025 - TGA Admits Risks Outweigh Benefits for Covid jabs in kids

A teaching moment for parents in Australia

Along with Julian Gillespie of

Jules On The Beach

and Katie Ashby-Koppens, I spent a big chunk of 2021 and 2022 in the Federal and High Court trying to put forward ~2000 pages of evidence asserting that the Pfizer and Moderna jabs (in particular) were not safe or effective for children.

First, in the Federal Court, we argued that the provisional approval of those drugs was unlawful, because under the Therapeutic Goods Act, the Secretary of the Department of Health can only extend the provisional approval of a medicine to a new age group if "an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition". That was clearly not the case here, as there was no clinical evidence to show Covid-19 was life-threatening or that it caused seriously debilitating outcomes in babies and infants aged 6 months to 5 years old. However, once being administered this experimental injectable, these children would be exposed to a significant risk of suffering an adverse event from the injectable, including possible death.

The Federal Court wouldn’t allow us to proceed to hearing because they said that our two plaintiffs, a pro-choice organisation with 30+ years experience advocating for informed consent and vaccine safety, and the father of a child who was about to be vaccinated against his will, didn’t have sufficient interest (standing) in the proceeding to go ahead.

So, we then asked the High Court to consider the fact that granting provisional approval to Moderna for use of its product (Spikevax) in children aged 6 months to 5 years old in Australia was unlawful.

We pointed out that being provisionally approved meant the injectable was still the subject of human clinical trials for determining whether they are truly safe and effective and that the clinical trial in question sought to include the babies and infants of Australia.

Despite those Covid-19 injectables by 2022 clearly reporting historically unprecedented numbers of deaths, adverse events, and long-term side-effects, Australian authorities refused to remove them from the market, even though the number of reported deaths and adverse events from the Covid-19 injectables, far exceeded, in 2022, the number of deaths considered to be "due to" Covid.

The science in 2022 was already clear:

· Covid-19 poses a statistically negligible risk to children (see https://pubmed.ncbi.nlm.nih.gov/32531620/ and; https://onlinelibrary.wiley.com/doi/10.1111/apa.15270, among many other such studies); and

· The Moderna vaccine presents significant risk to those to whom it is administered (see https://www.sciencedirect.com/science/article/pii/S0264410X22010283 and https://doi.org/10.3390/jcm11082219 and https://www.nature.com/articles/s41467-022-31401-5, among many other such studies)

In those circumstances, provisionally approving the Moderna injectable for this age group was already very obviously inappropriate and unethical.

In our case, the High Court told us the matter was too scientifically and factually complex and they would have to remit it back to the Federal Court. We knew there was no hope of victory there - they had already knocked us back once, so we withdrew.

Now, in mid 2025, days after the USA equivalent body made the same declaration, the TGA is finally admitting as follows. In their own words:

”COVID-19 vaccine[s] is not recommended for healthy infants, children or adolescents who do not have medical conditions that increase their risk of severe illness. This is because the risk of severe illness was extremely low in this cohort over the course of the pandemic, and benefits of vaccination are not considered to outweigh the potential harms”.

This isn’t about “I told you so”

I don’t care about being vindicated or being right. I already knew we were right. That’s why, like so many, I made major sacrifices in the context of my own life to proceed according to my own value system as opposed to what I was being coerced to say and do.

However, I do believe that this admission from the TGA is very important and it should be spread as far and as wide as possible.

The fact is that thousands of parents in Australia subjected their children to injection with a provisionally approved, experimental product which the TGA, several years later, admits are associated with potential harms which render them too risky. They also admit that the risk of illness is “extremely low”. This was all clearly verifiable in 2022. We sent them all of the evidence they could need. The precautionary principle and the functioning of the Therapeutic Goods Act means that they should never have provisionally approved it anyway.

The conclusion must be as follows:

1. The TGA failed in properly assessing the safety profile of the most controversial drug in history for the most vulnerable age cohort, completely ignoring the precautionary principle as well as the relevant provisions of its own enacting legislation;

2. The parents of Australia were misled and coerced into a procedure without the benefit of information which would allow them to give fully informed consent and in fact on the basis of information which was inaccurate and lacking in scientific basis; and

3. Brendan Murphy, the prior Secretary of the Department of Health, is personally responsible for all injuries and deaths which have occurred, or which will occur, in children as a result of his decision to provisionally approve the Covid-19 drugs for that age cohort.

Moving forward, at the very least, this is an about-face that can be pointed to both inside litigation and outside of it.