Other safety alerts
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| European Union: EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events: further update |
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European Medicines Agency (EMA) announces that several authorities responsible for national vaccine campaigns in European Union countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. This is a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine, as previously reported.
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 European Union 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 working closely with the company, with experts in blood disorders, and with other health authorities including the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) based on its experience with around 11 million administered doses of the vaccine.
EMA’s investigation has been continuing over the weekend, 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 Pharmacovigilance Risk Assessment Committee (PRAC) will further review the information on 16 Mar 2021 and has called an extraordinary meeting on 18 Mar 2021 to conclude on the information gathered and any further actions that may need to be taken.
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.
EMA will continue to communicate further as appropriate. In the meantime, anyone who has received the vaccine and has any concerns should contact an appropriate healthcare professional. It is important that people who suspect they may have a side effect after vaccination report this to the national medicines regulator, or to a healthcare professional who can help them do so.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/emas-safety-committee-continues-investigation-covid-19-vaccine-astrazeneca-thromboembolic-events
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 15 Mar 2021.
Ends/Tuesday, Mar 16, 2021
Issued at HKT 16:00
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