The European Medicines Agency reaffirms that AstraZeneca "is not associated" with an increased risk of thrombosis: what has the EMA decided and what will happen now

After a very intense week of decisions, controversies and stoppages, all of Europe looked at the European Medicines Agency (EMA) and the recommendations of its safety committee to resume immunizations or begin to rebuild vaccination plans for the middle of the continent.

Finally, after gathering all possible data and mobilizing numerous experts in hematology and thrombosis, the EMA has reaffirmed its support for AstraZeneca. In the words of Emer Cooke, the director of the Agency, “AstraZeneca is safe and effective and after reviewing all the available evidence, our conclusion is robust: it is not related to an increase in cases of thrombosis “.

Even so, the Agency recognizes what reported cases are serious and will continue to monitor and investigate these possible adverse effects. However, they remain “convinced that the benefits of this vaccine outweigh the risks” and, as a consequence, it is recommended to resume vaccinations.

AstraZeneca shutdown, explained

In recent weeks, several national pharmacovigilance systems detected some cases of venous sinus thrombosis that coincided in time with the administration of the vaccine by AstraZeneca. As David García Azorín explained, member of the Spanish Society of Neurology, “venous thromboses were a bit rare, they did not correspond to those usually seen in the general population.” These were more serious than usual cases.

However, as this type of thrombosis also occurs in the general population (two cases per 100,000 people per year), the countries that detected them decided to start an investigation, report to the European Medicines Agency (EMA) and preventively paralyze only the batch that could be related. After all, neither clinical trials nor the British pharmacovigilance system had detected any such problem.

On Wednesday, March 10, the EMA issued a statement in which he explained that, although they were investigating the possible relationship, the data they had so far did not seem to indicate that such a connection existed, nor that the risk / benefit balance of the vaccine was altered. And, shortly after, both World Health Organization as the International Society of Thrombosis and Hematosis recommended to continue using AstraZeneca injectable.

However, on March 11 Denmark announced that it was temporarily halting vaccinations with AstraZeneca and triggered a chain reaction in the rest of the European Union countries what ended the stoppage of the vaccine in Spain this same monday.

Parallel to the decisions of each of the countries and the possible political ramifications, EMA technicians collected information facing the position taking you just took. Spain, for its part, has already announced that it will follow these recommendations of the Agency and, after today’s decision, everything seems to indicate the vaccinations will resume soon.

Picture | GenCat

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The European Medicines Agency reaffirms that AstraZeneca is “not associated” with an increased risk of thrombosis: what has the EMA decided and what will happen now

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Engadget

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Javier Jimenez

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