AUSTRALIA TGA SAFETY SURVEILLANCE - 19.08.2021

AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION

WEEKLY SURVEILLANCE REPORT

19.08.2021

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Adverse event reports: 50,597 Doses administered: 15,341,039

1 adverse event report submitted for every 303 doses administered

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View TGA Safety Surveillance report

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TTS (Clots with low platelets)

112 cases (1 / 50,000 initial doses)

6 fatalities (6% case fatal)

Current Status of TTS cases

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Myocarditis / Pericarditis

DAEN: 208 cases (1 / 37,583 doses)

TGA: 188 cases

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Facial swelling in people who have had dermal filler injections

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THROMBOSIS CASES

As reported in the Database of Adverse Event Notifications (DAEN)

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Guillain-Barre Syndrome

82 cases (1 / 86,000 doses)

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Immune Thrombocytopenia Purpura (ITP)

47 cases (1 / 150,000 doses)

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DATABASE OF ADVERSE EVENT NOTIFICATIONS MOVED TO 14 DAYS

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MODERNA 'SPIKEVAX' APPROVED BY THE TGA

CLICK HERE to access the Australian Public Assessment Report

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WANT MORE INFORMATION ON THE PFIZER COVID-19 VACCINES APPROVALS IN AUSTRALIA?

https://www.tga.gov.au/foi-disclosure-log