270. Page 64 – FOI 2389-3-2 – Investigators are not obligated to actively seek AEs or SAEs after the participant has concluded study participation? If investigators don’t have to seek out all adverse events how does the TGA know the investigator has detected all possible side effects? 271. As per Page 64- FOI 2389-3-2 – All pregnancies have to be reported to the sponsor – if this is the case why is so much data on pregnancy missing from the Pfizer Covid vaccine post marketing data? 272. I note on page 69 of FOI 2389-3-2 that adverse events of special interest aren’t applicable but that in the post marketing data there are over 1000 of them mentioned? 273. Of the circa 44,000 participants in the Pfizer Covid vaccine trial how many were checked up at the 6-month, 12 month and 24 month time frame as per the requirements of the CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) (around pages 80-90 of 2389-3-2)?

Question Number: 259
PDR Number: SQ22-000630
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 270 FOI 2389-3-2 Page 64 refers to the specific study parameters of Protocol C4591001, which formed one part of the clinical trial data collected back in 2020-21 for the BNT162 RNA-Based COVID-19 Vaccines. The primary objective of the study included investigating serious adverse events (SAEs) from Dose 1 up to six months after the last dose. As a result, the formal data collection for this question concluded at six months. However, if the investigator learned of any SAE, including a death, at any time after a participant has completed the study, and they considered the event to be reasonably related to the study intervention, the investigator was required to promptly report the event. This study protocol is not related to the separate and stringent requirements on Sponsors to report adverse events to the Therapeutic Goods Administration (TGA) in the post-approval setting.

Question 271 In this specific clinical trial protocol, patients who became pregnant whilst participating in the study were identified; however, this was not the primary focus of the study. This protocol is not reflective of all data received for the product. In addition, there are legally-binding requirements on Sponsors to report certain conditions in the post-market setting. Reassuringly, real-world global surveillance data have demonstrated that COVID-19 mRNA vaccines are safe at any stage of pregnancy. This data has been published in over a dozen papers in top medical journals.

Question 272 In this particular clinical trial study protocol, all identified adverse events and SAEs were considered. Adverse Events of Special Interest (AESI) refer to a specific subgroup of adverse events that are nominated by the study protocol. The phrase “not applicable” on page 69 does not mean that adverse events were excluded from the protocol. It is not clear what post marketing data the Senator is referring to, however, the AESI lists may vary from study to study.

Question 273 At the six-month follow up, 44,165 participants were 16 years of age or older, and 2,264 participants were aged 12 to 15 years. Data for 12- and 24-month follow-ups do not exist on the basis that Study C4591001 was terminated early, noting significant changes in the real-world landscape including COVID-19 infection rates. Specifically, those who were in the control group (unvaccinated at the beginning on the trial) were vaccinated prior to the end of the trial – to not offer vaccination would have been unethical noting the seriousness of the pandemic. On this basis, regulators agreed that continued follow-up would no longer be informative. This justification for termination was accepted by major regulators around the world, including the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA). Since these vaccines were granted provisional approval, more than 12 billion doses have been administered worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety in the subpopulations of concern. This is supported by reviews of safety data by top international medicines regulators in countries with extensive COVID-19 vaccination levels who have found no new safety concerns associated with the use of COVID-19 vaccines in these populations.