AstraZeneca is concerned about rollout of Covid-19 vaccine in Europe into deeper disorder

Germany, France, Italy and Spain have become the latest countries to suspend vaccine use, even as a third wave of the pandemic threatens the continent.

ROME – As a third wave of the pandemic crashes across Europe, questions about the safety of one of the most common vaccines on the continent have led Germany, France, Italy and Spain to suspend its use. The suspensions caused further chaos in the vaccination, even though new coronavirus variants were still spreading.

The decisions follow reports that a handful of people who received the vaccine made by AstraZeneca suffered fatal brain haemorrhages and blood clots.

The company strongly defended its vaccine, saying there was ‘no evidence’ of the increased risk of blood clots or bleeding among the more than 17 million people who received the shot in the European Union and the UK.

“The safety of all is our top priority,” AstraZeneca said in a statement on Monday. “We are working with national health authorities and European officials and look forward to their review later this week.”

The timing of the vaccination by some of Europe’s largest countries – which followed a spate of similar actions by Denmark, Norway and several others – could not have been worse.

Europe’s vaccine deployment is already far behind that in Britain and the United States, and there is a realization that much of the continent is experiencing a third wave of infections. Leading immunologists were concerned yesterday that the decision by several of Europe’s leading countries to suspend the use of AstraZeneca would make vaccination efforts even more difficult by encouraging enthusiasts in countries where they are particularly based.

The European Medicines Agency and the World Health Organization have warned of an outbreak of vaccines that would undermine the deployment at an important moment.

“We do not want people to panic,” said WHO chief scientist Soumya Swaminathan at a news conference, adding that no link had been found between the coagulation disorders reported in some countries and Covid-19 shots. . A WHO advisory committee plans to meet on Tuesday to discuss the vaccine.

The European Medicines Agency, or EMA, said on Monday that it would continue to investigate a possible link between the AstraZeneca shots and blood clots or bleeding in the brain. But the agency said the numbers of such problems reported in vaccines do not appear to be higher than what is commonly seen in the general population. Germany, for example, reported seven cases of a “rare cerebral arthritis” out of 1.6 million people who received the vaccine there.

“While the investigation is ongoing, the EMA currently considers that the benefits of the AstraZeneca vaccine to prevent Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects,” said the agency.

The European Union worked hard on AstraZeneca, a British-Swedish company, last year.

In France, where AstraZeneca is being trusted to speed up the country’s vaccination campaign, and where top officials have been urging people to trust the vaccine for days, President Emmanuel Macron called the suspension a “precautionary measure” and “hoped to speed it up.” to pick up again. ”

In Italy, police on Monday seized nearly 400,000 doses of AstraZeneca vaccine ordered by local prosecutors investigating the death of a teacher who received the vaccine. The Italian medicine agency said in a statement that the suspension of the vaccine, one of the most common distributions in the country, was “preventive and temporary”. Its director, Nicola Magrini, said on television on Monday night: “at this moment there is no reason to instill doubt and make people prefer one vaccine over another.”

“We are confident that we can pick it up after the EMA’s inquiry,” said Cesare Buquicchio, a spokesman for the Italian health minister.

In Germany, which had previously supported the vaccine despite concerns from other countries, Health Minister Jens Spahn called the decision to suspend shots a pure precaution. ‘More than 1.6 million doses of AstraZeneca have been administered in Germany, relying heavily on the BioNTech-Pfizer vaccine.

But the country’s Paul Ehrlich Institute said the country had decided to suspend AstraZeneca shots because cases of “rare cerebral arthrombosis” had been reported in the country after vaccinations.

Mr. Spahn acknowledged that the seven cases of thrombosis made it very rare, but he defended the decision to interrupt the shots as necessary to ensure confidence in the vaccine.

“For almost everyone, there is no risk, but a connection can not be completely ruled out,” Spahn said. “That’s why we decided to make this decision.”

Spain followed suit on Monday night. At the news conference, Carolina Darias, the Spanish Minister of Health, said she was in contact with European counterparts before ordering a two-week suspension of the vaccine. This would give time for the relevant medical agencies to provide ‘answers’ about the cases of thrombosis that have been detected recently, she said.

Across Europe, officials and immunologists were concerned that the action would cost a lifetime in the race against rapidly spreading variants.

“This is a catastrophe,” said Heike Werner, the health minister in the eastern German state of Thuringia. He has already struggled to learn that her region would only receive 9,600 of 31,200 doses of AstraZeneca due to a shortage of stock. “A lot of people are desperately waiting for this vaccine.”

Roberto Burioni, a leading Italian virologist, expressed on Twitter his concern that people will now avoid the vaccine.

“I understand that you will decide not to be vaccinated, afraid of unexplained decisions,” he said. “I understand that, and I’m sorry, because you would be taking a serious risk to avoid a negligible one.”

Dr Michael Head, senior research fellow in global health, University of Southampton, said “the decisions of France, Germany and other countries seem staggering.” He said the delay in vaccinations, and ‘the possibility of increased hesitation against vaccines’, hampered any new or conclusive data.

Britain approved the AstraZeneca vaccine in late December and administered 9.7 million doses at the end of February.

The drug regulator reported no concerns about blood clotting for the vaccine or the Pfizer shot, saying latest safety report that ‘the number and nature of the suspected side effects reported so far are not uncommon compared to other types of vaccines that are frequently used.’

Among the millions of people who received the AstraZeneca shot in Britain, 14 cases of deep vein thrombosis and 13 cases of a pulmonary embolism were reported, both of which can be caused by blood clots. Only one of the people died. 35 cases of thrombocytopenia have been reported, a condition with a low platelet count. It also led to one death.

“We are reviewing reports carefully, but the available evidence does not indicate that the vaccine is the cause,” said Dr. Phil Bryan told a British regulatory agency in a statement..

The World Health Organization has signed on to the safety of the vaccine developed by researchers at the University of Oxford, in partnership with the pharmaceutical company AstraZeneca. The European Medicines Agency, the European Union’s regulatory authority, has also approved its use after monitoring approximately five million vaccinations already administered across the continent. Monday’s lead remained the same.

Norwegian authorities held a news conference on Monday to explain their earlier decision to suspend the vaccine.

They said a 50-year-old patient who died was in good health before receiving the vaccination, but suffered a fatal aftermath.intracerebral haemorrhage

Another health worker who died Friday is described as a 30-year-old woman who died of the same cause ten days after receiving a shot.

Doubts, whether deserving or not, surrounding the AstraZeneca vaccines come as more countries embrace or consider broad new restrictions – in some places for a third or fourth time in a year.

Shortly due to widespread vaccinations, and with the more easily transmitted and potentially deadly British variant dominating infections, Italy on Monday severely expanded new restrictions on movement nationwide, deepening a year of economic and psychological damage.

The silence in the streets of Rome and elsewhere was reminiscent of a year ago, when Italy became the first European country to close, and underlined how frustratingly little progress has been made in combating the pandemic.

“The second, the third wave, I lost count,” said Barbara Lasco, 43, as she sat in a park in Milan, near the epicenter of the original European outbreak in northern Italy. ‘I’m surprised and disappointed; one year was enough time to make it happen again. ”

Progress against the virus, almost everywhere, has been hampered. In Germany, even though many non-essential stores opened last week for the first time in months, health officials have called for caution.

“We are seeing clear signs: in Germany, the third wave has already begun,” Lothar H. Wieler, president of the Robert Koch Institute, the equivalent of the CDC in Germany, said Friday. Since then, the daily number of infections has increased.

The virus is also spreading, and hospitals are once again expanding throughout Central Europe.

Hungarian Prime Minister Viktor Orban has predicted that this week will be the most difficult since the start of the pandemic in terms of allocating hospital beds and ventilators, as well as mobilizing nurses and doctors.

In Germany, where infections are driven by the British variant, a more lasting suspension of AstraZeneca could delay the vaccination of the population by a month, according to the Central Institute of Registered Physicians.

France hopes to ward off a new surge of infections with local restrictions, but some health officials think the time has come for a third national exclusion because intensive care units have been raided. “New decisions” will be taken in the coming days to address the increase in infections in France, said Mr. Macron said Monday.

Greek authorities last week reported the highest daily infection rate since mid-November, driven by the British variant; the rise has led to the reversal of plans to reopen schools and shops later this month.

Italian Prime Minister Mario Draghi warned on Friday that the country was facing a ‘new wave of infection’, driven by more contagious variants of the coronavirus.

He put an army general in charge of vaccinating and hoped to increase the vaccination from 100,000 a day to 500,000.

But that was before the fears of AstraZeneca spread.

On Monday, Iacopo Benini, a 32-year-old professor, canceled his vaccination on AstraZeneca 20 minutes before arriving in Milan. “Who is going to accept AstraZeneca now?” he said.

Reporting was contributed by Melissa Eddy and Christopher Schuetze of Germany; Constant Méheut and Aurelien Breeden of France; Emma Bubola of Milan; Matina Stevis-Gridneff and Monika Pronczuk from Brussels; Benjamin Mueller and Marc Santora of London; Benjamin Novak of Hungary; Niki Kitsantonis of Greece; Rebecca Robbins of Bellingham, Wash., Gaia Pianigiani of Siena; Thomas Erdbrink of Amsterdam; and Raphael Minder of Madrid.

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