France reports three new cases of thrombosis, more deaths after AstraZeneca jabs
rfi.fr
rfi.fr
https://www.theatlantic.com/health/archive/2021/03/astrazene...
This is not a simple issue. The implications are serious in Europe in the short and medium term, as they're quite far behind in vaccinations compared to the US and UK. Then the implications for global health equity are even more worrisome.
But.
This AstraZeneca trial has been a bit of a gong show.
https://www.reuters.com/article/us-health-coronavirus-vaccin...
“About 1,500 of the initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca COVID-19 vaccine were given the wrong dose, but weren’t informed that a mistake had been made after the blunder was discovered”
They’ve had a series of data issues, and they have not be super transparent about them. Is it safe? I think so, given the results from the deployment we’ve seen, but they didn’t inspire perfect confidence as they rolled this out.
"There have been two cases of CVSTs after Pfizer in the UK, out of more than 10 million vaccinated, but these did not have the low platelet levels."[0]
So currently a one in half a million chance of being effected. For comparison 1 in 1000 women per year taking the contraceptive pill have a chance of a blood clot. Obviously this is a new drug and should be scrutinised, better understood, and if possible fixed - but at what point do we consider the daily articles scaremongering by people with an agenda?
I am not sure older people would be too fond of this risk calculus. What about using "the others" on older people, and producing more of "the others" to vaccinate younger people later on?
The risk for the general population of younger people is low, they are not too afraid about the virus, and a potentially large part of them have already gotten COVID and recovered just fine. So there is no hurry in general. From what I read, people who are at risk without being extremely ill in the first place are old people and over-weight people (regardless of age). cf. https://doi.org/10.1161/CIRCULATIONAHA.120.051936
The difference is part of the concern in continental Europe.
from https://www.ft.com/content/d5cd63c6-af01-4d29-a5e5-b69ade4f3...
I would assume as UK starts vaccinating younger people it's likely to show the same impact? (also is continental europe using more AZ vaccines than UK overall?)
Estrogen is a clotting factor and if you have elevated risk markers (like Factor V Leiden) that risk skyrockets when you add extra estrogen.
Many insurance companies get angry when you ask for blood tests to check before getting birth control (my wife was charged an extra 1k because she requested a blood screening after she learned she had a history with clotting).
I've had a cousin hospitalized for birth control related thrombosis, so again: my input could be biased here.
Does 1 in 1000 women taking oral contraceptives having rare strokes every year sound right to you?
Indeed, at what point do we consider that?
Is it after half the world has been indoctrinated into taking a several-month old experimental medicine for an illness that the overwhelming majority of people under the age of ordinary life-expectancy survive - or, more commonly - barely notice?
Or is it after we've spent so many trillions on that illness so as to be able to turn each and every one of the 9 million per year of us who simply do actually starve to death each and every year, into a millionaire?
Yes, do please tell us about daily scaremongering by people with an agenda and how bad it is for everyone, you just go right ahead and do that.
Absolutely not opposed to the latter, vaccines are and have been of tremendously huge benefit to humanity.
Not the full spectrum, the trials are still ongoing. That’s why they have, in the US (and the equivalent in many other jurisdictions) Emergency Use Authorizations, not regular approvals.
Each of the Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines all have Conditional Marketing Authorisation in the EU.
The EU contrasts this as being much more robust and stringent that a mere Emergency Use Authorisation.
See the section “What are the different data requirements between an Emergency Use Authorisation and a Conditional Marketing Authorisation, and what are the potential consequences of these?” https://ec.europa.eu/commission/presscorner/detail/en/qanda_...
Contraceptive pills are taken by millions of women, of course, but there is a large proportion of women (possibly a majority) that do not want to take them. Alternatives like the condom, IUD, sterilization, etc. are widespread even if they are more uncomfortable, precisely due to the pill's side effects. And no one (or no one in their right mind, at least) questions a woman's decision to not take the pill.
Here we are talking about a vaccine that your health system actively calls you to take in the context of a campaign, no alternatives are given (in the words of a politician in my country, "vaccines are not yoghurts, you cannot pick your favorite flavor"), and while you are free to refuse it, you are then called an antivaxxer, and not given any guarantees about being able to take another in the future.
The standards really cannot be the same for something that you take at your own risk among tens of alternatives versus something that you are pressured to take without even a clear guarantee of alternatives. And you cannot use contraceptive pills as a metaphor for something that people just take willy-nilly without a second thought, because plenty of women definitely don't do that.
I have no idea if it is a bad batch or some unusual conditions in the Nordic countries (previous vaccines administered to this cohort?) -- but it does seem to be way beyond noise.
https://www.ema.europa.eu/en/human-regulatory/research-devel...
Find link with "European database for suspected adverse drug reaction reports.",
click Human,
click "en",
click "Search for report",
click "Suspected adverse drug reaction reports for Substances"
click "C"
search for "COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)"
click tab "Number of Individual Cases for a selected Reaction"
select "Nervous system disorders" from the dropdown
select "Cerebral venous sinus thrombosis" from the list
You get this: https://ibb.co/VDbYXpC
107 cases, 22 dead, 5 recovered (as of 3rd April). Note that UK doesn't put their numbers in this database so these adverse events are only out of the EU doses.
For extra fun look up Pfizer or other vaccines or other side effects like general brain hemorrhaging or strokes
The blood clot stories hitting the headlines are doing a disservice. If one out of a million of something happens, the human cognitive bias will make it feel like it's likelier than it is.
.. or do Europeans prefer to be locked down for the rest of their lives?
People should ignore the news media and take the vaccine for God's sake, it hasn't killed 40% of the UK, has it ?
"German regulators said they had received 31 reports of rare blood clots in the head in recipients of the AstraZeneca vaccine and nine deaths up to March 29, roughly doubling
Cooke said the EMA will include the Germany cases in its review "and they will form part of the ongoing evaluation that the committee is undertaking, as will any additional cases that are reported from other countries and regions.”
Based on the numbers reported to the agency so far, there have been 4.8 cases of the rare blood clots per million doses of the AstraZeneca vaccine administered, she said."
(https://www.france24.com/en/europe/20210331-eu-says-no-evide...)
The key word is "so far", the article explains that Germany saw the number double since the reporting.
https://www.ft.com/content/d5cd63c6-af01-4d29-a5e5-b69ade4f3...
Reports it as 10x the normal occurence of 3 per 100k. (and I assume that's before doing further slicing, probably slicing for younger women would show even more impact?).
I'm all for vaccine but it's a tight rope to have a successful rollout in EU: https://www.theatlantic.com/health/archive/2021/03/astrazene...
Maybe they could consider reserving the non-AZ doses to the most likely to be affected demographic.
(personally I'm lucky enough to be in a country that's not planning on using the AZ vaccine so there's no question, but rest of EU is different)
https://www.bbc.com/news/health-56616119
"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
(...)
Meanwhile, the MHRA said there had been no reports of blood clots following use of the Pfizer-BioNTech vaccine.
As of 21 March, an estimated 10.8 million first doses of the Pfizer-BioNTech jab had been administered in the UK, the regulator said."
Honestly, political sanctions are one thing, but refusing help for political reasons?
https://amp.cnn.com/cnn/2021/04/03/europe/europe-russia-vacc...
https://www.bbc.com/news/55800921
Can you tell me the difference between these two situations? Leadership lets their own regular citizenry die for political reasons. USSR refused food aid from western Europe during Holodomor. Venezuela refused food aid recently also. You can describe it all as “has no approval”. WHY does it have no approval — that’s the question.
When I was growing up we Europeans saw movies about the USSR, we heard news stories about Soviet citizens needing approvals to travel in their own countries, we saw checkpoints and checking of ID, and we patted ourselves on the back because we're Free. So - what happened?
The EU is really bureaucratic, more than any governing body, it is a huge flaw, but in reality it make it easy to dismiss claim that a decision is political. If it not a decision made by the council, it is not political.
There is no Israeli vaccine. Israel mainly uses imported Pfizer vaccine.
Refusing emergency aid and help because of some postulated alleged unspecified “motives” and not even willing to debate with others what those motives could be — is highly irresponsible.
You have to put aside political chauvinism when it comes to aid. It’s like when Palestinians refuse Israeli vaccine or when USSR refused European food aid during Holodomor, or when Venezuela did similar recently.
What about all the regular people who need emergency aid now, why are some people in the “leadership” able to deny them even access to it, for political reasons — while their own families secretly get all the best resources first? They don’t worry for their own families, so the plebes can just wait while the situation is resolved eh...
It's not like the choice was between vaccinating with X or waiting, availability is similar (or worse).
Trying to find number, but seems like so far there's been 30M doses produced. I think a few european countries are planning to manufacture it for Russia.
In any case doesn't really help, it's not like it's more easily available (and I guess costs are similar to AZ or J&J vaccines)
Yes. The incidence is as of a week or two ago significantly above what one would expect. Additionally this effect can be shown in all countries where AZ was given to people below the age of 55 and no such cases happened to people given other vaccines. You can quickly google for the numbers and days if you want.
For people 35-39 it appears to be 0.01%-0.1%.
This is a key flaw in your logic. The choices aren't just "get the AZ vaccine" or "100% chance of catching COVID", so you need to multiply the IFR of COVID by the chance you'll catch it to have a fair comparison.
And even if the chance is only 1/4, I would estimate that the numbers would still be higher for covid than for AZ for people in their 30s and above.
That seems unlikely. For one thing, after more than a year, there have been 130 million cases out of a population of 8 billion, which is less than 2%. Do you expect this to dramatically spike in only a few months at this point? Also, remember that there are other vaccines available, so it's not the case that AZ or catching COVID are the only two ways to herd immunity.
I'm making the assumption that we want to reopen our economies again at some point, at which point the infection risk will obviously rise much higher than that (unless we have reached herd immunity). The only way to prevent that is to get people vaccinated. And right now for many countries in Europe AZ is the only vaccine available, since the supply of the mRNA vaccines is for too low.
There were more than 50 deaths by COVID-19 in Norway last month. How many people were vaccinated with AZ and didn't die? How many of them won't die in the coming months? Could they have gotten a different vaccine? What if there wasn't enough of those other vaccines?
In this statement: "AZ could kill more people in the affected age ranges than the virus has done so far"
What are "the affected age ranges"? Affected by what? COVID-19? AZ vaccinations? Thrombosis due to AZ?
Newer testing is showing a near complete stop of transmissions with vaccines. CDC is actively changing guidelines as these studies come out.
If I were you I would see the vaccine as a "booster shot" for whatever natural immunity you may still have, with the expectation that it will improve and prolong your immunity.
Are you taking into account that these blood clot deaths are happening disproportionately in younger people? Also, are you assuming that anyone who turns down the AstraZenaca vaccine is definitely going to get COVID?
OP is claiming that "AZ could kill more people in the affected age ranges than the virus has done so far." so that's what I'm questioning.
In regions where COVID is well-controlled, you might save lives by rejecting the AZ vaccine and maintaining the current lockdown/measures until non-AZ vaccines are available.
The risk of death from the AZ vaccine seems to be about 1 in 500k. If you're a country of 10 million people, you would expect roughly 20 deaths from the vaccine. If fewer than 20,000 people would get COVID, the vaccine would kill more people than COVID would. If more than 20,000 people would get COVID, the vaccine would save lives.
Basically the risk of dying from the vaccine applies to everyone, because we want everyone vaccinated. The risk of dying from COVID only applies to people who actually get COVID. You'd have to look at projections to see which is likely to be more risky, but you would have to have really good control of COVID for the vaccine to be riskier.
or
10's of thousands of deaths out of millions of covid infections.
or
forever lockdown.
The choices are grim but after a year of lockdown... I'm worried about what happens in the next elections.
My retort is, for those who don't like vaccines, if you don't want a vaccine what IS the solution to the problem of covid?
Interestingly lockdowns, freedom passes, vaccine passports and masking are proposed as the new normal. Vaccination doesn't guarantee an end to lockdowns. Much like the post 9/11 anti-terrorism measures never ended. Fear is used to rationalize further encroachments on civil liberties.
For example
> In a separate development, the UK medical regulator said on Saturday that out of 30 people who suffered blood clots after receiving the Oxford-AstraZeneca vaccine, seven have died.
Excluding that that population sample is in the region of 19 million people who have received at least one dose of ChAdOx in the UK and the incidence of the clot is likely lower than the incidence rate in the population in general, as I understand it.
It's lower than the incidence rate of general blood clots, not than that specific type of blood clots. One of Norway's chief physicians (not just some quack) concluded that the clots are indeed due to the AstraZeneca vaccine: https://sciencenorway.no/covid19/norwegian-experts-say-deadl... . At the time that occured, only 130,000 people had been vaccinated in Norway, and so the four deaths of people under age 50 resulting from the clots actually suggested the AstraZeneca might be more dangerous to young people than Covid (which has a less than 4/130,000 fatality rate for the young).
AZ is safe. Get your shots, people.
This attitude is what is causing people to distrust authorities.
If you want to feel smug and superior, make dogmatic statements. If you want to change opinions, then you have to treat denialists with respect for their humanity, and separate the person from the opinion.
Norway has 3.414.711 people under 50, of which 13 have died from COVID since the start of the pandemic. Approximately one per month. Source: https://dc-covid.site.ined.fr/en/data/norway/
Thus, if you're under 50 in Norway, your risk of dying from COVID in the next 3 months is approximately 1 in 1 million. This is even lower for younger age groups (e.g. the population under 40 is 2.691.048 and only 3 have died in the whole pandemic).
The estimates on the risk of death from these clots range from 1 in 100.000 to 1 in 1 million.
So tell me again, how is it that obvious from the numbers that, say, a Norwegian 25-year-old woman should get her AZ shot instead of waiting for Pfizer/Moderna/J&J to be plentiful in 3 months?
Note that I'll probably get AZ myself if offered (for several reasons, notably including that COVID also comes with other risks apart from death, and also I'm from a country with more incidence than Norway). But no, it's not an obvious choice. And indeed, that kind of arrogant attitude does cause distrust.
By the way, I would take a 1:10 that you're American because 99% of the arrogant posts lecturing Europeans to take our AZ shots come from there. Of course, it's easy to speak so categorically from a country where you don't even need to make the decision of taking AZ or waiting for a better vaccine. The FDA shields you from that inconvenience by not even bothering to approve it, and your doses will end up being sent to Canada and Mexico. So basically, you don't have to decide to accept or refuse AZ because your institutions have already decided to refuse it (and rightly so, any country would do it if they were swimming in other vaccines... but then let's not pretend that they are all the same).
Cite? That's absolutely not consistent with the 7-fatality (yes, seven) value listed above.
The 1 in 100K estimate comes from the EMA. Here they report it:
https://www.bbc.com/news/health-56616119
"The EMA, which has assessed data from around the world, estimates there is around a one in 100,000 risk of a CVST in people under the age of 60 who have been given the Oxford-AstraZeneca vaccine"
(not the primary source, but it's quite clear that the British national media station would not have a bias against the British vaccine...)
Usually N denotes the sample size, but in this case the sample size is <the number of people under 55 vaccinated with AZ>.
Edit: clarification
What matters is the number of clots relative to the normal (incidence) rate, and the odds that you'd find 30 clots when sampling a randomized size-matched subset of the total population.
Please don't try to talk with authority on a topic when you're undereducated, aside from coming across as an ass, your brazen confidence and lack of knowledge just gives room to counter-argue that would instead harm your supported causes.
China and Spain both reported 0.2% death rate in the 20-29 range. 4/130,000 is 0.03%
The worst case scenario for vaccine side effect seems to be almost 7 times better than the disease.
Original comment:
I'm not sure I follow your logic? Haven't we already allowed for that by comparing via percentages?
Unless we expect younger people to have a higher rate of side effects?
Sorry if I'm being dull...
Based on Figure 2 of this paper the IFR for people 35-39 is between 0.01 and 0.1%. So in 130,000 infected people you would still expect between 13 and 130 to die from covid. And that's ignoring all sorts of other issues, like the amount of people that will need to be hospitalised, long covid, etc.
Was a pretty good overview of the issues