AstraZeneca vaccine suspended in France: European Medicines Agency to vote on Thursday

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France on Monday (March 15th) decided to suspend the AstraZeneca vaccine “as a precaution” pending an opinion from the European Medicines Agency (EMA), which will be decided on Thursday. Several countries such as Germany, Denmark, and the Netherlands had made the same decision shortly before. What’s the problem? “Severe case reports of blood clots.”
Since February 6, the Oxford-AstraZeneca vaccine is available in France. GPs can vaccinate people aged 50 to 74 with comorbidities with this serum, but also those over 75 years of age. Some very high-risk conditions of severe Covid-19 also pave the way for vaccination regardless of the age of patients.

What about its side effects? In a pharmacovigilance report, the National Agency for the Safety of Medicines and Health Products (ANSM) reported that the vast majority of these cases were influenza-like syndromes, often high-intensity, including high fever, aches, and headaches. But there are other potential side effects of the AstraZeneca vaccine abroad.

AstraZeneca vaccine: why France is suspending its use
After the discovery of cases of post-vaccination thrombosis, some countries suspended the AstraZeneca serum as a precautionary measure. On Monday, March 15, France followed suit. At a press conference in Montauban (Tarn-et-Garonne) on the occasion of the 26th Franco-Spanish summit, Emmanuel Macron announced that France was also suspending the vaccine, pending an opinion from the European Medicines Agency (EMA), which will vote on Thursday 18 March. “The decision that has been taken, in accordance with our European policy, is to suspend vaccination with AstraZeneca as a precaution, hoping to resume vaccination as soon as possible if the opinion is favorable,” the President of the Republic said.

On Monday 15 March, the European Medicines Agency also commented on the subject: “While its investigation is ongoing, the EMA currently believes that the benefits of the AstraZeneca vaccine in the prevention of Covid-19, along with its associated risk of hospitalization and death, outweigh the risks of side effects.”

For its part, the World Health Organization (WHO) on Monday (March 15th) called on countries to continue vaccination. “We don’t want people to panic and, for now, we recommend that countries continue to vaccinate with AstraZeneca,” WHO Chief Scientist Soumya Swaminathan told a news conference. The organization is meeting on Tuesday, March 16, to study the safety of this serum.

Germany, Italy, Denmark… Other countries that have suspended the AstraZeneca vaccine
Among the countries that decided to suspend the AstraZeneca vaccine before France was Denmark. On Thursday 11 March, the Danish authorities announced the decision. What’s the problem? “Severe reports of blood clots in people who have been vaccinated with AstraZeneca’s Covid-19 vaccine,” the National Health Agency said. However, it states that “at present, there is no evidence that there is a link between the vaccine and blood clots”.

For the same reasons, Norway and Iceland also took this decision. Norway has since raised concerns about cases of skin hemorrhage in relatively young people who have received the vaccine. The link between the vaccine and these manifestations has not yet been clearly established, but the Norwegian Institute of Public Health said that “this is serious and may be a sign of a decrease in the number of platelets”.

On Friday 12 March, Bulgaria decided to suspend the vaccine. “I am ordering a cessation of vaccinations with AstraZeneca until the European Medicines Agency (EMA) dispels any doubts about its safety,” Prime Minister Boyko Borisov said in a statement.

Ireland and the Netherlands also made the decision on Sunday (March 14th). In the Netherlands, the suspension will be effective until 28 March. “We must always exercise caution, which is why it is wise to press the pause button now as a precaution,” said Health Minister Hugo de Jonge. On Monday, 15 March, Germany also decided to suspend the AstraZeneca vaccine. A decision then applied by France, Italy, Spain, and Luxembourg. On Tuesday 16 March, Sweden and Cyprus also implemented the suspension.

Outside the European Union, two countries have also taken decisions on the AstraZeneca vaccine: Thailand and the Republic of Congo have delayed the start of their vaccination campaign with this serum.

AstraZeneca vaccine: which countries have suspended batches?
Other countries have decided to suspend some batches of the AstraZeneca vaccine. It all started in Austria, after the death of a 49-year-old nurse eleven days after injecting the first dose of AstraZeneca serum. The victim died as a result of severe bleeding disorders.

On Sunday 7 March Austria announced the withdrawal from the market of the batch of vaccine in question, numbered ABV5300. “Currently, there is no evidence of a cause-and-effect relationship with vaccination. On the basis of known clinical data, a cause-and-effect relationship cannot be established, as thrombotic events, in particular, are not part of the known or typical side effects of the vaccine in question,” the Federal Office for Health Care Safety (BASG) said in a statement. Other countries subsequently suspended the lot: Estonia, Lithuania, and Latvia.

Before suspending the AstraZeneca vaccine, Italy had suspended another batch, numbered ABV2856, “following information on certain serious adverse reactions”. Romania has also suspended this lot. After the death of a 57-year-old teacher, the Italian region of Piedmont withdrew the ABV581 lot.

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