TGA “EVALUATING” MODERNA SHOTS FOR BABIES AND TODDLERS. WHAT’S THE RUSH?
Despite conclusive evidence that young children are at virtually no risk at all of severe complications or death from the virus, the TGA announced last month it is evaluating an application from Moderna to inject its experimental mRNA shots into the arms of babies as young as six months.
Currently, Israel is the only country that has approved the shots for this age cohort, although the US Advisory Committee is voting on the issue this week.
I can’t find anything online about Moderna running any clinical trials for this age bracket, although there Moderna was reported as saying last year that they were hoping to carry out their baby and toddler trials here in Australia.
Pfizer’s baby trials are being run in the US and according to reports, these have not been completed yet and the clinical trial group was fairly small.
According to the TGA’s media release: “the authorisation (for Moderna shots) would be for a two-dose regimen, with the possibility of extending it to a third dose”.
Why is this even being considered here in Australia, given the risks involved?
It is well-known that the messenger RNA-based injections have been linked to heart conditions such as myocarditis and pericarditis, particularly in young men.
Some countries have even said they won’t even consider shots in this age group “after some studies showed it was tied to a higher risk of the heart inflammation”, according to a report in the West Australian yesterday:
The FDA itself said recently that myocarditis is a known risk and that the clinical trials for these age groups WERE NOT LARGE ENOUGH TO QUANTIFY THE FREQUENCY OF THE INFLAMMATION.”
Moreover, the FDA has revealed that early trial data for 2-5-year-olds showed an efficacy rate of just 36.8% using the CDC case definitions, and 50.6% for the 6-23 month group.
So again, what on earth is the rush here?
Historically, young children and pregnant women were always excluded from early human trials, irrespective of the drug.
As I mentioned, children are virtually at zero risk of dying from this virus. They may test positive and even develop symptoms, but they get through it the same way they get through any other cold or flu.
There is simply no justification for the TGA to even consider extending the shot to a group this young.
Especially when we are talking about a radically new treatment that has never been tested on animals and for which there is no long term safety data.
The risk of harm to these vulnerable babies is just too great.
(This is NOT medical advice – Just my opinion!!)