182. As per FOI 2986, in January 2021 the TGA recruited a new lead to run the Pharmacovigilance “vaccine safety” system – Michael Nissen. Michael Nissen spent 8 prior years working for GSK (whose healthcare division merged with Pfizer in 2019). How can the TGA claim there are no conflicts of interest when it own staff are long term Big Pharma employees? 220. The serious injury rate of vaccines is 1 in a 1000 people which is much higher than serious rate of injury from omicron – why hasn’t the TGA pulled the vaccine? 226. Isn’t there an inherent conflict of interest between the TGA approving drugs and then reviewing vaccine injuries from those drugs that is has previously claimed as safe? 247. Given the AZ and Pfizer shot are expected to do the same thing then how can the TGA claim they don’t have similar side effects?

Question Number: 226
PDR Number: SQ22-000596
Date Submitted: 21/11/2022
Department or Body: Department of Health

182 The Therapeutic Goods Administration (TGA) has robust policies and procedures for managing conflicts of interest. This applies to both staff and expert committee appointments. All procedures were followed during and after the appointment of Michael Nissen. Dr Nissen is no longer an employee of the Department of Health and Aged Care, but this has no relationship to assertions of conflict of interest made by the Senator. 220 It is not clear what evidence the question is referring to and no reference is provided for the figure quoted. The rate of serious adverse events is very significantly lower than 1 in a 1000 for each of the COVID-19 vaccines. Current evidence both within Australia and world-wide confirms that at a population level, the benefits of COVID-19 vaccination remain greater than the potential side effects from each TGA-approved vaccine. 226 This question has been answered previously – refer to SQ22-000154. 247 There are different types of COVID-19 vaccines approved for use in Australia and each type of vaccine can have different side effects. The AstraZeneca COVID-19 vaccine is called a viral vector vaccine and the Pfizer COVID-19 vaccine is called an mRNA vaccine. These vaccines work in different ways at a cellular level to offer protection against COVID-19, and because of their different cellular mechanisms it is not unexpected that their serious adverse events, although rare, differ in nature.