257. The TGA report on the Pfizer vaccine said, “The duration of protection afforded by COMIRNATY is unknown as it is still being determined by ongoing clinical trials.” – why did the TGA say it was safe and effective if you didn’t know how effective it was going to be. See 2389-2 page 6? 258. As per Page 7 of FOI 2389-2 – given the high mortality rate in the older age group don’t you think the Covid Pfizer vaccine rollout should be stopped? To quote “The data for use in the frail elderly (>85 years) is limited. The potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis”

Question Number: 251
PDR Number: SQ22-000621
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 257 The Therapeutic Goods Administration (TGA) has comprehensively evaluated each of the provisionally registered COVID-19 vaccine to ensure that they meet Australia’s high standards of safety, quality, and efficacy based on the information available at the time of application. This statement was made in the AusPARS report written in January 2021, almost two years ago, when extensive information on the duration of protection from infection or from serious illness was not well established. It would have been massively negligent in January 2021 for governments to wait until say six or 12 months or more after that date to obtain results from studies of duration of protection as many millions more globally would have died if the rollout of vaccines had been correspondingly delayed. Since that time there have been dozens of studies published in top-tier international medical journals on the duration of protection from vaccination, both from infection and serious illness and hospitalisation. Since these vaccines were granted provisional approval more than five billion people have received COVID-19 vaccines worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety and effectiveness. This is supported by reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience who have found no new safety concerns associated with the use of COVID-19 vaccines in these populations.

Question 258 Again, this statement was made at an early stage of the pandemic and much more information is now available on the benefit risk of the vaccines in those over 65. Overall, the benefits overwhelmingly outweigh the risks given that that this age group is the most susceptible to serious illness or death from SARS-Cov 2 infection. However, the decision to vaccinate very frail or elderly persons should be made on a case-by-case basis, in consultation with health care professionals, with consideration of the potential risks and benefits for the individual.