Europe Covid vaccines: Italy, Norway, Demark halt use of AstraZeneca jab

A host of European countries including Denmark, Norway and Iceland have halted the use of AstraZeneca jabs amid fears they cause blood clots, while Italy has suspended a specific batch following the death of a naval officer. 

A nurse in Austria, 49, died from a clot on Monday shortly after taking the vaccine amid reports of a few similar cases across the continent, despite millions of doses being administered safely.

Austria, Estonia, Latvia, Lithuania and Luxembourg have suspended the use of the same batch given to the nurse, ABV5300, which was sent to 17 European countries and consisted of one million jabs.

Denmark, Norway and Iceland on Thursday went further, suspending the total use of AstraZeneca’s Covid-19 vaccine.

Denmark suspended the shots for two weeks after a 60-year-old woman, who was given an AstraZeneca shot from the same batch used in Austria, formed a blood clot and died, Danish health authorities said.

Their response was also prompted by reports ‘of possible serious side effects’ from other European countries. 

Italy’s medicine regulator banned a different batch of the jabs, ABV2856, after non-commissioned naval officer Stefano Paternò died in Sicily of a cardiac arrest 24 hours after receiving a dose. 

A second man in Sicily has also died after recently receiving the jab, and a police officer died within 12 days of a vaccination, sparking an investigation by health authorities into any potential links to the jabs. 

The moves come despite Europe’s own medical regulator saying there is no clear link between the nurse’s death and the jab, and UK regulators saying data shows those with the jab are no more likely to suffer clots than the general population.

The European Medicines Agency said in a statement: ‘The position of EMA’s safety committee… is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.’

Many European leaders have frequently doubted the effectiveness of the Oxford vaccine which has subsequently seen a low uptake compared to other jabs.

But that did not stop the EU from blocking a shipment of AstraZeneca vaccines to Australia using controversial export laws last week.

Authorities in Italy refused to grant a licence for 250,000 doses manufactured in the country to be exported, meaning the shipment could not leave as planned. 

It comes after a host of countries including Germany and France restricted the AstraZeneca jab’s use to over-65s, claiming it was ineffective in the elderly – despite Europe’s medical regulator saying otherwise.

Those restrictions were largely dropped after data showed the jab works in all ages. 

Scaremongering around the jab has led some Europeans to refuse to take it, with authorities in Germany forced to resort to threatening people who balk at it.

That has hampered Europe’s already-slow vaccine drive which has been plagued by supply issues and has seen just 10 per cent of people given at least one dose, compared to 36 per cent in the UK.

European countries are lagging behind the UK in vaccination numbers after fuelling fears over the effectiveness of the AstraZeneca jab

European countries are lagging behind the UK in vaccination numbers after fuelling fears over the effectiveness of the AstraZeneca jab

European countries are lagging behind the UK in vaccination numbers after fuelling fears over the effectiveness of the AstraZeneca jab

Italy's medicine regulator banned a different batch of the jabs, ABV2856, after non-commissioned naval officer Stefano Paternò (pictured with his wife) died of a cardiac arrest 24 hours after receiving a dose

Italy's medicine regulator banned a different batch of the jabs, ABV2856, after non-commissioned naval officer Stefano Paternò (pictured with his wife) died of a cardiac arrest 24 hours after receiving a dose

Italy’s medicine regulator banned a different batch of the jabs, ABV2856, after non-commissioned naval officer Stefano Paternò (pictured with his wife) died of a cardiac arrest 24 hours after receiving a dose

Denmark's health minister Magnus Heunicke

Denmark's health minister Magnus Heunicke

Principal Pharmacist Davinder Manku (right) receives an injection of the Oxford/Astrazeneca coronavirus vaccine at The Black Country Living Museum in Dudley

Principal Pharmacist Davinder Manku (right) receives an injection of the Oxford/Astrazeneca coronavirus vaccine at The Black Country Living Museum in Dudley

Denmark’s health minister Magnus Heunicke said authorities were probing whether there was a link between having the jab and blood clotting, after several cases and one death

Despite the news that that some EU countries would stop giving the AstraZeneca vaccine, France’s minister said that the country sees ‘no need’ to suspend its use. 

Olivier Veran said he had consulted with the French medicines agency which advised him against taking similar action.

He said the agency urged him to follow the EU drug regulator’s ruling that AstraZeneca was still safe to use.

‘There is no need to suspend AstraZeneca,’ Veran told a news conference.  

The decision comes as France scrambles to boost its Covid vaccination rollout in the hope of avoiding a third lockdown.

Veran said the daily average virus infection appeared stable for France as a whole, but added it hid huge regional disparities.

The greater Ile de France region, which includes Paris, the northern region of Hauts de France and the southern Provence-Alpes-Cote d’Azur region were the three biggest infection hotspots, he said.

Daily numbers of admissions into intensive care in the Paris region were now so high that hospital capacity risked being overrun.

A ‘critical level’ of capacity could be reached by the end of March, Veran said.

Authorities were therefore preparing to evacuate ‘dozens or even hundreds’ of intensive care patients away from the capital and its suburbs to other regions of France, Veran said. 

Downing Street defended the vaccine following the news, calling it ‘both safe and effective’ and insisted Britain would continue with its own rollout. 

‘We’ve been clear that it’s both safe and effective… and when people are asked to come forward and take it, they should do so in confidence,’ Prime Minister Boris Johnson’s official spokesman told reporters.

‘And in fact you’re starting to see the results of the vaccine programme in terms of the (lower) number of cases we’re seeing across the country, the number of deaths, number of hospitalisations.’

Denmark was first to announce its suspension this week, ‘following reports of serious cases of blood clots’ among people who had received the vaccine, the country’s Health Authority said in a statement.

The vaccine would be suspended for 14 days in Denmark. 

It stressed the move was precautionary, and that ‘it has not been determined, at the time being, that there is a link between the vaccine and the blood clots’. 

‘This is a cautionary decision,’ Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health (FHI), told a news conference.

FHI did not say how long the suspension would last.

‘We … await information to see if there is a link between the vaccination and this case with a blood clot,’ Bukholm said. 

So far, 138,148 Danes have received a shot with AstraZeneca’s vaccine in a country of 5.8 million. 

Denmark’s Health Authority said the final date for when it expects all Danes to have been fully vaccinated would be pushed back by four weeks to Aug. 15. 

The Nordic country, which also uses vaccines from Pfizer-BioNTech and Moderna, is set to receive 2.6 million doses from AstraZeneca over the coming months. 

A host of countries including Germany and France restricted the AstraZeneca jab's use to over-65s

A host of countries including Germany and France restricted the AstraZeneca jab's use to over-65s

A host of countries including Germany and France restricted the AstraZeneca jab’s use to over-65s

Magnus Heunicke said: ‘At present it can not be concluded whether there is a connection. We are acting early, it must be thoroughly investigated.’  

As of March 9, 22 cases of blood clots had been reported among more than three million people vaccinated in the European Economic Area, the European Medicines Agency (EMA) said.  

Denmark however suspended the use of all of its AstraZeneca supply, as did Iceland and Norway in subsequent announcements on Thursday citing similar concerns. 

As well as the woman’s death, another three cases of blood clotting issues had been reported in Austria from people who had taken the vaccine.

One of those patients, a 35-year-old woman, developed a pulmonary embolism – a blockage of an artery on the lung – but is now recovering.  

The EMA said that the batch which had been singled-out in Austria, labelled ABV5300, comprised one million doses and had been delivered to 17 EU countries.

Meanwhile Italian authorities decided to halt the delivery of a different batch of AstraZeneca jabs over safety fears.

‘Following the reporting of some serious adverse events… AIFA has decided, as a precaution, to issue a ban on the use of this batch throughout the national territory,’ AIFA said in a statement.

It said that it ‘reserves the right to take further measures, if necessary,’ in coordination with the European Medicines Agency (EMA).

But it stressed that at the moment there had been no established link between the administration of the vaccine and the alleged side-effects.

The batch mentioned by the Italian regulator, batch ABV2856, is different to the ABV5300 suspended by Austria and other countries.

It has been linked to the death of two men in Sicily – Stefano Paternò this week after he suffered a cardiac arrest 24 hours after taking a jab – and another unnamed man.

A policeman, Davide Villa, 50, also died 12 days after receiving a vaccine from the same batch.

The Italian ministry of health will investigate the possible links between their deaths and the jabs while the batch of doses is on pause.

But many health experts said there was little evidence to suggest the AstraZeneca vaccine should not be administered and that the blood clots and deaths corresponded with the rate of such cases in the general population.

‘The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence,’ Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told Reuters. 

Phil Bryan, head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) said reports of blood clots so far didn’t exceed what would have occurred naturally in the vaccinated population.

The EMA added: ‘Although a quality defect is considered unlikely at this stage, the batch quality is being investigated.’

It said the Pharmacovigilance Risk Assessment Committee (PRAC) were investigating the thrombosis conditions linked to the same batch as well as all other reports of thrombosis and related blood clotting conditions reported post-vaccination.

‘The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population,’ it said.

Today, the UK government defended the vaccine and insisted it would continue with its own rollout.

‘We’ve been clear that it’s both safe and effective… and when people are asked to come forward and take it, they should do so in confidence,’ Prime Minister Boris Johnson’s official spokesman told reporters.

‘And in fact you’re starting to see the results of the vaccine programme in terms of the (lower) number of cases we’re seeing across the country, the number of deaths, number of hospitalisations,’ he said.

Britain began the world’s first mass vaccination drive against the coronavirus in December, underpinned largely by the Oxford-AstraZeneca jab and another from Pfizer-BioNTech. 

EU regulators on January 30 approved the AstraZeneca vaccine, saying it was effective and safe to use. 

Adverse reactions seen in trials were short-lived for the most part and blood clotting issues were not reported. 

An AstraZeneca spokeswoman told MailOnline: ‘We’re aware of the statement made today by Sundhedsstyrelsen [the Danish health authority] that they are currently investigating potential adverse events related to vaccination against COVID-19.

‘Patient Safety is the highest priority for AstraZeneca. Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca.

‘The safety of the vaccine has been extensively studied in Phase III clinical trials and Peer-reviewed data confirms the vaccine is generally well tolerated.’

The investigation by the EU comes after a humiliating U-turn by European leaders who have given their backing to the vaccine after claiming it was ineffective at the height of their row with the vaccine-maker and Britain in January.  

During the ongoing row, the EU has furiously blamed Britain for its woeful vaccine rollout, blocked doses from leaving to Australia and begged the USA to give them its surplus doses. 

Last week, Italy stood at the European vanguard as it embargoed 250,000 doses which were destined for Sydney.  

The agency confirmed it had received two reports 'in a temporal connection' with a vaccine from the same batch in the district clinic of Zwettl, Lower Austria, but said the suspension was a precautionary measure. Picture: File image

The agency confirmed it had received two reports 'in a temporal connection' with a vaccine from the same batch in the district clinic of Zwettl, Lower Austria, but said the suspension was a precautionary measure. Picture: File image

The agency confirmed it had received two reports ‘in a temporal connection’ with a vaccine from the same batch in the district clinic of Zwettl, Lower Austria, but said the suspension was a precautionary measure. Picture: File image

The move raised eyebrows Down Under, as Australia’s finance minister Simon Birmingham said it is ‘a reminder of the desperation that exists in other parts of the world, compared with the very good position we found ourselves in here’. 

‘We are obviously disappointed and frustrated by this decision,’ he added.

Over the weekend, it was reported that the EU had gone cap in hand to Washington to beg them to provide some of their surplus AstraZeneca.

It’s a humiliating U-turn for Brussels whose leaders had wildly claimed that the AstraZeneca vaccine was ineffective earlier this year.

Emmanuel Macron was accused of anti-vax propaganda when he claimed the jab was only ‘quasi-effective’ for elderly patients.

French PM Jean Castex has since endorsed the vaccine, saying it is just as effective as any other approved in the EU.  

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