Science and Technology

Covid-19 vaccine safe; based on scientific evidence, says AstraZeneca

Our Bureau Bengaluru | Updated on March 15, 2021

Says, review of available safety data of over 17 mn people vaccinated in the EU, and UK with the Covid-19 vaccine has shown no evidence of increased risk of pulmonary embolism, DVT or thrombocytopenia

Astra Zeneca has said that its Covid-19 vaccine is safe and is based on clear scientific evidence.

In a press statement on Monday, AstraZeneca said a careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and the UK with the Covid-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the company has received as of March 8. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for Covid-19, the statement.

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.

Ann Taylor, Chief Medical Officer, said: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety," she said in the statement.

In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests has shown cause for concern. During the production of the vaccine, more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

The statement said the safety of the public will always come first. The company is keeping this issue under close review but the available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people get vaccinated when invited to do so.

Published on March 15, 2021

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