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Benefits of AstraZeneca COVID-19 vaccine outweigh risks of side effects: EMA

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Agency’s safety committee continues investigation of  blood clots associated with the vaccine, to meet on March 18 to decide further action

As several authorities responsible for national vaccine campaigns in EU countries temporarily paused vaccination with AstraZeneca’s COVID-19 vaccine, the EMA continues to investigate a number of events of blood clots in people who had received the vaccine.

A version of AstraZeneca’s COVID-19 vaccine, Covishield, made under licence by Serum Institute of India, is one of the two vaccines authorised for use as part of India’s national COVID-19 vaccination campaign

While its investigation is ongoing, an update from the EMA states that it currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

The update notes that events involving blood clots, some with unusual features such as low numbers of platelets, have occurred in a very small number of people who received the vaccine. Many thousands of people develop blood clots annually in the EU for different reasons. The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.

EMA is reporetdly working closely with the company, with experts in blood disorders, and with other health authorities including the UK’s MHRA based on its experience with around 11 million administered doses of the vaccine.

EMA’s investigation continued over the weekend, noted the updated, and rigorous analysis of all the data related to thromboembolic events will be carried out in the coming days. Experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the vaccine might have contributed or if the event is likely to have been due to other causes.

EMA’s safety committee (PRAC) is to further review the information on March 16 and has called an extraordinary meeting on Thursday March 18 to conclude on the information gathered and any further actions that may need to be taken.

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