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 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. “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.”
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.
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.
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.
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.
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.
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.
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.
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?
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.
The Pfizer/BioNTech 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.
Here’s a recent (Mar 28) prepublication (not yet peer reviewed) paper on the blood-clotting issue and its association with the AZ vaccine.
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 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.
It’s interesting that you mentioned women because they are more prone to CVST based on newer studies. WIKI:
While it may occur in all age groups, it is most common in the third decade. 75% are female.[4] Given that older studies show no difference in incidence between men and women, it has been suggested that the use of oral contraceptives in women is behind the disparity between the sexes.[2]
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.