Ema will speak on Thursday 18 on AstraZeneca

by time news

Time.news – The last word on AstraZeneca is expected for Thursday 18 March when the EMA Committee for Safety (Prac) will meet in an extraordinary frantic race against time to analyze the largest amount of data and give an opinion on thrombosis cases reported as possible side effects of vaccination.

“Several authorities responsible for national vaccination campaigns in EU countries have temporarily suspended vaccination with the Covid-19 AstraZeneca vaccine. it is a precaution taken in the light of their national situation while Ema investigates a series of blood clot events in people who had received the vaccine, as previously reported, “the European Medicines Agency explained.

“Events involving blood clots, some with unusual characteristics such as low platelet counts, have occurred in a very limited number of people who have received the vaccine. Many thousands of people develop blood clots each year in the EU for several reasons. The number of overall thromboembolic events in vaccinated people does not appear to be higher than that observed in the general population“, he stressed.

EMA is working “closely with the company, with experts in blood diseases and with other health authorities, including the UK MHRA,” based on his experience with approximately 11 million administered doses of the vaccine“. The EMA investigation” continued over the weekend and a rigorous analysis of all data relating to thromboembolic events will be conducted in the coming days. Experts are examining in detail all available data and clinical circumstances affecting specific cases to determine if the vaccine may have contributed or if it is likely that the event was due to other causes. “

The EMA Safety Committee (Prac) will further review the information on Wednesday and has called an extraordinary meeting on Thursday 18 March to conclude the information collected and any further action that may be necessary. The review of thromboembolic events with the AstraZeneca vaccine is underway in the context of a safety report, with an accelerated timetable.

The safety report is information about a new or not fully documented adverse event which is potentially caused by a medicine and which requires further investigation. The review is being conducted by the Pharmacovigilance Risk Assessment Committee (Prac), the committee responsible for the evaluation of safety issues for human medicines. Once the review is complete, the PRAC will make all the necessary recommendations to minimize the risks and protect the health of patients.

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