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March 14, 2021

"So far in the EU and the UK, 15 Tvp events (deep vein thrombosis) and 22 pulmonary embolism events have been reported among those given the vaccine, based on the number of cases the company has received at all. 'March 8. This is much lower than would be expected to occur naturally in a general population of this size and is similar for other licensed Covid-19 vaccines. The monthly safety report will be made public on the Agency's website. European Union for medicines in the following week, in line with the exceptional transparency measures for Covid ".

Thus, in a note, AstraZeneca, on the basis of concern, after some cases of "serious adverse events" found in some patients in temporal concomitance with the administration of its vaccine.

"In clinical trials - continues the company - even though the number of thrombotic events was small, these were lower in the vaccinated group. There was no evidence of an increase in bleeding in the over 60,000 enrolled participants".

From analysis of over 17 million people no increase in thrombosis


"A careful review of all available safety data of over 17 million people vaccinated in the European Union and the UK with the Covid-19 AstraZeneca vaccine showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any age group, sex, batch or country. "

"About 17 million people in the EU and the UK have received our vaccine and the number of reported blood clot cases in this group is fewer than the hundreds of cases that would be expected among the general population. The nature of the pandemic. has led to increased focus on individual cases and we are moving beyond standard practices for monitoring the safety of licensed medicines in reporting vaccination events to ensure public safety, "explains Ann Taylor, Chief Medical Officer US AstraZeneca, in relation to the recent concern about possible adverse events encountered in some patients after the administration of the anti-Covid vaccine.

The multinational also points out that "the safety of the public will always come first. The company is closely monitoring this problem, but the available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people come vaccinate when invited to do so ".

No quality problems in batches Europe


"In terms of quality there are no confirmed problems with any batch of our vaccine used in Europe or the rest of the world. Further tests have been and are being conducted by ourselves and independently by the European health authorities and none of these new tests have shown cause for concern, "continues the AstraZeneca note.

"More than 60 quality tests are conducted during vaccine production by AstraZeneca, its partners and more than 20 independent testing laboratories. - explains the company - All tests must meet strict quality control criteria and these data is sent to regulators within each country or region for independent review before any batches can be released into the countries. "