124. How many teams of many dozens of people working many long hours over many months, were funded, the number of EFT, and cost centre reports accounting for these items and how or by whom were these resources paid by?

Question Number: 121
PDR Number: SQ22-000132
Date Submitted: 24/02/2022
Department or Body: Department of Health

Since the beginning of the COVID-19 pandemic it is estimated that there have been approximately 99.5 Therapeutic Goods Administration (TGA) Full Time Equivalent (FTE) staff across multiple Branches involved in the pre-market evaluation of applications for COVID-19 vaccines (including laboratory assessment), post-market laboratory batch release testing, and post-market COVID-19 vaccine safety monitoring (pharmacovigilance). This is broken down as follows:

• Prescription Medicines Authorisation Branch – 18
• Scientific Evaluation Branch – 3
• Pharmacovigilance Branch – 53
• Laboratories Branch – 24
• Executive – 1.5

Based on the average staff member salary for medical officers, scientific and support staff and executives at a grossed up cost of $200,000 per annum, this equates to $19.9 million investment in regulation of COVID-19 vaccines – note this does not include work on COVID-19 treatments, PPE, ventilators, diagnostic tests, hand sanitiser or COVID-19 related education, communication and compliance, which in total would significantly exceed this sum. It also does not include costs for international recognition of vaccines or medical review of vaccine compensation claims.

Of the $19.9 million, about 30 per cent ($6.06m) was funded through government appropriations (see Appendix) while the remaining 70 per cent ($13.84m) was funded through TGA industry fees and charges.

Appendix: COVID-19 vaccination delivery package (government appropriation)

For 2020-21, this package included $1.33m to fund 7.6 resources

For 2021-22, this package included $3.01m to fund 18.5 resources

For 2022-23 this package includes $1.72m to fund 10.84 resources (July to December 2022).

The resourcing is used to contribute to the costs of:

• Laboratory batch testing of COVID-19 vaccines and,

• Implementation of enhancements to the Pharmacovigilance system to support the COVID -19 vaccine rollout, including:

o enhanced reporting of adverse events following vaccination
o enhanced safety signal detection and investigation
o regulatory and programmatic responsiveness
o safety communications; and
o international collaborations on safety surveillance and vaccine confidence.