Is there not a conflict of interest in the TGA approving vaccines and collating adverse events – shouldn’t this be a separation of duties as the TGA will never admit to approving a drug that has subsequently be proven to be ineffective or unsafe?

Question Number: 181
PDR Number: SQ22-000154
Date Submitted: 24/02/2022
Department or Body: Department of Health

It is not a conflict of interest for the Therapeutic Goods Administration (TGA) to approve vaccines and to monitor their safety after approval. The TGA applies scientific and clinical expertise to regulatory decision making to ensure that medicines and vaccines supplied in Australia continue to meet acceptable standards of quality, safety and efficacy throughout their life cycle.

A vaccine is only registered for use if its benefits are much greater than its risks. The TGA’s decision to register a vaccine is informed by the advice of the independent committee, the Advisory Committee on Vaccines (ACV). The ACV is appointed by the Australian Government’s Minister for Health composed of members with expertise in science, medicine, and public health. The ACV complements the expertise of the TGA, ensuring that assessments of vaccines are as robust as possible.

The TGA has a track record of identifying, investigating and addressing safety issues associated with approved medicines and vaccines. It is quite wrong to sate that “The TGA will never admit to approving a drug that has subsequently been proven to be ineffective or unsafe”. We communicate information on drug safety concerns to the public and healthcare professional very regularly. Notable safety actions are published on the TGA’s website in Medicines Safety Updates and for the COVID-19 vaccines, in the TGA’s weekly COVID-19 vaccine safety report. As a result of the TGA’s safety monitoring activities, the prescribing information for doctors (Product Information documents) for the COVID-19 vaccines have been updated with new safety information on a number of occasions.