The COVID-19 vaccines were developed incredibly quickly, but no shortcuts were taken. To save time, processes were run in parallel, but the scientific testing and regulatory approvals were the same as all other vaccines used in Australia.
Before a vaccine is approved for use in Australia it must pass an approval process by the Therapeutic Goods Administration (TGA). The COVID-19 vaccines were required to meet the TGA’s same high standards of safety, quality and effectiveness as any other vaccine¹ ².
A vaccine goes through several stages before it can be approved for use – from the exploratory science, to the clinical development which includes three phases of human trials. Throughout the development of the COVID-19 vaccines there have been many checks and balances to ensure their safety. In fact, the vaccines for COVID-19 were tested with the same high scientific standards, and went through the same review process as all other vaccines ³.
Since early 2020, different groups around the world worked together to make it easier to develop and review the vaccines. This collaboration made it possible to break down barriers related to funding, manufacturing, testing and approvals .
In Australia, the TGA will only register and approve a vaccine if it is safe and effective. The TGA will look closely at the data that comes from clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information5.
Due to the serious nature of the pandemic, the TGA looked at COVID-19 vaccine applications as a matter of priority.6 The vaccines were given provisional approval, which is a mechanism that the TGA has used since 2018 to ensure medicines that provide a major therapeutic advance for Australians could come to the market up to two years sooner while they transition to full registration. An evaluation under the provisional pathway is still a full review, and the TGA does not have a mechanism for emergency use authorisations.1, 3
Under normal circumstances, the TGA will wait until it has all information on a new vaccine before it begins its review. For COVID-19 vaccines, the TGA accepted data as it became available to avoid delays. This gave the TGA the chance to evaluate the data step-by-step, rather than waiting until the end of the process. TGA’s technical experts did not skip any stage of the review process.
The TGA studied the results of clinical trials and the way they were designed and carried out. For example, the TGA looked to make sure the trials were conducted for a sufficient amount of time and with enough participants.
The TGA only made the decision to approve the vaccines once all required data relating to safety, quality and efficacy had been provided and assessed as meeting their high standards.
The assessment process applied to COVID-19 vaccines is the same as any vaccine approved in this country.7,8 The TGA did not cut any corners when assessing COVID-19 vaccines for safety, quality and effectiveness.9 No part of the process was rushed, and there was no emergency authorisation granted (as in other countries).7
The TGA also worked closely with other organisations around the world to access and share data. This includes the World Health Organisation (WHO), which assembled an external panel of experts to analyse the results from clinical trials and provide an extra layer of confidence in the COVID-19 vaccines.10 The TGA’s evaluation is also informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts.1 Collaborations such as these helped the TGA to reach its decision without compromising its strict requirements for safety, quality and effectiveness.11
The COVID-19 mRNA vaccines are the first vaccines with this new technology to be approved for use. Were they fully tested? The mRNA vaccines have been rigorously assessed for safety, and clinical trials have shown that they provide a long-lasting immune response. Dan Barouch, director of the Center for Virology and Vaccine Research at Harvard Medical School, states that the use of new vaccine technology like mRNA “has shown that the development process can be accelerated substantially without compromising on safety.”12