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Medical officers at the TGA continue to investigate suspected cases of TTS (Thrombosis with thrombocytopenia syndrome ) and share information with other medicines regulators. As previously reported, the TGA determines whether a report is likely to represent TTS by assessing cases against a consistent set of criteria, based on the case definitions established by the UK’s Medicines and Healthcare products Regulatory Agency.
Since last week’s report, a further six reports of blood clots and low blood platelets have been assessed as confirmed TTS likely to be linked to the AstraZeneca vaccine. These cases were in two women from NSW (a 60-year-old and an 82-year-old), a 72-year-old male from WA, a 51-year-old woman from WA, a 73-year-old woman from Victoria and a 63-year-old man from Queensland.
In addition, there were three cases classified as probable this week. These cases were in an 85-year-old woman from NSW, a 62-year-old man from Victoria and a 76-year-old woman from Victoria.
This takes the total Australian reports of cases assessed as TTS following the AstraZeneca vaccine to 27 confirmed cases and six probable cases.
We have information about all but two cases at this stage:
- 17 have been discharged from hospital and are recovering
- four have left hospital but require outpatient medical care
- nine patients remain in hospital.
As previously reported, one case in a 48-year-old woman from NSW was unfortunately fatal.
Updated reporting rates of TTS in Australia have been published in the latest statement from ATAGI. These reporting rates remain consistent with what is being seen internationally, including in Europe, the UK, the Middle East and Canada. It is important to highlight that due to better awareness, early diagnosis and appropriate treatment, the outcome and prognosis of the majority of those who have experienced this syndrome is good.
Up-to-date information about the expected side effects of the AstraZeneca COVID-19 vaccine can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).
Comirnaty (Pfizer) vaccine
Side effects to the Comirnaty vaccine continue to be reported to the TGA and are consistent with what has been observed internationally.
Myocarditis and pericarditis
The TGA continues to investigate a small number of Australian cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) following vaccination with Comirnaty. There is no indication at the moment that these cases are due to the vaccine but the TGA is collaborating with international medicine regulators on this issue.
Up-to-date information about Pfizer Comirnaty can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).
SOURCE : https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-27-05-2021
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