I’m interested in the statistical analysis. That’s how this type of science is done. You typically don’t have doctor-detectives proving the mechanism of the injury from the drug. You have a group of people who took the drug, and the group who didn’t, and you compare the rate at which a symptom or outcome occurs in each group. You may have to do some sophisticated statistical analysis to control for differences in the makeup of the two groups.
I don’t need a blood clot specialist to tell me whether the vaccine has this additional risk. I need someone who is an expert at analyzing the data to do it.
Having spent twice the amount of time in a hospital for blood clots than open heart surgery I’m going with scientific review of what happened rather than a number cruncher. I almost lost my leg because a specialist thought the numbers favored his diagnosis.
A scientific review will be number-crunching. There is no other way to do it. Correlation is not causation.
If blood clot specialists study it what is to stop them from saying it’s not the AZ/O vaccine just to have more blood clots to play with? [I know doctors wouldn’t do this]
Let the number crunchers do it-they don’t have a vested interest.
But there’s no way to approach this other than with numbers.
Are there likely to be adverse events with this vaccination? with all vaccinations? Yes, certainly and in some rare cases people will die because they had a vaccine but that is exactly the same for any treatment you wish to name.
Take a read of the info leaflet for any drugs you happen to have at hand. On there you will find lots of side-effects, some minor, some serious. I’m not aware of any treatment that is risk-free (e.g. the birth-control pill mentioned above has a 1-1000 blood clot risk).
The “thorough examination” you request is an ongoing process, the result of recording and collating all adverse events and investigating deeply where high risk of harm can be concluded from the data.
The events seen so far…taken as a whole…warrant investigation as this is an emergency use product in the first stages of use, but that is what would happen anyway.
The additional political decisions to pause the roll-out are not warranted by the data.
The stark fact is that those unnecessary pauses have already meant the unnecessary deaths of hundreds of people and the potential for thousands more. That will still be the case, and the pausing will still be a baffling decision, even if a slam-dunk causal effect can be shown.
It is a medical trolley-problem of sorts, The political powers have switched the points to save a hypothetical handful of vulnerable people tied to the tracks, knowing that it means a real train full of hundreds gets hurled off a cliff.
In a world where the vaccine was a luxury then sure, take an abundance of caution. We aren’t in that world.
In general, good medicine combines “number crunching” with an understanding of the mechanics. So does good data analysis in other fields. An understanding of plausible mechanisms isn’t going to overwhelm 10,000-1 odds or anything. But it will inform what studies to do, who to enroll, and help to disentangle causation from correlation. “Do we see this artifact because people in this subgroup are older, or because they have higher blood pressure? The effect we see can plausibly be caused by age-related changes in the immune system…the effect we see can plausibly be caused by high blood pressure…the effect we see might be caused by the interaction of certain types of cholestorol molecules that differentially absorb X…”
Good researchers will consider those hypotheses and design studies to differentiate, and to look for evidence that likely causative factors are also statistically significant.
That’s also how new drugs are developed. Researchers either guess or demonstrate that the effect of drug X is caused by such and so a mechanism, and engineer new compounds that ought to have a similar (or improved) such mechanism.
Especially with new drugs that lack massive data (such as all the covid vaccines) understanding the likely mechanism givens useful guidance.
the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
The release goes on to discuss the possibility of a causal relationship between vaccination and two rare conditions (cerebral venous sinus thrombosis, CVST and disseminated intravascular coagulation, DIC) noting that no link has been established but that further investigation is merited.
Looks like the AstraZeneca is now back in favour in Europe.
I expect the nationalist argument over which country is first in line for the output of the vaccine from AZ factories on its territory will now be back on the table. The EU leadership and many polticians in European governments are feeling the pressure.
The data on deep venous thrombosis and pulmonary embolism show that these conditions are showing up in those who’ve gotten the AstraZeneca vaccine at rates lower than what we’re used to seeing in unvaccinated people. In other words, the background level of these conditions exceeds what’s being seen post-vaccination. Remember also that most of those vaccinated so far are in older age groups with co-morbidities that predispose to these thrombotic/embolic events.
As to a “very rare blood clotting disorder” that the Guardian article mentions, they describe 5 cases of cerebral venous sinus thrombosis occurring in the U.K. among those who got the AstraZeneca vaccine. At least 25 million doses of this vaccine have been given in the EU and U.K. so far. The normal background rate of CVST is 5 in a million people per year.
At this point it would be unreasonable to conclude that the AstraZeneca vaccine protects against these disorders or that it causes them. Study any possible links, yes. Hype the idea that correlation equates to causation, no. Governments have a special obligation to listen to their experts and not be buffaloed by sensationalist reporting from the likes of the Daily Mail and Fox News.
If you want to play a numbers game the chances of dying from covid are very low. I’m saying that to point out the fallacy in the argument.
Where we cross paths is numbers vs people. If someone has a history of blood clots then it’s important to establish whether or not it’s an issue. Statistics don’t mean much to the dead but scientific evaluation means something to the living. As I said before, I was taking a drug that had full approval right up until they pulled it from the market because it caused heart attacks…
People are not statistics in the sense that everybody is the same.
This problem with this argument is that there are several other vaccines available. The policy makers were not shutting off all vaccines, but just shifting to using other ones temporarily while the situation was sorted out. The ones who had enough non-AZ vaccines were able to temporarily pause them all, while other countries only paused certain batches.
So there were never any people being driven off a cliff. They were just diverted to another track, while they checked on this one. They thought there might be people getting tied to the tracks, so they diverted the traffic while they went and checked. That’s just proper maintenance.
That’s why I argue against seeing this as some general policy about all such concerns. I say to look at this situations pecifically. I mean, this thread was originally about the US, who hasn’t even approved this vaccine, and yet we apparently have already secured enough vaccines for all adults. We do in fact have the luxury of taking a “wait and see” approach on it.
I suspect the other countries that chose to do any sort of pause did as well.
Well, the difference is that the US is hoarding vaccines and Europe isn’t. It isn’t proof that there’s an overabundance of vaccines and Europe can just randomly pause one vaccine then pick and choose what to replace it with.
Surely you see with the numbers being reported, numbers immediately accessible to health authorities, shows that this pause was utterly unjustified regardless of current logistics.
We have to know what it is about an individual that may cause the bad reaction to the vaccine. Otherwise all we have are statistics and probabilities.
Right now, we don’t know what individual differences might lead to a bad vaccine reaction, so there isn’t anything to take into account at an individual level.
We have much more experience with the flu vaccine, so that does have individual recommendations.
People who SHOULD NOT get the flu shot:
Children younger than 6 months of age are too young to get a flu shot.
People with severe, life-threatening allergies to flu vaccine or any ingredient in the vaccine. This might include gelatin, antibiotics, or other ingredients. See Special Considerations Regarding Egg Allergy for more information about egg allergies and flu vaccine. (Cite)
That is a case where we know a person’s history of bad reactions, so we can make a decision informed by individual information. That person right there (), who had a severe reaction to the flu vaccine previously, should not get one. All of those other people who have never gotten the flu vaccine should get the flu vaccine, because statistics tell us the risk of the vaccine is much less than the risk of flu ( ). One of them may have a severe reaction, but we don’t have any evidence of that, so all we can go on is that the risk of a severe reaction to the flu vaccine is much lower than the risk of a severe reaction to the flu.
Talking about someone misdiagnosing you based on statistics is so irrelevant to this discussion that it amounts to a hijack, as far as I’m concerned.
The safety and efficacy of a vaccine is based on statistics. Those are gathered at the individual level, but to make judgments about safety and efficacy, you have to crunch the numbers.
Making a diagnosis may take probabilities into account, but ultimately is about the individual and their symptoms, exposures, risks, test results, etc.
Trying to apply issues of misusing statistics in the latter to argue against the former just doesn’t make sense.
No, they weren’t. There is not enough supply of the other vaccines, and they were not able to completely shift to other ones. Even if that were the case the pause was immediate so the supply chain would take time to switch over. It is not as simple as simply taking a different tin of beans of the shelf.
So yes. Temporarily people went unvaccinated and every day that that happened people definitely died.
What fallacy? The numbers as presented for the risk of death from covid, the risk in the population for clotting disorders and the risk for clotting disorders in the vaccinated populations are pretty well understood.
We aren’t crossing paths. It is important to understand the evolving picture and associated risks. That’s what is happening, that was what was happening before any of it hit the headlines. You seem to think that people like me are against doing that. That’s simply not the case.
Do you think pausing the vaccinations was right?
If not then you and I have no difference in our view.
If you think it was the right thing to do then I have to ask on what grounds you make that assessment? Is it when any single serious event occurs? Or only when it rises above a certain level? How are we to calculate what that certain level is other than by statistical analysis?
That sounds profound but it isn’t. Statistics and evaluation are intrinsically linked and are the means by which we make the best decisions to prevent the greatest number of living from becoming dead.
looking at this chart we can see the % increase in population vaccination flatlining over the last week for Spain, Germany, Italy, France. They are collectively 1 to 1.5% behind where the trend was taking them.
Lets be charitable and say that only 1% of that is down to pausing the AZ jab.
That’s 1% of 250 million people or 2.5 million have missed out on being protected and that is against a backdrop of rising cases in most of those countries.
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.