EMA Finds “Possible Links” Between Very Rare Cases of Thrombi and AstraZeneca Vaccine | Society

In video, the director of the European Medicines Agency (EMA) announced at a press conference this Wednesday that they have found “possible links” between cases of thrombi in vaccinated with AstraZeneca.(EBS)

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“The risk of mortality from covid-19 is much higher than mortality from these very rare side effects,” Cooke said at a press conference from Amsterdam. The message from the EMA is clear: there is a link between the thrombi detected and the administration of the vaccine by the Anglo-Swedish pharmaceutical company, but these are very rare cases and the benefits of the vaccine continue to prevail. “Covid-19 is a very serious disease, and the vaccine is effective in preventing illness, hospitalization, and mortality. As a whole, the benefit outweighs the risk, ”said Sabine Straus, head of the EMA Safety Committee. The decision was made after having also studied the reports of independent experts.

The EMA has explained that for now there is no specific treatment for these side effects. The countries will have to decide how to apply the conclusions of that report, especially after the alarm that may have been generated by the communication missteps of the countries and of the EMA itself. The Netherlands and Germany have so far decided to use this vaccine only with people over 60 years of age. According to the community agency, most of the cases they have analyzed correspond to women under the age of 60, who have suffered a clot in the two weeks after being vaccinated. However, Community experts consider that no general conclusions can be drawn from this circumstance. In fact, Straus has explained that since there are important differences between countries in how the vaccine is being used, with greater administration to younger women, it cannot be concluded that this population group is at higher risk.

The European agency began to investigate cases of thrombi among citizens who received the vaccine – very rare – which in the middle of last month led to a halt in immunization with that drug in 16 countries of the European Union, including Spain. In your first evaluations, the EMA already concluded that the vaccine was “safe and effective” and stressed that the benefits it brought to society far outweighed the risks. The drug has been shown to be 100% effective in severe cases of COVID-19 and, unlike the Pfizer-BioNTech and Moderna vaccines, it can be stored in normal refrigerators.

This first evaluation allowed the majority of community partners to reactivate their vaccination processes with AstraZeneca, including Spain. The EMA, however, did not rule out the link with thromboembolic events, but warned that further investigation was needed. In the cases detected by the health authorities, the Netherlands and Germany decided to use the drug only in people over 60 years of age. In Spain, its use, initially only approved until 55 years of age, was extended to those under 65 years of age. The EU presidency, which Portugal occupies this semester, has convened a Council of Health Ministers for this afternoon with the aim of adopting a joint decision for the 27 EU countries.

The EMA has been investigating 86 cases of these strange thrombi, of which 62 are cerebral and 24 abdominal. Of these, 18 were deceased, according to a statement distributed by the European agency. The EMA has been insisting that these are rare episodes, since more than nine million injections have already been administered in the EU. However, the statements of two agency executives in Italian media this week about this relationship of the vaccine with thrombi has generated even more confusion, so that even regions such as Castilla y León decided to suspend again on a precautionary basis, despite causing discomfort in the central government, his employment until the opinion of the European agency.

EMA’s head of vaccination strategy, Marco Cavalieri, stated in the Italian newspaper The Messenger that, in his opinion, the links between the vaccine and the cases of blood clotting were “clear”. “In my opinion, we can say, there is clearly an association with the vaccine. However, we still don’t know what causes this reaction. These platelet-deficient brain thromboses appear to be the main event to investigate. In short: in the next few hours we will say that there is a connection, but we still have to understand how it happens, “he said. In a different interview in The printArmando Genazzani, another EMA executive, stated that this link was “plausible.”

The statements of both directors occurred just the day in which the EMA’s Pharmacovigilance Risk Assessment Committee met to provide an “updated recommendation” after having analyzed all rare episodes of thrombosis and having studied the works developed by experts independent. That is, both managers came to advance the conclusions of a meeting that lasts all week. The agency warned that a decision had not yet been made, but had to set an appearance for this Wednesday afternoon to explain the test results.

AstraZeneca’s vaccine was the third to be released on the market by the EMA and the European Commission. Before, those of Pfizer-BioNTech and Moderna had done it, and then that of Janssen. The drug’s journey in the EU has been plagued by controversies, setbacks and run-ins, after the Anglo-Swedish firm has continuously lowered its delivery forecasts and disrupted the first-quarter vaccination schedule. To top it off, the drug has been questioned due to thrombi or the lack of data on its efficacy in people over 65 years of age. The EMA, however, has been clearing these doubts: in the middle of the third wave of infections in the EU, this vaccine has been effective in reducing infections, income and deaths.

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