Adverse event of special interest (AESI) long-term follow-up program

As part of the AESI long term follow-up program, AusVaxSafety is actively engaging with individuals diagnosed with thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination in Australia through follow-up interviews and surveys to assess their physical and psychological health over a 12-month period to better understand the long-term health impact of TTS.

What is thrombosis with thrombocytopenia syndrome?

Thrombosis with thrombocytopenia syndrome (TTS) is a new, very rare condition that has been found to be causally associated with the AstraZeneca COVID-19 vaccine.

TTS involves blood clots (thrombosis) in body places such as the brain and abdomen, which prevents blood flowing normally through the body. TTS also leads to low levels of blood-clotting cells called platelets (thrombocytopenia) that help the blood to clot and stop excessive bleeding. Because the blood cannot form clots, low platelets can lead to bleeding problems.

What are we doing? 

As TTS is a relatively new condition, research is being conducted around the world to better understand all aspects of this syndrome. The AusVaxSafety long-term follow-up program will help us gain a greater understanding of the characteristics, progress and clinical outcomes of TTS by actively engaging with individuals in Australia affected by this syndrome over a 12-month period following diagnosis.

The collection and analysis of clinical data from individuals affected by TTS will provide important information for clinicians treating TTS and may inform future vaccination policies in Australia.

How are we doing this?

Individuals affected by TTS who meet the eligibility criteria will be invited to participate in this AusVaxSafety follow-up program. Those who agree to participate in the program will be contacted and sent surveys at different time points over a 12-month period. These survey would ask questions around general health, relevant follow-up tests and psychological health. With permission, the treating specialists of participants will also provide additional information regarding their care and progress. 

Data collected from participants will be de-identified and analysed by clinical specialists and epidemiologists and results, highlighting key findings and recommendations for the future, will be published.

Who can take part?

Any individual, aged 18 years and older, who has been classified as confirmed or probable case of TTS by the Therapeutic Goods Administration (TGA) is eligible to participate in the TTS study arm.

Eligible individuals will be identified and contacted by a nurse or doctor from state/territory health departments.  

Participation in the TTS study arm is voluntary and all individuals affected by TTS will receive the best possible care whether they participate or not.

Where is it up to?

AusVaxSafety is currently recruiting participants for the TTS study arm.

For more information, please contact AusVaxSafety at SCHN-AusVaxSafety@health.nsw.gov.au 

Last updated August 2022
Adverse event of special interest (AESI) long-term follow-up program