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Germany, France among nations to resume use of AstraZeneca vaccine after regulators back shot


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Posted

2021-03-18T192956Z_3_LYNXMPEH2H1GW_RTROPTP_4_HEALTH-CORONAVIRUS-EU-ASTRAZENECA.JPG
A person receives a dose of Oxford/AstraZeneca's COVID-19 vaccine at a vaccination centre in Antwerp, Belgium March 18, 2021. REUTERS/Yves Herman

By Anthony Deutsch, Toby Sterling and Alistair Smout

AMSTERDAM/LONDON (Reuters) - Germany, France and other European nations announced plans to resume using AstraZeneca's COVID-19 vaccine on Thursday after EU and British regulators moved to shore up confidence in the shot, saying its benefits outweigh the risks.

Reports of rare brain blood clots had prompted more than a dozen nations to suspend use of the shot, the latest challenge for AstraZeneca's ambition to produce a "vaccine for the world", as the global death toll from the coronavirus passes 2.8 million.

The European Medicines Agency's (EMA) "clear" conclusion following an investigation into 30 cases of unusual blood disorders was that the vaccine's benefits in protecting people from coronavirus-related death or hospitalisation outweighs the possible risks, though it said a link between blood clots in the brain and the shot could not be definitively ruled out.

"This is a safe and effective vaccine," EMA director Emer Cooke told a briefing. "If it were me, I would be vaccinated tomorrow."

Within hours, Germany said it would resume administering the AstraZeneca vaccine from Friday morning. Health Minister Jens Spahn said suspending the vaccine out of caution had been the right call "until the clustering of this very rare type of thrombosis had been examined."

France too said it would resume use of the vaccine, with Prime Minister Jean Castex saying he would receive the shot himself on Friday afternoon.

Italian Prime Minister Mario Draghi said Italy would do the same, and that his government's priority remained to vaccinate as many people as quickly as possible.

Spain said it was evaluating a possible resumption, while Cyprus, Latvia and Lithuania said they would restart administering the vaccine.

Many governments had said the decision to pause inoculations was out of an abundance of caution. But experts have warned political interference could undermine public confidence in vaccinations as governments struggle to tame more infectious virus variants.

"We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe," said AstraZeneca Chief Medical Officer Ann Taylor in a statement.

EUROPE LAGS BRITAIN, U.S.

The EMA's review covered 20 million people given the AstraZeneca shot in the UK and the European Economic Area (EEA), which links 30 European countries.

Safety concerns had led at least 13 European countries to stop administering the shot, slowing an already faltering inoculation campaign in the EU, which lags Britain and the United States.

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said earlier that it was investigating five cases of the rare brain blood clot that had been reported out of 11 million shots administered in the UK.

It said it would investigate reports of clots in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination. But the agency said use of the vaccine should continue and one official said Britain's rollout would likely continue even if a link was proved.

The AstraZeneca shot was among the first and cheapest of the COVID-19 vaccines to be developed and launched at volume and is set to be the mainstay of vaccination programmes in much of the developing world.

"The EMA's (verdict) now provides clarity about the safety of this vaccine, which should now be vaccinated at a high rate after this safety stop in order to efficiently prevent the actual risk, i.e. sometimes serious medical harm from Covid-19," said Clemens Wendtner, head of infectious diseases at Munich clinic Schwabing.

The drugmaker's own review covering more than 17 million people who have received its shot in the EU and Britain found no evidence of increased risk of blood clots.

The World Health Organization this week also reaffirmed its support for the shot.

The EMA said it would update its guidance on the AstraZeneca vaccine to include an explanation for patients about the potential risks and information for healthcare professionals.

The agency said it is in touch with regulators around the world to keep tabs on possible side effects of all COVID-19 vaccines.

(Reporting by Anthony Deutsch and Toby Sterling in Amsterdam, Ludwig Burger in Frankfurt, Kate Kelland and Alistair Smout in London and Caroline Copley in Berlin; Writing by Josephine Mason, Elaine Hardcastle and Nick Tattersall; Editing by Bill Berkrot)

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-- © Copyright Reuters 2021-03-19
 
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Posted

Factbox: Countries resuming AstraZeneca's COVID-19 vaccine after investigation into blood clots

2021-03-18T191611Z_1_LYNXMPEH2H1GB_RTROPTP_4_HEALTH-CORONAVIRUS-GERMANY-VACCINE.JPG FILE PHOTO: A vial of AstraZeneca's vaccine is prepared during a vaccination of teachers and nursery teachers, in Grevesmuehlen, Germany, March 5, 2021. REUTERS/Fabian Bimmer

(Reuters) - The European medicines regulator said on Thursday the benefits of AstraZeneca's COVID-19 vaccine outweigh the risks after an investigation into blood clots, prompting several countries to say they will resume use of the vaccine.

At least 17 countries had suspended or delayed the vaccine after reports of blood clots in people who have received the shot.

Below is a list of countries and regions to resume using the vaccine:

(In alphabetic order)

CYPRUS:

Cyprus, which suspended the vaccine on March 15, will restart administering it on Friday.

FRANCE:

French Prime Minister Jean Castex said the country will resume vaccinations with the vaccine. 

ITALY:

Italy will resume using the vaccine from Friday, Prime Minister Mario Draghi said.

LATVIA:

Latvia also said it would restart administering the shots.

LITHUANIA:

Lithuania's health minister said the country will restart administering the vaccine and people will be able to pick their vaccine starting Friday.

COUNTRIES WHERE THE VACCINE SUSPENSION CONTINUES:

AUSTRIA:

Suspended use of one batch of the vaccine on March 7 after the death of one person and the illness of another. That batch was shipped to 17 EU countries.

BULGARIA:

Halted inoculations with vaccine until the European regulator sends a written statement dispelling all doubts about safety.

DENMARK:

On Thursday, suspended use for two weeks after reporting "highly unusual" symptoms in a 60-year-old citizen who died from a blood clot after receiving vaccine.

GERMANY:

On March 15, Germany paused use of the shot as a "precaution".

The premier of the Western-German region of Rhineland-Palatinate told Funke newspapers that it would resume the shots as soon as the government gives the green light.

ICELAND:

Suspended vaccine use on March 11 following halt by Norway and awaits results of an investigation by European regulators.

INDONESIA:

Delayed giving vaccine on March 15 while awaiting WHO review.

IRELAND:

Ireland expects to announce on Friday its decision on whether to resume the rollout of the vaccine, after suspending it on Sunday.

THE NETHERLANDS:

The government put its vaccination programme on hold on Sunday due to side-effects in other countries. On Monday, it reported 10 cases of noteworthy adverse side-effects from the vaccine.

NORWAY:

Halted the rollout of the vaccine on March 11, and later said three health workers were being treated for bleeding, blood clots and a low count of platelets. One of the individuals has since died, authorities said.

ROMANIA:

Temporarily stopped vaccinating people with one batch of vaccine on March 11.

SPAIN:

Spain's government has called a meeting of the interregional council for the coronavrius response on Thursday to evaluate possible resumption of vaccinations with AstraZeneca shots.

SWEDEN:

Sweden needs "a few days" to decide whether to restart paused vaccinations with the vaccine.

THAILAND:

Going ahead with the vaccine on March 15, after having delayed the rollout last week.

VENEZUELA:

Venezuela will not authorize the vaccine, citing its "effects on patients".

(Reporting by Pushkala Aripaka and Yadarisa Shabong, Manas Mishra, Mrinalika Roy in Bengaluru; Editing by Josephine Mason, Barbara Lewis, Philippa Fletcher and Shinjini Ganguli)

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-- © Copyright Reuters 2021-03-19
 
Posted
24 minutes ago, lkv said:

And what did you expect them to do, pretend those deaths did not happen?

The conclusion is, the overall benefit of the vaccine to the population outweighs those "rare" deaths and cases.

"Rare" deaths and cases that never happened.  It's horrible what the EU leaders did.  Possibly a political ploy.  Either way, it was a win for the virus, and a loss for the people.

Let's get back to the jabs and get this virus behind us.

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Posted
7 minutes ago, candide said:

OMG, a customer suing a supplier for not honouring its commitments! What a shame! ????

BTW the EU did not stop to use it. Some countries, mostly in the EU but also outside the EU, decided to suspend it because a neighbouring non-EU country reported it could be dangerous. In case AZ would sue for defamation (which would be ridiculous), they could only sue Norway, which US not in the EU.

So stop using it and suspending it are different?

 

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Posted
4 minutes ago, sungod said:

So stop using it and suspending it are different?

 

The point was not about stop using it vs suspending it. It was about the fact that it's not the EU who did it

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Posted
1 hour ago, lkv said:

And what did you expect them to do, pretend those deaths did not happen?

The conclusion is, the overall benefit of the vaccine to the population outweighs those "rare" deaths and cases.

Those "rare" deaths were in line with the NORMAL incidence of such events. Yes some people had blood clots.  In a perfect world Europeans would not get them and people would not suffer heart attack, stroke, DVT, and others.   The reporting of the  issue was taken out of context for political reasons and now people will die.     |t would have been nice to know if the blood clot people had a history of  heart disease, smoked, were  fatties, or lived on bad processed food.

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Posted
2 hours ago, wombat said:

So the regulators will back it and the company producing has no legal liability...why do they give a toss?

The regulators will back it and there is definitely legal liability.  So they do give a toss.  One reason they put a hold on until it was determined it was safe.  A bit drastic, IMHO, but they did it.

Posted
4 hours ago, RichardColeman said:

Just listening to the news that the EU were about to start legal action against AZ for not supplying what they ordered. Considering they stopped using it saying it could be dangerous I think AZ should counter sue for defamation and slander !

Yep. It seems that the serious clots to be concerned about originate from within the EU.

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Posted (edited)
5 hours ago, RichardColeman said:

the EU (...) stopped using it saying it could be dangerous

The EU didn’t. 
 

 

 

Edited by cocoonclub
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Posted
1 hour ago, nauseus said:

Yep. It seems that the serious clots to be concerned about originate from within the EU.

Come on, read the article before posting. The clots happened in the UK. 

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Posted
4 hours ago, JoePai said:

Does anyone really give a flying fig what the EU thinks, the main thing is we know the AZ vaccine is ok so bring it on

Since you’re actively posting in these threads, at least you seem to be giving a flying fig. 

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Posted
7 hours ago, Tug said:

Another bit of good news the more folks that get vaccinated the quicker we can put this mess behind us!we are making progress here in the USA we are set to pass the 100 million vaccinations mark tomorrow in 55 days not 100 days getting it done!

It is amazing what the USA can do with a sane responsible adult in charge.

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Posted
7 hours ago, lkv said:

And what did you expect them to do, pretend those deaths did not happen?

The conclusion is, the overall benefit of the vaccine to the population outweighs those "rare" deaths and cases.

So, did the EU stop vaccinating due to recorded sex or DIY related deaths after vaccinations that were either matched or less than before vaccination ?

No, they just all jumped on the same bandwagon, and now potentially thousands of people could die due to a bunch of silly people not reading the facts that our own UK could have spelled out in building blocks for them.

 

 

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Posted
7 hours ago, Jeffr2 said:

"Rare" deaths and cases that never happened.  It's horrible what the EU leaders did.  Possibly a political ploy.  Either way, it was a win for the virus, and a loss for the people.

Let's get back to the jabs and get this virus behind us.

Well said.

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Posted
8 hours ago, JoePai said:

Does anyone really give a flying fig what the EU thinks, the main thing is we know the AZ vaccine is ok so bring it on

Which is what the EU regulatory body has said, the benefits outweigh the potential dangers, which would appear to be very remote.

Posted
1 hour ago, RichardColeman said:

So, did the EU stop vaccinating due to recorded sex or DIY related deaths after vaccinations that were either matched or less than before vaccination ?

No, they just all jumped on the same bandwagon, and now potentially thousands of people could die due to a bunch of silly people not reading the facts that our own UK could have spelled out in building blocks for them.

 

 

As said below, they suspended, not stopped : it's called" prevention ": why believe UK 100 % because UK says it's ok ? when problems happen, it's safe to momentary stop and look at  why there are problems somewhere 

better one thousand people not vaccinated during one week than thousands people with health problems due to the vaccine 

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