No Covid-19 vaccine has received full TGA approval in Australia

Despite claims otherwise, the Covid-19 vaccines in fact have “provisional” approval only with the Therapeutic Goods Administration (TGA), and DO NOT have full approval as is implied by the Government and in the media. Despite the claims of a “stringent process”, provisional approvals are based on preliminary data.

As of 24 October 2021, the following is a list of the Covid-19 vaccines with provisional approval ​[1]​:

  • Moderna Spikevax (mRNA)
  • Janssen-Cilag Covid-19 Vaccine Janssen (viral vector)
  • AstraZeneca Vaxzevria (viral vector)
  • Pfizer Comirnaty – BNT162b2 (mRNA)​[1]​

The TGA provides an explanation of the provisional approval process:

Provisional registration process
As part of the provisional approval pathway, the provisional registration process will allow certain medicines to be provisionally registered in the Australian Register of Therapeutic Goods (ARTG) for a limited duration. These medicines are registered on the basis of preliminary clinical data, where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required. ​[2]​ (emphasis added)

Clearly, the provisional approval process is not the same process as undertaken by other vaccines. While Australia does not have an Emergency Use Listing (EUL) as per other countries globally, this terminology is merely semantics. To be clear, the TGA has no other “emergency” process, and fast tracking of approvals occurs via the provisional pathway.

Any suggestion that the Covid-19 vaccines have gone through the same process as other medications is a deliberate and horrific deception.

  1. 1.
    Therapeutic Goods Administration (TGA): COVID-19 vaccine: Provisional registrations,
  2. 2.
    Therapeutic Goods Administration (TGA): Provisional registration process,