# 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:** 12
**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 29, 2021, 1:26am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/221 "2021-03-29T01:26:50Z")
> [@Magiver](#): > > Highly skilled people were engaged in risk assessment based on their investigation. That involved information not available to the public. This appears to be false. The WHO and some European health agencies said that the vaccine shouldn’t have been put on hold. The decision seems to have been a political one. Here’s an article from when this was all going down: > The administration of Oxford/AstraZeneca’s COVID-19 shot has been put on pause in Thailand and at least 10 European countries following reports of a small number of recipients developing blood clots. The World Health Organization and European health authorities are investigating these cases, but they say there’s no evidence that the vaccine is unsafe and urge inoculation campaigns to continue, [_The Washington Post_](https://www.washingtonpost.com/nation/2021/03/12/coronavirus-covid-live-updates-us/) reports. > > “There is currently no indication that vaccination caused these conditions, which are not listed as side effects of the vaccine,” reads the European Medicines Agency’s [statement](https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-march-2021). “The vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.” From here: [Oxford/AstraZeneca COVID-19 Vaccine on Hold in Some Countries | The Scientist Magazine®](https://www.the-scientist.com/news-opinion/Oxford-Astrazeneca-COVID-19-Vaccine-on-Hold-in-Some-Countries-68543) I think you’re just misinformed on some aspects of what happened. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 29, 2021, 2:22am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/222 "2021-03-29T02:22:55Z")
> [@RitterSport](#): > > I think you’re just misinformed on some aspects of what happened. How so? I wasn’t involved in it in any form. Tell me how I’m misinformed about the decisions made by other people? Explain how you knew it was safe before the investigation. ---
**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 29, 2021, 2:33am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/223 "2021-03-29T02:33:18Z")
It’s not a question of “knowing it was safe”. It’s a question of weighing the uncertain danger of potentially more blood clots against the certain danger of delaying the vaccination of a lot of people. As I have said, I do not know the data nor the medicine well enough to have a good sense of the magnitude of the risk of continuing vaccination while studying the issue, but I know that there was a real cost, to be paid in human lives, for having done so. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 29, 2021, 4:00am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/224 "2021-03-29T04:00:56Z")
> [@puzzlegal](#): > > It’s not a question of “knowing it was safe”. It’s a question of weighing the uncertain danger of potentially more blood clots against the certain danger of delaying the vaccination of a lot of people. That is exactly correct. And that decision changes with each country based on a review of any issues that come up. If you looked at Hungary they had 26 deaths per million on the 27th. Germany had 1.2. That’s a single day snapshot but if it’s an indication of the trend in each country that’s a substantial difference. The risk involved is different for each country. We’re not talking about Astrazeneca withdrawing the vaccine, we’re talking about individual countries weighing risk. ---
**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 29, 2021, 9:47am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/225 "2021-03-29T09:47:20Z")
You’re misinformed when you said that medical experts said it should have been put on hold. From what I can tell, medical experts said that the vaccines should continue while they study the data. I mean, you’re also obviously wrong about the availability of other vaccines for the EU to switch to in the meantime, but you appear to be unable to accept that. Of course, none of this has anything to do with approval in the US, which is the subject of this thread. The US didn’t approve it because AZ hadn’t asked the FDA for the approval, and when they did, it appears they submitted old data. ---
**Author:** ![Fiendish\_Astronaut](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/fiendish_astronaut/32/3295_2.png) [@Fiendish\_Astronaut](https://boards.straightdope.com/u/Fiendish_Astronaut)\ **Post date:** [March 29, 2021, 10:44am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/226 "2021-03-29T10:44:53Z")
I’m pretty confident that the EU will look back on this episode and conclude they messed this up amongst other failures. They have constantly undermined this vaccine whilst at the same time loudly bemoaned their lack of access to it. Pausing it would have been the right thing to do if this was a flu jab being administered to people ahead of a season, but in the midst of a pandemic where you count the fatalities in thousands per day it was madness. And they have undermined public trust in not just the AZ vaccine but in all vaccines which will also lead to more deaths. I don’t think AZ come out of this covered in roses either, but ultimately they are a company whose vaccine appears to work really well, is really easy to ship and store, and which they are going to sell at cost to less wealthy countries and a relatively low cost to everyone else. So whilst they could and should have handled their trial better and been more transparent about the data at times I do feel sorry for them. They’ve been taking a beating from all sides but have actually produced something really useful without profiteering as much as some other companies. ---
**Author:** ![casdave](https://avatars.discourse-cdn.com/v4/letter/c/c6cbf5/32.png) [@casdave](https://boards.straightdope.com/u/casdave)\ **Post date:** [March 29, 2021, 11:09am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/227 "2021-03-29T11:09:05Z")
France has been a major player in pausing the Oxford vaccine on very slight evidence in a hurry during a pandemic crisis which - for France - is increasing. All a political stageshow to diguise their previous incompetence art commissioning, approving and innoculating its citizens - and the flaws in the Euro dream cannot be revealed can they? Yet France does not seem to be so vigilant with drugs made in France, despite its European partners having banned this particular product decades ago. Hypocrites much? > **[Mediator drug: French pharmaceutical firm fined over weight loss pill](https://www.bbc.co.uk/news/world-europe-56562909)** > > The drug was authorised for overweight diabetics but is believed to have killed hundreds of people. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 29, 2021, 11:45am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/228 "2021-03-29T11:45:13Z")
> [@RitterSport](#): > > You’re misinformed when you said that medical experts said it should have been put on hold. that’s complete nonsense on your part. > [@RitterSport](#): > > I mean, you’re also obviously wrong about the availability of other vaccines for the EU to switch to in the meantime, but you appear to be unable to accept that. Cite that the other vaccines approved in Europe were suspended. This didn’t stop the vaccination process. If it did it would have changed the nature of the decision to pause it. ---
**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 29, 2021, 11:48am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/229 "2021-03-29T11:48:41Z")
> [@Magiver](#): > > that’s complete nonsense on your part. OK, then please provide a cite that medical experts said that the vaccination should be put on hold. I’ve provided one that showed at least some medical groups disagreed with the decision to stop the vaccination process. Thanks. ---
**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 29, 2021, 11:52am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/230 "2021-03-29T11:52:11Z")
> [@Magiver](#): > > Cite that the other vaccines approved in Europe were suspended. This didn’t stop the vaccination process. If it did it would have changed the nature of the decision to pause it. Sorry, I missed this second part. What a bizarre answer! I didn’t say they were suspended, I said they were unavailable. Before I provide any cites, is it your claim that there is sufficient vaccine availability in the EU for everyone who wants a vaccine to get one? ---
**Author:** ![wolfpup](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/wolfpup/32/10618_2.png) [@wolfpup](https://boards.straightdope.com/u/wolfpup)\ **Post date:** [March 29, 2021, 11:33pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/231 "2021-03-29T23:33:39Z")
Based on input from the vaccine advisory committee in Canada, the AstraZeneca vaccine has been suspended for everyone under 55. They appear to believe there is a remote possibility of blood clots, though none have occurred in the approximately 900,000 doses administered so far. [https://www.cbc.ca/news/health/canada-suspends-astrazeneca-vaccine-covid-19-1.5968657](https://www.cbc.ca/news/health/canada-suspends-astrazeneca-vaccine-covid-19-1.5968657) ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 30, 2021, 12:22am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/232 "2021-03-30T00:22:58Z")
> [@RitterSport](#): > > is it your claim that there is sufficient vaccine availability in the EU for everyone who wants a vaccine to get one? no, I said they had other vaccines available. ---
**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 30, 2021, 12:31am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/233 "2021-03-30T00:31:47Z")
“Available” meaning produced and ready to go into an arm? Otherwise, who gives a shit? Answer if you’d like, or don’t. I feel like there’s little chance of further productive conversation. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 30, 2021, 12:48am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/234 "2021-03-30T00:48:33Z")
[The Pfizer/BioNTech](https://www.politico.eu/article/coronavirus-covid19-vaccine-deliveries-in-europe-by-the-numbers/) vaccine makes up the vast majority of delivered doses to date, with three out of four delivered doses across the EU coming from the US-German manufacturer. ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 30, 2021, 12:57am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/235 "2021-03-30T00:57:30Z")
Tensions in Europe have risen after a production problem at a contract manufacturing facility used by AstraZeneca in Belgium has left the EU facing a [shortfall of 60% fewer doses than it was expecting this quarter](https://www.thechemicalengineer.com/news/what-is-causing-astrazeneca-s-vaccine-production-woes/). ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 31, 2021, 1:49am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/236 "2021-03-31T01:49:42Z")
> [@wolfpup](#): > > Based on input from the vaccine advisory committee in Canada, the AstraZeneca vaccine has been suspended for everyone under 55. They appear to believe there is a remote possibility of blood clots, though none have occurred in the approximately 900,000 doses administered so far I wonder if the US will focus on the other vaccines and redirect AstraZeneca to other countries after it’s approved. ---
**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 31, 2021, 2:19am UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/237 "2021-03-31T02:19:19Z")
…nm… ---
**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 31, 2021, 5:01pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/238 "2021-03-31T17:01:30Z")
Here’s a recent (Mar 28) prepublication (not yet peer reviewed) paper on the blood-clotting issue and its association with the AZ vaccine. > **[A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced...](https://www.researchsquare.com/article/rs-362354/v1)** > > Background. Vaccines are important for managing the COVID-19 pandemic caused by SARS-CoV-2. However, following widespread vaccination using a recombinant adenoviral vector encoding the spike protein antigen of SARS-CoV-2 (AZD1222, AstraZeneca),... It’s way too technical for me to read the fine detail. I’m posting it because this caught my eye: > **Conclusions**. The AZD1222 vaccine is associated with development of a prothrombotic disorder that clinically resembles heparin-induced thrombocytopenia but which shows a different serological profile. Yeah, it’s a preprint, and maybe “is” will be changed to “may”. We’ll see. To return to the OP (and speaking in general terms about the licensing of medicines): risk/benefit is a relative concept; it depends upon context. The positive risk/benefit profile of a drug may be changed by the ready availability of alternatives with a better safety profile ([terfenadine](https://en.wikipedia.org/wiki/Terfenadine) being perhaps the best known example of this; it was widely restricted or discontinued when the safer active metabolite fexofenadine was introduced.) Equally, something which has a generally positive risk/benefit may have a poorer risk/benefit in specific populations, and therefore be restricted in them (for example, NSAIDs in asthmatics). Speaking hypothetically, if it were to be shown that, for a particular vaccine, women between the ages of [TBD] were exposed to a risk that was significant - then the vaccine could be licensed accordingly, restricting its use in that group. Any restriction could be introduced/changed over time, depending on the ready availability of alternative vaccines. j ---
**Author:** ![Magiver](https://avatars.discourse-cdn.com/v4/letter/m/4491bb/32.png) [@Magiver](https://boards.straightdope.com/u/Magiver)\ **Post date:** [March 31, 2021, 6:01pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/239 "2021-03-31T18:01:53Z")
> [@Treppenwitz](#): > > Speaking hypothetically, if it were to be shown that, for a particular vaccine, women between the ages of [TBD] were exposed to a risk that was significant - then the vaccine could be licensed accordingly, restricting its use in that group. Any restriction could be introduced/changed over time, depending on the ready availability of alternative vaccines It’s interesting that you mentioned women because they are more prone to CVST based on newer studies. [WIKI](https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis#Pathogenesis): While it may occur in all age groups, it is most common in the third decade. 75% are female.[[4]](https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis#cite_note-EFNS-4) Given that older studies show no difference in incidence between men and women, it has been suggested that the use of [oral contraceptives](https://en.wikipedia.org/wiki/Combined_oral_contraceptive_pill) in women is behind the disparity between the sexes.[[2]](https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis#cite_note-Stam2005-2) ---
**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:** [March 31, 2021, 6:09pm UTC](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911/240 "2021-03-31T18:09:23Z")
It’s important to look at this from both the public health _and_ individual, informed consent, levels. I’ve said that I would take any vaccine I could get, when they seemed to have similar risk profiles, and good effectiveness. From a public health perspective, you’d want people to get any vaccine with say, at least 50% effectiveness and a risk profile that means fewer people will die if they get that vaccine. There’s some more complicated decision-making about messaging, and about very short delays for more effective vaccines. I might make a different choice if I were presented with one vaccine that has roughly the same effectiveness against most variants, but has a tiny risk of a very serious to fatal side effect, vs waiting a short time for a safer vaccine. I am at very low risk of exposure. I live in a state that’s been doing things right. I’m home except for necessary shopping and distanced outdoor activities. Some people are even safer than me – just not going out, doing all shopping remotely. It would not be crazy to choose to wait a short time – weeks, say, to get a safer vaccine. From a public health perspective, that’s undesirable. It’s especially undesirable because some people are not good at comparing the risks, and will make the wrong decision as individuals and for public health. [Previous page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=11) [Next page](https://boards.straightdope.com/t/astrazeneca-approval-in-the-us/937911.md?page=13)