其 他 安 全 警 示
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| Australia: AstraZeneca ChAdOx1-S COVID-19 vaccine: Update: European and UK reviews find no proven link with blood clots (English only) |
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Therapeutic Goods Administration (TGA) announces that The European Medicines Agency (EMA) and the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) have completed preliminary reviews of the risk of blood clots in people vaccinated with the AstraZeneca COVID-19 vaccine. These reviews have found the benefits of the vaccine continue to outweigh the risks, and the vaccine is not associated with an increase in the overall risk of blood clots.
The TGA attended the EMA's safety committee meeting on 18 Mar 2021, which found the number of blood clotting cases reported after vaccination, both in the large clinical trials undertaken prior to vaccine authorisation and during rollout of vaccination programs across the world, was lower than that expected in the general population. Around 20 million people in Europe, and several million more in other parts of the world, have received the vaccine.
The EMA safety committee noted there had been a very small number of cases of a rare type of blood clotting disease (disseminated intravascular coagulation) associated with low levels of blood platelets (blood cells that normally help blood to clot), with or without bleeding, as well as extremely rare cases of clots in the vessels draining blood from the brain (cerebral venous sinus thrombosis, CVST). It has not been proven that these cases were caused by the vaccine and a plausible mechanism for how they could have been caused by the vaccine has not been established. These conditions are also sometimes seen in people who have not received a COVID-19 vaccine or other vaccine. The EMA safety committee also noted that COVID-19 disease itself is often associated with serious clotting problems, which can themselves be fatal. Additionally, the EMA found there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
The MHRA has also published a statement with its own separate review of reported cases and data from hospital admissions and general practitioner (GP) records. They found that all the available evidence did not suggest common blood clots in veins were caused by the vaccine. The MHRA is undertaking a detailed review of the five cases of CVST with low blood platelets that occurred in the UK, and also notes that these events can occur naturally. The MHRA is advising that people in the UK should continue to get the AstraZeneca COVID-19 vaccine when invited to do so.
The relevant expert clinical society, the International Society on Thrombosis and Haemostasis also recommends that all eligible adults continue to receive COVID-19 vaccinations, with the benefits of vaccination strongly outweighing any potential complications even for patients with a history of blood clots or for those taking blood thinning medications.
To 18 Mar 2021, the TGA has not received any reports of blood clots following administration of the AstraZeneca COVID-19 vaccine in Australia. The TGA advises that people in Australia should continue to get the AstraZeneca vaccine when eligible.
The TGA continues to closely monitor the safety of the AstraZeneca COVID-19 vaccine and will work with AstraZeneca to update Product Information as required. If the TGA detects a safety concern, it will take rapid action to address it and promptly provide information to the public.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine
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 17 Mar 2021.
Ends/Friday, Mar 19, 2021
Issued at HKT 16:00
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