In February, Spain received 228,000 doses from the batch of AstraZeneca withdrawn in Austria after cases of thrombosis: several Autonomous Communities paralyze its administration

Although the European Medicines Agency has confirmed that there is no observed causal relationship between the administration of the AstraZeneca vaccine and the formation of blood clots, several European countries are acting on the principle of prudence. Austria was the first to withdraw the batch ABV5300, with which the nurse who died of thrombosis 10 days after being injected was vaccinated. Spain is one of the 17 countries that has also received doses from this same batch, and several autonomous communities have already announced the suspension of the use of those 228,000 distributed doses.

AstraZeneca’s batch ABV5300 has been delivered to 17 EU countries and consists of one million doses of the antidote. In addition to Spain, Denmark and Austria, the list of recipient countries is completed by Bulgaria, Cyprus, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland and Sweden. until you get more information.

In Spain, the batch was received on February 12 and is made up of 228,000 doses of the antidote distributed among the autonomous communities following population criteria, as confirmed by the Ministry of Health. Given the thirty thrombotic episodes detected in several European countries, several autonomies have decided to suspend the administration of injections of this batch.

The Spanish Medicines Agency: “There is no evidence that the vaccine was the cause of the thrombosis episodes”

These are Castilla y León, Andalusia, Catalonia and the Canary Islands, which have precautionarily stopped the use of doses from batch number ABV5300, although they maintain vaccination with this company’s drug. Andalusia will thus stop using 1,200 doses of vaccines. The Minister of Health and Families, Jesús Aguirre, has attributed the decision to the “precautionary principle”. He has stressed that the immobilization does not affect the rest of the AstraZeneca doses that do not belong to this batch.

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In Asturias, on the other hand, some of the doses of AstraZeneca have been “withheld”: “Out of a principle of maximum prudence, the General Directorate of Public Health, together with the Health Service, have decided to withhold some doses of COVID-19 vaccines related to said batch. “Vaccination will continue normally with other batches,” confirmed the Principality’s Ministry of Health.

The Spanish Agency for Medicines and Health Products (Aemps), in the same wake as the European Medicines Agency, has reported that “there is no evidence that the vaccine was the cause of these events”, referring to the thrombosis detected between vaccinated from Denmark and Austria.

No case of thrombosis in Spain

“So far, no relevant adverse event of the type that has been reported in Austria with the AstraZeneca vaccine has been registered in Spain,” the Spanish agency reported, replicating the position declared this Thursday by Minister Carolina Darias. The head of Health asked for peace of mind and aligned herself with the European recommendations not to stop vaccination. “In Spain, no effect of this type of thrombotic events has been reported. In relation to other things, yes, such as headaches, pain in the area and intestinal disorders,” she said in a television interview.

The European Medicines Agency (EMA), whose safety committee already investigated the batch withdrawn in Austria after the death by thrombosis was notified in this country, has reiterated a few hours ago that there is currently no indication that the AstraZeneca vaccine is responsible of these effects. of its antidote. “The benefits of the vaccine continue to outweigh the risks, so it can continue to be administered while the investigation of cases of thromboembolic events continues,” the EMA safety committee has resolved.

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The position is also based on statistical data. The Aemps has recalled that, to date, 22 cases of thrombosis episodes have been reported in the European Union among the 3 million vaccinated citizens, which would not mean a higher figure than expected in the general population.

Despite the prudence of the countries and some regions in Spain, the Aemps considers that there are no reasons to adopt precautionary measures such as the withdrawal of the batch of AstraZeneca received in Spain, and urges to continue with the planned vaccination plan.

Risk of serious allergies as an adverse effect

The EMA Pharmacovigilance Risk Assessment Committee, on the other hand, has identified serious allergies, such as anaphylaxis, as possible side effects of the coronavirus vaccine developed by AstraZeneca.

The entity has released a statement after conducting a review of 41 case reports of possible anaphylaxis observed in around 5 million vaccines administered in the United Kingdom. “After careful review of the data, we believe a link to the vaccine is likely in at least some of these cases.”

Anaphylaxis is a known side effect that can occur, very rarely, with vaccines, and is in fact included as a potential risk in the AstraZeneca coronavirus vaccine risk management plan.

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