EU agency says AstraZeneca vaccine is 'safe and effective' | Hacker News Reader

EU agency says AstraZeneca vaccine is 'safe and effective'

bbc.co.uk

64 pointsncw9638 comments

A clarification - this isn't just 'blood clots', it is an extremely rare form of blood clotting that has a 40% risk of death, in a population that has an extremely low risk of death from COVID, where it works out to be 7x as many people have died from this new form of clotting than the general population at large would have expected in the time frame given. Given the numbers we know so far, if you are a young woman who considers herself as having a 10% chance of catching COVID, the 'known' risk of dying from the AZ vaccine is now already higher than your chances of dying from COVID. Specifically, COVID has a 10x higher known death rate than the rate of this complication in the appropriately considered population. A young woman who is working from home and taking precautions could reasonably decide that the AZ vaccine is not worth the risk, without being 'statistically illiterate'.

about 3/4 of theway thru the text i finally find some numbers

>>What has AstraZeneca said?

The company says there is no evidence of an increased risk of clotting due to the vaccine.

It said it had received 37 reports of blood clots out of more than 17 million people vaccinated in the EU and UK as of 8 March.<<

37 reports out of 17 million vaccinations.

this is aprox. 1 report out of 510 000 vaccinations.

what is not shown is spatial distribution over population. this would provide insight regarding statistical groups such as those who recieved a bad batch [if extant] or those with existing cerebovascular pathology concurrent with vaccination.

i cant say im a fan of the adenovirus vector approach, for technical reasons, however it does appear to be a vaccine for those not immune to adenovirus.

According to some interviews and sources, the Sinus blood clots are more likely to happen with AZ. I haven't seen any numbers, especially accounting for age and demographic groups, so I cannot tell.

That being said, every drug has side effects. A vaccine isn't any different.

i would like the opportunity to read these "some interviews and sources" do you have any citations to append to your qualitative comment?

One from the vaccine and immunology head of the Charité in Berlin. No idea where I read the other one, but it was in German as well. The Charité one is here:

https://www.spiegel.de/wissenschaft/medizin/astrazeneca-das-...

It was expected all along as the EMA never suggested otherwise.

It's baffling that so many countries rushed into suspending the vaccine. By all means they should track and investigate potentially serious side effects but it's unclear to me why they escalated this so much when, at least based on the raw numbers (ie. about 50 cases of blood clots out of about 17 million injections), the incidence of blood clots is minimal even if caused by the vaccine (people have a higher risk of dying in a car accident than developing a blood clot after an injection...)

I feel some countries suspended it out of 'peer pressure'. For example it seems to me that France did not really want to suspend it but did soon after Germany announced it would. Now they have already said they will resume immediately and that the PM will get an AZ injection tomorrow to show it's fine.

For those that want a bit of evidence and scientific background on this, Derek Lowe's writings are, as usual, an excellent source. https://blogs.sciencemag.org/pipeline/archives/2021/03/16/wh...

It is a scientifically and statistically rigorous look at the available data that takes into account how people probably feel about the whole issue.

I think this article is a bit more nuanced based on what they are seeing on the ground. Derek brings up good points about background rates, but papers over some things. It's a complex picture and the below article paints it well.

Also scientists in Norway claim they found the mechanism that causes it.

https://www.sciencemag.org/news/2021/03/it-s-very-special-pi...

https://www.vg.no/nyheter/innenriks/i/KyGv2G/professor-says-...

I was going to post the same link, as I also feel that this article is more nuanced.

There is also a twitter thread by one of the article's authors summarizing the article and discussing some additional information.

https://twitter.com/kakape/status/1372315648894844940

> AstraZeneca supplies Europe with vaccine from several plants, however, and EMA could not say whether all of the batches involved came from the same facility.

Is there an answer to this yet? The batch that a particular person's dose came from is carefully documented (or at least should be - it is in the USA).

In the EMA statement from today they said:

> there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;

https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene...

I think the EMA press release is a better source: https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene...

Specifically it doesn't say "safe and effective", it says "benefits outweight risks" (BBC says that at well, but they removed that bit from the headline).

I believe the title is from the EMA press conference, @ 07:20[1]

“ The committee has come to a clear scientific conclusion: This is a safe and effective vaccine. Its benefits in protecting people from COVID19 with the associated risks of death and hospitalization outweigh the possible risks.”

  [1] https://youtu.be/qYmP02SIQNI

Surely it's inevitable that during a worldwide rollout of a new vaccine a few 'pauses' happen -- even if people find them deeply distressing. Lots of people were claiming this was politically motiviated reather than scientificially motivated.

Does this confirm the motivations were scientific?

> Does this confirm the motivations were scientific?

No.

If they keep vaccinating with this vaccine and it does turn out that the vaccine causes the deadly blood clots it will destroy the legitimacy of vaccines. "they pushed the vaccine despite knowing that it kills some people" is how it will be framed. Even though I agree that for health reasons continuing to use it is almost certainly correct, not considering the public opinion is madness and will cause massive issues. Do not increase vaccine skepticism beyond where it's already at.

We have no innate sense for probabilites. To give people a bit of intuition about the risk, a good approach might be to try put the risk in relation with the risk that comes with activities and drugs that people already know and do.

Example, with made up numbers:

"You are 4 times as likely to suffer a blood clot from a 4 hour flight than from getting vaccinated with the AZ vaccine."

And yet, if vaccinations don't continue, it's highly likely more people would die, that otherwise may have lived.

  Paul Hunter, an infectious disease expert at the University of East Anglia, noted in a statement that even if the risk of CVT is raised by the vaccine to five or more cases per million people vaccinated, the COVID-19 infection fatality rate for men in their mid-40s is 0.1%, or 1000 deaths per million infected.

So it's a tricky problem. I do believe you are correct though - even just evidence of missed side effects would be like meat and drink to anti-vaccination sentiments.

The problem is the perceived risk, for many people getting COVID is avoidable if they take precautions, while the scenario of willingly take a vaccine that can result in death is way more darker.

A lot of young people won't even find the "relief" they got from knowing COVID is more lethal on the elderly, since this seems to be happening on younger females.

It's not an easy problem to fix, and I see a lot of people refusing this until they get to the bottom of the reason, a safe treatment for these cases. I'd say this will probably be the end of the road for AZ vaccine in a lot of places.

Not to mention the pile of fuck-ups AZ did for months in a row, they painted themselves as unreliable and liars to the public.

Plus, what else might be hiding in the vaccine that we may find years from now?

> The problem is the perceived risk

Communication helps a lot.

If you say "50 cases in 17 million injections" people might not know what that exactly means and might be worried simply by the way it is reported. Now, if instead you qualify the above with "which is less than the chance of dying in a car crash so it's very safe" then people may be unfazed.

I feel the main problem is the way this was reported, which created an overblown perceived risk.

I think they spoke too soon, either way, they said it should be brought to attention of people of the potential symptoms and what they should do in that event - something that the manufacturer itself hasn't even acknowledged yet. Here in Portugal when this was addressed to the public it was brought to people's awareness that skin bruises, bleeding, general pain for few days should be reported to the doctor.

Let's see what Norway and Germany will do, I think the eyes are more on them - since they are dealing with those cases. Also if more cases keep showing.

Covid kills about 100:1, hospiltalises 20:1. IF the vaccine causes clots, it does so in about 140.000:1.

At the moment this is right next to “ Norwegian experts say AstraZeneca vaccine is behind the deadly blood clots” on the front page. I think it’s up to each nation to decide for itself if a vaccine is going to work or not, but I pitty the ones they go first and suffer from overzealous cheerleading of a particular vaccines efficacy.

>but I pity the ones they go first and suffer from overzealous cheerleading of a particular vaccines efficacy

Given the incident rate and the growing COVID swells in a few european countries (France and Italy especially), the slow vaccination progress, not helped by hesitance over AZ and surprising prevalence of vaccine hesitancy in general, you could just as well argue the opposite. Nations that are overcautious may lose far, far, far, far more lives thanks to covid infections than an extremely rare handful of blood clots which haven't even been tied causally to the vaccine yet. The risk reward narrative on this topic has been really bizarre so far.

> Nations that are overcautious may lose far, far, far, far more lives thanks to covid infections than an extremely rare handful of blood clots which haven't even been tied concretely to the vaccine yet. The risk reward analysis on this topic has been really bizarre so far.

You seem to suggest risk-reward analysis be viewed at by the number of deaths.

Germany had to suspend vaccination (temporarily) due to legal reasons and risk of a lawsuit to the state.

Actually talking about the risk reward analysis in the media and general commentary reaction to the AZ vaccine rather than by nations. Think it's perfectly reasonable for nations to conduct safety checks and research on new vaccines

Right. The WHO listed 'vaccine hesitancy' as one of the top global health threats, and that was in mid 2019, before the pandemic. [0] On the other hand, vaccine side-effects have never been a major health threat.

[0] https://en.wikipedia.org/wiki/Vaccine_hesitancy

I think this vaccine and vaccines in general are overwhelmingly safe, but has this not been a slightly different situation?

Admittedly, I don't know much about vaccine safety, but isn't it unusual to have a vaccine rolled out to millions of otherwise healthy people without any long-term studies into its safety? I understand we create new flu vaccines yearly, but my understanding is that's a slight variant of previous flu vaccines which have been proven to be safe over long periods of time – and it's only rolled out to vulnerable people who want it, not everyone under threat of not being able to travel, etc.

I think we probably should have some level of caution when taking any new drug or vaccine – especially one that is going to be rolled out to millions of people. How many times would we need to run this experiment before a 'safe' vaccine does actually cause blood clots or some similar side effect? Or are side effects from vaccines basically impossible? (I genuinely don't know).

For some context, I'm saying this as someone who now suffers from permanent side effects after taking a medication that was once deemed safe and without risk of permanent side effects so unfortunately its hard for me not to be a little hesitant.

Delayed side effects is a thing, especially due to interaction with other meds. Huge swaths of americans have hypertension and diabetes and take meds regularly.

I am no expert at all, or from a medical field. But my understanding is, that long term effects of vaccines are effects that last for a long time, and not effects that tale a long time to manifest.

What we see bow is the rare side effects, like blood clots, in the 30 in 5 million range. These effects are close to impossible to discover in clinical trials, because they are too rare. Again, nothing really unusual.

Once the body developed anti bodies and general resistance, the vaccine doesn't have any effects anymore anyway. So either side effects, also in conjunction with other meds, manifest right after vaccination or they don't at all.

> What we see bow is the rare side effects

Causation hasn't been proved and cannot be assumed.

It makes little sense to worry about this for AZ, it's a very standard viral vector vaccine.

The brand new mRNA family of vaccines however are untested in the long-term...

But it's not really up to each nation, because the EU is centrally managing the supply. If individual countries aren't willing to endorse the EMA's judgment here, it's likely they'll end up wedged in a state where they just can't get many vaccinations done over the next few months.

If it is up to each nation, that's too bad. We should be treating adults as adults, telling them "here's the information: about 30 people had bloodclots out of 5,000,000 having received the vaccine (source: https://www.bbc.com/news/uk-56397592). We're not sure if any of those 30 are linked to the vaccine. If those risks seem acceptable to you, here's the vaccine."

Well I think the other side of the calculation is a probability that you may be able to get vaccinated with the Biontech vaccine if you wait.

I'm in the US (New Jersey specifically, which has done terribly with the roll out), so maybe it's different in the EU, but at least here we don't have an over-abundance of vaccine doses. Eliminating one of the vaccines currently limits vaccine supply in most places.

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