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Germany, Italy, France suspend AstraZeneca shots amid safety fears, disrupting EU vaccinations


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2021-03-15T195328Z_3_LYNXMPEH2E19N_RTROPTP_4_HEALTH-CORONAVIRUS-GERMANY-VACCINE.JPG
Teacher, Rene Kirstein, receives his first dose of AstraZeneca's COVID-19 vaccine from nurse Susanne Kugel, amid the spread of the coronavirus disease (COVID-19) in Grevesmuehlen, Germany, March 5, 2021. REUTERS/Fabian Bimmer

By Thomas Escritt and Stephanie Nebehay

BERLIN/GENEVA (Reuters) - Germany, France and Italy said on Monday they would suspend AstraZeneca COVID-19 shots after several countries reported possible serious side-effects, but the World Health Organization (WHO) said there was no proven link and people should not panic.

Still, the decision by the European Union's three biggest countries to put inoculations with the AstraZeneca shot on hold threw the already struggling vaccination campaign in the 27-nation EU into disarray.

Denmark and Norway stopped giving the shot last week after reporting isolated cases of bleeding, blood clots and a low platelet count. Iceland and Bulgaria followed suit and Ireland and the Netherlands announced suspensions on Sunday.

Spain will stop using the vaccine for at least 15 days, Cadena Ser radio reported, citing unnamed sources.

The top WHO scientist reiterated on Monday that there have been no documented deaths linked to COVID-19 vaccines.

"We do not want people to panic," Soumya Swaminathan said on a virtual media briefing, adding there has been no association, so far, pinpointed between so-called "thromboembolic events" reported in some countries and COVID-19 shots.

WHO chief Tedros Adhanom Ghebreyesus said an advisory committee meeting on AstraZeneca would be held on Tuesday. EU medicines regulator EMA will also convene this week to assess the information gathered into whether the AstraZeneca shot contributed to thromboembolic events in those inoculated.
 

Germany, France and Italy said on Monday they would hit pause on AstraZeneca COVID-19 shots after several countries reported possible serious side-effects, throwing Europe's already struggling vaccination campaign into disarray. Emer McCarthy reports.

The moves by some of Europe's largest and most populous countries will deepen concerns about the slow rollout of vaccines in the region, which has been plagued by shortages due to problems producing vaccines, including AstraZeneca's.

Germany warned last week it was facing a third wave of infections, Italy is intensifying lockdowns and hospitals in the Paris region are close to being overloaded.

German Health Minister Jens Spahn said that although the risk of blood clots was low, it could not be ruled out.

"This is a professional decision, not a political one," Spahn said, adding he was following a recommendation of the Paul Ehrlich Institute, Germany's vaccine regulator.

France said it was suspending the vaccine's use pending an assessment by EMA.

"The decision taken, in conformity also with our European policy, is to suspend, out of precaution, vaccination with the AZ shot, hoping that we can resume quickly if the EMA’s guidance allows,” French President Emmanuel Macron said.

Italy said its halt was a "precautionary and temporary measure" pending EMA's ruling.

"The EMA will meet soon to clarify any doubts so that the AstraZeneca vaccine can be resumed safely in the vaccination campaign as soon as possible," said Gianni Rezza, Director General of Prevention at Italy's Ministry of Health.

Austria and Spain have stopped using particular batches and prosecutors in the northern Italian region of Piedmont earlier seized 393,600 doses following the death of a man hours after he was vaccinated. It was the second region to do so after Sicily, where two people had died shortly after having their shots.

The WHO appealed to countries not to suspend vaccinations against a disease that has caused more than 2.7 million deaths worldwide. WHO Director-General Tedros said systems were in place to protect public health.

"This does not necessarily mean these events are linked to COVID-19 vaccination, but it's routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place," he told the media briefing.

The United Kingdom said it had no concerns, while Poland said it thought the benefits outweighed any risks.

The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.

Michael Head, a senior research fellow in global health at the University of Southampton, said the decisions by France, Germany and others looked baffling.

"The data we have suggests that numbers of adverse events related to blood clots are the same (and possibly, in fact lower) in vaccinated groups compared to unvaccinated populations," he said, adding that halting a vaccination programme had consequences.

"This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned. There are no signs yet of any data that really justify these decisions.”

A senior German infectious diseases physician, however, said the background incidence of 2-5 thromboses per million per year was significantly lower than the number of 7 out of 1.6 million vaccinated people cited by Germany's health ministry.

"This should be the reason to suspend the vaccination in Germany until all cases, including suspected cases in Germany and Europe, have been completely cleared up," said Clemens Wendtner, head of the special unit for highly contagious life threatening infections at the Schwabing Clinic in Munich.

'UNUSUAL' SYMPTOMS

AstraZeneca's shot was among the first and cheapest to be developed and launched at volume since the coronavirus was first identified in central China at the end of 2019, and is set to be the mainstay of vaccination programmes in much of the developing world.

Thailand announced plans on Monday to go ahead with the Anglo-Swedish firm's shot after suspending its use on Friday, but Indonesia said it would wait for the WHO to report.

The WHO said its advisory panel was reviewing reports related to the shot and would release its findings as soon as possible. But it said it was unlikely to change its recommendations, issued last month, for widespread use, including in countries where the South African variant of the virus may reduce its efficacy.

The EMA has also said there was no indication the events were caused by the vaccination and that the number of reported blood clots was no higher than seen in the general population.

But the handful of reported side-effects in Europe have upset vaccination programmes already stumbling over slow rollouts and vaccine scepticism in some countries.

The Netherlands said on Monday it had seen 10 cases of possible noteworthy adverse side-effects from the AstraZeneca shot, hours after putting its vaccination programme on hold following reports of potential side-effects in other countries.

Recent information indicates "a very special, rarely occurring form of thrombosis, of which some cases appear to have occurred shortly after vaccination. This is of course suspicious and should be investigated," said Anke Huckriede, vaccinology professor at the University of Groningen in the Netherlands.

Denmark reported "highly unusual" symptoms in a 60-year-old citizen who died from a blood clot after receiving the vaccine, the same phrase used on Saturday by Norway about three people under the age of 50 it said were being treated in hospital.

One of the three health workers hospitalised in Norway after receiving the AstraZeneca shot had died, health authorities said on Monday, but there was no evidence the vaccine was the cause.

AstraZeneca said earlier it had conducted a review covering more than 17 million people vaccinated in the EU and the UK which had shown no evidence of an increased risk of blood clots.

Long-awaited results from AstraZeneca's 30,000-person U.S. vaccine trial are now being reviewed by independent monitors to determine whether the shot is safe and effective, a top U.S. official said on Monday.

(Reporting by Panarat Thepgumpanat in BANGKOK, and Andreas Rinke, Paul Carrel and Douglas Busvine in BERLIN, Angelo Amante in ROME, Christian Lowe in PARIS, Toby Sterling in AMSTERDAM, Jacob Gronholt-Pedersen in COPENHAGEN, Kate Kelland in LONDON, Emilio Parodi in MILAN, Nathan Allen in MADRID, Emma Farge in GENEVA and Stanley Widianto in JAKARTA; writing by Philippa Fletcher; editing by Nick Macfie and Mark Heinrich)

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-- © Copyright Reuters 2021-03-16
 
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This is what happens when you let civilians run countries.  Luckily Thailand has a military led leadership who will not buckle and will be right there after breakfast for their well deserved jabs.  Provided the paperwork is in order of course.

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Yep, all eurovision-style, political voting. The thing is the nobs in suits are messing with ordinary people's lives. Rushing to block a life-saving jab administered to untold millions with no ill effect, yet a few have blood clots which in all likelihood is unrelated. Even a few hundred deaths would be acceptable where thousands are saved. Europe all over. How many of those countries getting on the bandwagon ever achieved anything or got their hands dirty when the chips were down? pffft!

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4 minutes ago, John Drake said:

Seems appropriate to take precautions with a vaccine whose trials and testing have already had problems. Why so much cheerleading for AZ? It should be a matter simply of getting a vaccine that works effectively and safely. But many people on this forum are acting like they have stock in the company, like it's a personal affront to them to see that the vaccine is safe and sound. Strange behavior.

 

... absolutely, it's kinda entertaining.

《 ... A recent YouGov survey found that people in Europe were less receptive to the vaccine than people in the U.K., where the shot is a point of national pride. ... 》

That's how they put it in the article below, sure seems to be the case here on TV, 555 ...

 

https://www.fiercepharma.com/pharma/astrazeneca-stands-by-covid-19-vaccine-safety-but-says-it-s-shipping-fewer-doses-than-hoped

 

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41 minutes ago, jollyhangmon said:

 

... absolutely, it's kinda entertaining.

《 ... A recent YouGov survey found that people in Europe were less receptive to the vaccine than people in the U.K., where the shot is a point of national pride. ... 》

That's how they put it in the article below, sure seems to be the case here on TV, 555 ...

 

https://www.fiercepharma.com/pharma/astrazeneca-stands-by-covid-19-vaccine-safety-but-says-it-s-shipping-fewer-doses-than-hoped

 

Decades ago, I had a Hungarian teacher explain to me the paranoia and excessive nationalism of small nations. According to her, the smaller the country the more zeal there is to assert your individual identity through your country. Sure see a lot of that on this forum, and especially with the AZ vaccine commentary. People simply will not accept that there are any questions that can be asked about it, despite widespread fears and precautions. Personally, I rank the vaccines as follows. Unusable: the Russian and Chinese vaccines, because they hide their data and go ape if anyone asks for any. Don't trust them at all. Questionable: Astra-Zeneca, because of trial and testing sloppiness, plus its reduced effectiveness against some of the strains, and now questions about side effects. Questionable but Slightly Less So: Pfizer, because of the early deaths associated with it, and the fact I can't get the picture out of my mind of that nurse who took it and immediately fainted dead away. Seems Okay: Moderna and J&J; haven't seen anything negative about these two and the J&J, in addition to requiring only a single shot, apparently did its trials against the backdrop of the existing variants and still yielded highly effective results.

Edited by John Drake
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Meanwhile, Canada, Australia and Vietnam are going ahead with inoculating people with the AZ vaccine. Vietnam, having recently started its AZ campaign, has injected more than 10,000 citizens.  The only serious side effect has been several cases of anaphylaxis, which were handled promptly, the health ministry said.

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7 hours ago, daveAustin said:

Yep, all eurovision-style, political voting. The thing is the nobs in suits are messing with ordinary people's lives. Rushing to block a life-saving jab administered to untold millions with no ill effect, yet a few have blood clots which in all likelihood is unrelated. Even a few hundred deaths would be acceptable where thousands are saved. Europe all over. How many of those countries getting on the bandwagon ever achieved anything or got their hands dirty when the chips were down? pffft!

"The thing is the nobs in suits are messing with ordinary people's lives."

Au contraire, the only reason jabs are suspended is due to social media uproar.

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35 minutes ago, robertson468 said:

I have to agree with you.  I think the EU is punishing Astra Zenica for providing so many doses to the UK, which of course has provided far less cases of illness due to Covid.  Combine that with the fact that the UK has left the EU and is mounting up free trade agreements around the World.,  Nasty, nasty EU acting like a spoiled child!

Firstly it is not the EU but individual countries, and this all started with a country not even in the EU.

Total nonsense.

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On 3/16/2021 at 12:48 AM, JonnyF said:

There's a bad whiff about all this. A concerted effort to discredit AZ. First Macron saying it was quasi-ineffective in over 65's with zero evidence,

There was no evidence at that time either way because such data for the over 65 age group was very sparse.

Even the UK's MHRA said that the number of older people contracting the virus in the AstraZeneca trial was "too few to draw conclusions on efficacy". (Source)

Subsequent data has shown that it is effective for the over 65s, and the French government authorised it's use for the over 65s on the 2nd March.

On 3/16/2021 at 12:48 AM, JonnyF said:

and now this from Germany, Italy and France (coincidentally the 3 largest and most influential EU member states) contrary to WHO advice.

Did you not read the OP? Had you done so you would know that it is also against the EU's advice via their EMA!

You forget that this all started following a report from Norway's Medicines Agency; and Norway is not an EU member.

You also forget that not all EU members have suspended the use of the vaccine whilst some non EU members have.

Whilst the USA have still not even authorised it's use in the first place. Do you also believe the USA has some political axe to grind with us and is taking it our via not approving this vaccine?

 

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4 minutes ago, 7by7 said:

There was no evidence at that time either way because such data for the over 65 age group was very sparse.

Even the UK's MHRA said that the number of older people contracting the virus in the AstraZeneca trial was "too few to draw conclusions on efficacy". (Source)

Subsequent data has shown that it is effective for the over 65s, and the French government authorised it's use for the over 65s on the 2nd March.

Did you not read the OP? Had you done so you would know that it is also against the EU's advice via their EMA!

You forget that this all started following a report from Norway's Medicines Agency; and Norway is not an EU member.

You also forget that not all EU members have suspended the use of the vaccine whilst some non EU members have.

Whilst the USA have still not even authorised it's use in the first place. Do you also believe the USA has some political axe to grind with us and is taking it our via not approving this vaccine?

 

So far 13 EU countries have stopped using it due to zero evidence of a link to blood clots.

https://www.cnbc.com/2021/03/16/more-eu-countries-halt-astrazeneca-shot-as-ema-reviews-side-effects-.html

It could just be a coincidence that so many EU countries have stopped. Maybe coincidence that it was Macron who made the inaccurate claims about it's ineffectiveness. That's the thing, when you continuously act with spite and vindictiveness towards something it's possible that you are incorrectly labelled as spiteful and vindictive in the future.

Doctors appear as baffled as I am.

https://www.cnbc.com/2021/03/16/astrazeneca-covid-vaccine-doctors-react-as-eu-countries-suspend-shot.html

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On 3/16/2021 at 4:41 AM, robertson468 said:

I have to agree with you.  I think the EU is punishing Astra Zenica for providing so many doses to the UK, which of course has provided far less cases of illness due to Covid.  Combine that with the fact that the UK has left the EU and is mounting up free trade agreements around the World.,  Nasty, nasty EU acting like a spoiled child!

 If what you say has any merit at all, which it doesn't, how do you explain the fact that the EU, via it's EMA, has, as the OP says, ".....said there was no indication the events were caused by the vaccination and that the number of reported blood clots was no higher than seen in the general population."

It is not the EU which has made this decision, it is the governments of individual, sovereign nations, many of whom are EU members, on the advice of their own medical authorities.

 More countries pause Oxford/AstraZeneca vaccine against EU regulator’s advice

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4 minutes ago, JonnyF said:

So far 13 EU countries have stopped using it due to zero evidence of a link to blood clots.

https://www.cnbc.com/2021/03/16/more-eu-countries-halt-astrazeneca-shot-as-ema-reviews-side-effects-.html

It could just be a coincidence that so many EU countries have stopped. Maybe coincidence that it was Macron who made the inaccurate claims about it's ineffectiveness. That's the thing, when you continuously act with spite and vindictiveness towards something it's possible that you are incorrectly labelled as spiteful and vindictive in the future.

Doctors appear as baffled as I am.

https://www.cnbc.com/2021/03/16/astrazeneca-covid-vaccine-doctors-react-as-eu-countries-suspend-shot.html

 As I say in my previous post, as it says in the OP; those countries who have suspended the use of this vaccine have done so on the advice of their own medical authorities and against that of the EU.

Not for the first time, you have shown that you blame the abject failure of Brexit on what you perceive as the EU's spite and vindictiveness. That you'll you'll latch onto anything which you think proves that point; whilst at the same time ignoring the facts prove you wrong.

You have ignored the fact of the EMA's advice not to suspend the use of the vaccine. 

You have ignored the fact that this started in a country which is not an EU member.

You have ignored the fact that non EU members have suspended the vaccine's use.

Most telling of all, you have ignored the fact that the FDA in the USA has not yet approved the use of this vaccine and are conducting further trials before they do so.

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11 minutes ago, 7by7 said:

 As I say in my previous post, as it says in the OP; those countries who have suspended the use of this vaccine have done so on the advice of their own medical authorities and against that of the EU.

Not for the first time, you have shown that you blame the abject failure of Brexit on what you perceive as the EU's spite and vindictiveness. That you'll you'll latch onto anything which you think proves that point; whilst at the same time ignoring the facts prove you wrong.

You have ignored the fact of the EMA's advice not to suspend the use of the vaccine. 

You have ignored the fact that this started in a country which is not an EU member.

You have ignored the fact that non EU members have suspended the vaccine's use.

Most telling of all, you have ignored the fact that the FDA in the USA has not yet approved the use of this vaccine and are conducting further trials before they do so.

I was referring to EU countries, not the EU.

The fact the USA is still in the approval process has nothing to do with it. They are way outperforming the EU (who isn't!) on vaccine rollout so they can take their time.

How has Brexit failed? We only left the withdrawal period a few weeks ago. Sterling has risen by almost 4% against the Euro in 2021 since we left that mess behind once and for all. The EU vaccine rollout has been one disaster after another. By contrast the UK is leading the world with the speed and efficiency of their rollout.

I'd be worrying about the EU if I was you, not Britain, especially if EU countries refuse to vaccinate their own people with a perfectly safe vaccine simply because of it's links to the UK. 

 

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@JonnyF,

Your attempts to deny blaming this on your imagined spite and vindictiveness of the EU over Brexit in what you posted, whilst at the same time trying to justify it, whilst amusing, are also rather sad and repetitive.

1 hour ago, JonnyF said:

The fact the USA is still in the approval process has nothing to do with it. They are way outperforming the EU (who isn't!) on vaccine rollout so they can take their time.

Really?

Why AstraZeneca and J&J's vaccines, in use elsewhere, are still on hold in America

Quote

The world has seven vaccines with completed clinical trials, yet the U.S. has approved only two, Gandhi and others lament.

 

1 hour ago, JonnyF said:

How has Brexit failed?

There is plenty of evidence of Brexit's failure in the media as well as posts in the relevant threads here. If you want to discuss it further, I suggest we do so in one of those threads.

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