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LATEST TGA SURVEILLANCE REPORT - 13.06.2021


 

TTS - Time to onset, treatment, and outcomes for TTS cases

The TGA’s adjudication committee, which met to review these cases on 16 June 2021, confirmed that 7 of the 12 new cases this week were in individuals aged 50–59 years old.

 

Capillary leak syndrome

The TGA continues to monitor for this following vaccination. A causal link between capillary leak syndrome and the vaccine has not been established


The TGA has received one case of a patient who died from multi-organ failure but had signs of capillary leakage. Although there was a temporal link with the vaccine, an expert vaccine safety investigation group was unable to establish a causal link as other causes could not be ruled out.


 

Immune thrombocytopenic purpura

 

Myocarditis and pericarditis

Since the beginning of the vaccine rollout in Australia (to 13 June 2021), the TGA has received 1 report of myocarditis and 14 reports of pericarditis following immunisation with the Comirnaty vaccine.


Approximately two million doses of the vaccine have been given during this time. Three cases were in men (aged 18, 23 and 72 years) and 11 were in women (aged 26-44 years). There is no indication at present that these cases are due to the vaccine but the TGA is continuing to monitor this issue and is collaborating with international medicine regulators.

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Link to TGA report:

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