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QUESTION ON NOTICE

Question:

21 November 2022

166. The AusVax safety data showed over 5 million people reported side effects 3 days after taking the Covid-19 vaccine and around 1 in 100 had to see a doctor or go to emergency just 3 days after taking a vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high? 167. The AusVax safety data says 8% reported missing work, study or routine duties after dose 1 of the Covid vaccine, 21% after dose 2 of the Covid vaccine and 15% after dose 3 of the Covid vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high?

Answer:

Question Number: 182
PDR Number: SQ22-000552
Date Submitted: 21/11/2022
Department or Body: Department of Health

The safety of the Australian population has always been the Australian Government’s highest priority. For this reason, decisions regarding COVID-19 vaccines have been, and continue to be, based on the expert medical advice of the Australian Technical Advisory Group on Immunisation (ATAGI) and the Therapeutic Goods Administration (TGA). Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks. Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills. This reflects what was seen in the clinical trials. The most recent TGA COVID-19 vaccine safety report shows an adverse event reporting rate of 2.1 per 1,000 COVID-19 vaccine doses as at 13 November 2022. The TGA collaborates closely with national stakeholders on COVID-19 vaccine safety activities and issues, including the ATAGI, the National Centre for Immunisation Research and Surveillance (NCIRS), the Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) and the Adverse Events Following Immunisation – Clinical Assessment Network (AEFI-CAN).

AusVaxSafety is a national collaborative vaccine safety surveillance system led by the National Centre for Immunisation Research and Surveillance (NCIRS) and funded by the Australian Government Department of Health and Aged Care. AusVaxSafety expands on and enhances the TGA’s established AEFI surveillance system to monitor the safety of vaccines through four components:
• active surveillance
• clinical assessment network
• adverse events of special interest follow up, and
• population-based safety investigation using linked data.

Adverse events reported to the TGA and AusVaxSafety may not be caused by the vaccine. Adverse events are suspected by the reporter of possibly being related to the vaccine, but this relationship is usually not certain – the event may be coincidental.

Safety reports from the TGA and AusVaxSafety are available at:
• TGA: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports
• AusVaxSafety: www.ncirs.org.au/ncirs-covid-19-response/covid-19-vaccine-safetymonitoring-ausvaxsafety.

Question 166 The AusVaxSafety report outlines that those who presented to General Practitioners (GPs) and emergency departments had similar adverse events to those who didn’t. AusVaxSafety does not specifically ask participants the reason why they accessed medical care in the days following vaccination, therefore medical attendance reported may or may not be related to any adverse events reported.

Question 167 The AusVaxSafety report outlines most participants who reported not being able to perform routine duties experienced lethargy, headache and joint pain. These are common adverse events linked to the immune response following immunisation, and understandably some people have chosen to rest after vaccination. The majority of participants who reported any impact on routine activities missed one day or less.