Germany, Italy and France suspend AstraZeneca shots for safety fears, disrupting EU vaccinations

BERLIN / GENEVA (Reuters) – Germany, France and Italy said on Monday they would suspend AstraZeneca COVID-19 recordings after several countries reported possible serious side effects, but the World Health Organization

(WHO) said there was no proven link and people shouldn’t panic.

Still, the decision of the three largest countries in the European Union to delay vaccinations with the AstraZeneca confused the already struggling EU vaccination campaign involving 27 countries.

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

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

The WHO’s top scientist reiterated Monday that there have been no documented deaths related to COVID-19 vaccines.

“We don’t want people to panic,” Soumya Swaminathan said at a virtual media briefing, adding that so far there has been no link between so-called “thromboembolic events” reported in some countries and COVID-19. recordings.

WHO chief Tedros Adhanom Ghebreyesus said an advisory committee meeting on AstraZeneca on Tuesday. The EU drug regulator EMA will also meet this week to assess whether the information gathered on whether the AstraZeneca injection has contributed to thromboembolic events in those vaccinated.

The measures taken by some of Europe’s largest and most populous countries will raise concerns about the slow roll-out of vaccines in the region, plagued by shortages due to problems producing vaccines, including AstraZeneca’s.

Germany warned last week that it was facing a third wave of infections, Italy is intensifying lockdowns and hospitals in the Paris region are at risk of overload.

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,” said Spahn, adding that he was following a recommendation from the Paul Ehrlich Institute, Germany’s vaccine regulator.

France said it is suspending use of the vaccine pending an EMA review due on Tuesday.

“The decision that has been taken, in accordance with our European policy, is to suspend vaccination with the AZ injection as a precaution, in the hope that we can resume soon if guidance from the EMA allows,” said the French. president Emmanuel Macron.

Italy said the shutdown was a “preliminary and precautionary measure” pending the EMA’s ruling.

“The EMA will meet soon to address any doubts so that the AstraZeneca vaccine can be safely resumed in the vaccination campaign as soon as possible,” said Gianni Rezza, Director General for Prevention at the Italian Ministry of Health.

Austria and Spain have stopped using certain parties, and prosecutors in the northern Italian region of Piemonte 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 had died shortly after their shots.

The WHO has called on countries not to suspend vaccinations against a disease that has caused more than 2.7 million deaths worldwide. WHO Director General Tedros said there are systems in place to protect public health.

“This does not necessarily mean that these events are related to COVID-19 vaccination, but it is routine to investigate them and it shows that the monitoring system is working and that there are effective controls,” he told the news conference.

The UK said it was not concerned, while Poland said it thought the benefits outweigh the possible risks.

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

Michael Head, a senior research fellow in global health at the University of Southampton, said the decisions made by 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 even lower) in vaccinated groups compared to unvaccinated populations,” he said, adding that the discontinuation of a vaccination program had consequences.

“This results in delays in protecting people and the potential for greater vaccine reluctance as a result of people seeing the headlines and understandably becoming concerned. There is no data yet to really justify these decisions. “

The general manager of the Italian drug agency Aifa, Nicola Magrini, said several European countries preferred to suspend the vaccine “in the presence of some very recent and very few cases of side effects” in women and young people.

“… Those who have already had the vaccine can and should stay safe,” she told a radio station. “I feel like saying the vaccine is safe even after looking at all the data.”

‘UNUSUAL’ SYMPTOMS

The AstraZeneca shot was one of the first and cheapest to be widely developed and launched since the coronavirus was first identified in central China in late 2019, and it will become the mainstay of vaccination programs in much of the developing world.

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

The WHO said its advisory panel was reviewing reports on the shot and would release its findings as soon as possible. But it said its recommendations, released last month, would be unlikely to change for widespread use, including in countries where the South African variant of the virus may reduce its effectiveness.

The EMA also said there was no evidence that the events were caused by the vaccination and that the number of blood clots reported was no higher than in the general population.

The handful of reported side effects in Europe have upset vaccination programs, which in some countries are already stumbling over slow rollout and vaccine skepticism.

The Netherlands said on Monday that it had seen 10 cases of possible notable side effects from the AstraZeneca injection hours after the vaccination program was stopped following 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 by Norway on Saturday about three people under 50 who were treated in hospital, according to him.

“It was an unusual disease course surrounding the death that prompted the Danish Medicines Agency to respond,” the agency said in a statement late on Sunday.

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

AstraZeneca previously said it had conducted a survey of more than 17 million vaccinated people in the EU and the UK, who had shown no evidence of an increased risk of blood clots.

The long-awaited results of AstraZeneca’s 30,000-person US vaccine study are now being reviewed by independent observers to determine if the shot is safe and effective, a top US official said Monday.