(WHO) on Thursday called on countries to continue using the vaccine

Author : deriyadi99
Publish Date : 2021-03-19 04:56:36

(WHO) on Thursday called on countries to continue using the vaccine

The EU's leading states are to restart their roll-out of the Oxford-AstraZeneca Covid-19 vaccine after Europe's medicines regulator concluded it was "safe and effective".

The European Medicines Agency (EMA) reviewed the jab after 13 EU states suspended use of the vaccine over fears of a link to blood clots.

It found the jab was "not associated" with a higher risk of clots.

Germany, France, Italy and Spain said they would resume using the jab.


It is up to individual EU states to decide whether and when to re-start vaccinations using the AstraZeneca vaccine. Sweden said it needed a "few days" to decide.

The World Health Organization (WHO) on Thursday called on countries to continue using the vaccine, and is due to release the results of its own review into the vaccine's safety on Friday.

The agency's investigation focused on a small number of cases of unusual blood disorders. In particular, it was looking at cases of cerebral venous thrombosis - blood clots in the head.

Decisions to suspend use of the vaccine sparked concerns over the pace of the region's vaccination drive, which had already been affected by supply shortages.

French Prime Minister Jean Castex announced new measures for his country on Thursday, saying the pandemic was clearly accelerating and a "third wave" of infections looked increasingly likely.

Mr Castex, 55, said he would receive the jab himself on Friday afternoon.
What did the EMA say exactly?

Emer Cooke, the agency's executive director, told a news conference: "This is a safe and effective vaccine."

"Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks.

The EMA's expert committee on medicine safety, Mrs Cooke said, had found that "the vaccine is not associated with an increase in the overall risk of... blood clots".

But the EMA, she added, could not rule out definitively a link between the vaccine and a "small number of cases of rare and unusual but very serious clotting disorders".

Therefore the committee has, she said, recommended raising awareness of these possible risks, making sure they are included in the product information. Additional investigations are being launched, Mrs Cooke added.

"If it was me, I would be vaccinated tomorrow," Mrs Cooke added. "But I would want to know that if anything happened to me after vaccination what I should do about it and that's what we're saying today."

Welcoming the review's endorsement of the vaccine as safe and effective, German Health Minister Jens Spahn added, "Doctors should be informed about the risk of venous thrombosis in women under 55 years of age, so that they in turn can inform patients."
Why did European countries act?


Thirteen EU countries suspended use of the vaccine, after reports of a small number of cases of blood clots among vaccine recipients in the region.

Leading EU states said they had opted to pause their use of the drug as a "precautionary measure"

There were a few very unusual and troubling cases which justify this pause and the analysis," French immunologist Alain Fischer, who heads a government advisory board, told France Inter radio. "It's not lost time."

In Germany, the health ministry also pointed to a small number of rare blood clots in vaccinated people when justifying its decision. It postponed a summit on extending the vaccine rollout ahead of the EMA's announcement.

Other countries, such as Austria, halted the use of certain batches of the drug, while Belgium, Poland and the Czech Republic were among those to say they would continue to administer the AstraZeneca vaccine.

Decisions to halt rollouts of the AstraZeneca vaccine were criticised by some politicians and scientists.

A spokeswoman for Germany's opposition Free Democrats said the decision had set back the country's entire vaccination rollout. German Greens health expert Janosch Dahmen, meanwhile, argued that authorities could have continued using the drug.


Dr Anthony Cox, who researches drug safety at the UK's University of Birmingham, told the BBC it was a "cascade of bad decision-making that's spread across Europe

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.

These figures were "much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines", it said.

Professor Andrew Pollard, director of the Oxford vaccine group which developed the Oxford-AstraZeneca jab, told the BBC on Monday that there was "very reassuring evidence that there is no increase in a blood clot phenomenon here in the UK, where most of the doses in Europe [have] been given so far".

British Health Secretary Matt Hancock this week urged people to "listen to the regulators" and to "get the jab".

A number of countries have decided to suspend use of the Oxford-AstraZeneca vaccine as a precaution following reports that some people have suffered blood clots after being given the jab.

But is it a case of being too cautious? Are these nations missing the bigger picture?

The decision has been made on the basis of the precautionary principle - a well-established approach in science and medicine that stresses the need to pause and review when evidence is uncertain.

But in a fast-moving pandemic, when each decision can have major consequences, it is an approach which can sometimes do more harm than good.
Cause or coincidence?

The data supplied by AstraZeneca shows there have been 37 reports of blood clots among the 17m people across Europe who have been given the vaccine.

But the key question that has to be asked is whether this is cause or coincidence? Would these clots have happened anyway?

Adverse events like this are monitored carefully, so regulators can assess if they are happening more than they should.

The 37 reports of clots are below the level you would expect. What is more, there is no strong biological explanation why the vaccine would cause a blood clot.

It is why the World Health Organization and UK drugs regulators have all said there is no evidence of a link.

Even the European Medicines Agency, which is looking into the reports, has suggested the vaccine should continue to be used in the meantime given the risk Covid presents to health.

Unsurprisingly, therefore, the decisions by individual nations to pause their rollouts have baffled experts.

Prof Adam Finn, a member of the WHO's working group on Covid vaccines, says stopping rollout in this way is "highly undesirable" and could undermine confidence in the vaccine, costing lives in the long-term.

"Making the right call in situations like this is not easy, but having a steady hand on the tiller is probably what is needed most."

This is not the first time countries in Europe have exercised caution about the AstraZeneca vaccine.

The precautionary principle was adopted by Germany, France and others when they did not initially recommend use of the vaccine for the over-65s. French President Emmanuel Macron even called it "quasi-ineffective".

The over 65s decision has now been reversed, but the impact is still being felt it seems.

Germany and France have supplies of the vaccine going to waste, with both countries having used fewer than half their supplies of the AstraZeneca jab so far. It has left them far more reliant on the Pfizer vaccine than the UK is.

And this is threatening to have deadly consequences. France, Germany and the other major European nations all have higher rates of infection than the UK, and face the prospect of things getting worse before they get better.

Category : general

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