If the shots happened to take 8 doses to be completely delivered, by tracking shots instead of complete treatments as your denominator, you've just artificially deflated any concern level by 8 times.
100 deaths / 8,000,000 doses = 0.0000125 (in 80,000 people, one is killed - not too worrying, or so it would seem)
100 reactions / 1,000,000 treatments = 0.0001 (in 10,000 people, one is killed - uh oh)
The issue you are tracking is how many humans are impacted by the treatment. In the case of COVID-19 treatments (which are two-dose in the UK) - if you choose to track shots versus reports, you lose accuracy by a factor of 2, and this accuracy is skewed against safety. By tracking treatments, you get slower feedback, but it is accurate and supports the correct interpretation of safety levels.
Tracking shots may be partially useful as an early warning signal. Other than that though, it's not just not useful, it's completely wrong.
The "sobering" references the massive disconnect between what is typically reported by media, and what is reported in the system by doctors and nurses on behalf of, or in limited cases directly by, harmed people. If you read the entire report, and bear in mind these are under-reporting figures, you may - if you're lucky, perhaps - experience a moment of sobriety when it comes to the actual experienced level of safety of what's being assured as "safe".
I knew someone with a preexisting blood condition who got clotting after taking the vaccine. So for those people the chance is way higher. But the risks for clotting were not as well known at the time as they are now, and she didn't do her own research.
Physicians don't exactly do the research better than you do. They accept the standard line from their decades-old schooling, or CDC bulletins, or hospital administrators as gospel truth, and may occasionally update their priors in a year after attending a conference.
In the general case, a physician is obviously better than a patient in terms of being informed.
On the margin, however, a well-researched patient will almost always be better informed than a physician accustomed to the average patient. This is particularly relevant to the ~130 IQ HN populace.
> On the margin, however, a well-researched patient will almost always be better informed than a physician accustomed to the average patient. This is particularly relevant to the ~130 IQ HN populace.
It's quite dangerous and egotistical to think that you are in that group, though. When most people think they're a better than average driver, many are bound to be wrong.
If you think you're right about something and the doctor is wrong, get a second opinion. Don't assume you know better than a medical professional.
Someone responded with a good question but then deleted it: Aren't you allowed to disagree with your doctor?
Sure, in the sense that you can get second opinions if you're extra concerned about the topic.
If you're pregnant or have a blood clotting issue, by all means get a first and second opinion if you're worried about getting the vaccine.
But don't think that you are more qualified than medical professionals to understand the risks and side effects (unless of course you are a medical professional).
What you should be saying is that a more-informed person is less likely to make mistakes than a less-informed person.
You assume that doctors, in the couple of hours they may dedicate each day to catch up on all of the many plethora issues affecting all of their patients covering thousands of different areas of research that affect human health (and retain all of these things), is going to be more informed about the particular health issue affecting one person, who is extremely invested in this one aspect of their own health, and can dedicate the same or greater amount of their time researching that specific issue.
A specialist, possibly - but a general practitioner - unlikely.
"Nutjobs" is still a bit harsh, no? :) I do know a fair number of people who fall into the first category (but unfortunately, know far more in the second category).
I'd agree but I have never seen someone that said "I did my own research" in this context who is not a nutjob. "I did my own research" in this context deeply implies that there is a conspiracy going on. This disease has been the primary focus of the whole world for the last 1.5 years, all data is publicly available, and is publicly interpreted by countless independent top experts in the field frequently. If you "did your own research" and believe things to be opposite of countless independent experts are saying, you probably believe in a conspiracy around all this - that is nutjob territory to me. If you are researching a very niche, understudied subject, sure. But in contexts like this, you probably won't hear the words "I did my own research" from people who know what they are saying.
From what David Spiegelhalter said earlier it's about 1 in 250k for the under-30s. That's 0.0004%. The problem is that if you control for the right parameters the expected outcome is worse, possibly by multiple orders of magnitude, than that of being infected with covid.
"While the AstraZeneca vaccine has been the focus, other vaccines have also been reporting adverse events. Searching the EMA EV database for Moderna vaccine reports for deep vein thrombosis and pulmonary embolism identified 29 DVTs, of which 12 also had pulmonary embolism; no reported deaths or fatal events [16]. Similarly, searching for the Pfizer vaccine reports, 13 DVTs were found in the same study period, from 17 February to 12 March, as this paper reporting on the AstraZeneca vaccine adverse events. With the Pfizer vaccine, 11 people also developed pulmonary embolism and two died [16]."
Seems to be the case that Pfizer and Moderna didn't get in as much trouble with clot risk I guess?
Agreed, but I doubt that the difference in # of AZ and Moderna/Pfizer doses administered is off by too many orders of magnitude [edit : on second thought, could be off by a factor of 10]. The central issue in my mind is the difference in populations since Americans have predominantly received Pfizer/Moderna while Brits have predominantly received AZ. Its possible that Brits have an intrinsically higher clot risk with the AZ preparation than Americans do with the Pfizer/Moderna vaccines (although, the J&J clots in the US certainly questions this idea too).
> The problem is that if you control for the right parameters the expected outcome is worse, possibly by multiple orders of magnitude, than that of being infected with covid.
How come? COVID infections have a high probability of causing blood clots.
Use a hypothetical set of parameters to study a subset of the population. For example it could be a yet unidentified genetic variant related to blood clotting. Or just whether or not you already had the disease. Statisticians try to identify these parameters with the limited data available.
Remember to divide by fully-vaccinated persons, not shots administered. It's not the shots that experience the blood clotting.
Also, bear in mind that adverse event reporting has been clocked (in pretty much every study) at under-reporting adverse reactions anywhere from a handful of times to hundreds of times (even for serious or fatal reactions).[0]
Finally, after you've accounted for those trifling caveats, you've now arrived at an approximation of the odds for a princely one adverse effect, that happened to be apparently causal enough to be readily discovered, and also accurately reported enough to be identified almost immediately.
There could be many others of course, complicated by genetics and unforeseen reactions with other medications or conditions, along with that not insignificant variable of time. (Ordinarily, for new substances injected intravenously, a generous several years is afforded to that one.)
You also don't know if there is a large demographic out there who share both a reluctance to sign up for medical trials, along with a propensity to exhibit an as-yet undetected adverse reaction. (Quite a reasonable proposition, if you think about it. Don't we always find things in the last place we look?)
And all this for a disease most people below average life-expectancy have little risk of dying from, even if they catch it and undergo no treatment, and for which safe, high-efficacy preventative measures and treatments already exist.[1]
I have a genuine question about this. If we discover issues within 60 days of getting the vaccine, what does it mean for the next 70 years of my life?
I understand that the odds of getting thrombosis are very low, but what about the chances of other serious issues cropping up later? Is this a reasonable concern?
The blood clotting is a side-effect of the immune response, so we expect it to be correlated with the initial dose, usually within 2 weeks. I think they chose 60 days here as the largest reasonable upper bound to be as certain as possible they caught all cases.
No one knows right now, but we will know more over time. I guess we can take comfort in that a lot of people are in the same boat. I would like to better understand how/why mRNA vaccines can't/won't eventually turn into a dangerous prion.
I am genuinely confused as to why there seems to be more side effects/issues with the 'traditional' J&J vaccine vs. the mRNA Moderna/Pfizer vaccines. I would have thought the opposite to have been true.
But then again the Sputnik vaccine seems to be doing ok? So maybe it's just the J&J formulation. Who knows though, the peer reviewed data for this hasn't had much time to go through rigorous scrutiny.
Prions are proteins, so that's not much of a risk with the mRNA vaccines. But I do get your general point. As to why J&J seems to have more side-effects, its hard to tell. More than the peer-review step (which is attacked all the time), my sense is that the clot risk is so rare that the number of participants needed to observe enough clots was much much larger than the number of Phase 3 trial participants.
As for the Sputnik vaccine (and the Sinovac one in China), sampling rare events such as these and reporting them is a function of how many people have been given the vaccine + the amount of transparency of the authorities in the countries administering these vaccines.
> I would like to better understand how/why mRNA vaccines can't/won't eventually turn into a dangerous prion.
Why would it? A prion is a specific protein, why would this specific mRNA molecule, which only exists in our body for hours, cause that specific protein expression, when we have hundreds of thousands of other mRNA molecules per cell all similarly experiencing their own self destruction?
You're right, I may have been too dismissive, and you're right, science is about curiosity, but the "just asking questions" approach is a way to demolish perfectly good science. You can't prove a negative, and so throwing doubt after doubt at something is a good way to discredit a perfectly valid point because eventually you run out of answers. That's why I asked why they had that belief.
The user that asked the question didn't further engage, they just threw in some doubt and walked away. That doesn't feel like scientific curiosity. That feels like pot stirring.
That's what long-term studies are for, but we've bypassed those for this vaccine.
Just as a layman though, my instinct would be that something like a vaccine would have pretty short-lived side-effects. It's a single dose (or maybe two, depending) and it doesn't persist in the body for very long. Most drugs with bad long-term effects are ones that are taken on an ongoing basis.
What time frame would these long term studies normally be done over? My understanding is most of the acceleration came in the form of ramping up manufacturing early and moving to Phase III faster, but we're now 1 year out from when Pfizer started their first study and we've obviously been giving out ton of vaccines for a bit since then. We understand pretty well what sort of side-effects come from vaccines and they aren't invisible for this long
I think the issue wouldn’t be that the vaccine is in the body for a long time to damage something but that it damages something in a way in a short time frame that keeps damaging other things or starts going wrong.
Hi throwawayboise, Boise resident and native myself for the record, the idea these bypassed needed studies is a complete fabrication. Please stop harming both of the communities we seem to share by spreading this nonsense.
It's not a fabrication. These vaccines haven't even existed for a year; there is no possible way to do a long term study in under a year. Whether you feel like a long term study is needed is certainly up for debate, but none have actually been done.
The idea that they have been "bypassed" is indeed a fabrication. That phrasing implies that long-term studies are usually carried out in vaccine trials and an exception was made for COVID-19 vaccines. That is not the case. Long-term studies are always carried out after a vaccine has already hit the market.
It would be correct to say that no long-term studies have taken place, not that they have been "bypassed."
Most doctors I have heard from note that side effects for vaccines (if they occur) almost always pop up shortly after the vaccine is administered. There are rarely, if ever, side effects that have occurred years after vaccine administration. Thus, we have no reason to believe these vaccines will have any significant long term side effects.
I have seen reports that Pfizer and Moderna have had blood clot numbers too. I'm getting pretty tired of all the anti-AZ hysteria. I got the 1st shot of it and will get the second.
Put it this way, if you get actual covid, your risk of getting a blood clot drops to something like out of 1,000. That's way better odds than a million. So logically right there, the vaccine is a great idea.
Secondly, I haven't been convinced that some of this negative press isn't intentional. AZ is non-profit, Pfizer and the others are for-profit. Who benefits from negative AZ stories?
There are a number of reasons other than "cui bono" why AZ is more in focus.
First one: Astrazeneca (and for what it's worth, also Sputnik and Sinovac) uses a vectorvirus with all problems that come with that (as the "carrier" virus is still somewhat alive).
Second one: Biontech/Moderna got used for the elderly population in many countries as they were the first to market, whereas AZ was mainly used for younger care staff in countries like Germany (and UK, which almost exclusively used AZ, prioritized the elderly, too). Given that the clotting issue seems to be drastically more prevalent in young women (which is the common demographics for care staff) it's not surprising to see a rush of clotting cases prop up in Germany and not in UK. An uninformed at best and clickbait/scaremongering/ragebait-interested at worst press is bound to take that cheap bait.
Third one: AZ completely fucked up its deliveries to the EU and had massive issues with intransparency, which leads to even more, this time legitimate and massive, press and political attention.
Side note: AZ vaccine was developed by non-profit Oxford University, but AZ is still a for-profit company!
(Also, if I would have the chance of an AZ dose I'd gladly take it, but here in Germany our politicians are incompetent buffoons so God knows when I'll get a shot)
I don't understand that any question about a potential corruption motive is treated as a taboo.
Corruption is more rife than ever in the current politics and nothing is being done about it.
Why people downvote genuine worry that such thing might be happening is beyond me.
Corruption is what destroys societies and yet people look away hoping if they don't see it then it is not happening.
I don't consider blood clots as genuine worry. The risk of getting a blood clot from covid is much higher. The risk of suffering a serious adverse medical event from covid is much higher. There is a much higher risk/reward ratio for public health to have vaccines proceed than to not.
The narrative of AZ being scary is fueling vaccine hesitancy and contributing to vaccine shopping.
> I don't consider blood clots as genuine worry. The risk of getting a blood clot from covid is much higher. The risk of suffering a serious adverse medical event from covid is much higher.
This is simply not true. COVID does not have a higher risk of inducing this specific kind of blood clots, the risk of death from which seems to be around 20% based on the available data.
Furthermore, the risk of suffering such an event from the AZN vaccine seems to increase with lower age while the risk of serious medical events from COVID appear to rise exponential with age, i.e. the risk to a young person is almost negligible. Obviously, there must exist an equilibrium at which the risk of taking this vaccine equals the risk from COVID.
But given that other vaccines are available that a) have higher efficacy, and b) have a substantially lower risk of causing blood clots than the AZN vaccine, we need to assume that the age of equilibrium lies relatively high. This means that if you life in a country with access to mRNA vaccines in the foreseeable future, and if you are healthy and below the age bracket of 60-70 where the risk of serious complications from COVID starts ramping up substantially, you are better off waiting if only the AZN vaccine is available.
The real problem isn't people pointing out these issues with the AZN vaccine, but people like you who insist that they are perfectly safe even though that is objectively untrue, and better alternatives exist.
"The MHRA said about four people in a million would normally be expected to develop this particular kind of blood clot - though the fact they are so rare makes the usual rate hard to estimate."
Since 22 million people got at least one dose of the vaccine in UK you'd expect 88 of them to get this issue without taking a vaccine. 41 after vaccine doesn't sound alarming at all.
First off, the statistical chance of developing a clot is already pretty damn low.
The odds of that being a fatal clot are even lower than that, as now that the side-effect is understood and you can monitor for symptoms, it's typically a very treatable condition.
In the end I guarantee you that, thanks to the poor government response and irresponsible reporting around this issue, more people will die from Covid as a consequence of people delaying or refusing vaccination than will die from this side effect.
It seems that as the number of vaccines administers goes up, the rate of CSVT is converging on slightly more frequent than 1/100k. They have now also confirmed that there is an age effect which they found in the previous data release as well but which the EMA, with a smaller sample size at the time, had not been able to determine to their satisfaction previously.
The JCVI now has the challenging task of making a recommendation for people in their 30s without occupational or health reasons for priority, whose turn it will be over the coming weeks to start receiving vaccines. (People from 18-30 have already been recommended a different vaccine "if available", there is probably just barely enough Moderna on order for Q2 to give most of them that).
Making that decision is a very difficult one because it depends on a lot of context. You're not just deciding between giving the vaccine and not ever vaccinating, you first have to decide what the counterfactual scenario is where you don't give a 35 year old an AZ dose next week.
This on:
a) The incidence rate for each demographic of CSVT-type clotting from the vaccine[s].
b) The expected distribution of clinical outcomes from those events, making reasonable assumptions about likelihood of early detection and outcomes with treatment for heparin induced thrombosis.
Those two give you the clinical risk of the vaccine.
Then you compare those with the clinical benefit from:
1) The relative likelihood of infection for a person, given their demographics, personal exposure profile etc.
2) The absolute likelihood of infection in the country / region in question based on assumptions about the future of the pandemic
3) The expected distribution of clinical outcomes from infection given the person's characteristics
(2) is important because you're comparing a one-time risk of side-effects with a time-related risk of infection.
Clearly, the same person in Delhi or New Zealand is not really making the same trade-off even if in the abstract, the side-effects and IFR are the same.
You also need the counterfactual: If you decide not to give an ad vectored vaccine, you are not deciding never to vaccinate, you are deciding that this person will get a different vaccine, probably later. How much later depends on the location. If you're in the US, you've got Moderna and Pfizer/Biontech coming out of your ears so it might only delay any individual vaccination by a few weeks. If you're a healthy 25 year old who can work from home, the risk trade-off of having to wait an extra 6 days is very different than that same person if they have to wait another 6 months.
As a result, different countries, looking at the same data will rationally make different decisions because their counterfactuals are different.
The US has lots of mRNA vaccines so will choose one thing, the EU has been badly hit by the failure of Sanofi/GSK to deliver a working vaccine, by AstraZeneca scaling problems, and by J&J coming along later than anticipated but has quite a lot Pfizer production capacity, the UK has used up its Pfizer stocks and will now only use it for second shots. CureVac and Novavax may be able to supply some doses at some point but aren't in the picture yet. Several European countries are negotiating to get Sputnik but that is also ad vectored so may have the same problem (and according to reports from Anvisa in Brazil appears to have replication competent adenovirus in it which is definitely not the intention). That changes the risk calculation because it changes the time that people will remain unvaccinated in the counterfactual where ad vectored vaccines are not used for their age group.
Of course, you also have to consider the risks from the other vaccines. Risks from the mRNA vaccines appear very low but J&J seems to have the same clotting issue though maybe at a lower frequency. So if you're delaying someone's vaccine in order to get them J&J, you have to calculate the (seems to be lower) CSVT rate in the counterfactual as well.
All of this is before the complicated public health element of keeping messages for the public simple and the issues caused by changing that message frequently and the long-term need to ensure that public trust in vaccine programmes remains deserved by the honesty with which they are conducted.
It's pretty clear that in the UK where there is just about enough AZ to slowly vaccinate the 30-40s and enough Moderna for the 18-30s (but not any more than that), the public health professionals and immunologists on the JCVI are agonising over the right thing to do. I would be too, even though for myself I have happily received AZ in my mid 30s but it must be an awesome and terrible weight to make a recommendation like that for other people, knowing that they trust you to make the right decision.
We've heard now of two deaths after AZ shots in our vincinity (a pharmacist and a kindergarten employee), plus we heard from a doctor in Scotland who said he himself had two dead patients after AZ shots while the hospital he worked at had dozens. We haven't heard anything noteworthy about other vaccines so far (that includes Russian and Chinese vaccines).
I'll take 5 nines success chance.