Blood clots: states suspend AstraZeneca vaccine, reassuring regulator

Denmark, Norway and Iceland on Thursday suspended the use of the AstraZeneca vaccine against COVID-19 due to concerns related to blood clots, despite reassuring statements from the European regulator and the manufacturer.

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“The information available so far indicates that the number of blood clots in vaccinated people is not higher than what is observed in the entire population,” confirmed Thursday afternoon the European Medicines Agency (EMA) after the decisions of the three Nordic countries.

The Danish Health Authority was the first on Thursday morning to suspend the AstraZeneca vaccine “after reports of serious cases of blood clots” in people who have been vaccinated with the AstraZeneca COVID-19 vaccine.

She stressed that this choice, however, is a “precaution” pending the results of health surveys and “at the present time, we cannot conclude that there is a link between the vaccine and blood clots.”

According to the EMA count, only 22 cases of thrombosis were reported as of Tuesday of more than three million people who were vaccinated in its region (European Union, Norway and Iceland).

Lundi, l’Autriche avait annoncé avoir cessé d’administrer un lot de vaccins produits par le laboratoire anglo-suédois, après le décès d’une infirmière de 49 ans qui a succombé à de «troubles de la coagulation» quelques jours après ‘Received.

Four other European countries, namely Estonia, Lithuania, Latvia and Luxembourg, immediately stopped vaccination with doses of this batch, which were delivered to 17 countries, which included one million vaccines.

A preliminary investigation by EMA had estimated on Wednesday that there was no link between the AstraZeneca vaccine and the death in Austria.

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The Danish decision, which concerned both AstraZeneca, was soon followed by the same choice in Iceland and Norway, again in the name of the “precautionary principle”.

“Sincerely wisdom”

For Stephen Evans, professor of pharmacological epidemiology at the London School of Hygiene and Tropical Medicine, these choices are based on a “very cautious” approach based on isolated cases in Europe “and the balance of benefits and risks of a vaccine is still too large for AstraZeneca.”

The Anglo-Swedish laboratory, which developed the vaccine with the University of Oxford, defended the safety of its product, as did the British government, which described it as “safe and effective” and will continue to use it.

“The safety of the vaccine has been studied extensively in phase III clinical trials, and the data confirm (…) that the vaccine was generally well tolerated,” an AstraZeneca spokesperson told AFP.

Other countries, such as Sweden and the Netherlands, have announced that they will continue to inject it.

In Denmark, this comment, which will be reassessed within two weeks, upsets the schedule for the vaccination campaign, which is by far one of the fastest in Europe.

Copenhagen now plans to vaccinate its adult residents in mid-August, compared to early July so far.

Danish Prime Minister Mette Frederiksen, a leading advocate of speeding up vaccination campaigns, while defending the choice of the health authority, responded: “Of course we are upset with this news and this information.”

“There is always a risk associated with vaccines (…). Things have gone well in Denmark, but there are some risks with the AstraZeneca vaccine that need to be looked at further. It seems to me the right way to go forward,” she said.

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Denmark recorded a death due to a blood clot of a person who received the AstraZeneca vaccine, which was transferred to the EMA.

“Given the number of people who have been vaccinated, it is difficult for me to believe that there is a real problem but it is important to conduct a thorough investigation,” said Alan Randrup Thomsen, professor of virology at the University of Copenhagen.

In the Scandinavian country of 5.8 million, 13.4% of the population has already received at least one dose of the COVID-19 vaccine, a quarter of which are with an AstraZeneca dose.

Italy bans the use of the AstraZeneca range

Italy decided, Thursday, as a precaution, to ban the use of a group of vaccines against the emerging corona virus from AstraZeneca / Oxford, due to concerns related to the formation of blood clots, the Italian Drug Agency (AIFA).

“After information related to some serious negative reactions (…), AIFA decided as a precaution to ban the use of this batch in all parts of the country,” the agency announced in a press release posted on its website.

The AIFA has made it clear not to rule out other measures if needed, in coordination with the European Medicines Agency (EMA), based in Amsterdam.

The AIFA also confirmed that no cause-and-effect association has been established at this time between the administration of the AstraZeneca vaccine and some of the serious reactions observed in the vaccinated subjects.

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