Other safety alerts
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| Australia: AstraZeneca ChAdOx1-S COVID-19 vaccine: Update |
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Therapeutic Goods Administration (TGA) is aware that some additional European countries have paused vaccination with the AstraZeneca ChAdOx1-S COVID-19 vaccine in response to reports of blood clots in vaccinated individuals.
European Medicines Agency (EMA) continues to investigate the issue and EMA 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 EMA's safety (Pharmacovigilance Risk Assessment) committee will meet on 18 Mar 2021 to determine the outcome of its investigation. TGA continues to be in close and frequent communication with EMA regarding its review, and continues to liaise with international counterparts through the International Coalition of Medicines Regulatory Authorities (ICMRA).
The United Kingdom regulator, Medicines and Healthcare products Regulatory Agency (MHRA) has also released an updated statement: 'It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so'.
To 15 Mar 2021, TGA has not received any reports of blood clots following administration of the AstraZeneca COVID-19 vaccine in Australia. AstraZeneca has submitted to TGA a detailed summary of adverse events reported globally related to blood clots to 8 Mar, as part of the sponsor's routine safety reporting obligations. TGA does not have any evidence of a biologically plausible relationship that could suggest a cause and effect relationship between vaccination and blood clots.
Blood clots are considered 'adverse events of special interest', which are closely monitored in Australia and by overseas regulators. TGA and other regulators conduct analyses to compare the number of reports of these events against the expected rate of events in the population in the absence of vaccination.
Venous thromboembolism (VTE), including deep vein thrombosis (a blood clot in a vein deep below the skin) and pulmonary embolism (a blood clot blocking a blood vessel in the lungs), is the third most common cardiovascular disease globally, with an annual incidence of over 10 million people. In Australia, at least 17,000 people develop VTE each year. This equates to an average 50 people per day, so unfortunately a significant number of people develop this medical condition. The 2019 Australian guidelines for the diagnosis and management of venous thromboembolism stress that the condition is common, with Australians having an 8% (almost one in 12) risk of developing VTE at some state in their lifetime.
As of this time there is no indication of an increased rate of blood clots happening or cause and effect with the AstraZeneca vaccine in Australia.
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 15 Mar 2021.
Ends/Tuesday, Mar 16, 2021
Issued at HKT 16:00
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