European Medicines Agency (EMA) announces that EMA’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) made further progress on 16 Mar 2021 in its detailed evaluation of cases of blood clots, some with unusual features such as low numbers of platelets, in recipients of COVID-19 Vaccine AstraZeneca. As previously stated, while its investigation is ongoing, EMA 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 evaluation is looking at the available data related to all thromboembolic events reported after vaccination. National agencies are providing additional support to gather missing and incomplete information as quickly as possible, particularly where it relates to these unusual cases. Rapid and thorough analysis of the available data and clinical circumstances surrounding specific cases is continuing, to determine whether the vaccine might have contributed or if events are likely to have been due to other causes.
PRAC will conclude on the information available at its meeting on 18 Mar 2021, and issue any necessary recommendations for further action.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/investigation-covid-19-vaccine-astrazeneca-thromboembolic-events-continues
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 11 Mar 2021, with the latest update posted on 16 Mar 2021.
Ends/Wednesday, Mar 17, 2021
Issued at HKT 17:00
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