Germany, Italy and France suspend AstraZeneca vaccines amid safety fears, disrupting EU vaccines


BERLIN / GENEVA (Reuters) – Germany, France and Italy said on Monday they would pause COVID-19 injections from AstraZeneca after several countries reported potential serious side effects, prompting Europe’s vaccination campaign , which was already in distress, would fall apart.

Teacher Rene Kirstein receives his first dose of AstraZeneca COVID-19 vaccine from nurse Susanne Kugel, amid the spread of coronavirus disease (COVID-19) in Grevesmuehlen, Germany, on March 5, 2021 REUTERS / Fabian Bimmer

Denmark and Norway stopped injecting last week after reporting isolated cases of bleeding, blood clots and a low platelet count. Iceland and Bulgaria followed suit and Ireland and the Netherlands announced suspensions on Sunday.

Spain will stop using the vaccine for at least 15 days, Cadena Ser radio reported, citing unidentified sources.

The actions of some of the largest and most populous countries in Europe will deepen concerns about the slow launch of vaccines in the region, which has been plagued by shortages due to problems in vaccine production, including that of AstraZeneca.

Germany warned last week it was facing a third wave of infections, Italy is stepping up lockdowns and hospitals in the Paris region are close to being overloaded.

German Health Minister Jens Spahn said that although the risk of blood clots was low, it could not be ruled out.

“This is a professional decision, not a political one,” Spahn said, adding that he was following a recommendation from the Paul Ehrlich Institute, Germany’s vaccine regulator.

France said it would suspend use of the vaccine pending an evaluation by the EU drug regulator scheduled for Tuesday. Italy said its suspension was a “precautionary and temporary measure” pending the regulator’s decision.

Austria and Spain have stopped using private lots, and prosecutors in the Piedmont region of northern Italy previously seized 393,600 doses following the death of a man hours after being vaccinated. It was the second region to do so after Sicily, where two people had died shortly after being shot.

The World Health Organization called on countries not to suspend vaccines against a disease that has caused more than 2.7 million deaths worldwide. WHO chief Tedros Adhanom Ghebreyesus said systems exist to protect public health.

“This does not necessarily mean that these events are related to COVID-19 vaccination, but it is routine practice to investigate them, and it shows that the surveillance system is working and that there are effective controls in place,” Tedros said during a virtual press conference in Geneva. . .

He said an advisory committee meeting on AstraZeneca would take place on Tuesday.

The UK said it had no concerns, while Poland said it thought the benefits outweighed any risks.

The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among about 5 million people vaccinated with the AstraZeneca vaccine in the European Economic Area, which links 30 European countries.

Michael Head, a senior researcher in global health at the University of Southampton, said the decisions by France, Germany and others seemed puzzling.

“The data we have suggests that the number of adverse events related to blood clots is the same (and possibly, in fact, lower) in vaccinated groups compared to unvaccinated populations,” he said, adding that stopping a vaccination program had consequences.

“This results in delays in protecting people and the potential for doubts about vaccines to grow, as a result of people seeing the headlines and understandably worrying. There is still no indication of any data that really justifies these decisions. “

The director general of the Italian medicine agency Aifa, Nicola Magrini, told a radio station that several European countries preferred to suspend the vaccine “in the presence of some very recent cases and very few adverse events” in women and young people. .

“… Those who have already received the vaccine can and should remain safe,” he said. “I want to say that the vaccine is safe, even after I have reviewed all the data.”

“UNUSUAL” SYMPTOMS

The AstraZeneca injection was one of the first and cheapest to be developed and launched in volume since the coronavirus was first identified in central China in late 2019 and will become the mainstay of vaccination programs on a large scale. part of the developing world.

Thailand announced plans on Monday to go ahead with the injection from the Anglo-Swedish firm after suspending its use on Friday, but Indonesia said it would wait for the WHO to report.

The WHO said its advisory panel was reviewing reports related to the injection and would publish its findings as soon as possible. But he said he is unlikely to change his recommendations, issued last month, for widespread use, even in countries where the South African variant of the virus may reduce its effectiveness.

The EMA has also said that there was no indication that the events were caused by vaccination and that the number of reported blood clots was not greater than that seen in the general population.

The few side effects reported in Europe have disrupted vaccination programs that are already under pressure from slow launches and skepticism of vaccines in some countries.

The Netherlands said on Monday it had seen 10 cases of notable potential adverse side effects from the AstraZeneca vaccine, hours after the government suspended its vaccination program following reports of possible side effects in other countries.

Denmark reported “very unusual” symptoms in a 60-year-old citizen who died of a blood clot after receiving the vaccine, the same phrase used on Saturday by Norway on three people under the age of 50 who it said were being treated. in a hospital.

“It was an unusual course of illness around death that caused the Danish Medicines Agency to react,” the agency said in a statement Sunday night.

One of three health workers hospitalized in Norway after receiving the AstraZeneca injection had died, health authorities said Monday, but there was no evidence that the vaccine was the cause.

AstraZeneca previously said that it had conducted a review covering more than 17 million vaccinated people in the European Union and the United Kingdom, which had shown no evidence of an increased risk of blood clots.

Independent monitors are reviewing the long-awaited results of the AstraZeneca vaccine trial with 30,000 people in the US to determine whether the injection is safe and effective, a senior US official said Monday.

Reporting by Panarat Thepgumpanat in BANKOK and Andreas Rinke and Paul Carrel in BERLIN, Angelo Amante in ROMA, Christian Lowe in PARIS, Toby Sterling in AMSTERDAM, Jacob Gronholt-Pedersen in COPENHAGEN, Kate Kelland in LONDON, Emilio Parodi in MILAN, Nathan Allen in MADID and Stanley Widianto in JAKARTA; written by Philippa Fletcher; Nick Macfie edit

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