EMA say AZ is safe.

[pinkearedcow]

Such good news!

From Guardian live feed:

Dr Sabine Strauss, chair of the EMA vaccine safety committee, reiterates Cooke’s sentiment over the benefits of the jab and that it has found “no evidence of a quality or a batch issue”. She says individual cases from across Europe of thromboembolic events were investigated that that there is no higher overall risk of such things happening after being vaccinated. In fact, she says it likely reduces the likelihood of these events.

However, “in a few cases, tiny clots developed in multiple blood vessels in the first 7-14 days after vaccination ... Also in a few cases we saw clots developing in blood vessels, draining blood from the brain ... These conditions are linked to low levels of blood platelet. At the moment, the evidence we have is at the moment not sufficient to conclude with certainty whether these adverse events are indeed caused by the vaccine or not.” She adds further studies are to be commissioned, and stresses these events are extremely rare among some 20 million vaccinated people.

EMA chief Emer Cooke says the committee has ruled “this is a safe and effective vaccine” and the benefits outweigh any possible risks. The jab is not associated with an increase in the overall risk of thromboembolic events or blood clots, she adds.

I hate to break it but that’s not really what they’ve said.

They kept saying it’s safe but also said they can’t confirm the vaccine didn’t cause these issues and are therefore adding a warning to the patient leaflet.

They also advise if anyone has a headache for more than 4 days post vaccine that medical advice should be sought

I guess that's the thing with anything. A medication I take has to be administered in hospital for the first 2-4 doses as there's a black box warning for anaphylactic reaction. And it's not 15 mins monitoring it's about 2hrs! They warn you can have ana anaphylactic reaction to it even weeks after it's been administered
It's not been withdrawn. I still choose to have it

They have said that younger women seem to be more “at risk” of the blood clotting issues and one of the doctors hypothesised that the Uk has seen less cases of these clot events because we have vaccinated more elderly unlike the EU who will have vaccinated more young.

EMA chief Emer Cooke says the committee has ruled “this is a safe and effective vaccine

They are saying it is safe to use, @doireallyneedaname. I am not an idiot, I know that no medicine is ever 100% safe, that's why they all have leaflets stating possible side effects and contraindications. The AZ leaflet will be amended as set out in EMA's statement.

@pinkearedcow I’ve watched the whole thing. They have no clue if the vaccine is causing these events and it needs further investigation.

@doireallyneedaname

I hate to break it but that’s not really what they’ve said.

They kept saying it’s safe but also said they can’t confirm the vaccine didn’t cause these issues and are therefore adding a warning to the patient leaflet.

Name one medicine 100% free from all side effects.

This is normal.

@pinkearedcow Sure, side effects. But death?

@doireallyneedaname

They have said that younger women seem to be more “at risk” of the blood clotting issues and one of the doctors hypothesised that the Uk has seen less cases of these clot events because we have vaccinated more elderly unlike the EU who will have vaccinated more young.

Don't young women have a heightened risk of blood clots anyway due to birth control pills? (1 in 1000 women per year, which interestingly is often described as "very rare"!)

The UK has vaccinated many healthcare staff and younger people using the AZ vaccine also.

@Circumlocutious Potentially. They don’t know but will continue investigating. It’s very ambiguous.

[quote doireallyneedaname]@pinkearedcow Sure, side effects. But death?[/quote]
I've seen death listed as a side effect on several medications. One actually said to seek medical assistance if you suffered any of the listed side effects, one of which was death!

[quote doireallyneedaname]@pinkearedcow Sure, side effects. But death?[/quote]
There are a handful of deaths in the UK every year due to the blood clots caused by the pill.

[quote doireallyneedaname]@pinkearedcow Sure, side effects. But death?[/quote]
There is a tiny chance of dying from many, many medicines, but the benefits far outweigh the risks. If a medicine needed to have zero risk of death attached to its use to be deemed safe, we wouldn't have many medicines. Maybe just nettle tea or something.

They have no clue if the vaccine is causing these events and it needs further investigation

I've said this on the other thread. So much fuss and basically we are in the same situation as before this "review".

@Circumlocutious It’s not simple blood clots that are the problem. It’s a rare condition.

[quote doireallyneedaname]@pinkearedcow Sure, side effects. But death?[/quote]
Paracetemol is responsible for 200 deaths per annum in the UK alone.

Aspirin is responsible for over 3000 deaths per year

And that's before you start on the non-drug substances - alcohol, caffeine - I mean people die from eating apples occasionally ffs.

In short nothing you put into your body, including air, is 100% safe.

[quote doireallyneedaname]@Circumlocutious It’s not simple blood clots that are the problem. It’s a rare condition.[/quote]
Five in 11 million people vaccinated (In the UK). One of whom has died. 1 death in 11 million.

From the UK regulator:

But, they note, such rare blood clotting events can occur naturally in those who have not received the vaccine, and among those who have had Covid.

This thread is going to become a totem pole for people who couldn't even pass science at GCSE, to announce how THEIR opinions are more scientifically valid than those of the world's leading authorities...

I can't wait to see the insights....

I had a stroke almost a year ago due to a blood clot. My first vaccination in January and it was the Pfizer vaccine. I am considering refusing the second one if it's the AZ one.

Given you can be allergic to nettles, probably not even that, @pinkearedcow

They can't, and will never, be able to say "this vaccine will never ever cause a serious side effect, or death." It doesn't mean there is any sort of measurable risk at all.

I think you should watch the briefing and make your own mind up. It’s nice that the UK press are painting a rosy picture but that’s far from what’s been said.

My first vaccination in January and it was the Pfizer vaccine. I am considering refusing the second one if it's the AZ one.

It won't be - it will be the same as the first jab.

[quote doireallyneedaname]@pinkearedcow Sure, side effects. But death?[/quote]
Yes.

We accept the pill can cause problems. Thats why its not prescribed to certain women for certain reasons now we understand who this is.

Its a calculated risk assessment.

As it stands they are looking to raise awareness of this as a potential problem so if it does occur it can be spotted more quickly and treated appropriately in order to try and reduce the very small number of adverse reactions causing death and so that any common factors can be identified quickly. But they are stressing its very rare.

Ironically this is a good thing because its been noticed. Its quite possible that other vaccines may yet turn out to have serious side effects (including some that result in death) which have not yet been identified in the data. Its the old age: Lack of evidence is not evidence of absence (of a potential problem).

Of course people are still going to jump on this and say 'this is bad because they can't rule it out'. But the lack of evidence of a direct causal link is also not a bad thing. It just means they can follow the science to a black and white yes/no answer. (In other words there was no smoking gun).

ALL medicial decisions should be made on the balance of probabilities. Thats what medicine effectively is. Assessing a situtation and coming up with a best fit plan because no doctor is a magician and is incapable of seeing the future and knowing beyond all doubt the certainity of an outcome. All medicine is effectively a risk assessment process.

And the conclusion they came to was that the risk assessment was that AZ is safe and it was certainly safer than the alternative of potentially catching covid.