Question Number: 170
PDR Number: SQ22-000125
Date Submitted: 24/02/2022
Department or Body: Department of Health
The Therapeutic Goods Administration (TGA) has comprehensively evaluated each of the provisionally registered COVID-19 vaccines, including Pfizer’s Comirnaty, to ensure that they meet Australia’s high standards of safety, quality, and efficacy.
As part of this process, the TGA must first establish the acceptable safety, quality, and efficacy of the vaccine based on the comprehensive evaluation of a wide range of information. This includes clinical studies, non-clinical toxicological studies, chemistry, risk management and manufacturing information.
Clinical trials are a key part of the scientific evidence that are reviewed during the assessment of a new vaccine. The TGA requires well-designed trials of a sufficient length with a sufficient number of people who represent the people for whom the vaccine is intended. The results must demonstrate that the benefits of the vaccine greatly outweigh the risks. In addition, all clinical trials must comply with the Guideline for Good Clinical Practice to ensure that the results are credible and obtained ethically in the setting of informed consent where the rights of trial subjects are protected.
The decision to provisionally approve a vaccine is also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
Based on the comprehensive data provided to the TGA, Comirnaty has been evaluated as effective and safe for use in adults, adolescents and children aged five years and above. These decisions were made by senior medical officers on the basis that the benefits of the vaccine outweigh any potential risks and is in keeping with current international data.
Australian Technical Advisory Group on Immunisation has also recommended the use of Comirnaty in these age groups.
The provisional approval of Comirnaty, as with all provisionally approved COVID-19 vaccines, is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. These studies are ongoing and are continuing to gather data on longer-term safety and effectiveness to complement post-market monitoring and spontaneous adverse event data. It is anticipated that these will be completed between late 2021 and mid-2024. Continued approval of Comirnaty depends on this longer-term efficacy and safety data.
Given the number of vaccines administered to date (and the time that has passed since vaccination began), it is highly likely that serious side-effects would have been detected by now. The TGA continues to closely monitor adverse events reported in Australia, and evidence from the use of the vaccines in young people around the world, to identify and investigate possible emerging safety issues. This is the most comprehensive safety monitoring program of therapeutic goods ever conducted in Australia. Where the TGA confirm a safety concern, the TGA will take action, including informing health professionals and the public. For COVID-19 vaccines, that includes putting the latest information in our weekly safety report at: www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report.
In addition, the TGA undertakes an independent assessment of every batch of vaccine supplied in Australia to ensure that it meets the required quality standards and publishes reports of suspected side effects on its website at: www.tga.gov.au/database-adverse-event-notifications-daen.
