EMA Finds "Possible Links" Between Very Rare Cases of Thrombi and AstraZeneca's Vaccine

The European Medicines Agency (EMA) concluded this Wednesday that blood clots should be listed as "very rare side effects" of the AstraZeneca vaccine.

This has been considered by the Pharmacovigilance Risk Assessment Committee (PRAC), meeting since Tuesday to evaluate 86 cases of thrombosis that have been transferred so far by national authorities, the majority in women under 60 years of age.

The EMA, which has not confirmed risk factors by age or gender, continues to consider that the benefits continue to outweigh the risks.

"The vaccine is highly effective in saving lives and vaccination is extremely important," said EMA Executive Director Emer Cooke.

After preparing the report, it is up to the countries to decide to whom to administer the vaccine.

The 27 Ministers of Health will meet by videoconference at 6:00 p.m. to agree on the measures that should be derived from that opinion.

The Countries and Germany until now had decided to use this vaccine only with people over 60 years of age.

"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 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 European Union countries, including Spain.

In its first evaluations, the EMA already concluded that the vaccine was "safe and effective" and highlighted 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.

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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 to thromboembolic events, but cautioned that it needed further investigation.

Given 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 over 65 years of age.

Last week, Cooke reiterated that "further testing" was underway to determine that link.

The EMA has been investigating 86 cases of these rare thrombi.

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 directors of the agency in Italian media this week about the relationship of the vaccine with thrombi has generated even more confusion, so that even regions such as Castilla y León decided to once again suspend their use in a precautionary way. until knowing the opinion of the European agency.

EMA's head of vaccination strategy, Marco Cavalieri, said in the Italian newspaper

that, in his opinion, the link between the vaccine and cases of blood clotting was "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

, Armando 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 taken, but had to set an appearance for this Wednesday afternoon to explain the results of the analyzes.

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 been continuously lowering its delivery forecasts and derailing 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.