AstraZeneca’s Covid vaccine changed its name to Vaxzevria. The pharmaceutical company proposed it and the change of name was approved by the European Medicines Agency (EMA) on 25 March. It is learned from the EMA website which also specifies that the new leaflet of the drug has been published where, among the side effects, the very rare cases of thrombosis are mentioned. Naming a customary new drug. And a process that takes place separately from regulatory approval, the vaccine didn’t have a name and now it does, the company explained.

The new package insert

To better investigate the rare adverse events, a precautionary suspension of the AstraZeneca vaccine in Italy and other European countries was decided in mid-March. After careful examination, the EMA had judged safe the vaccine, stating that its benefits outweigh the risks. The warnings added to the package insert concern disseminated intravascular coagulation, which, rarely, can lead to a cerebral venous thrombosis, due to the occlusion of a vein in the brain. The invitation on the AstraZeneca vaccine package insert is that of seek medical attention in case of: shortness of breath, chest pain, leg swelling, persistent abdominal pain after vaccination. In addition, anyone who experiences neurological symptoms including severe or persistent headache or blurred vision after vaccination or bruising (petechiae) in a different site than the vaccination site after a few days.

EMA updates

Due to the slight increase in thrombotic episodes observed in young women (under 55) and not seen in the older population, the EMA has not ruled out (nor established) a link between these cases and the vaccine and therefore studies on these forms of thrombosis are continuing. EMA says it will post an update on the vaccine at the next meeting of its safety committee, to be held from 6 to 9 April, meeting that will help clarify the frequency with which the reported adverse effect occurs e whether the risk may vary based on age or gender.

In Germany recommended under 60

For the same reason, on Tuesday the Vaccine Commission in Germany, Stiko, decided to recommend vaccination with AstraZeneca only for people over 60. The Anglo-Swedish company’s vaccine can always be given to younger patients at the discretion of their doctor. Germany is now investigating 31 cases of rare blood clots in the brain, 9 of which resulted in death in people who received the vaccine (the numbers have just been updated). Earlier this month, after about 1.6 million AstraZeneca vaccinations and 7 cases of rare thrombosis reported, the Institute’s experts Paul Ehrlich they said that normally about 1 case would be expected in that time window in that number of people. So far, most of the cases have been observed in women under 65, but this could be due to the vaccinated population: many countries initially used AstraZeneca only in people under 65. This meant that the vaccine was used in priority groups such as health professionals and teachers, the majority of whom were women.

How do they explain

Pending coordinated decisions by the German federal states after the suspension of some, comes a study by a group led by the German coagulation specialist Andreas Greinacher of the University of Greifswald, who may have found a explanation for the rare forms of thrombosis and, above all, a way to prevent and deal with them.

Similarities to a side effect of heparin

German research teams looked at some reports and found that this rare and very unusual combination of symptoms – widespread blood clots and, at the same time, a low platelet count, sometimes with bleeding – looks like a rare side effect of the blood thinner heparin, called heparin-induced thrombocytopenia (HIT). Identifying similarities and course can help prevent and, if so, treat the manifestations of adverse reactions. We know what to do: how to diagnose it and how to treat it, said Greinacher, speaking of the disorder he called vaccine-induced prothrombotic immune thrombocytopenia syndrome (VIPIT). Even if it is just a hypothesis, the professor’s study (not yet published, nor reviewed), is taken seriously. Two German medical societies have released press releases praising him for solving the dilemma. In the Netherlands, the Dutch Internal Medicine Society urged internists to study recommended intervention guidelines in research.

The common mechanism

The better known heparin induced thrombocytopenia (HIT) can occur precisely in patients who have been given heparin as a drug. For reasons that are not understood, some people produce antibodies against the binding that the drug triggers with a protein called platelet factor 4 (PF4) which, in turn, triggers a out of control clotting reaction. Greinacher and the other scientists thought that something similar could have happened in the case of the rare thrombosis, but without the heparin. Greinacher received blood samples from 9 vaccinated patients who had had thrombosis problems for the study – all of them had both low platelets and unusual clotting. In four samples, the researchers found evidence of antibodies against PF4, a hallmark of HIT. Despite these observations, the link between vaccine and eventual HIT not proven, nor is it explained how the vaccine could favor its onset, but Greinacher says it is crucial notify doctors the potential complication.

How to deal with the problem

When recognized in time, in fact, theHIT can be treated with immunoglobulins which help to curb platelet activation. Blood thinners (without heparin) can help dissolve clots. Rare thrombosis VIPIT should be treated in a similar way, says the specialist. In at least one case, Greinacher says on Sciencemag, a doctor asked his team for advice and the patient recovered. The German Society for the Study of Thrombosis and Hemostasis, of which Greinacher a member, has meanwhile published a series of recommendations for diagnosis and treatment of VIPIT.

March 30, 2021 (change March 30, 2021 | 18:15)

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