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Health experts pore over AstraZeneca safety data as Europe reels from vaccine suspensions


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2021-03-16T192408Z_2_LYNXMPEH2F0X6_RTROPTP_4_HEALTH-CORONAVIRUS-ASTRAZENECA.JPG

FILE PHOTO: Boxes of the Oxford/AstraZeneca COVID-19 vaccine are pictured in a refrigerator at a NHS mass coronavirus vaccination centre at Robertson House in Stevenage, Hertfordshire, Britain January 11, 2021. Joe Giddens/Pool via REUTERS//File Photo

By Anthony Deutsch and Caroline Copley

AMSTERDAM (Reuters) - Global health experts came under increasing pressure on Tuesday to clear up questions over the safety of AstraZeneca's COVID-19 shot, as Sweden and Latvia joined countries suspending their use in a further blow to Europe's vaccination rollout.

The European Medicines Agency (EMA) said it was investigating reports of 30 cases of unusual blood disorders out of 5 million recipients of the AstraZeneca vaccine. In total, 45 million COVID shots have been delivered across the region.

The EU regulator will release its findings on Thursday but its head, Emer Cooke, said she saw no reason to change its recommendation of AstraZeneca - one of four vaccines that it has approved for use.

"The benefits continue to outweigh the risks, but this is a serious concern and it does need serious and detailed scientific evaluation," Cooke told a news conference.

A World Health Organization (WHO) committee of experts was reviewing the cases and was expected to issue a statement by the end of the day, a spokesman said.

The EU's largest members - Germany, France and Italy - suspended use of AstraZeneca's vaccine on Monday pending the outcome of investigations into unusual cases of a rare cerebral thrombosis in people who had received it.

The addition of Sweden and Latvia on Tuesday brought to 13 the number of EU countries to act since reports first emerged of thromboembolisms affecting people after they got the AstraZeneca shot.

The WHO and EMA had earlier joined AstraZeneca in saying there is no proven link, but some experts said the episodes of blood clots, bleeding and low platelet counts in younger people seemed to indicate a causal connection to the AstraZeneca shot.

"The benefits of vaccination significantly outweigh the risks, especially for the elderly," said Karl Lauterbach, health spokesman for Germany's Social Democratic Party.

"But it could be the case that the risks of the vaccine are higher for certain patient groups such as young women," Lauterbach, an epidemiologist whose party is part of the Berlin coalition, told Deutschlandfunk radio in an interview.

Other epidemiologists note that similar cases have not been found in unusual numbers in Britain, which began using AstraZeneca earlier and has given more than 10 million doses.

"A very likely explanation of at least some of the clotting disorders seen are a result of COVID-19 rather than the vaccine," said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

"There are published papers that make clear that these problems definitely occur in COVID-19 and there is no doubt that all the vaccines in use prevent that disease. Hence the risk and benefit balance for the AstraZeneca vaccine remains clearly in favour of its benefits."

Graphics: Vaccine rollout across EU by brand -

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ECONOMIC FALLOUT

In the EU's largest states, including Germany, France, Italy, the Netherlands and Spain, AstraZeneca has accounted for about 13-15% of shots given since the rollout began almost three months ago, with Pfizer-BioNTech making up the majority, according to official data.

As one as the cheapest to be developed, the AstraZeneca shot is set to be the mainstay of vaccination programmes in much of the developing world.

Governments say they acted on the AstraZeneca shot out of an abundance of caution - of 1.6 million people in Germany given the vaccine, seven fell ill with a very rare cerebral vein thrombosis of whom three died.

In a detailed analysis of its findings Germany's vaccine oversight body, the Paul Ehrlich Institute, said six of the cases were in women of young or middle age - a number statistically significantly higher than normally expected.

Nicola Magrini, the director general of Italy's medicines authority AIFA, told daily la Repubblica the AstraZeneca shot was safe and its benefit to risk ratio was "widely positive". There have been eight deaths and four cases of serious side-effects in Italy following vaccinations, he added.

In France, Health Minister Olivier Veran told reporters the risk-reward ratio for the AstraZeneca vaccine remained positive.

A third wave of infection in Europe, driven by more infectious viral variants, threatens to worsen a pandemic that has claimed 575,000 lives in the European Union and further delay recovery from a pandemic economic slump.

Deutsche Bank on Tuesday slashed 2021 economic growth forecasts for the euro area by a whole percentage point, citing spillover of the ongoing pandemic-linked activity restrictions.

Coronavirus infections are rising exponentially in Germany, an expert at the Robert Koch Institute for infectious diseases said, putting at risk plans to lift its lockdown. France is considering a possible third national lockdown.

Vaccination campaigns had got off to a slow start due to scarce supply, but the European Commission said on Tuesday it expects to receive more than 200 million doses of vaccine from Pfizer and BioNTech in the second quarter, putting the EU on course to meet its targets.

The EU aims to vaccinate at least 255 million people, or 70% of its adult population, by the end of the summer. The bloc has administered 11 shots so far for every 100 residents, while Israel - a world leader in vaccination - has given 108 doses, according to Our World in Data.

(Anthony Deutsch reported from AMSTERDAM and Caroline Copley from BERLIN; Additional reporting by Kate Kelland, Elizabeth Piper, Giulia Segreti, Emilio Parodi, Matthias Blamont, Sudip Kar-Gupta, Matthieu Protard, Andreas Rinke, Francesco Guarascio, Anna Ringstrom, Johan Ahlander and Andrius Sytas; Writing by Douglas Busvine; editing by Josephine Mason and Philippa Fletcher)

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-- © Copyright Reuters 2021-03-17
 
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0.0001%!!! Yep, europe continues to make a complete hash of this. But to be fair, THIS TIME, it is not the eu machine but individual nations finding their voice and making the wrong call based on politics and thinking UK, for whatever reason, being some kind of evil. Carry on.

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1 hour ago, MasterBaker said:

more men die from Viagra side effects and nobody cares

But men are evil and need to be locked up after 6pm.

Seriously though, this blood clot issue is a total non event. It's about the same amount as the normal population. It's really as if these European countries have lost their minds. As if their vaccine rollout wasn't going badly enough...

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3 hours ago, RichardColeman said:

Since Covid-19 can cause blood clots and death,  the issue of 30 in 5 million or what ever seems mute to me,

Send them all back to us in the UK, we can make use of them while you dither EU

 

11 minutes ago, mtls2005 said:

37 with blood clots in 17 million doses.

 

Not sayin' DVT and PE aren't serious and significant.

 

https://www.nbcnews.com/science/science-news/covid-vaccines-blood-clots-experts-warn-little-evidence-concern-rcna416

Yes its 37 in 17million also they had expected 200.in 1 million its all ready in reports by CDC, FDA. AND WHO. and UK medical dept  so in EU over 1000. people will die because they wont give them the vaccine and no one will answer for this 

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I agree its just a small chance, but if other vaccines don't have that risk then it might be better to choose the other variant. Though if you can't get the other vaccine then this is better then noting. 

But they have to alley fears so they don't get accused later.

It also might be a cover up for the late rollout so they have something to blame. Not sure personally if i were in charge id just keep vaccinating people as the Covid risk is higher.

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3 hours ago, robblok said:

I agree its just a small chance, but if other vaccines don't have that risk then it might be better to choose the other variant. Though if you can't get the other vaccine then this is better then noting. 

But they have to alley fears so they don't get accused later.

It also might be a cover up for the late rollout so they have something to blame. Not sure personally if i were in charge id just keep vaccinating people as the Covid risk is higher.

Yes but other vaccines are the same Rob!  Check out thrombocytopenia/USA on google search.

I think each country must go its own way.  For sure there are risks using vaccinations- perhaps 1-2 in a million.  I understand that EU countries might prefer to sit back for a year or so when we have a clearer picture.

But no matter what is decided, there's no arguing with the hard data on 11 million people in the UK- it's been a spectacular success so far.

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9 hours ago, welshguy said:

I had my first covid jab (Astra Zeneca) today.

 

Got my second shot in 11 weeks.....grateful to have received it.

Your second sentence is contradictory. Do you mean that you have been told to expect your second shot in eleven weeks time?

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5 hours ago, robblok said:

I agree its just a small chance, but if other vaccines don't have that risk then it might be better to choose the other variant. Though if you can't get the other vaccine then this is better then noting. 

But they have to alley fears so they don't get accused later.

It also might be a cover up for the late rollout so they have something to blame. Not sure personally if i were in charge id just keep vaccinating people as the Covid risk is higher.

Other vaccines aren't as effective.

Sinovac for instance. 

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2 hours ago, mommysboy said:

Yes but other vaccines are the same Rob!  Check out thrombocytopenia/USA on google search.

I think each country must go its own way.  For sure there are risks using vaccinations- perhaps 1-2 in a million.  I understand that EU countries might prefer to sit back for a year or so when we have a clearer picture.

But no matter what is decided, there's no arguing with the hard data on 11 million people in the UK- it's been a spectacular success so far.

I don't think it will take that long, as you said the risk is not that high, and like i mentioned they can't get enough other vaccines. I am also not sure that its not being used as an excuse in failing to be as fast as the UK with vaccination.

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Now that  Generalisimo has had his AZ EU should  send all theirs to Asean preferably Thailand.  By the way  did anybody  see the rather strange salute he have gave after?. No not  sanitizer more like a Boy Scout salute? Probably me seeing things! 

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12 minutes ago, robblok said:

I don't think it will take that long, as you said the risk is not that high, and like i mentioned they can't get enough other vaccines. I am also not sure that its not being used as an excuse in failing to be as fast as the UK with vaccination.

I can't ever see the AZ vaccine gaining acceptance in most Euro countries now. They would do better to go with another one such as JJ if they can get hold of some.  Or simply go with the Pfizer as this seems more popular.

Just to put some flesh on the bones: In Germany they experienced 7 brain clots, all of them youngish women!  It is a remarkable coincidence and you can understand the concern.  

But as a Brit, I have to say that I don't like this vaccine and my country being treated EU wide in this way, and I feel the sensible thing would be to just ditch supplies to EU - sensible for both parties. There are even fears in the UK that it is putting people off getting the vaccine. 

 

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42 minutes ago, PETERTHEEATER said:

Your second sentence is contradictory. Do you mean that you have been told to expect your second shot in eleven weeks time?

A 1,000 apologies sir!

 

I should have written "I have got"  not I got....i had my first jab yesterday,,,the next one is to be on June 01 2021.

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Im no scientist, or no statistician even.

 

So. I assume . out of all the people who have had their jabs......for arguments lets use a !round number" and  say 10,000,000      Out of that number, some are guaranteed to get..? Strokes. heart attacks. cancers., dementia, run over by a car, etc etc etc.

 

I wanted the covid jab...to give me a better chance of surviving ? COVID!  

 

Im well aware, I could leave the house today, or tomorrow, or whenever..and get? Run over by a bus. have a fridge falling from the sky dropping on my head, have a blood clot anytime, develop cancer (actually a pretty good chance of that , as Ive already had it!, have a stroke , or heart attack etc etc etc.

 

So..if one of the above happens to me...(or indeed anybody that has had the jab!) OK I got run over/heart attack/stroke/blood clots etc etc.... its will be just because Ive had a COVID jab??

 

 

Yeah ok....!!

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24 minutes ago, mommysboy said:

But as a Brit, I have to say that I don't like this vaccine and my country being treated EU wide in this way,

In what way is your country being mistreated? Is the EU denying you vaccine? Are you somehow being denied an economic benefit for a vaccine whose makers say they will distribute it at cost? I just don't understand this attitude. It's a vaccine.  The British got their share and more. They are entirely unaffected by whether these other nations take it or not. So why the aggression, the anger, the perceived insults? It seems to me the only people that should be reacting to this, one way or the other, are those in the countries who have suspended AZ. As an American, it doesn't bother me who takes what in Britain or Europe. You want AZ, sputnik, or godhelpyou, Sinovac, go ahead. My only wish is that I have the option to take, preferably, J&J, here, in Thailand, rather than the only two existing options right now. But I do wonder why you personally feel insulted because somebody in France or Germany is not taking the vaccine you want to take for yourself.

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Whether or not there is any substance to these claims the cat is out of the bag........people will opt (understandably?) for an alternative vaccine, if available.......what the impact that will be we shall have to wait and see..........maybe all the more AZ to go around for those prepared to accept it.

Very sad if this transpires to be a political move!!

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Of course it's political!

If it wasn't they would have banned Pfizer and AZ as well as Moderna as they are all in the same ballpark wrt thrombus

They are not following the fact's or the science and unfortunately that will cost the lives of vulnerable Europeans 

Does Pfizer vaccine cause blood clots? Data shows surprising results as AstraZeneca banned | Express.co.uk

Does the Pfizer vaccine cause blood clots?

Pfizer’s Covid vaccine has been linked to more blood clots than AstraZeneca’s, according to the vaccine’s data.

Information from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK suggests more people have reported blood clots after a Pfizer vaccine than with the AstraZeneca.

Up to February 28, there were 38 reports from about 11.5million doses of Pfizer’s vaccine – compared to 30 from 9.7million AstraZeneca doses.

There are no hard facts that AZ has more risks than any other vaccine and even the European Medicines Agency (EMA) have confirmed this:

Emer Cooke, executive director of the European Medicines Agency (EMA) said that other EU-approved vaccines, the Pfizer and Modern jabs, appeared to be linked to similar numbers of blood clots as the suspended vaccine.

What is known is that your chance of getting covid and dying is exponentially higher than your chance of dying of a blood clot

I hope these idiots are held to account by the families of the people who will die due to this as well as the businesses that will undoubtedly fail due to all the Euro flip-flopping

 

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10 minutes ago, mark131v said:

Europe Covid vaccines: Leaders turn on each-other over AstraZeneca ban | Daily Mail Online

Europe's vaccine civil war: Leaders turn on each other as Brussels calls for AstraZeneca roll-out to continue, Poland accuses bloc of 'giving in to panic' and Italy and France signal U-turn

 

 

That's the Dailymail making up a "civil war"! There are disagreements but no one really cares what other countries are doing.

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4 minutes ago, candide said:

That's the Dailymail making up a "civil war"! There are disagreements but no one really cares what other countries are doing.

Daily Mail probably but it does show Europe is in disarray regarding covid vaccination, headless chickens comes to mind...

 

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33 minutes ago, mark131v said:

Of course it's political!

If it wasn't they would have banned Pfizer and AZ as well as Moderna as they are all in the same ballpark wrt thrombus

They are not following the fact's or the science and unfortunately that will cost the lives of vulnerable Europeans 

Does Pfizer vaccine cause blood clots? Data shows surprising results as AstraZeneca banned | Express.co.uk

Does the Pfizer vaccine cause blood clots?

Pfizer’s Covid vaccine has been linked to more blood clots than AstraZeneca’s, according to the vaccine’s data.

Information from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK suggests more people have reported blood clots after a Pfizer vaccine than with the AstraZeneca.

Up to February 28, there were 38 reports from about 11.5million doses of Pfizer’s vaccine – compared to 30 from 9.7million AstraZeneca doses.

There are no hard facts that AZ has more risks than any other vaccine and even the European Medicines Agency (EMA) have confirmed this:

Emer Cooke, executive director of the European Medicines Agency (EMA) said that other EU-approved vaccines, the Pfizer and Modern jabs, appeared to be linked to similar numbers of blood clots as the suspended vaccine.

What is known is that your chance of getting covid and dying is exponentially higher than your chance of dying of a blood clot

I hope these idiots are held to account by the families of the people who will die due to this as well as the businesses that will undoubtedly fail due to all the Euro flip-flopping

 

That's right. However, I think the concern comes from the fact that the AZ cases have been observed during a relatively short period of time, and in countries which distributed relatively few vaccines. It may well be mere coincidence, but there may be other factors, I.e. production site or batch.

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8 minutes ago, mark131v said:

Daily Mail probably but it does show Europe is in disarray regarding covid vaccination, headless chickens comes to mind...

 

Health is not a prerogative of the EU, so by definition, there is no head. Of course, delays in deliveries and distribution don't help.

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Just now, candide said:

That's right. However, I think the concern comes from the fact that the AZ cases have been observed during a relatively short period of time, and in countries which distributed relatively few vaccines. It may well be mere coincidence, but there may be other factors, I.e. production site or batch.

And whilst Rome burns Nero fiddled!!

Millions of doses have been administered the WHO, MHRA and EMA all agree that stopping vaccination at this time is foolhardy

All agree that your chance of dying from covid is exponentially higher than dying of a blood clot

It would be highly amusing if it wasn't so serious...

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