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

BERLIN / GENEVA (Reuters) – Germany, France and Italy said on Monday they would pause AstraZeneca COVID-19 injections after several countries reported possible serious side effects, disrupting Europe’s already difficult vaccination campaign.

Denmark and Norway stopped giving the injection last week after reporting isolated cases of bleeding, blood clots and low platelet counts. 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 distribution of vaccines in the region, which has been affected by scarcity due to problems in vaccine production, including that of AstraZeneca.

Germany warned last week that it faces a third wave of infections, Italy is stepping up blockages and hospitals in the Paris region are close to becoming overloaded.

German Health Minister Jens Spahn said that while the risk of blood clots is low, it cannot be ruled out.

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

France said it was suspending the use of the vaccine pending an assessment 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 specific batches and prosecutors in the northern Italian region of Piedmont have previously seized 393,600 doses after the death of a man hours after he was vaccinated. It was the second region to do so after Sicily, where two people died shortly after being vaccinated.

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

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

He said an AstraZeneca advisory committee meeting would be held on Tuesday.

The UK said it had no concerns, while Poland said it believed the benefits outweigh any risks.

The EMA reported that by March 10, a total of 30 blood clotting cases 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 in France, Germany and others looked baffling.

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

“This results in delays in protecting people and the potential for increased hesitation to the vaccine, as a result of people who saw the headlines and, understandably, were concerned. There is still no evidence of data that really justifies these decisions ”.

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

“… Anyone who has had the vaccine can and must remain safe,” she said. “I want to say that the vaccine is safe, even though I have reviewed all the data.”

“UNUSUAL” SYMPTOMS

The AstraZeneca injection was one of the first and cheapest to be developed and launched in high volume since the coronavirus was first identified in central China in late 2019 and should be the mainstay of vaccination programs in much of the world in development.

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

The WHO said that its advisory panel was analyzing reports related to the injection and would release its findings as soon as possible. But he said it was unlikely to change his recommendations, issued last month, for widespread use, including in countries where the South African variant of the virus could reduce its effectiveness.

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

The handful of side effects reported in Europe have disrupted vaccination programs, which were already under pressure due to the slow release and skepticism of the vaccine in some countries.

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

Denmark reported “highly 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 for about three people under 50 who were being treated at the hospital.

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

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

AstraZeneca said earlier that it carried out a review covering more than 17 million vaccinated people in the European Union and the United Kingdom, which showed no evidence of an increased risk of blood clots.

The long-awaited results of the AstraZeneca vaccine trial of 30,000 people in the U.S. are currently being analyzed by independent monitors to determine whether the injection is safe and effective, a senior US official said on Monday.