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  5. European Medicines Agency finds AstraZeneca vaccine is ‘safe and effective’ 

Новости

European Medicines Agency finds AstraZeneca vaccine is ‘safe and effective’ 

A medical worker holds the AstraZeneca vaccine.

Credit: AFP

The European Medicines Agency has said that the AstraZeneca vaccine should continue to be used, paving the way for a slew of EU nations to reboot their faltering rollout of the Oxford University jab. 

France, Germany, Italy, Spain and 13 other EU countries suspended the use of AstraZeneca, amid fears over blood clots linked to the jab, pending an investigation by the bloc’s medicines watchdog. 

They said that the ban, imposed against World Health Organisation and European Medicines Agency (EMA) advice and despite the EU having vaccinated just 12 percent of its population, was a temporary precaution. 

Emer Cooke, the EMA executive director, said: "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 committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots."

Oxford-AstraZeneca vaccine supply in EU

There was no evidence of a quality or batch issue with the vaccine. The EMA said there had been cases of "very rare and unusual but serious clotting disorders", which it was not able to definitely rule out as linked to the Oxford jab. It said that a warning of the possible link would be included in product information for patients and doctors.  

"If it was me, I would be vaccinated tomorrow, but I would want to know that if anything happened to me after vaccination what I should do about it," Ms Cooke said.  

"Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects," she added. 

The EMA said there had been seven cases of cerebral venous sinus thrombosis in Germany, three in Italy, three in the UK, two in Norway, one in Spain and two in India. 

France and Italy are now expected to move quickly to lift the suspension, after Emmanuel Macron and Mario Draghi agreed to do so if the EMA gave the green light. The other countries, including Germany and Spain, are expected to do the same. 

Matteo Salvini, the leader of the hard-Right League and a member of Mr Draghi’s ruling coalition, said the government should press on "full steam ahead" with its vaccination program and attacked the EU.

“Further mistakes by Brussels are not tolerable. We’re awaiting the firing of all those who got things wrong,” the leader of the country’s most popular party said.

"We’re very much aware that some member states have paused vaccinations," Ms Cooke said, before adding she hoped the investigation would allow countries to make "an informed decision" about the vaccine and rebuild trust in it. 

Less than half of the stockpiled AstraZeneca vaccine in the EU have been used. There are unfounded fears that it is inferior to other jabs after Mr Macron and false German media reports said it was “quasi-ineffective” in the other 65s in January.

The British-Swedish pharmaceutical giant has been locked in a row with the EU over supply shortfalls and delays. 

On Wednesday, Ursula von der Leyen threatened Britain with a vaccine export ban unless AstraZeneca began exporting UK manufactured jabs to the bloc.

AstraZeneca is required under its contract with the EU to deliver 300 million doses by the end of June, but it said last week it aimed to ship only 100 million, due to production problems and export restrictions. 

It was announced yesterday that supplies to Britain have also been hit by delays with a significant reduction in supplies from March 29, which is linked to supply problems from India. 

The EMA and the World Health Organisation both said the vaccine was safe before today’s announcement but the EU medicines watchdog carried out a fresh investigation to assuage fears over the shot.

WHO Europe Director Hans Kluge said: ‘Benefits of the AstraZeneca vaccine outweigh any risks and its use should continue to save lives."

Not everyone of the EU’s 27 countries paused their rollout. Belgium and Poland criticised the decision, with Belgium’s health minister branding it “irresponsible” in a pandemic. 

One British man has died and four more have suffered a dangerous blood clotting condition after being given the AstraZeneca vaccine, the Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed on Thursday.

Britain’s medicines regulator said the evidence does not suggest that the AstraZeneca vaccine causes blood clots but added that the very rare and specific type of blood clot in cerebral veins was being investigated.

"The available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca," the MHRA said.

"A further, detailed review into five UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing."

If a causal link was established, an official said, it would not lead to a pause in the vaccination rollout but guidance would be updated. 

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