Don’t worry about what’s in the vials will you!
“In addition the preparations comply with the test if number of particles in the tested dose does not contain 6,000 per container equal to or greater than 10 microns and does not exceed 600 per container equal or greater the 25 microns……..so requirements in the default standards for Australia don’t require that there’s identification of the particles.”
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In estimates I asked why there were so many large particles in the Covid batches. A standard dose was 30 microns yet in one batch there were 67 particles greater than 10 microns which is at least a third the size of the standard dose.
It turns out that pharmaceutical companies don’t have to identify what these particles are!
I find this quite shocking. The rules allow for up to 600 unidentified contaminants as large as 25 microns or practically the entire dose.
This is shocking quality assurance standards.
With so such much crap in the vials how can the TGA tell what is causing a person’s reaction to a vaccine?
Glass and steel are very good cutting compounds are they not? How many arteries have been cut by these contaminants? Imagine that in your body organs – especially your heart!
People shouldn’t be forced to take products with so many unknown contaminants.
We are not guinea pigs.
Community Affairs Legislation Committee
26/02/2025
Estimates
HEALTH AND AGED CARE PORTFOLIO
Department of Health and Aged Care
Senator RENNICK: I’d just like to ask a question about the FOI 3390/11 regarding the 67 particles greater than 10 microns that were in the vials. I’ve asked questions about it before, and I’d just like to follow up again.
Prof. Lawler : I’ll just ask Dr Kerr to the table to respond.
Senator RENNICK: Dr Kerr, I asked you last time what those particles were that were greater than 10 microns. Just for context, the size of the average dose was meant to be 30 microns, so this particular contaminant was at least a third of the size of a potential dose, if not bigger. You said you didn’t know what the contaminants were. I have two questions. How then do you know it’s not DNA? If it’s not DNA, shouldn’t you know what it is from a safety perspective before allowing it to proceed, given it’s such a large portion of the actual dose?
Dr Kerr : We know it’s not DNA because we have tested for DNA, and DNA is well within the acceptance criteria for those products. In addition, the preparations comply with the test for particles if the number of particles present in the tested dose does not exceed 6,000 per container equal to or greater than 10 microns and does not exceed 600 per container equal to or greater than 25 microns. DNA is not that large.
Senator RENNICK: That’s fine. Shouldn’t you still know what those particles were?
Dr Kerr : The requirements in the default standards for Australia don’t require that there’s identification of the particulates. There are other tests to determine whether or not there are leachables and whether or not the preparations are sterile. Essentially, the particulates that are in injectables are three types. There are either intrinsic particles which come from the actual product itself. For example, preparations that have proteins in them can have aggregates of protein. That’s acceptable. There are inherent particles that come from the manufacturing process. For example, if your manufacturing line has stainless steel in it, then you may expect some stainless steel particles or, if you’re filling glass vials, you may expect some glass particles in the preparations. And then there are extrinsic particles which come from other sources—for example, fibres from clothing.
Senator RENNICK: So you’re saying it could’ve been glass or steel?
Dr Kerr : That’s why we’ve got limits of them. There are very strict limits on the number and size of particulates that are allowed in injectables. It is globally recognised that it is not possible to make particle-free injections.
Senator RENNICK: But how does glass and steel get into the dose?
Dr Kerr : If you’ve got bits coming off the manufacturing line. That’s why the manufacturers are required to test for it.
Senator RENNICK: Right. Sixty-seven particles greater than 10 microns are quite a lot of glass or steel, aren’t they?
Dr Kerr : They’re very small and they’re within the globally accepted acceptance criteria.
Senator RENNICK: Thank you.
