Vaxine Pty Ltd fined $13,320 for alleged unlawful advertising of an unapproved COVID-19 vaccine

The Therapeutic Goods Administration (TGA) has issued an infringement notice for $13,320 to Vaxine Pty Ltd for advertising a COVID-19 vaccine in alleged breach of the Therapeutic Goods Act 1989 (the Act). The infringement notice was issued as in TGA’s view the company did not adequately address a range of concerns with the social media advertisement communicated earlier by the TGA to the Director of Vaxine Pty Ltd by telephone and in writing.

Vaxine Pty Ltd allegedly advertised, on its Facebook page and YouTube, an unapproved COVID-19 vaccine, which is subject to a clinical trial. While factual information on clinical trials underway is published on Australian New Zealand Clinical Trials Registry and related overseas registries, the advertising of unapproved therapeutic goods to the public, including a vaccine undergoing a clinical trial, is not permitted in Australia as those goods have not been assessed by the TGA.

Publicly available information about any clinical trial must be factual and balanced and must not promote the use or supply of the therapeutic goods that are the subject of the trial.

Advertisers of therapeutic goods are reminded that the term 'advertise' in relation to therapeutic goods refers to any statement, pictorial representation or design that is intended to promote the use or supply of the goods in the eyes of a reasonable consumer.

The TGA encourages the reporting of suspected non-compliant advertising and you can report illegal or questionable practices online to the TGA.