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QUESTION ON NOTICE

Question:

21 November 2022

161. “Pfizer has asked a U.S. court to throw out a lawsuit from a whistle-blower who revealed problems at sites that tested Pfizer’s COVID-19 vaccine. Pfizer stated that the regulations don’t apply to its vaccine contract with the U.S. Department of Defence because the agreement gives contract holders the ability to skirt many rules and laws that typically apply to contracts.” Pfizer Moves to Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement (theepochtimes.com) – Has Australia signed a Covid-19 contract with Pfizer that has similar conditions? 162. Why are you penalising Australians $10,000 of dollars for importing Ivermectin worth $40 but doing nothing about Pfizer not living up to its promise about the safety and efficacy of the vaccine? 165. Can the TGA provide all correspondence with Pfizer regarding the Covid vaccine in regards to purchase agreements, testing and safety concerns? 183. Is the vaccine injury scheme going to be updated to include additional side effects that have been reported to the TGA by Health Professionals rather than Pfizer who have a conflict of interest in reporting side effects from their own drugs? 191. The normal default for contracts is to reserve a “right” to buy. Are these the terms the Pfizer Covid vaccine contract was based on, or do have an “obligation” to buy the Covid vaccines regardless of performance? If so, why did the health department deviate from the normal procedure for a contract that covers Australia’s needs many times over, for a period where all would already be vaccinated (2022 and 2023). 262. The contract between Pfizer and the US government prohibits independent researchers from studying the vaccines. They claim it would ‘divert’ these precious resources away from their intended use fulfilling an ‘urgent’ need. Is this true? If so, then why is Pfizer hiding from independent scrutiny?

Answer:

Question Number: 178
PDR Number: SQ22-000548
Date Submitted: 21/11/2022
Department or Body: Department of Health

161 The details of Advance Purchase Agreements with pharmaceutical companies for the purchase of COVID-19 vaccines are commercial-in-confidence.

162 The controls on the importation of therapeutic goods exist to ensure that only goods subject to regulatory oversight are supplied in Australia to manage these risks. An unapproved medicine sold online and imported may not meet the Australian standard of safety, quality and efficacy, posing a risk to consumers. In Australia, Ivermectin is a prescription-only medicine included in Schedule 4 of the Poisons Standard. The unlawful importation of unapproved prescription-only medicines in particular where the product imported is counterfeit and/or in high quantity, is of particular concern to the health and safety of Australians. We do not believe that Pfizer has “not lived up to its promise on the safety and efficacy of their vaccines”. COVID vaccines are estimated to have saved the lives of about 20 million people globally. Numerous studies and data sources have confirmed the real-world safety and efficacy demonstrated in clinical trials. The Therapeutic Goods Administration (TGA) continues to closely monitor the safety of COVID-19 vaccines as part of the most intensive safety monitoring ever conducted in Australia. Pfizer, like all medicine sponsors, is legally obliged to report serious adverse events and significant safety issues to the TGA within mandated timeframes.

165 A significant number of documents that are relevant to this request have already been released under a previous FOI request (FOI 2389). For documents released regarding Pfizer’s COVID-19 vaccine, Comirnaty, please see the TGA’s Disclosure Log at www.tga.gov.au/foi-disclosure-log. The TGA has also published a range of regulatory documents relating to the provisional approval of each COVID-19 vaccine, including Comirnaty, which provide detailed information regarding the evaluation process and the data that were considered. These include the Australian Public Assessment Report (AusPAR), the Product Information (PI) and the Consumer Medicine Information (CMI), and they are available at: www.tga.gov.au/covid-19-vaccines. The TGA publishes all adverse event reports, including those submitted by sponsors, in our Database of Adverse Event Notifications (DAEN). For COVID-19 vaccines, the TGA publishes regular safety reports which include updates on any emerging safety issues identified with each vaccine (www.tga.gov.au/periodic/covid-19- vaccine-weekly-safety-report). Conditions of provisional registration for all new COVID-19 vaccines in Australia include the submission of monthly safety summary reports for the first six months, and thereafter at the TGA specified interval, and 6-monthly periodic safety update reports (PSURs). Frequency of submission may be increased as required, based on emerging safety information. These reports include summaries of global post-market safety data as summary of interval and cumulative data. To date, Pfizer has provided 19 such reports to the TGA. Conditions of provisional registration for Pfizer COVID-19 vaccine also require the submission of study reports to collect confirmatory safety and efficacy data. These are listed in the AusPAR for BNT162b2 (mRNA) published on the TGA website (www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf). Members of the public can request access to other safety correspondence, safety reports submitted by sponsors including the PSURs and monthly summary safety reports under the Freedom of Information Act 1982. The TGA publishes the batch release assessment of COVID-19 vaccines including testing results at: www.tga.gov.au/batch-release-assessment-covid-19-vaccines Regarding the documents not released via the TGA’s Disclosure Log, the information in the documents is considered commercial in confidence. This information was provided to the TGA for the purpose of evaluating a product during the relevant regulatory processes after the parties had executed a Confidentiality Disclosure Agreement. That is, this information is known only to the TGA and Pfizer. The investment in research and development that is contained in the material offers a competitive advantage to Pfizer that would be reduced if that information was available on the public record and thus to other pharmaceutical companies. 183 The list of eligible conditions covered by the COVID-19 Vaccine Claims Scheme is not determined by Pfizer. This scheme is administered by Services Australia with the Department of Health and Aged Care holding responsibility for policy decisions about which conditions are eligible based on recommendations from the TGA. To be eligible, conditions must be verified by the TGA as moderate to significant clinical conditions listed in the Product Information (PI) document for that vaccine. The TGA has initiated multiple safety updates to the PI documents for COVID-19 vaccines. Changes to the PI are communicated to the public via the COVID-19 vaccine safety report www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf. 191 The details of Advance Purchase Agreements with pharmaceutical companies for the purchase of COVID-19 vaccines are commercial-in-confidence.

262 The Department cannot comment on contracts between Pfizer and the United States government.