - look at this - we got clots, we got CVST_ - the British position was essentially that there was nothing - actually a lower rate than would be expected amongst those vaccinated. _Then_ the UK finds the cases. The full picture is still emerging, but it’s not a good look for your ability to perform pharmacovigilance - which is, as I said, critical in this roll-out. j ETA - I should say that this is particularly concerning from a British perspective, as we are largely reliant on the AZ vaccine. We have more experience of it. We should understand it better than anyone else. ---
**Author:** ![PookahMacPhellimey](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/pookahmacphellimey/32/3175_2.png) [@PookahMacPhellimey](https://boards.straightdope.com/u/PookahMacPhellimey)\ **Post date:** [April 5, 2021, 6:03pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/273 "2021-04-05T18:03:21Z")
If anyone cares, here’s a link to an English version of the Dutch article on tHrombosis. > **[Thrombosis experts furious about AstraZeneca vaccine halt - DutchNews.nl](https://www.dutchnews.nl/news/2021/04/thrombosis-experts-furious-about-astrazeneca-vaccine-halt/)** > > Thrombosis experts have reacted furiously to the government’s decision to again stop using the AstraZeneca coronavirus vaccine because of a possible risk of developing blood clots, saying they have not been consulted. The decision, they argue, has... ---
**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:** [April 5, 2021, 6:03pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/274 "2021-04-05T18:03:46Z")
> [@Tfletch1](#): > > Johns Hopkins states that CVST affects 5 people out of a million each year. Maybe it’s the shortened time frame? Making up numbers, if they have been giving out the AZ vaccine for 2 months, then you have to multiply the numbers by 6 to get the annual rate. Still seems quite small, and who knows what the lockdown did for stress and health levels anyway. ---
**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:** [April 5, 2021, 6:06pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/275 "2021-04-05T18:06:33Z")
Well, you are missing that the background rate is 5 per million _per year._ The 1.2 cases per million have occurred in some short-ish period of time following being vaccinated. Given that shorter time frame, there may well be a significantly higher-than-background rate, which would tend to imply being caused by the vaccine. However, it’s still really very low in absolute terms, and extremely low in comparison to the mortality rate of covid. Until the world either no longer has a critical shortage of covid vaccine supply, or covid infection and mortality rates drop dramatically, such a low rate of complications shouldn’t be allowed to slow a vaccination campaign. I mean, maybe you defer vaccinations of a few people at significant individual risk of clotting, or at least heighten monitoring of such individuals for the complication, but that’s about it. If there does turn out to be a causal link, it would seem to be at the sort of rate that Guillain-Barre Syndrome is caused by the flu vaccine, where GBS is a 1 to 2 in a million complication of flu vaccination. And just as covid can cause clotting, so can the flu cause GBS, and in spite of causing a few cases of GBS every year the flu vaccine actually decreases the total incidence rate of GBS by decreasing the number of people who get it as a flu complication. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [April 5, 2021, 6:07pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/276 "2021-04-05T18:07:22Z")
> [@PookahMacPhellimey](#): > > \*I’d link it, but I think we can’t link foreign language articles. It will make it’s way over to a linkable article so we should see it in the near future. ---
**Author:** ![Tfletch1](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/tfletch1/32/5340_2.png) [@Tfletch1](https://boards.straightdope.com/u/Tfletch1)\ **Post date:** [April 5, 2021, 7:37pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/277 "2021-04-05T19:37:01Z")
Ah, yes. Thanks @RitterSport and @Gorsnak. Of course the usual rate is per year. So we may find a slightly higher rate in vaccinated people by the end of the year. Still seems to be a small risk compared to getting covid. ---
**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:** [April 5, 2021, 7:45pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/278 "2021-04-05T19:45:54Z")
> [@Tfletch1](#): > > Still seems to be a small risk compared to getting covid. In my non-epidemiologist opinion, I wholeheartedly agree. ---
**Author:** ![eschrodinger](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/eschrodinger/32/122_2.png) [@eschrodinger](https://boards.straightdope.com/u/eschrodinger)\ **Post date:** [April 5, 2021, 7:46pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/279 "2021-04-05T19:46:41Z")
> [@Gorsnak](#): > > However, it’s still really very low in absolute terms, and extremely low in comparison to the mortality rate of covid. Until the world either no longer has a critical shortage of covid vaccine supply, or covid infection and mortality rates drop dramatically, such a low rate of complications shouldn’t be allowed to slow a vaccination campaign. I mean, maybe you defer vaccinations of a few people at significant individual risk of clotting, or at least heighten monitoring of such individuals for the complication, but that’s about it. At the numbers we are aware of. I doubt its way higher, but suddenly “finding” 6 times as many instances of a critical complication doesn’t breed confidence in the numbers. And the whole idea that the numbers are “actually lower than expected” should have been a red flag, not a defense, unless there was some reason to believe that the AZ vaccine would prevent these kinds of thromboses, other than the ones caused by Covid (which are also not part of the background rate). I agree that, as a public health matter, the vaccine should continue to be used in a manner that makes the balance of risks clearly favor it. In places where some other vaccine is also in use, but is not sufficient to cover everyone, it probably makes sense to split it by age. AZ to older people who are at less risk of CSVT, but at higher risk of severe Covid, and use whatever other vaccine you have access to for younger people who are at higher risk of CSVT, and lower severe Covid risk. For countries with only AZ available, presumably it makes sense to keep using it, but the information needs to get out there for informed consent purposes, monitoring and cautions, and perhaps targeted contraindications to take some high risk people out of the vaccination pool, if the evidence points that way. I would be ashamed if I were part of the entity that was touting the “there’s no evidence of this” line, when it was actually a case of, “we didn’t check for or record evidence of this, as we were required to.” ---
**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:** [April 5, 2021, 8:55pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/280 "2021-04-05T20:55:34Z")
> [@eschrodinger](#): > > At the numbers we are aware of. I doubt its way higher, but suddenly “finding” 6 times as many instances of a critical complication doesn’t breed confidence in the numbers. And the whole idea that the numbers are “actually lower than expected” should have been a red flag, not a defense, unless there was some reason to believe that the AZ vaccine would prevent these kinds of thromboses, other than the ones caused by Covid (which are also not part of the background rate). Yes. Covid causes blood clots. Covid is no doubt a lot more dangerous than this vaccine, and unless you live in a cave and never catch a cold because you never interact with anyone else, taking this vaccine almost certainly reduces your overall risk of blood clots, as compared to taking no vaccine. As there’s not enough other vaccine to go around, it’s almost certainly right to keep using it. But not right to pretend there is no evidence of risk. (And fwiw, I was reading the emergency authorization for the J&J vaccine the other day, and it mentioned a couple of blood clots in the vaccine cohort – not enough to be statistically significant, since the total number of people wasn’t all that large – but something that I hope they are monitoring with all the vaccines as they are rolled out and more data accumulates.) [Previous page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=13) [Next page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=15)