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The Ministry of Health has decided to suspend vaccination with the AstraZeneca vaccine against Covid-19 for the next two weeks.

The decision, preventive, is due to the notification of cases of cerebral venous thrombosis, which are very rare in the general population and that "it is necessary to study more in depth".

What happened?

Why is the suspension occurring?

The Spanish Agency for Medicines and Health Products (AEMPS) announced this Monday that in the last week it has received notification of "several cases of thrombotic events in some European countries, including Spain, temporarily related to the AstraZeneca vaccination against Covid-19. ".

At first, the health authorities did not consider that there was any possible relationship between these coagulation problems and the administration of the vaccine, since they were neither related to a specific batch, nor was there "a disproportion between the number of cases reported between vaccinated people and the number of naturally occurring cases in the general population. "

However, between Saturday March 13 and Monday March 15 there were several cases of "a very specific type of thrombotic event that needs to be studied further since it is very rare in the general population," says the AEMPS. it's a statement.

As the Minister of Health, Carolina Darias, stressed yesterday, "the cases identified are out of the common pattern, they are rare. They are very few, but significant."

In any case, Health also wanted to send a message of tranquility to the population: "In Spain there has only been one case and it is recovering."

It is a precautionary measure, as a precaution, stressed the minister.

What is the problem?

These are cases of cerebral venous thrombosis (specifically cerebral venous sinus thrombosis) with the particularity, details the AEMPS, that these thromboses are associated with a decrease in the number of platelets in the blood, "which would suggest an abnormal activation of the blood pressure system. the coagulation that would result in this obstruction of the cerebral veins. "

According to data from the Spanish Society of Neurology (SEN), cerebral venous sinus thrombosis is a rare cerebrovascular disease (it represents less than 0.5% of the total cases of cerebrovascular diseases that occur in Spain).

Its incidence is considered to be around 1 - 1.3 cases / 100.

000 inhabitants per year.

It can affect any age group, although it is slightly more common in women and young patients.

Among the sex-specific risk factors are oral contraceptives, pregnancy, and the use of hormonal therapies.

What will happen from now?

All European regulatory agencies work to collect and analyze the available information.

According to AEMPS data, approximately 17 million people have received the AstraZeneca vaccine in the EU and the UK and "the number of reported cases is very low in proportion to the number of people vaccinated."

Specifically, in the European Union about 6 million doses of the vaccine have been administered and the AEMPS has reported 11 cases of cerebral venous sinus thrombosis.

Despite the low incidence, "this subgroup of cases should be studied to know if, in addition to having a temporal relationship with the administration of the vaccine, there is a possible causal relationship."

It is possible that there is no type of causal relationship or that it is due to an alternative justification.

If there is a relationship, the AEMPS points out, measures that try to minimize the risk to the maximum may also be studied, such as the identification of factors that predispose to the appearance of this type of thrombi.

What measures have been taken?

While it is being investigated, "the Ministry of Health considers it prudent to suspend the vaccination with the AstraZeneca Covid-19 vaccine from tomorrow [for today] and for the next two weeks," said Health.

What are the symptoms of a venous thrombosis?

After receiving a vaccine against Covid-19, it is common to notice a headache.

However, "if you have received the vaccine in the last 14 days and the headache is severe and persistent, changes significantly when lying down or is associated with visual disturbances or other persistent neurological symptoms, it is recommended to consult your doctor," he says. the AEMPS.

According to data from the Spanish Society of Neurology, the headache that generates a cerebral venous sinus thrombosis is very characteristic: it can have a sudden onset, it can be located only on one side of the head, it worsens when the patient is lying down or exercising. , interrupts the night's rest and, in addition to not responding to the usual treatments for the headache, it progressively worsens.

In addition, signs similar to those of stroke may also appear (focal deficits, loss of strength or sustained sensitivity, impaired gait or language or speech disturbance, confusional episodes, loss of vision, etc.).

Generally and, especially if it is treated in time, patients suffering from cerebral venous sinus thrombosis have a favorable prognosis.

In Spain, recovery after cerebral venous sinus thrombosis is complete in approximately 80% of patients and only 5% develop some type of severe sequelae, according to the SEN.

What other countries have suspended vaccination?

Denmark was the first country to activate an alert a few days ago for a group of serious cases of rare thromboembolic phenomena, which had coincided in time with vaccination.

These notifications led to the first precautionary suspensions of vaccination.

Later, other countries have made the same decision, such as Iceland, Norway, Ireland, Germany, France, Portugal or Sweden.

In other countries, such as Austria, Estonia, Latvia, Lithuania and Luxembourg, the use of some specific lots has been suspended.

What do the WHO and the European Medicines Agency say?

For now, the WHO continues to recommend normal vaccination, although its safety committee is expected to pronounce on the matter in the next few hours.

The European Medicines Agency (EMA) is also analyzing what happened and its safety committee is scheduled to meet today to decide whether to change its position.

While the investigation is ongoing, the EMA continues to note that the benefits of the vaccine outweigh its risks.

What is the AstraZeneca vaccine like?

The AstraZeneca vaccine was developed by modifying an adenovirus to contain genetic information for SARS-CoV-2.

It does not contain the complete coronavirus and cannot cause disease.

According to the criteria of The Trust Project

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