warnings, rare thrombosis, symptoms to watch out for – Corriere.it

Is the AstraZeneca vaccine safe?
The European Medicines Agency (EMA) judged it as such after reviewing the data in its possession, which became necessary after some reports of new adverse events. The benefits of the vaccine to protect people from Covid outweigh the possible risks, the regulatory body said.

Can it cause thrombosis?
The EMA evaluated that the vaccine was not associated with an increased risk of thromboembolic events, which, in general, were 469 (between clinical trials and post-authorization reports): less than expected in the population (in Italy there are around 60 thousand cases per year , 166 per day). Furthermore, no physiological basis is currently known that allows us to affirm that this type of vaccine is capable of triggering thrombotic mechanisms.

The EMA has not ruled out a link to a particular type of thrombosis. Which?
Disseminated intravascular coagulation, which can rarely lead to cerebral vein thrombosis, due to the occlusion of a vein in the brain. This atypical thrombosis occurs in patients with blood cancers or in women on estrogen-progestin therapy. After analyzing all the reports, there was an increase in episodes in young women (under 55 years of age) not seen in the older population, and the EMA did not rule out a link between these cases and the vaccine. However, it is a matter of few cases and too short an observation time. From a statistical point of view, the distortion can be considerable.

There will be warnings in the leaflet related to this pathology, which ones?
An invitation to see a doctor in case of shortness of breath, pain in the chest or stomach, swelling or cold in an arm or leg, severe or worsening headache or blurred vision after vaccination, persistent bleeding, multiple small bruises, reddish or purplish spots, or blood blisters under the skin.

How do we intervene in these cases?
Many of the symptoms described are nonspecific and common in normal reactions to vaccines. If the diagnosis is confirmed, anticoagulant therapy is usually effective. The point is to understand who needs to investigate and who does not. Unfortunately, rapid clotting tests have not been validated in these rare and atypical thromboses. If a patient exhibits these symptoms, a personal and family history of thrombotic events would help, but confirmatory diagnostic tests are absolutely mandatory before starting treatment.

Can people at higher thrombotic risk do anything before getting vaccinated?
It would not be advisable to administer therapy first: it is not yet known whether anticoagulant prophylaxis can reduce the risk of the rare form of thrombosis. What I do notice, however, is the danger of bleeding from the administration of drugs such as heparin. Although very low in percentage terms, this danger in absolute terms certainly outweighs the (yet to be demonstrated) risk of thrombosis. There are tens of thousands of people who have a history of thrombosis or thrombotic risk, so giving heparin to everyone would be an unbalanced measure.