The AstraZeneca vaccine and withdrawn lots, in Italy and in several European countries – Corriere.it

L ‘Aifa, an Italian drug agency, has blocked the use of a lot of the Covid vaccine AstraZeneca.

The decision, related to a single lot, code ABV2856, came after the notification of some “serious adverse events”, in “temporal concomitance administering doses of the vaccine.

Aifa claims that this decision has been made as a precaution: in other words there is no evidence that the vaccine caused the “adverse events” – called circulatory problems thrombosis – while, for the moment, it is reports related to “temporary concurrency”.

In its statement, Aifa writes that “at the moment no causal link has been established between the administration of the vaccine and these events”, and explains that it is “carrying out all the necessary truths, acquiring clinical documentation in close collaboration with the NAS and the competent authorities “. The samples from the withdrawn lot “will be analyzed by the Istituto Superiore di Sanità”.

What are the “adverse events” in Italy?

Aifa did not specify the “adverse events” that led to the precautionary suspension. The agency Reuters, which cites sources familiar with the matter, explains that there would be two deaths registered in Sicily.

One of these cases concerns a soldier serving in Augusta, Stefano Paternò, 43 years old, originally from Corleone, but residing in Misterbianco (Ct). For his death there are about ten suspects, accused of involuntary manslaughter.

Another case is that of Villa Davide, 50 years old, police officer.

Villa and Paternò had received the AstraZeneca vaccine: the first a few days before, the second the day before death. The doses belonged to the recalled batch of AIFA. There is no confirmation, it must be repeated, that these deaths are attributable to the vaccine.

Denmark’s decision on the AstraZeneca vaccine

On the same day today, the Denmark and 6 other European countries have decided to discontinue the use of the AstraZeneca vaccine.

This decision, the Danish authorities explained, is linked to reports of “Serious adverse events” registered in Denmark, thrombosis again, so at this time the causal link with the administration of the vaccine is not certain. In particular, in Denmark one of these adverse events is related to a death.

Denmark decided to suspend the use of the AstraZeneca vaccine for 14 days and specified that this choice does not imply that the AstraZeneca vaccine is no longer used in the country.

What we are talking about in this case is different from the one distributed in Italy, and instead it was distributed in 17 European countries. Seven of these countries (Estonia, Lithuania, Luxembourg, Latvia, Norway, Iceland, and Denmark) have decided to discontinue the use of the AstraZeneca vaccine.

Spain stated that it has not registered any case of thrombosis and that it will continue to use the vaccine produced by the Anglo-Swedish company on a regular basis.

Ema response in cases of thrombosis

Ema, the European Medicines Agency, reported that the risk of blood clots is not higher in vaccinated people. “The information available so far,” Ema said, “indicates that the number of thromboembolic events in vaccinated people is not higher than that observed in the rest of the population.”

According to the EMA, out of 3 million people who received the AstraZeneca vaccine (data is current as of March 9), 22 cases of thrombosis were recorded.

Ema said that the use of the vaccine remains safe.

According to reports from Stephan Evans, professor of pharmacoepidemiology at the London School & Tropical Medicine, to Reuters, “the approach taken by all these countries is one of extreme caution and is based on isolated cases. The problem is the enormous difficulty of distinguishing a causal chain with a coincidence.

The safety of the AstraZeneca vaccine, in Italy

The second Pharmacovigilance Report on Covid-19 vaccines, published on Wednesday by Aifa, reiterated the high safety profile of the vaccines currently used in Italy and Europe. From the end of December (administration of the first vaccines) to the end of February, 729 adverse events have been reported for every 100,000 doses administered, regardless of the type of vaccine. These are mostly non-serious adverse events: fever, headache, muscle / joint pain, injection site pain, chills, and nausea.

For AstraZeneca, most events also involve fever, chills, asthenia / fatigue, and pain at the injection site. 90% of these reports are classified as non-serious. Most of the 79 reports of serious adverse events refer to high fever, tremors, dizziness, excessive sweating, drowsiness, shortness of breath, generalized pain.

As of February 26, 2021, for all vaccines, not just AstraZeneca, 40 reports were entered with a “death” result. However, the evaluations of the cases reported by the AIFA report indicate the absence of responsibility for the vaccine: they were people who had previous illnesses and who were taking multiple medications at the same time. The average age of fatal cases is 86 years. There are no cases of death as a result of anaphylactic shock or major allergic reactions. However, very often, death was associated with cardiovascular causes in patients who had underlying cardiovascular disease.

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