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EU agency says AstraZeneca vaccine is 'safe and effective'

64 points| ncw96 | 5 years ago |bbc.co.uk | reply

38 comments

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[+] kian|5 years ago|reply
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'.
[+] rolph|5 years ago|reply
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.

[+] hef19898|5 years ago|reply
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.

[+] mytailorisrich|5 years ago|reply
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.

[+] an_d_rew|5 years ago|reply
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.

[+] tobias3|5 years ago|reply
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).

[+] MrAlex94|5 years ago|reply
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
[+] s_dev|5 years ago|reply
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?

[+] hayd|5 years ago|reply
> Does this confirm the motivations were scientific?

No.

[+] rurban|5 years ago|reply

[deleted]

[+] the_dune_13|5 years ago|reply
"obvious lie" it is not that obvious and quite complex situation all in all.
[+] hayd|5 years ago|reply
citation needed.
[+] Smithalicious|5 years ago|reply
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.
[+] libertine|5 years ago|reply
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.

[+] _Microft|5 years ago|reply
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."

[+] martin_bech|5 years ago|reply
Covid kills about 100:1, hospiltalises 20:1. IF the vaccine causes clots, it does so in about 140.000:1.
[+] Varriount|5 years ago|reply
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.
[+] underseacables|5 years ago|reply
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.
[+] willmw101|5 years ago|reply
>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.

[+] jkingsbery|5 years ago|reply
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."
[+] SpicyLemonZest|5 years ago|reply
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.