Question Number: 102
PDR Number: SQ22-000114
Date Submitted: 24/02/2022
Department or Body: Department of Health
47. Pfizer submitted all relevant available data from the COVID-19 clinical trials to the Therapeutic Goods Administration (TGA) with its application for provisional registration. 48. As noted in response to Q47, Pfizer submitted all relevant available data from the COVID-19 clinical trials to the TGA with its application for provisional registration. 49. As noted in response to Q47, Pfizer submitted all relevant available data from the COVID-19 clinical trials to the TGA with its application for provisional registration. Due to the commercial in confidence nature of the agreements the Commonwealth has with COVID-19 vaccine manufacturers, the details of the indemnity provisions under the advance purchase agreements are confidential. 50. The TGA has comprehensively evaluated each of the provisionally registered COVID-19 vaccines to ensure that they meet Australia’s high standards of safety, quality, and efficacy based on the information available at the time of application. The TGAs technical and clinical experts are undertake a formal evaluation of the application, which includes assessing clinical studies, non-clinical toxicology studies (including carcinogenic risks), chemistry, risk management, and manufacturing information. The TGA does not generally request that all raw individual participant data (IPD) be submitted with applications to register a medicine. Some regulators such as the United States Food and Drug Administration (US FDA) do this. The TGA has met regularly with the US FDA throughout the COVID-19 pandemic and several of the meetings have included discussion of the data FDA have reviewed. However, the TGA does receive and review some raw individual participant data, such as information about serious adverse events. These are the same requirements as other comparable international regulators. Even though the decision to provisionally approve these vaccines was made on the basis of short-term efficacy and safety data, the data submitted to support the quality, safety and efficacy of the COVID-19 vaccines showed a positive benefit-risk ratio. Waiting for data to establish the duration of protection would not have allowed these vaccines to have been available. The short-term efficacy of these vaccines has been proven, with the six-month protection period preventing many hospitalisations and death. For example, carcinogenicity studies take six to 24 months to be completed. The available evidence submitted to the TGA was considered adequate to indicate that the vaccines were unlikely to be carcinogenic. Identical decisions were made by other overseas regulators such as the US FDA and the European Medicines Agency. Carcinogenic risks This question has been answered in the response to Q98 in SQ22-000144 Initial Pfizer trials. Data for immunocompromised patients, pregnant women, breast feeding women, reactions to other drugs and longitudinal studies Response has been previously provided in: SQ21-001264 – Testing on pregnant women and the safety of vaccines (answer date: 28 January 2022, Q125), and SQ21-001176 – COVID vaccine approval process (answer date: 31 January 2022, Q119). 51. When Pfizer submitted its initial application for provisional registration of Comirnaty, individuals aged 75 years and over comprised approximately four per cent of participants (804/18,242 participants in the vaccinated group: 812/18,379 participants in the placebo group). The initial trial results demonstrated that the vaccine was safe and effective at preventing COVID-19 infection in this age group only one participant in this age group from the vaccinated group developed symptoms of COVID-19 seven days post dose two, compared to 26 participants in the placebo group. It is incorrect to equate the vulnerable population with those over 75. There are many younger people with significant comorbidities who are highly vulnerable to infection with SARS-CoV-2. Real-world evidence from post-approval use of this vaccine in elderly and vulnerable people has demonstrated the great benefits of the vaccination for elderly and vulnerable people around the globe. 52. This question has been addressed in the response provided in SQ22-000150 – Efficacy of Pfizer vaccine in the initial trials.
